SNPMiner Trials by Shray Alag


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Report for Mutation T380A

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There are 16 clinical trials

Clinical Trials


1 Immediate vs. Delayed Post-abortal Copper T 380A IUD Insertion in Cases Over 12 Weeks of Gestation

The purpose of this study is to compare delayed vs. immediate insertion of the Copper T 380 IUD after termination of pregnancy after 12 weeks.

NCT00540046 Contraception Behavior Device: Copper T 380A IUD

Number of participants using Copper T380A IUD 6 months after surgery. --- T380A ---

Primary Outcomes

Description: Number of participants using Copper T380A IUD 6 months after surgery

Measure: Use of IUD

Time: 6 months

Secondary Outcomes

Description: IUD was not removed by provider but fell out on its own.

Measure: Expulsion

Time: 6 months

2 Immediate Versus Delayed IUD Insertion Following Suction Aspiration Between 5 and 12 Weeks Gestation: a Randomized Trial

The purpose of this multi-center clinical trial is to evaluate the safety and effectiveness of inserting an intrauterine device (IUD) immediately after a suction aspiration procedure compared to inserting the IUD 2-6 weeks after the procedure. This study will also evaluate how satisfied women are with the timing of their IUD placement. Subjects will be able to choose between the Paraguard IUD or the Mirena IUD. The researchers hypothesize that: 1. the expulsion rates measured at 1, 3 and 6 months will be clinically equivalent with immediate insertion compared with delayed insertion, 2. satisfaction and tolerance of side effects will be higher with immediate IUD insertion compared with delayed insertion, and 3. overall IUD use/continuation rates measured at 1, 3 and 6 months will be higher with immediate IUD insertion compared with delayed insertion.

NCT00562276 Contraception Procedure: Immediate IUD insertion

laminaria) or misoprostol for cervical preparation during the aspiration procedure - Allergy to polyethylene - Allergy to levonorgestrel (for levonorgestrel-containing IUS only) - Allergy to copper (for copper T380A IUD only) - Wilson's disease (for copper T380A IUD only) - Current participation in another research study which would interfere with the conduct of this study Inclusion Criteria: - Female - 18 years or older - Requesting suction aspiration for spontaneous or elective abortion - Intrauterine pregnancy documented with ultrasound. --- T380A ---

laminaria) or misoprostol for cervical preparation during the aspiration procedure - Allergy to polyethylene - Allergy to levonorgestrel (for levonorgestrel-containing IUS only) - Allergy to copper (for copper T380A IUD only) - Wilson's disease (for copper T380A IUD only) - Current participation in another research study which would interfere with the conduct of this study Inclusion Criteria: - Female - 18 years or older - Requesting suction aspiration for spontaneous or elective abortion - Intrauterine pregnancy documented with ultrasound. --- T380A --- --- T380A ---

laminaria) or misoprostol for cervical preparation during the aspiration procedure - Allergy to polyethylene - Allergy to levonorgestrel (for levonorgestrel-containing IUS only) - Allergy to copper (for copper T380A IUD only) - Wilson's disease (for copper T380A IUD only) - Current participation in another research study which would interfere with the conduct of this study Contraception null --- T380A ---

laminaria) or misoprostol for cervical preparation during the aspiration procedure - Allergy to polyethylene - Allergy to levonorgestrel (for levonorgestrel-containing IUS only) - Allergy to copper (for copper T380A IUD only) - Wilson's disease (for copper T380A IUD only) - Current participation in another research study which would interfere with the conduct of this study Contraception null --- T380A --- --- T380A ---

Primary Outcomes

Measure: IUD expulsion

Time: 1, 3 and 6 months after insertion

Secondary Outcomes

Measure: IUD continuation

Time: 1, 3 and 6 months after insertion

3 A Pilot Study of Copper T380A IUDs Versus Oral Levonorgestrel for Emergency Contraception

The purpose of this study is to see if women presenting for emergency contraception (EC) are willing to accept the copper intrauterine device (IUD). This study will also compare the use of effective methods of contraception between women who selected the copper IUD or Plan B 6 months after they received EC.

NCT00669396 Pregnancy Drug: Copper T380 IUD Drug: levonorgestrel
MeSH: Emergencies

A Pilot Study of Copper T380A IUDs Versus Oral Levonorgestrel for Emergency Contraception. --- T380A ---

Primary Outcomes

Description: Use of a method of contraception with a typical efficacy rate >= to 92%. This includes combined hormonal contraception (combined oral contraceptive pills, the contraceptive patch and ring), sterilization, IUDs, Depo-provera, and contraceptive implants.

Measure: Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception

Time: 6 months

Secondary Outcomes

Description: positive urine pregnancy test at anytime within 6 months of presenting for emergency contraception.

Measure: Pregnancy

Time: 6 months

Description: diagnosis and treatment for pelvic inflammatory disease

Measure: Infection

Time: 6 months

Description: patient reports IUD expulsion, removal, or perforation OR one of these events was documented at the clinic where patient received care.

Measure: IUD Expulsion, Removal, or Perforation

Time: 6 months

4 A Randomized Trial of Immediate Versus Delayed Insertion of the Copper T380A Following Medication Abortion

After medication abortion, women may quickly become pregnant again and therefore need an effective birth control method right away. Intrauterine devices (IUDs) are very effective for preventing pregnancy. IUDs are usually placed more than a month after abortion. This study will randomly assign women having a medication abortion to two groups, either having the IUD inserted one week after medication abortion or having the IUD inserted more than four weeks later. Women will be followed for six months to compare how many return for IUD placement in the two groups, how many are using the IUD after six months, experience with pain, bleeding, and cramping, how easy or difficult it is to insert the IUD, how many IUDs are expelled or removed, and how many women are using any birth control six months after the abortion.

NCT00737178 Contraception Device: CuT380A

A Randomized Trial of Immediate Versus Delayed Insertion of the Copper T380A Following Medication Abortion. --- T380A ---

Primary Outcomes

Description: Six months after enrollment, we determined whether or not women were using the IUD through in-person exit interviews and phone interviews. This was an intention to treat analysis, comparing the proportion of women using the IUD based on their group assignment (immediate or delayed).

Measure: Use of the IUD for Contraception at Six Months

Time: 6 months

Secondary Outcomes

Description: Insertion rates are the proportion of women in each allocation group (immediate, delayed) who ultimately had the IUD inserted within the 6 month study period.

Measure: Insertion Rates

Time: By six months after medication abortion

Description: Expulsion rates were defined as the number of IUDs expelled from the uterus among participants who had the IUD inserted during the study. Removal rates were defined as the number of IUDs that were electively removed by participant request among participants who had the IUD inserted during the study.

Measure: Expulsion and Removal Rates

Time: Within six months of medication abortion

5 Preventing Future Pregnancy After Choosing the Copper IUD vs. Oral Levonorgestrel for Emergency Contraception

The purpose of this study is to see if women presenting for emergency contraception (EC) and choose the copper intrauterine device (IUD) will have fewer unplanned pregnancies in the next year compared to women who choose oral levonorgestrel for EC. The study will also compare use of an effective method of contraception in the year after they received EC.

NCT00966771 Pregnancy Drug: Copper T380 IUD Drug: Oral levonorgestrel
MeSH: Emergencies

The Copper T380A IUD vs. Oral Levonorgestrel for Emergency Contraception The purpose of this study is to see if women presenting for emergency contraception (EC) and choose the copper intrauterine device (IUD) will have fewer unplanned pregnancies in the next year compared to women who choose oral levonorgestrel for EC. --- T380A ---

Primary Outcomes

Measure: Unplanned pregnancy

Time: within 12 months of presenting for EC

Secondary Outcomes

Measure: Use of an effective method of contraception in the year following use of emergency contraception.

Time: 12 months

Measure: IUD expulsion, removal or perforation

Time: 12 months

6 A Pilot Study Of A Randomized Trial Comparing Two Different Time Frames For Copper T380A Intrauterine Contraception Insertion; Immediately Postpartum Compared To 4-6 Weeks Postpartum In Lilongwe, Malawi

The purpose of this non-blinded randomized clinical trial is to pilot the design of a randomized clinical trial to be conducted in Malawi to investigate immediate postpartum insertion of the Copper T380 intrauterine contraceptive device (CuT380A-IUCD) compared to placement at the 6-week postpartum visit. The investigators hypothesize that it will be feasible to enroll 140 women into this study, and that women will find the 10 minute to 48 hour time frame for IUCD placement acceptable.

NCT01175161 Contraception Intrauterine Devices Pilot Study Africa Device: Copper T380A Intrauterine Device

A Pilot Study Of A Randomized Trial Comparing Two Different Time Frames For Copper T380A Intrauterine Contraception Insertion; Immediately Postpartum Compared To 4-6 Weeks Postpartum In Lilongwe, Malawi. --- T380A ---

Primary Outcomes

Description: Estimate the time required to enroll 140 women into this study

Measure: Time

Time: 6 months

Secondary Outcomes

Description: Estimate the expulsion rate of the CuT380A-IUCD

Measure: Expulsion rates

Time: 6 months

Description: Assess patient and provider satisfaction when the CuT380A-IUCD is placed 10 minutes - 48-hours postpartum.

Measure: Satisfaction

Time: 6 months

7 Transcesarean IUD Insertion: A Prospective Cohort Study

The purpose of this study is to determine the expulsion rates of copper Intrauterine Devices (IUDs) placed at time of Cesarean Delivery.

NCT01439802 Intrauterine Device Expulsion Device: Copper IUD placement at time Cesarean Delivery (Copper T 380A)

After delivery of the placenta, a ParaGard® copper T380A IUD was inserted through the hysterotomy site. --- T380A ---

Primary Outcomes

Description: Expulsion of IUDs placed at time of cesarean delivery

Measure: Expulsion

Time: 6 months postpartum

Secondary Outcomes

Description: Satisfaction of subjects who received an IUD at time of cesarean delivery will be measured with the Likert Scale.

Measure: Satisfaction

Time: 6 months postpartum

8 Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women: a Randomized Controlled Trial

This study is designed to evaluate if self-inserted intravaginal 2% lidocaine gel is effective at decreasing pain during intrauterine device insertion in nulliparous women.

NCT01534520 Pain Drug: Lidocaine Drug: Placebo

Inclusion criteria: - Nulliparous, as defined in this study as no history of pregnancy ≥ 24 weeks gestational age - Desires insertion of either levonorgestrel-releasing IUD (LNG-IUD) or copper T380A IUD (Cu-IUD) - No history of pregnancy in the last 6 weeks - Able to provide written informed consent in English and comply with all study procedures Exclusion criteria: - Known allergy or hypersensitivity to lidocaine or other amino amide local anesthetics - Prior failed IUD insertion - Prior IUD use - Use of narcotic or benzodiazepine medication within the last 24 hours - U.S. Centers for Disease Control Medical Eligibility Criteria (MEC) category 3 or 4 classification for use of an IUD - Positive pregnancy test or reasonable risk of pregnancy due to unprotected heterosexual intercourse since the last menstrual period Inclusion criteria: - Nulliparous, as defined in this study as no history of pregnancy ≥ 24 weeks gestational age - Desires insertion of either levonorgestrel-releasing IUD (LNG-IUD) or copper T380A IUD (Cu-IUD) - No history of pregnancy in the last 6 weeks - Able to provide written informed consent in English and comply with all study procedures Exclusion criteria: - Known allergy or hypersensitivity to lidocaine or other amino amide local anesthetics - Prior failed IUD insertion - Prior IUD use - Use of narcotic or benzodiazepine medication within the last 24 hours - U.S. Centers for Disease Control Medical Eligibility Criteria (MEC) category 3 or 4 classification for use of an IUD - Positive pregnancy test or reasonable risk of pregnancy due to unprotected heterosexual intercourse since the last menstrual period Pain Intrauterine devices (IUDs) are among the most effective forms of reversible contraception. --- T380A ---

Inclusion criteria: - Nulliparous, as defined in this study as no history of pregnancy ≥ 24 weeks gestational age - Desires insertion of either levonorgestrel-releasing IUD (LNG-IUD) or copper T380A IUD (Cu-IUD) - No history of pregnancy in the last 6 weeks - Able to provide written informed consent in English and comply with all study procedures Exclusion criteria: - Known allergy or hypersensitivity to lidocaine or other amino amide local anesthetics - Prior failed IUD insertion - Prior IUD use - Use of narcotic or benzodiazepine medication within the last 24 hours - U.S. Centers for Disease Control Medical Eligibility Criteria (MEC) category 3 or 4 classification for use of an IUD - Positive pregnancy test or reasonable risk of pregnancy due to unprotected heterosexual intercourse since the last menstrual period Inclusion criteria: - Nulliparous, as defined in this study as no history of pregnancy ≥ 24 weeks gestational age - Desires insertion of either levonorgestrel-releasing IUD (LNG-IUD) or copper T380A IUD (Cu-IUD) - No history of pregnancy in the last 6 weeks - Able to provide written informed consent in English and comply with all study procedures Exclusion criteria: - Known allergy or hypersensitivity to lidocaine or other amino amide local anesthetics - Prior failed IUD insertion - Prior IUD use - Use of narcotic or benzodiazepine medication within the last 24 hours - U.S. Centers for Disease Control Medical Eligibility Criteria (MEC) category 3 or 4 classification for use of an IUD - Positive pregnancy test or reasonable risk of pregnancy due to unprotected heterosexual intercourse since the last menstrual period Pain Intrauterine devices (IUDs) are among the most effective forms of reversible contraception. --- T380A --- --- T380A ---

Primary Outcomes

Description: To assess change in pain from baseline to IUD insertion measured on a visual analog scale (VAS) from 0 mm (no pain) to 100 mm (worst pain in patient's life). This pain assessment was prior to (baseline) and at the time of IUD insertion following vaginal self-administration of study gel (either 2% lidocaine gel or placebo gel).

Measure: Change in Pain From Baseline to IUD Insertion

Time: change in pain score from baseline (before IUD insertion) to time of IUD insertion

Secondary Outcomes

Description: Number of participants who rated self-application of study gel as "some what easy" or "very easy" on Likert scale

Measure: To Evaluate Patient Experience of Self-inserting the Intravaginal Study Gel Prior to IUD

Time: After inserting the gel but prior to IUD insertion

Description: The physician who conducted the study visit and IUD insertion was asked about the difficulty/ease in placing the IUD immediately following the procedure and the percentage of IUD insertions considered to be "easy" was calculated for each study group.

Measure: Percentage of IUDs Considered by Physicians Easy to Insert

Time: Directly after IUD insertion

Description: Number of women taking pain medication for at least one day following IUD insertion

Measure: Need for Pain Medication up to 7 Days

Time: 7 days post-insertion

9 Early Versus Standard Interval Postpartum Intrauterine Device (IUD) Placement at 3 Weeks or 6 Weeks Following Delivery: A Prospective Randomized Trial

Women who have just given birth are at high risk for rapid repeat pregnancy, which can lead to negative consequences during the subsequent pregnancy. Providers have traditionally delayed starting birth control, especially placement of intrauterine devices (IUDs), post-delivery for a number of reasons. The first postpartum visit after a woman has given birth is typically scheduled for 6 weeks after her delivery, during which she is typically provided with her chosen method of birth control. This study will evaluate two different IUD placement times: 3 weeks and 6 weeks after delivery. This will allow the researchers to determine if placement time affects a woman's follow-through obtaining the IUD and keeping it inserted in place. The researchers will also look at bleeding patterns and patient/provider satisfaction with the IUD placement

NCT01594476 Contraception Drug: Levonorgestrel IUS

The distance from the left side of the 10 cm line to the mark will be measured in millimeters and compared between randomization groups if they received an IUD at the allocated timing of 18-24 or 39-45 days.. Inclusion Criteria: - Female - 18 years or older - Voluntarily requesting either copper T380A or levonorgestrel IUD placement for postpartum contraception - Within 5 days of vaginal or cesarean delivery of live born infant ≥32 0/7 weeks at the time of enrollment - English or Spanish speaking - Able to give consent and agree to terms of the study - No contraindications to use of either intrauterine device Exclusion Criteria: - Preterm delivery prior to 32 weeks gestation - Recent pregnancy with multiple gestation - Current incarceration - Known congenital or acquired uterine anomaly, including fibroids that distort the uterine cavity - Current or recent pelvic infection (chorioamnionitis treated for fever in labor only is not an exclusion) - Suspected hypersensitivity or contraindication to the chosen IUD - No insurance coverage for postpartum care, including Citizen Alien Waived Emergent Medical (CAWEM) Inclusion Criteria: - Female - 18 years or older - Voluntarily requesting either copper T380A or levonorgestrel IUD placement for postpartum contraception - Within 5 days of vaginal or cesarean delivery of live born infant ≥32 0/7 weeks at the time of enrollment - English or Spanish speaking - Able to give consent and agree to terms of the study - No contraindications to use of either intrauterine device Exclusion Criteria: - Preterm delivery prior to 32 weeks gestation - Recent pregnancy with multiple gestation - Current incarceration - Known congenital or acquired uterine anomaly, including fibroids that distort the uterine cavity - Current or recent pelvic infection (chorioamnionitis treated for fever in labor only is not an exclusion) - Suspected hypersensitivity or contraindication to the chosen IUD - No insurance coverage for postpartum care, including Citizen Alien Waived Emergent Medical (CAWEM) Contraception The goal of this study is to investigate whether early interval placement of a postpartum IUD at 3 weeks postpartum, compared to the usual 6 weeks postpartum, is associated with greater uptake of the IUD by 3 months after delivery. --- T380A ---

The distance from the left side of the 10 cm line to the mark will be measured in millimeters and compared between randomization groups if they received an IUD at the allocated timing of 18-24 or 39-45 days.. Inclusion Criteria: - Female - 18 years or older - Voluntarily requesting either copper T380A or levonorgestrel IUD placement for postpartum contraception - Within 5 days of vaginal or cesarean delivery of live born infant ≥32 0/7 weeks at the time of enrollment - English or Spanish speaking - Able to give consent and agree to terms of the study - No contraindications to use of either intrauterine device Exclusion Criteria: - Preterm delivery prior to 32 weeks gestation - Recent pregnancy with multiple gestation - Current incarceration - Known congenital or acquired uterine anomaly, including fibroids that distort the uterine cavity - Current or recent pelvic infection (chorioamnionitis treated for fever in labor only is not an exclusion) - Suspected hypersensitivity or contraindication to the chosen IUD - No insurance coverage for postpartum care, including Citizen Alien Waived Emergent Medical (CAWEM) Inclusion Criteria: - Female - 18 years or older - Voluntarily requesting either copper T380A or levonorgestrel IUD placement for postpartum contraception - Within 5 days of vaginal or cesarean delivery of live born infant ≥32 0/7 weeks at the time of enrollment - English or Spanish speaking - Able to give consent and agree to terms of the study - No contraindications to use of either intrauterine device Exclusion Criteria: - Preterm delivery prior to 32 weeks gestation - Recent pregnancy with multiple gestation - Current incarceration - Known congenital or acquired uterine anomaly, including fibroids that distort the uterine cavity - Current or recent pelvic infection (chorioamnionitis treated for fever in labor only is not an exclusion) - Suspected hypersensitivity or contraindication to the chosen IUD - No insurance coverage for postpartum care, including Citizen Alien Waived Emergent Medical (CAWEM) Contraception The goal of this study is to investigate whether early interval placement of a postpartum IUD at 3 weeks postpartum, compared to the usual 6 weeks postpartum, is associated with greater uptake of the IUD by 3 months after delivery. --- T380A --- --- T380A ---

Subjects will choose to receive either a levonorgestrel-containing IUS (Mirena) or copper T380A IUD (ParaGard). --- T380A ---

Primary Outcomes

Description: Subjects will be contacted by phone or email at 3 months after delivery. We will compare the proportion of subjects who report having an IUD in place at 3 months after delivery of those who are randomized to each group (placement at either 3 weeks or 6 weeks) .

Measure: Subjects With an IUD at 3 Months Postpartum

Time: Three months after delivery

Secondary Outcomes

Description: Subjects were asked to record their overall satisfaction with the timing of the IUD placement on a 100 millimeter (mm) visual analog scale (VAS). A VAS is a 100 mm horizontal line with anchors stating "very dissatisfied" and "very satisfied." The VAS score is calculated by measuring the distance in millimeters between the left end of the scale and the intersection of a vertical mark placed by the subject. Maximum score is 100 (range 0-100). Higher scores indicate higher satisfaction.

Measure: Satisfaction With the Timing of IUD Placement.

Time: Immediately following IUD placement.

Description: Transvaginal ultrasound will be performed immediately following IUD placement. The thickness of the uterine myometrium at the fundus from the endometrium to the outer edge of the serosa will be measured in centimeters using an ultrasound caliper in the sagittal view.

Measure: Uterine Thickness at the Fundus

Time: At IUD placement

Description: Subjects will return to clinic for an ultrasound and exam at six months after delivery. We will compare the proportion of subjects with an IUD at this time of those randomized to each placement timing.

Measure: Subjects With an IUD at 6 Months Postpartum

Time: Six months after delivery

Description: Subjects will be followed for 6 months each. Over the 6 month study period, the number and proportion of subjects who experience adverse events including treatment for infection, IUD expulsion or IUD perforation will be assessed.

Measure: Number of Subjects With Adverse Events

Time: Six months after delivery

Description: Subjects were asked to record their current pain immediate at the time of the IUD placement on a 100 millimeter (mm) visual analog scale (VAS). A VAS is a 100 mm horizontal line with anchors stating "no pain" and "worst pain in my life." The VAS score is calculated by measuring the distance in millimeters between the left end of the scale and the intersection of a vertical mark placed by the subject. Maximum score is 100 (range 0-100). Higher scores indicate higher pain. The distance from the left side of the 10 cm line to the mark will be measured in millimeters and compared between randomization groups if they received an IUD at the allocated timing of 18-24 or 39-45 days.

Measure: Pain With IUD Placement

Time: At the time of IUD placement.

10 Quick Start Insertion of Mirena and ParaGard Intrauterine Contraceptive Devices

Intrauterine devices (IUDs) are an effective form of contraception, but only about 3.4% of women in the US report using them. Women must often wait for their menses to start, or for results of screening for sexually transmitted infections (STIs), before their doctors will place IUDs for them. This is not the case with other birth control methods. Researchers know that it is safe to start oral contraceptive pills, transdermal patches or vaginal rings on the same day of a doctor's visit. In the investigators clinical practice, the investigators often place IUDs on the same day of a woman's visit, but outcomes have not been formally assessed. Currently, there are two kinds of IUDs available in the United States: the ParaGard T380A and the Mirena levonorgestrel intrauterine system (LNG-IUS). The investigators want to know if women who have IUDs placed at any time during their menstrual cycle have different experiences regarding the following, compared to those who have IUDS placed during the first 7 days of their cycle: bleeding or cramping patterns, active pelvic infections, becoming pregnant more often during that first cycle (window pregnancy). Women who come to their provider seeking an IUD for birth control will be asked to participate in this study. The investigators will ask them to keep track of their bleeding and cramping for three subsequent months to see if patterns differ according to the day in their menstrual cycle that the device was inserted. They will be randomly assigned either to record this information on paper, or to send in the information by responding to daily text messages. The investigators want to know if women who have an IUD placed at any time during the menstrual cycle have different outcomes compared to those who have IUDs placed during the first 7 days of their cycle. If the investigators have this information, the investigators can make recommendations to physicians, help counsel patients, and potentially expand access to IUDs.

NCT01730911 Bleeding Cramping Pregnancy With IUD in Place IUD Expulsion IUD Removal Other: Text message
MeSH: Muscle Cramp Spasm Hemorrhage
HPO: Hyperkinetic movements Muscle spasm

Currently, there are two kinds of IUDs available in the United States: the ParaGard T380A and the Mirena levonorgestrel intrauterine system (LNG-IUS). --- T380A ---

Primary Outcomes

Measure: Number of bleeding and cramping days

Time: 3 months

11 A Prospective, Randomized, Single Blind, Two Arms Controlled Study to Confirm the Safety and Verify Performance of the IUB™ SCu300A Intrauterine Device in Comparison to TCu380 IUD Intra-uterine Contraceptive Device

The novel SCu300A IUB™ (hereafter IUB™) will be evaluated for safety and effectiveness in comparison with a market approved standard T shaped IUD containing 380sq.mm. of copper. The Primary Endpoints for comparison are based on the objective and subjective parameters. The objective parameters are pregnancy rate, perforation, expulsion and mal -position rates, changes in the endometrial thickness, rate of complications such as infection and anemia and discontinuation rates after 2 years. The subjective parameters including Quality of Life (QoL) are: pain during insertion, menstrual characteristics and pain, bleeding in correlation to the bleeding pattern prior to insertion. The Secondary Endpoints are physician opinion (ease of use in insertion and removal) and subject satisfaction.

NCT02036177 To Assess the Safety, Effectiveness and User Experience of the Scu 300A IUB Device: SCu300A IUB intrauterine device Device: T380A IUD

Multivariate Assessment of the IUB Intrauterine Device Compared With a T380A IUD The novel SCu300A IUB™ (hereafter IUB™) will be evaluated for safety and effectiveness in comparison with a market approved standard T shaped IUD containing 380sq.mm. of copper. --- T380A ---

Primary Outcomes

Measure: Pregnancy rate

Time: 24 months

Description: Perforations, expulsions, mal-position etc

Measure: Safety issues

Time: 24 months

Measure: Discontinuation rate

Time: 24 months

Description: Recording of menstrual cramping, pain and bleeding irregularities during the trial period

Measure: Patient experience

Time: 24 months

Secondary Outcomes

Description: Ease of use in insertion and removal

Measure: Physician opinion

Time: 24 months

12 Immediate Postplacental Intrauterine Device Insertion in High-risk Patient Populations

The study will be a randomized clinical trial. Women with less than 10 prenatal visits and/or 2 or more no show visits who desire an Intrauterine Device (IUD) will be considered for enrollment. If consented and meet inclusion criteria, they will be randomized after delivery to receive an IUD immediately postplacental or at their routine postpartum visit. Women who plan to deliver a live birth singleton via vaginal or cesarean delivery at Oregon Health and Science University (OHSU) hospital will be considered for inclusion in the study. Women who desire an IUD for postpartum contraception will be approached for study participation. The postpartum contraception plan is routinely documented during their prenatal course. It is also addressed by the obstetrical team upon admission to Labor & Delivery at OHSU. The obstetrical team will identify subjects who present in labor who meet the criteria of poor prenatal clinic attendance and express interest in intrauterine contraception. Immediately after vaginal or cesarean delivery, consented subjects will be randomized to immediate postplacental IUD placement or IUD placement at their routine postpartum visit. Women randomized to the immediate postplacental IUD group will receive their IUD within 60 minutes of placental delivery. Prior to discharge from the hospital women who received a postplacental IUD will be assisted in scheduling a routine postpartum visit with their primary provider. Subjects who are randomized for IUD insertion at their postpartum visit will be assisted in scheduling a postpartum visit and IUD placement with their usual obstetrical care provider. All subjects in the delayed group will be provided with contact information for the Women's Health Research Unit (WHRU) at OHSU. If a subject cannot obtain an IUD at her usual place of care, the device will be placed at no cost through the WHRU. At 3 months after delivery, all subjects will be contacted by phone, text, or email to complete a questionnaire to determine whether they have had a known expulsion, pregnancy, or elective IUD removal. The questionnaire will include questions regarding ease of placement and overall satisfaction with the timing of placement. Subjects will be compensated for their participation in the study after the 3 month contact.

NCT02169869 Contraception Device: Mirena Device: Paragard

Comparison of the proportion of women randomized to placement of IUD within 60 minutes of placental delivery or at their 6-week routine postpartum visit who report having an IUD in place at 3 months after delivery.. Inclusion Criteria: - Female - 18 yo or older - Singleton pregnancy at ≥32 weeks gestation at time of enrollment - Voluntarily requesting either copper T380A or levonorgestrel IUD (LNG-IUS) placement for postpartum contraception - English or Spanish speaking - Able to give consent and agree to the terms of the study - Less than 10 prenatal visits or 2 or more no show visits - Since IUDs are not on our hospital formulary, the patient must qualify for a Long Acting Reversible Contraceptive (LARC) IUD (this includes all Oregon Health Plan (OHP) or Citizen/Alien Waived Emergent Medical (CAWEM) insured patients or women with income <300% of the federal poverty line). --- T380A ---

Exclusion Criteria: - Anatomic uterine abnormalities that prevent proper fundal placement of IUD (obstructive myomata, bicornuate, septate, etc) - Chorioamnionitis (also consider other risk factors such as prolonged rupture of membranes >18 hours, prolonged labor >24 hours, fever >38C) - Puerperal sepsis - Unresolved postpartum hemorrhage - Extensive genital trauma - Current incarceration - Known or suspected untreated endocervical gonorrhea, chlamydia - Wilson's disease, copper allergy (Paragard only) - Known or suspected cervical or endometrial cancer or pelvic tuberculosis - Current breast cancer (LNG-IUS only) - Systemic lupus erythematosus (SLE) with severe thrombocytopenia (Paragard only) - Trophoblastic disease (benign or malignant) - AIDS not stable on antiretroviral Inclusion Criteria: - Female - 18 yo or older - Singleton pregnancy at ≥32 weeks gestation at time of enrollment - Voluntarily requesting either copper T380A or levonorgestrel IUD (LNG-IUS) placement for postpartum contraception - English or Spanish speaking - Able to give consent and agree to the terms of the study - Less than 10 prenatal visits or 2 or more no show visits - Since IUDs are not on our hospital formulary, the patient must qualify for a Long Acting Reversible Contraceptive (LARC) IUD (this includes all Oregon Health Plan (OHP) or Citizen/Alien Waived Emergent Medical (CAWEM) insured patients or women with income <300% of the federal poverty line). --- T380A ---

Primary Outcomes

Description: Subjects were contacted at 3 months after delivery. Comparison of the proportion of women randomized to placement of IUD within 60 minutes of placental delivery or at their 6-week routine postpartum visit who report having an IUD in place at 3 months after delivery.

Measure: Proportion of Subjects With an IUD at 3 Months Postpartum

Time: 3 months postpartum (after delivery)

13 (TRIBE) Tracking IUD Bleeding Experiences: An Evaluation of Bleeding Profiles in New Intrauterine Device Users

This study aims to use validated tools as well as new technology to examine changes in bleeding patterns among women who are initiating the copper T380A IUD.

NCT02311478 Intrauterine Devices, Copper Metrorrhagia Menstruation Menstrual Cycle Device: T380A Intrauterine Copper Contraceptive
MeSH: Metrorrhagia Hemorrhage
HPO: Metrorrhagia

Tracking IUD Bleeding Experiences: An Evaluation of Bleeding Profiles in New Intrauterine Device Users This study aims to use validated tools as well as new technology to examine changes in bleeding patterns among women who are initiating the copper T380A IUD. --- T380A ---

Women will track bleeding after the insertion of the T380A IUD for 180 days. --- T380A ---

Participants will be contacted monthly to collect data.. Assess the Relationship of Menstrual Cycle Changes Among Women Initiating the Copper T380 IUD to Method Satisfaction and Continuation at 6 Months Post Insertion.. Determine rates of continuation and level of satisfaction with the IUD during the first 6 months of use.. Inclusion Criteria: - Healthy women ages 18-40 years with regular, normal menses (lasting between 3-7 days) and who are initiating an IUD - Women who can provide bleeding information for 3 cycles off of any hormonal contraception (or non-hormonal IUD) and are willing to track bleeding for 180 days - Women who are between 6 and 12 months postpartum (if they have had normal menses the last 3 cycles) Exclusion Criteria: - Use of any hormonal contraceptive method in the previous 3 months - Irregular duration of menstrual cycles in the last 3 cycles (<21 or >35 days) - Recent history of menstrual bleeding lasting less than 3 days or greater than 7 days based on self report of the last 3 cycles - Contraindication to use of the ParaGard® T380A IUD - Mucopurulent cervicitis at the time of IUD insertion - Unable to speak, read, and write in English - Currently pregnant - Plans for or desire for pregnancy in the next 6 months - Currently breastfeeding - Women who are <6 months postpartum - Participation in any clinical investigation utilizing an investigational drug or medical device or requiring invasive gynecologic procedures within the 30 days prior to enrollment - Wilson's disease - Known coagulopathy or bleeding disorder Inclusion Criteria: - Healthy women ages 18-40 years with regular, normal menses (lasting between 3-7 days) and who are initiating an IUD - Women who can provide bleeding information for 3 cycles off of any hormonal contraception (or non-hormonal IUD) and are willing to track bleeding for 180 days - Women who are between 6 and 12 months postpartum (if they have had normal menses the last 3 cycles) Exclusion Criteria: - Use of any hormonal contraceptive method in the previous 3 months - Irregular duration of menstrual cycles in the last 3 cycles (<21 or >35 days) - Recent history of menstrual bleeding lasting less than 3 days or greater than 7 days based on self report of the last 3 cycles - Contraindication to use of the ParaGard® T380A IUD - Mucopurulent cervicitis at the time of IUD insertion - Unable to speak, read, and write in English - Currently pregnant - Plans for or desire for pregnancy in the next 6 months - Currently breastfeeding - Women who are <6 months postpartum - Participation in any clinical investigation utilizing an investigational drug or medical device or requiring invasive gynecologic procedures within the 30 days prior to enrollment - Wilson's disease - Known coagulopathy or bleeding disorder Intrauterine Devices, Copper Metrorrhagia Menstruation Menstrual Cycle Metrorrhagia Hemorrhage New users of the intrauterine device (IUD) are most likely to discontinue use within the first six months after insertion. --- T380A ---

Participants will be contacted monthly to collect data.. Assess the Relationship of Menstrual Cycle Changes Among Women Initiating the Copper T380 IUD to Method Satisfaction and Continuation at 6 Months Post Insertion.. Determine rates of continuation and level of satisfaction with the IUD during the first 6 months of use.. Inclusion Criteria: - Healthy women ages 18-40 years with regular, normal menses (lasting between 3-7 days) and who are initiating an IUD - Women who can provide bleeding information for 3 cycles off of any hormonal contraception (or non-hormonal IUD) and are willing to track bleeding for 180 days - Women who are between 6 and 12 months postpartum (if they have had normal menses the last 3 cycles) Exclusion Criteria: - Use of any hormonal contraceptive method in the previous 3 months - Irregular duration of menstrual cycles in the last 3 cycles (<21 or >35 days) - Recent history of menstrual bleeding lasting less than 3 days or greater than 7 days based on self report of the last 3 cycles - Contraindication to use of the ParaGard® T380A IUD - Mucopurulent cervicitis at the time of IUD insertion - Unable to speak, read, and write in English - Currently pregnant - Plans for or desire for pregnancy in the next 6 months - Currently breastfeeding - Women who are <6 months postpartum - Participation in any clinical investigation utilizing an investigational drug or medical device or requiring invasive gynecologic procedures within the 30 days prior to enrollment - Wilson's disease - Known coagulopathy or bleeding disorder Inclusion Criteria: - Healthy women ages 18-40 years with regular, normal menses (lasting between 3-7 days) and who are initiating an IUD - Women who can provide bleeding information for 3 cycles off of any hormonal contraception (or non-hormonal IUD) and are willing to track bleeding for 180 days - Women who are between 6 and 12 months postpartum (if they have had normal menses the last 3 cycles) Exclusion Criteria: - Use of any hormonal contraceptive method in the previous 3 months - Irregular duration of menstrual cycles in the last 3 cycles (<21 or >35 days) - Recent history of menstrual bleeding lasting less than 3 days or greater than 7 days based on self report of the last 3 cycles - Contraindication to use of the ParaGard® T380A IUD - Mucopurulent cervicitis at the time of IUD insertion - Unable to speak, read, and write in English - Currently pregnant - Plans for or desire for pregnancy in the next 6 months - Currently breastfeeding - Women who are <6 months postpartum - Participation in any clinical investigation utilizing an investigational drug or medical device or requiring invasive gynecologic procedures within the 30 days prior to enrollment - Wilson's disease - Known coagulopathy or bleeding disorder Intrauterine Devices, Copper Metrorrhagia Menstruation Menstrual Cycle Metrorrhagia Hemorrhage New users of the intrauterine device (IUD) are most likely to discontinue use within the first six months after insertion. --- T380A --- --- T380A ---

This study aims to incorporate these validated tools as well as new technology to examine changes in bleeding patterns among women who are initiating the copper T380A IUD. --- T380A ---

Primary Outcomes

Description: Evaluate bleeding duration among women initiating the copper T380 IUD during the 90 days prior to initiation compared to two 90 periods after IUD insertion. Women will track bleeding after the insertion of the T380A IUD for 180 days. Participants will be contacted monthly to collect data.

Measure: Evaluate Changes in Bleeding Duration Among Women Initiating the Copper T380 IUD During the 90 Days Prior to Initiation Compared to Two 90 Periods After IUD Insertion.

Time: 3 months prior to insertion, month 1-month 3 , month 4-month 6

Secondary Outcomes

Description: Determine rates of continuation and level of satisfaction with the IUD during the first 6 months of use.

Measure: Assess the Relationship of Menstrual Cycle Changes Among Women Initiating the Copper T380 IUD to Method Satisfaction and Continuation at 6 Months Post Insertion.

Time: 6-month post insertion

14 Classic vs. Uterine Sound-sparing Approach for Insertion of Copper T380A Intrauterine Device

The intrauterine devices are a safe, reliable, long-acting and reversible contraceptive method. It is also sound safe and cheap contraceptive methods available and is nearly maintenance free for up to 10 years. The fear and the pain associated with intrauterine devices insertion consider barriers to using this contraception method, this is because that the mucosal lining of female genital tract is highly sensitive to touch and pain. However; most of small procedures done in this sensitive area are performed without analgesia. The pain during intrauterine devices insertion is due to application of the tenaculum , traction of the cervical canal, passing the uterine sound, insertion of the intrauterine devices through the cervix, and irritation of the endometrial lining by the intrauterine devices . Previous studies have reported different lines to decrease pain during intrauterine device insertion starting by simple methods such as pre-insertion ibuprofen use, intracervical or intrauterine lidocaine and misoprostol up to paracervical blocks. Previous studies, in literature, have found that the most painful steps during intrauterine devices insertion were uterine sounding then intrauterine device insertion itself, followed by tenaculum placement. One recent study addressed pain effect using an atraumatic vulsellum and a single-tooth tenaculum on pain perception during intrauterine devices and found no difference in reported pain.

NCT02842177 Contraception Procedure: Classic group Procedure: Uterine sounding sparing group Radiation: Transvaginal ultrasound Device: Cu-IUD

Classic vs. Uterine Sound-sparing Approach for Insertion of Copper T380A Intrauterine Device. --- T380A ---

Primary Outcomes

Description: defined by a distance from the intrauterine device to the end of endometrial line of less than 25 mm The degree of total pain perception during intrauterine contraceptive insertion measured by visual analogue scale

Measure: Successful intrauterine device insertion

Time: 5 minutes

Secondary Outcomes

Description: measured by Visual Analog Pain Scale

Measure: The degree of pain during intrauterine device insertion

Time: 5 minutes

Description: The time between start of IUD insertion and the end of the procedure

Measure: the duration of intrauterine device insertion

Time: 5 minutes

15 Celecoxib Versus Hyoscine Butyl-bromide in Reducing Pain Perception During Copper T380A Intrauterine Device Insertion: a Randomized Double-blind Controlled Trial

Many oral analgesic drugs such as the nonsteroidal anti-inflammatory drug (NSAID) are used to relieve pain from gynaecological procedures and dysmenorrhea. Hyoscine-N-butyl bromide, an antispasmodic drug is commonly used for relief of smooth muscle spasms and can be used to alleviate genito-urinary spasm. Some studies reported hyoscine couldn't relieve pain in minor gynaecological procedures. So the efficacy of Hyoscine-N-butyl bromide use is still controversial, and no previous studies investigated its effectiveness for pain relief in IUD insertion procedure.

NCT03499743 IUD Insertion Pain Drug: hyoscine butyl bromide Drug: Celecoxib 200mg Drug: Placebo Oral Tablet

Celecoxib Versus Hyoscine Butyl-bromide in Reducing Pain Perception During Copper T380A Intrauterine Device Insertion: a Randomized Double-blind Controlled Trial. --- T380A ---

Primary Outcomes

Description: the visual analog scale (VAS ) pain score reported by participants during IUD insertion.Pain scores will be measured using a visual analogue scale (VAS) consisting of a 10 cm horizontal straight line on which 0 cm corresponds to no pain and 10 cm to the worst pain. VAS is rated as 0 for no pain, 1-3 for mild pain, 4-6 for average pain, and 7-9 for severe pain and 10 for extremely severe pain an individual can experience.A research assistant standing beside the woman will hold the VAS sheet for the participant to select the point that corresponds to the level of pain she will experience.

Measure: self-reported pain score

Time: during IUD insertion

Secondary Outcomes

Description: the pain score at other different points; during tenaculum placement, during sound insertion, and 5 minutes after the end of insertion with a different sheet of paper at every point.

Measure: difference in pain score

Time: during tenaculum placement, during sound insertion, and 5 minutes after IUD insertion.

Description: the immediate complications related to IUD insertion such as uterine perforation, failure of insertion, vasovagal reaction and bleeding and the number of women who will need analgesics after insertion.

Measure: immediate complications related to IUD insertion

Time: 30 minutes after insertion

16 Effects of Prophylactic Vaginal Dinoprostone Administration Prior to a T380A Intrauterine Device Insertion in Nulliparous Women.

To investigate whether vaginal dinoprostone administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications and pain in nulliparous women.

NCT03686085 Intrauterine Device Drug: Dinoprostone 3 mg Drug: placebo vaginal tablet

Effects of Prophylactic Vaginal Dinoprostone Administration Prior to a T380A Intrauterine Device Insertion in Nulliparous Women.. Vaginal Dinoprostone Administration Prior to a T380A Intrauterine Device Insertion in Nulliparous Women. --- T380A ---

Effects of Prophylactic Vaginal Dinoprostone Administration Prior to a T380A Intrauterine Device Insertion in Nulliparous Women.. Vaginal Dinoprostone Administration Prior to a T380A Intrauterine Device Insertion in Nulliparous Women. --- T380A --- --- T380A ---

Primary Outcomes

Description: easiness score of IUD insertion (easy\difficult-very difficult)

Measure: easiness score of IUD insertion

Time: 5 minutes

Secondary Outcomes

Description: the difference in the pain intensity scores between the study groups BY visual analog scale score then categorized to absent-mild-moderate-severe.

Measure: the difference in the pain intensity scores between the study groups

Time: 5 minutes


HPO Nodes


Hyperkinetic movements
Genes 28
YME1L1 GRIN1 CACNA1E PTS PYCR2 TRAPPC11 CACNA1B NGLY1 GNAO1 NEUROD2 GCH1 SLC9A6 PRRT2 PNKD IQSEC2 PDE10A TRAPPC11 SUCLA2 ALDH5A1 ZNF142 SLC6A3 SYT1 FRRS1L NGLY1 RTTN GNE THOC2 PSAP
Muscle spasm
Genes 178
CACNA1S ACADVL GMPPB PRPH SMN2 RYR1 KY ATXN3 HSPB1 SNCA DNAJC13 PRPH DNA2 MYH7 UBQLN2 POLG2 WASHC5 VPS13C PON1 KCNA1 COL4A1 BSCL2 DNA2 SQSTM1 HADHB EPHA4 OPA3 POLG PMP22 ANG DCTN1 PON2 SOD1 SNCA BSCL2 TWNK TRNW SCN4A DGUOK GLT8D1 ATXN3 OPTN DCTN1 PRKN PFKM CHMP2B HNRNPA1 GFPT1 CFAP410 PFN1 GARS1 PYGM FKRP REEP1 MFN2 LDHA SOD1 DNAJC6 CACNA1S LRRK2 GNAS PINK1 TRAPPC11 C9ORF72 TRPM7 CPT2 TFG AMPD3 VAPB ATXN2 ATP1A1 GBA CHCHD10 FKRP PPARGC1A FLVCR1 GARS1 GFPT1 LAMP2 MPZ KCNJ18 CRPPA SLC12A3 TAF15 FUS ALG14 LAMA2 PGK1 COL4A1 TREM2 AR KCNJ1 FDX2 PHGDH GLA CAV3 FBXO38 STIM1 HINT1 FKRP DPAGT1 STX16 DMD SLC12A3 ALDH18A1 DOK7 ATXN2 TBK1 ATP6 SCN4A ALG2 UCHL1 MATR3 SLC12A1 ATXN3 DAO PGK1 CASQ1 GIGYF2 CHCHD10 SCN4A HINT1 NEFH GNAS STIM1 GNAS CAV3 ATP2A1 AR PARK7 SLC25A4 TRPM6 CCNF PSAT1 ANXA11 SLC16A1 CASR ORAI1 LRRK2 ATXN3 FIG4 TARDBP VAPB RRM2B RTN2 ABCB6 CASQ1 MAP3K20 PODXL HADHA HTRA2 GNA11 GMPPB EIF4G1 TRAPPC11 ERBB4 CHRNE GABRA3 FKTN GFPT1 POMT1 PON3 GLE1 VPS35 NEK1 SMN1 GARS1 ISCU PGAM2 ACADM CLCNKB UNC13A VCP NEFH DLD VCP AMPD1 MORC2
Metrorrhagia
Genes 16
RARA IRF2BP2 ZBTB16 NPM1 NABP1 PML USP8 CDH23 BCOR FLI1 PRKAR1A TBL1XR1 STAT3 STAT5B FIP1L1 NUMA1