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Report for Clinical Trial NCT01594476

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

1 Interventions

Name: Levonorgestrel IUS

Description: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device

Type: Drug

Levonorgestrel IUS insertion at 3 weeks Levonorgestrel IUS insertion at 6 weeks


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.

Purpose: Prevention

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 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 ---

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 ---



HPO Nodes