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Report for Clinical Trial NCT00562276

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

1 Interventions

Name: Immediate IUD insertion

Description: Insertion of either Paraguard or Mirena IUD within minutes of completing suction aspiration procedure between 5 and 12 weeks gestation
Type: Procedure
Group Labels: 1

1


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

Purpose: Prevention

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 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 ---

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 ---



HPO Nodes