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NCT02067663 · ClinicalTrials.gov registry record
Comparison of the Levonorgestrel IUD and the Copper IUD Placed in the Immediate Postplacental Period: A Prospective Cohort Study
A clinical trial of Contraception, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- 123
- Enrollment target
- 1
- Study location
NCT02067663 is a study of Contraception that has completed, run by University of Colorado, Denver. The registered enrollment target is 123 participants, below the 453-participant average among 72 other Contraception trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02067663, a study of Contraception, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- 123 participants
- Enrollment target
- 1
- Study location
Study Summary
The intrauterine device (IUD) is a safe, highly effective, long acting, and reversible form of contraception. The postpartum period is an important moment for contraceptive intervention; however there are many barriers to women obtaining birth control postpartum. The use of the IUD in the immediate postpartum setting offers many advantages and is considered safe, but the risk of expulsion appears to be higher than with interval insertion. Previous studies have shown the rate of expulsion of the copper IUD in the postplacental period to be in the range of 1-14% by 6-12 months, while the only study of the levonorgestrel IUD in the postplacental period documented a rate of expulsion of 24% by 12 months. While studies related to the copper IUD use ring forceps or the operator's hand for placement of the IUD, the only published study investigating immediate postplacental levonorgestrel IUD insertion utilized the manufacturer's inserter for IUD placement. The investigators therefore ask the question, is there a difference in expulsion rates between levonorgestrel and copper IUDs placed post-placentally when all providers undergo a standardized training, use a standardized insertion technique, and when patient level characteristics are controlled by randomization? The investigators propose to perform a prospective cohort trial comparing the rates of expulsion for the levonorgestrel and the copper IUD by 3 months postpartum when placed in the uterus within 10 minutes of the delivery of the placenta, using a standardized technique (placement with a ring forceps or the operator's hand) after all providers undergo a formal didactic and skills training. The investigators hypothesis is that the levonorgestrel IUD has a higher rate of expulsion as compared to the copper IUD. Additional objectives include a comparison of the rates of complete IUD expulsion, partial IUD expulsion, unrecognized expulsions, complications, IUD continuation, pregnancy, and satisfaction. Additionally,
Conditions Studied
Interventions
- DEVICE Paragard
- DRUG Mirena
Study Locations (1)
Colorado
- University of Colorado Denver - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2014-04 |
| Est. Completion | 2015-09 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02067663
The ClinicalTrials.gov registry entry for NCT02067663 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 123 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 453-participant average among 72 other Contraception trials with a reported enrollment target (73% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Contraception appearing as the primary indexed condition, and to 2 interventions - of which Paragard is the first listed.
NCT02067663 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT02067663 about?
NCT02067663 is a clinical study titled "Comparison of the Levonorgestrel IUD and the Copper IUD Placed in the Immediate Postplacental Period: A Prospective Cohort Study". The intrauterine device (IUD) is a safe, highly effective, long acting, and reversible form of contraception. The postpartum period is an important moment for contraceptive intervention; however there are many barriers to women obtaining birth control postpartum. The use of the IUD in the immediate ...
What is the current status of trial NCT02067663?
This trial is currently completed. The enrollment target is 123 participants. The study started on 2014-04. Estimated completion is 2015-09.
What conditions does trial NCT02067663 study?
This clinical trial studies the following conditions: Contraception.
What interventions are being tested in trial NCT02067663?
The interventions under investigation include: Paragard (DEVICE), Mirena (DRUG).
Who is sponsoring clinical trial NCT02067663?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02067663 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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