Phase 4
N=90
Copper Intrauterine Device (IUD) Insertion at Cesarean Delivery
Intrauterine Device Expulsion
Bottom Line
View on ClinicalTrials.gov: NCT01439802 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Number of Participants With Expulsion of IUD — 54; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Copper IUD placement at time Cesarean Delivery (Copper T 380A) (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Albert Einstein College of Medicine
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Expulsion of IUD |
42; 0 | — |
| SECONDARY Satisfaction of IUD Placement |
34; 4; 4; 0 | — |
| SECONDARY Number of Participants With Expulsion of IUD |
42; 0 | — |
Summary
The purpose of this study is to determine the expulsion rates of copper Intrauterine Devices (IUDs) placed at time of Cesarean Delivery.
Eligibility Criteria
Inclusion Criteria
- singleton gestation
- greater than 35 weeks gestation
- speaks English or Spanish
- desires IUD for contraception
- undergoing a cesarean delivery
Exclusion Criteria
- evidence of chorioamnionitis
- history of chlamydia within this pregnancy
Data sourced from ClinicalTrials.gov (NCT01439802). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.