N/A
Completed N=112
Immediate Postplacental Insertion of IUDs at Time of Cesarean Delivery: A Randomized Clinical Trial
Intrauterine Devices · Cesarean section
Source: ClinicalTrials.gov NCT01539759 ↗
Enrolled (actual)
112
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcomePrimary: IUD Use — 32; 40 participants
Summary
This is a randomized controlled trial among women who deliver by cesarean at UNC Women's Hospital and desire an Intrauterine Device (IUD) for contraception postpartum. After consenting, women will be randomized to receive an IUD at time of cesarean delivery or at a postpartum visit 4-8 weeks later. After randomization, subjects will be given a choice of the Mirena® IUD or the Paragard® IUD. Data collection will occur at baseline, delivery, the 4-8 week postpartum visit, and 2 follow-up encounters at 3 and 6 months. We hypothesize that women who receive an IUD at the time of cesarean will be more likely to use an IUD 6 months later than women who plan on receiving an IUD 4-8 weeks after delivery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY IUD Use |
32; 40 | — |
| SECONDARY IUD Expulsion |
1; 4 | — |
| SECONDARY Women's Satisfaction With IUDs |
92; 100 | — |
Eligibility Criteria
Inclusion Criteria
- Women ages 18-45
- Pregnant and greater than or equal to 24 weeks of estimated gestational age
- Live Pregnancy
- States a plan to use an Intrauterine Device (IUD) postpartum for contraception
- Plan for cesarean delivery
- Intend to stay in the Chapel Hill area for at least 6 months after birth
- Fluent in English or Spanish
Exclusion Criteria
- known uterine anomalies
- allergies to any component of the IUD of their choosing
- known or suspected carcinoma of the breast
- known acute liver disease or liver tumor (benign or malignant)
- known or suspected uterine or cervical neoplasia
- active pelvic inflammatory disease
- genital bleeding of unknown etiology
- history of solid organ transplantation
- positive test for gonorrhea or chlamydia during this pregnancy
Data sourced from ClinicalTrials.gov (NCT01539759). 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. Informational only — not medical advice.