Phase 4
N=29
A Pilot Study of Early Postpartum Intrauterine Contraception
Unplanned Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT00997932 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: IUD Expulsion — 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Levonorgestrel-Releasing Intrauterine Contraceptive System (LNG-IUS), 52 Mg, 5 Year Duration (Drug)
- Age
- Adult · 21+ yrs
- Sex
- Female
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY IUD Expulsion |
11 | — |
Summary
This is a prospective clinical trial of ultrasound guided intrauterine contraception insertion 10 minutes - 48 hours after vaginal delivery of single infant. A six month follow-up will entail three follow-up visits; 4-6 weeks, 3 months, and 6 months.
The objective of this study is to measure intrauterine device (IUD) expulsion and the feasibility of conducting a future clinical trial to evaluate placement of the levonorgestrel-releasing intrauterine contraceptive 10 minutes - 48 hours postpartum.
Eligibility Criteria
Inclusion Criteria
- Currently pregnant with a single gestation of at least 27 completed weeks estimated gestational age, with no complications of pregnancy including, but not limited to, preeclampsia, non-gestational diabetes, anemia.
- Desires to use intrauterine contraception (IUD) after delivery
- Anticipates having a vaginal delivery
- No intention to leave the area 7 months after enrollment
- Able to consent to participate in the study in English
- Has no known uterine anomalies
- Has no allergies to any components of the intrauterine contraception
Exclusion Criteria
- Prior cesarean delivery
- Having been treated for pelvic inflammatory disease within 3 months prior to the start of the pregnancy
- Allergic to betadine
- Allergy to lidocaine
- Medical or personal conditions which in the judgment of study staff contradict participation in the study
- Any contraindications to use of the levonorgestrel-releasing intrauterine contraceptive system which includes: known or suspected breast carcinoma, acute liver disease or liver tumor, history of ectopic pregnancy, cervical cancer or carcinoma in situ
- After enrollment, and after delivery of the infant but before IUD insertion subjects will be excluded by checking with the attending obstetric physician and/or obstetric medical chart for the following:
- Endometritis or chorioamnionitis during the intrapartum period
- Membranes ruptured for greater than 24 hours prior to delivery
- Fever greater than or equal to 38C
- The need to use additional medications other than pitocin and/or misoprostol to control postpartum bleeding
Data sourced from ClinicalTrials.gov (NCT00997932). 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.