A Pilot Study of Early Postpartum Intrauterine Contraception (NCT00997932) | Clinical Trial Compass
CompletedPhase 4
A Pilot Study of Early Postpartum Intrauterine Contraception
United States40 participantsStarted 2009-06
Plain-language 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.
Who can participate
Age range21 Years – 45 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 3…
What they're measuring
1
IUD Expulsion
Timeframe: From time of insertion to final study date which is 6 months after IUD insertion.