Unplanned Pregnancy Clinical Trial
— ImmPPIUDOfficial title:
A Pilot Study of Early Postpartum Intrauterine Contraception
Verified date | March 2017 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | November 2012 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years to 45 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | IUD Expulsion | Expulsion of the LNG-IUS | From time of insertion to final study date which is 6 months after IUD insertion. |
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