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A Pilot Study of Early Postpartum Intrauterine Contraception

Information source: University of North Carolina, Chapel Hill
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Unplanned Pregnancy

Intervention: Mirena Intrauterine Contraceptive System (Device)

Phase: Phase 4

Status: Completed

Sponsored by: University of North Carolina, Chapel Hill

Official(s) and/or principal investigator(s):
Gretchen Stuart, MD, MPHTM, Principal Investigator, Affiliation: University of North Carolina, Chapel Hill

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.

Clinical Details

Official title: A Pilot Study of Early Postpartum Intrauterine Contraception

Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: IUD expulsion

Secondary outcome: Feasibility of enrollment

Eligibility

Minimum age: 21 Years. Maximum age: 45 Years. Gender(s): Female.

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

Locations and Contacts

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27514, United States
Additional Information

Starting date: June 2009
Last updated: December 23, 2013

Page last updated: August 23, 2015

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