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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01539759
Other study ID # 11-2477
Secondary ID
Status Completed
Phase N/A
First received February 21, 2012
Last updated September 12, 2017
Start date March 2012
Est. completion date August 2014

Study information

Verified date September 2017
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Immediate Postplacental Placement of an IUD during cesarean delivery
Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta

Locations

Country Name City State
United States University of North Carolina, Chapel Hill Chapel Hill North Carolina

Sponsors (2)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary IUD Use The use of an IUD at 6 months postpartum is the primary outcome measure 6 months postpartum
Secondary IUD Expulsion 0-6 months postpartum
Secondary Women's Satisfaction With IUDs 0-6 months postpartum
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