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Postplacental Insertion of Levonorgestrel-releasing Intrauterine System (LNG-IUS) After Cesarean vs. Interval Insertion

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

Condition(s) targeted: Healthy

Intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) (Device); Levonorgestrel-releasing intrauterine system (LNG-IUS) (Device)

Phase: N/A

Status: Terminated

Sponsored by: University of Chicago

Official(s) and/or principal investigator(s):
Melissa Gilliam, MD MPH, Principal Investigator, Affiliation: University of Chicago

Summary

The study is a randomized controlled trial comparing outcomes of immediate postplacental insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) vs. interval insertion of the LNG-IUS performed 4-8 weeks after delivery for patients undergoing scheduled cesarean delivery. Our primary hypothesis is that the proportion of women using the LNG-IUS for contraception at 12 months after delivery will be higher in the group randomized to immediate post-placental insertion.

Clinical Details

Official title: Immediate Post-placental Insertion of the Levonorgestrel-releasing Intrauterine System (LNG-IUS) After Cesarean Delivery vs. 4-8 Week Post-delivery Interval Insertion: A Randomized Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Use of the LNG-IUS for Contraception

Secondary outcome:

Rates of Expulsion of the LNG-IUS

Perforation Rates

Satisfaction With LNG-IUS

Satisfaction With LNG-IUS

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Pregnant at time of enrollment

- Planning to undergo a scheduled cesarean delivery

- Desires to use the LNG-IUS for contraception

- Willing and able to sign an informed consent in English

- Willing to comply with the study protocol

- Age greater than or equal to 18 years

- English speaking

Exclusion Criteria:

- Allergy to either polyethylene or levonorgestrel, or other contraindications to use

of the LNG-IUS

- Positive testing for Gonorrhea, Chlamydia, or trichomoniasis during the pregnancy

without treatment and a subsequent test of cure confirming a negative result

- Presence of leiomyomata significantly distorting the uterine cavity and thus not

allowing placement of the LNG-IUS

- Uterine anomaly which would not allow placement of the LNG-IUS

- Current cervical cancer or carcinoma in-situ

- Desire for repeat pregnancy in less than 12 months

- History of postabortal or postpartum sepsis

Locations and Contacts

University of Chicago, Chicago, Illinois 60637, United States
Additional Information

University of Chicago Section of Family Planning and Contraceptive Research

Starting date: May 2007
Last updated: April 1, 2013

Page last updated: August 23, 2015

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