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

University of Chicago42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Healthy

Interventions

Levonorgestrel-releasing intrauterine system (LNG-IUS)DEVICE

Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta

Levonorgestrel-releasing intrauterine system (LNG-IUS)DEVICE

Insertion of the LNG-IUS 4-8 weeks after cesarean delivery

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

University of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Use of the LNG-IUS for Contraception

Time frame: 12 months after cesarean delivery

Secondary Outcomes

Rates of Expulsion of the LNG-IUS

Time frame: 12 months after cesarean delivery

Perforation Rates

Time frame: 12 months after cesarean delivery

Satisfaction With LNG-IUS

We measured satisfaction with the IUS at each visit using a single question with a 5 point Likert scale, with 1 being "very unsatisfied," 2 "unsatisfied", 3 "neutral," 4 "satisfied," and 5 "very satisfied." For statistical purposes, subjects were determined to be "SATISFIED" with the IUS if they chose either 4 or 5 for this question.

Time frame: 6 months after cesarean delivery

Satisfaction With LNG-IUS

Time frame: 12 months after cesarean delivery

Data from ClinicalTrials.gov

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