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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00635362
• Other study ID #: 15148A
• Status: Terminated
• Phase: N/A
• Start date: May 2007
• Est. completion date: February 2013

Study information

• Verified date: February 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: February 2013
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Levonorgestrel-releasing intrauterine system (LNG-IUS)
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)
Insertion of the LNG-IUS 4-8 weeks after cesarean delivery

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of the LNG-IUS for Contraception		12 months after cesarean delivery
Secondary	Rates of Expulsion of the LNG-IUS		12 months after cesarean delivery
Secondary	Perforation Rates		12 months after cesarean delivery
Secondary	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.	6 months after cesarean delivery
Secondary	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.	12 months after cesarean delivery

External Links

•   University of Chicago Section of Family Planning and Contraceptive Research