LNG-IUS at 2 Weeks Postpartum

NCT02121067 | Completed Phase 4 Results DMC

• 1 other identifier: 14-0202
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study of 50 postpartum women interested in having the Mirena® LNG-IUS placed for contraception. The Mirena® is an FDA approved intrauterine contraceptive device that provides contraception for 5 years with excellent effectiveness. Women enrolled in this study will only have the Mirena® placed at two-weeks postpartum (day 14-20 postpartum). The participants will be followed at 6-weeks and 6-months postpartum for study visits to evaluate for satisfaction, symptoms, expulsion, and perforation. The study will be completed at six-months postpartum, and participants will be able to keep their LNG-IUS following study completion.

Conditions

Contraception; Malposition of Intrauterine Contraceptive Device

Keywords

postpartum; contraception; intrauterine device; intrauterine system; mirena; uterine involution

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Would Recommend the LNG-IUS to a Friend at 6-months Postpartum.

  A dichotomous, yes/no answer to the following question "Would you recommend Mirena placement at two-weeks postpartum to a friend?"

  6 months postpartum

• Number of Participants Who Enrolled and Were Able to Have a Successful LNG-IUS Insertion in the 2 Week (Day 14-20) Postpartum Period.

  Was the LNG-IUS successfully placed in the study period, as determined by whether the participant had an LNG-IUS placed on the day of insertion?

  Day 14-20 postpartum

Secondary Outcomes (1)

• Number of Participants With Expulsion (Complete or Partial) of LNG-IUS at Six-months.

  6 months postpartum

Study Arms (1)

LNG-IUS placed at 2 weeks postpartum

EXPERIMENTAL

Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum

Drug: Levonorgestrel Intrauterine System (LNG-IUS)

Interventions

Levonorgestrel Intrauterine System (LNG-IUS) DRUG

The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled

Also known as: Mirena

LNG-IUS placed at 2 weeks postpartum

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Desiring a LNG-IUS
• Postpartum, ages 18-45 who deliver at a gestational age \> 32 weeks, delivery can be via cesarean or vaginal delivery
• Following a viable, singleton pregnancy
• Willing to return to UNC for their LNG-IUS insertion and study follow-up
• Who plan to stay in the UNC area for 6 months and willing to return to UNC for 3 visits
• Fluent in English or Spanish
• At risk of repeat pregnancy (i.e. excluding those who had tubal sterilization)

You may not qualify if:

• No genital bleeding of unknown etiology
• No personal history of known or suspected breast carcinoma
• No 4th degree vaginal laceration at time of delivery
• No documented uterine rupture during delivery
• No active liver disease (resolved pre-eclampsia may enroll)
• No evidence of vaginal, cervical or uterine infection at time of LNG-IUS insertion
• No history of postpartum endometritis treated with antibiotics or a postpartum readmission for a dilation and curettage
• No pre-existing contraindication to a LNG-IUS as determined by the CDC's Medical Eligibility Criteria (MEC) category 3 or 4
• Not currently incarcerated
• No known congenital or acquired uterine anomaly, including fibroids that distort the uterine cavity
• No suspected hypersensitivity or contraindication to the LNG-IUS
• With any other condition or circumstance that the PI determines could cause an adverse event or interfere with completing the study.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Society of Family Planning: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Zerden ML, Stuart GS, Charm S, Bryant A, Garrett J, Morse J. Two-week postpartum intrauterine contraception insertion: a study of feasibility, patient acceptability and short-term outcomes. Contraception. 2017 Jan;95(1):65-70. doi: 10.1016/j.contraception.2016.08.005. Epub 2016 Aug 20.

  PMID: 27554014 DERIVED

MeSH Terms

Interventions

Levonorgestrel

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Matthew Zerden, MD, MPH
• Organization: University of North Carolina

mzerden@gmail.com

6179352394

Study Officials

• Matthew L Zerden, MD, MPH

  UNCH

  PRINCIPAL INVESTIGATOR

• Gretchen S Stuart, MD

  University of North Carolina, Chapel Hill

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: April 23, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 24, 2017
• Results First Posted: June 1, 2017

Record last verified: 2017-07

Locations

US (1)