LNG-IUS at 2 Weeks Postpartum (LNG-IUS)

• ClinicalTrials.gov Identifier: NCT02121067
• Recruitment Status: Completed
• First Posted: April 23, 2014
• Results First Posted: June 1, 2017
• Last Update Posted: August 24, 2017
• Sponsor: University of North Carolina, Chapel Hill
• Collaborator: Society of Family Planning
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Contraception; Malposition of Intrauterine Contraceptive Device	Drug: Levonorgestrel Intrauterine System (LNG-IUS)	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Intrauterine Contraceptive Insertion at Two-weeks Postpartum: A Study of Acceptability and Short-term Outcomes
• Study Start Date: September 2014
• Actual Primary Completion Date: June 2016
• Actual Study Completion Date: June 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: LNG-IUS placed at 2 weeks postpartum; Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum	Drug: Levonorgestrel Intrauterine System (LNG-IUS); The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled; Other Name: Mirena

Outcome Measures

Primary Outcome Measures :

1. Number of Participants Who Would Recommend the LNG-IUS to a Friend at 6-months Postpartum. [ Time Frame: 6 months postpartum ]
   A dichotomous, yes/no answer to the following question "Would you recommend Mirena placement at two-weeks postpartum to a friend?"
2. Number of Participants Who Enrolled and Were Able to Have a Successful LNG-IUS Insertion in the 2 Week (Day 14-20) Postpartum Period. [ Time Frame: Day 14-20 postpartum ]
   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?

Secondary Outcome Measures :

1. Number of Participants With Expulsion (Complete or Partial) of LNG-IUS at Six-months. [ Time Frame: 6 months postpartum ]
   Expulsion will be defined as any of the following (1) patient report that the LNG-IUS came out, (2) ultrasound evaluation that demonstrates the LNG-IUS is not intrauterine (3) ultrasound or clinical evaluation that demonstrates the majority of the LNG-IUS is located in the cervix.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

United States, North Carolina

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Sponsors and Collaborators

University of North Carolina, Chapel Hill

Society of Family Planning

Investigators

• Principal Investigator: Matthew L Zerden, MD, MPH; UNCH
• Study Director: Gretchen S Stuart, MD; University of North Carolina, Chapel Hill

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT02121067
• Other Study ID Numbers: 14-0202
• First Posted: April 23, 2014
• Results First Posted: June 1, 2017
• Last Update Posted: August 24, 2017
• Last Verified: July 2017

Keywords provided by University of North Carolina, Chapel Hill:

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

Additional relevant MeSH terms:

Levonorgestrel; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral