LNG-IUS at 2 Weeks Postpartum

Contraception Clinical Trial

— LNG-IUS  

Official title:

Intrauterine Contraceptive Insertion at Two-weeks Postpartum: A Study of Acceptability and Short-term Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02121067
• Other study ID #: 14-0202
• Status: Recruiting
• Phase: Phase 4
• First received: March 24, 2014
• Last updated: April 6, 2015
• Start date: September 2014
• Est. completion date: January 2016

Study information

• Verified date: April 2015
• Source: University of North Carolina, Chapel Hill
• Contact: Matthew L Zerden, MD, MPH
• Phone: 919-843-5633
• Email: Matthew_Zerden[@]med.unc.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception
• Malposition of Intrauterine Contraceptive Device

Intervention

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

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To report the acceptability of receiving an LNG-IUS two-weeks 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	No
Secondary	To estimate the expulsion rate (complete or partial) at six months of LNG-IUS placed at two-weeks 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.	6 months postpartum	Yes
Secondary	To assess the pain experience of LNG-IUS insertion.	To assess the pain experience of LNG-IUS insertion.	immediately following placement	No