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Completed

NCT Number: NCT02121067

LNG-IUS at 2 Weeks Postpartum

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.

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Key information

Conditions

Contraception Malposition of Intrauterine Contraceptive Device

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.

Treatment and study plan

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

Other names: Mirena

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Society of Family Planning

Registry information

Official study title

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

Acronym: LNG-IUS

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 23, 2014
Registry last updated
Aug 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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