Postpartum Levonorgestrel-releasing Intrauterine System and Breastfeeding

NCT01555931 | Completed Phase 4 Results DMC

• 1 other identifier: 11-1786
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a randomized clinical trial of 190 women aged 18-45 who plan to breastfeed their infant for at least 6 months and desire to use the LNG-IUS as their primary contraceptive method postpartum. The investigators will compare the frequency of breastfeeding among women receiving the levonorgestrel-releasing intrauterine system (LNG-IUS) immediately after vaginal delivery compared to 4-8 weeks later. The investigators hypothesize there will be no difference in breastfeeding prevalence between the two groups.

Conditions

Postpartum Contraception

Outcome Measures

Primary Outcomes (1)

• Breastfeeding

  Reported any breastfeeding at the final 6 month visit

  6 months

Secondary Outcomes (1)

• LNG-IUS Expulsion or Removal

  up to 6 months

Study Arms (2)

Immediate

EXPERIMENTAL

Placement within 48 hours of delivery

Drug: Levonorgestrel-releasing intrauterine system

Control

ACTIVE COMPARATOR

Placement 4-8 weeks after delivery

Drug: Levonorgestrel-releasing intrauterine system

Interventions

Levonorgestrel-releasing intrauterine system DRUG

Placement within 48 hours of delivery

Also known as: Mirena

Control; Immediate

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

1. Women ages 18-45 2. Pregnant and equal to or more than 24 weeks of estimated gestational age 3. States an intent to breastfeed for at least 6 months 4. States a plan to use the LNG-IUS postpartum 5. Anticipates a vaginal delivery 6. HIV negative 7. Intend to stay in the Chapel Hill area for at least 6 months after birth 8. No medical or personal conditions which in the judgment of study staff preclude participation in the study 9. Have no allergies to any component of the LNG-IUS 10. No known uterine anomalies 11. Fluent in English 12. No history of ectopic pregnancy 13. No known or suspected carcinoma of the breast 14. No known acute liver disease or liver tumor (benign or malignant) 15. No known or suspected uterine or cervical neoplasia or unresolved abnormal pap smear 16. No active pelvic inflammatory disease 17. No known hypersensitivity to any component of the LNG-IUS 18. No genital bleeding of unknown etiology 19. No history of solid organ transplantation Additional eligibility criteria for entry into the randomized trial, as assessed postpartum 1. No endometritis or chorioamnionitis 2. Membranes ruptured for less than 24 hours prior to delivery (O'Hanley, Hayes) 3. No fever greater than or equal to 38°C during the intrapartum or postpartum period 4. Did not receive medications other than pitocin and/or misoprostol to control postpartum bleeding 5. Did not have a documented estimated blood loss of greater than 750mL intrapartum 6. Did not receive a blood transfusion for a diagnosis of postpartum hemorrhage 7. Did not have a third or fourth degree laceration at delivery. 8. The infant must be greater than 35 weeks EGA at birth as determined by physical exam at birth 9. The infant must weigh at least 2727 grams 10. Must have been a singleton birth 11. Infant not in the intensive care nursery 12. The infant has not been diagnosed with a condition which would preclude long term feeding

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Study Sites (1)

University of North Carolina Women's Hospital

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Interventions

Levonorgestrel

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Gretchen Stuart
• Organization: University of North Carolina School of Medicine

gstuart@med.unc.edu

919-962-4880

Study Officials

• Gretchen Stuart, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: March 16, 2012
• Study Start: March 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 25, 2014
• Results First Posted: August 25, 2014

Record last verified: 2013-06

Locations

US (1)