Postpartum Levonorgestrel-releasing Intrauterine System and Breastfeeding

Postpartum Contraception Clinical Trial

— PPIUD1  

Official title:

Immediate vs. 4-8 Week Postpartum Levonorgestrel-releasing Intrauterine System Placement: A Randomized Clinical Trial (Short Title: PPIUD1)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01555931
• Other study ID #: 11-1786
• Status: Completed
• Phase: Phase 4
• First received: March 14, 2012
• Last updated: August 21, 2014
• Start date: March 2012
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Postpartum Contraception

Intervention

Drug:
• Levonorgestrel-releasing intrauterine system
Placement within 48 hours of delivery

Locations

Country	Name	City	State
United States	University of North Carolina Women's Hospital	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	Breastfeeding	Reported any breastfeeding at the final 6 month visit	6 months	No
Secondary	LNG-IUS Expulsion or Removal	Expulsion or indicated removal of the originally placed LNG-IUS at any point during the study	up to 6 months	Yes