Postpartum Levonorgestrel-releasing Intrauterine System and Breastfeeding (PPIUD1)
This study is currently recruiting participants.
Verified October 2012 by University of North Carolina, Chapel Hill
Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01555931
First received: March 14, 2012
Last updated: October 22, 2012
Last verified: October 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Postpartum Contraception |
Drug: Levonorgestrel-releasing intrauterine system |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Immediate vs. 4-8 Week Postpartum Levonorgestrel-releasing Intrauterine System Placement: A Randomized Clinical Trial (Short Title: PPIUD1) |
Resource links provided by NLM:
Further study details as provided by University of North Carolina, Chapel Hill:
Primary Outcome Measures:
- Breastfeeding [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 190 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Immediate
Placement within 48 hours of delivery
|
Drug: Levonorgestrel-releasing intrauterine system
Placement within 48 hours of delivery
Other Name: Mirena
|
|
Active Comparator: Control
Placement 4-8 weeks after delivery
|
Drug: Levonorgestrel-releasing intrauterine system
Placement within 48 hours of delivery
Other Name: Mirena
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
- Women ages 18-45
- Pregnant and equal to or more than 24 weeks of estimated gestational age
- States an intent to breastfeed for at least 6 months
- States a plan to use the LNG-IUS postpartum
- Anticipates a vaginal delivery
- HIV negative
- Intend to stay in the Chapel Hill area for at least 6 months after birth
- No medical or personal conditions which in the judgment of study staff preclude participation in the study
- Have no allergies to any component of the LNG-IUS
- No known uterine anomalies
- Fluent in English
- No history of ectopic pregnancy
- No known or suspected carcinoma of the breast
- No known acute liver disease or liver tumor (benign or malignant)
- No known or suspected uterine or cervical neoplasia or unresolved abnormal pap smear
- No active pelvic inflammatory disease
- No known hypersensitivity to any component of the LNG-IUS
- No genital bleeding of unknown etiology
- No history of solid organ transplantation
Additional eligibility criteria for entry into the randomized trial, as assessed postpartum
- No endometritis or chorioamnionitis
- Membranes ruptured for less than 24 hours prior to delivery (O'Hanley, Hayes)
- No fever greater than or equal to 38°C during the intrapartum or postpartum period
- Did not receive medications other than pitocin and/or misoprostol to control postpartum bleeding
- Did not have a documented estimated blood loss of greater than 750mL intrapartum
- Did not receive a blood transfusion for a diagnosis of postpartum hemorrhage
- Did not have a third or fourth degree laceration at delivery.
- The infant must be greater than 35 weeks EGA at birth as determined by physical exam at birth
- The infant must weigh at least 2727 grams
- Must have been a singleton birth
- Infant not in the intensive care nursery
- The infant has not been diagnosed with a condition which would preclude long term feeding
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555931
Contacts
| Contact: Catherine Soriano | 919-843-3447 |
Locations
| United States, North Carolina | |
| University of North Carolina Women's Hospital | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Catherine Soriano 919-843-5633 | |
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Society of Family Planning
Investigators
| Principal Investigator: | Gretchen Stuart, MD | University of North Carolina, Chapel Hill |
More Information
No publications provided
| Responsible Party: | University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT01555931 History of Changes |
| Other Study ID Numbers: | 11-1786 |
| Study First Received: | March 14, 2012 |
| Last Updated: | October 22, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Levonorgestrel Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Contraceptives, Oral, Synthetic Contraceptives, Oral |
ClinicalTrials.gov processed this record on June 17, 2013