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BLIS - Breastfeeding Levonorgestrel IUD Study

Information source: University of Utah
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception

Intervention: Levonorgestrel IUD (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Utah

Official(s) and/or principal investigator(s):
David K Turok, MD, Principal Investigator, Affiliation: University of Utah Department of Obstetrics & Gynecology

Overall contact:
Maria Masters, Phone: 801-213-2286, Email: maria.masters@hsc.utah.edu

Summary

We are studying the effect of placing the levonorgestrel IUD (Mirena) immediately after birth on breastfeeding. Women who wish to have a levonorgestrel IUD placed after their birth, wish to breastfeed, and are willing to participate in the study will be randomly assigned to either get the IUD placed immediately after delivery of the baby and placenta or 4-6 weeks later. We do not believe there will be a difference in breastfeeding 8 weeks after delivery between those who get the IUD placed early or later.

Clinical Details

Official title: Randomized Controlled Trial of Early Versus Standard Postpartum Insertion of the Levonorgestrel IUD to Assess Breast Feeding Outcomes (BLIS - Breastfeeding Levonorgestrel IUD Study)

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Breastfeeding continuation rates at 8 weeks postpartum

Secondary outcome: Lactogenesis Stage 2

Detailed description: Increasing use of the levonorgestrel intrauterine device (LNG IUD) has become a cornerstone of U. S. efforts to decrease our nation's high rate of unplanned pregnancy. Many women initiate use of this method in the post partum period. The major advantage of immediate postplacental LNG IUD insertion is the prompt initiation of a highly effective contraceptive method at a time that does not interfere with the intense demands of newborn care, but any contraceptive method initiated in the postpartum period must not interfere with breastfeeding. Our long-term goal is to understand the impact of hormonal contraceptives, initiated early in the postpartum period, on breastfeeding. The central hypothesis is that quality of breastfeeding is not negatively affected by progestin-only hormonal contraceptives. We will pursue three specific aims comparing women randomized to immediate post-placental vs. delayed (4-6 week) postpartum LNG IUD insertion: Aim #1: To determine breastfeeding continuation rates at 8 weeks in both groups Aim #2: To determine timing of lactogenesis in both groups Aim #3: To assess breastfeeding continuation, exclusivity, and satisfaction as well as continuation and satisfaction with the LNG IUD at 26 weeks postpartum in both groups This proposal will support a non-inferiority RCT where participants will be randomly assigned to immediate postplacental insertion (within 10 minutes of placental delivery) or delayed postpartum insertion (4-6 weeks postpartum). This project will provide needed evidence on breastfeeding impact of early postpartum initiation of the LNG IUD.

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Healthy, 18-40 year old pregnant women

- Intend to breastfeed

- Desire the LNG IUD as their method of contraception

- Agree to be randomized to early versus standard postpartum insertion

- Have delivered a healthy term infant (37 weeks gestation)

- Willing to complete all study related procedures, visits and questionnaires

Exclusion Criteria:

- Chorioamnionitis

- Obstetric complications including transfusion

- Severe pregnancy induced hypertension

- Prolonged hospitalization

- Coagulopathy

- Liver disease

- Undiagnosed genital bleeding, or other relative contraindication to LNG IUD insertion

(known or suspected pregnancy, uterine cavity abnormality, known, suspected, or history of breast cancer, or hypersensitivity to any of the components in the LNG IUD).

Locations and Contacts

Maria Masters, Phone: 801-213-2286, Email: maria.masters@hsc.utah.edu

University of New Mexico, Albuquerque, New Mexico 87131, United States; Recruiting
Anne Fullilove, Phone: 505-272-6391, Email: AMFullilove@salud.unm.edu
Eve Espey, MD, Principal Investigator

University of Utah Health Sciences Center, Salt Lake City, Utah 84132, United States; Recruiting
David K Turok, MD, Email: david.turok@hsc.utah.edu
David K Turok, MD, Principal Investigator

Additional Information

Starting date: January 2014
Last updated: August 7, 2015

Page last updated: August 23, 2015

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