Progestin-Only Pill Use and Breastfeeding Study

Overview

This study will assess the impact of early initiation (less than one week postpartum) and delayed initiation (4 weeks postpartum) of two types of progestin-only contraceptive pills (POPs) on maternal, breastmilk, and infant outcomes.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 21, 2022

Detailed Description

This is a placebo-controlled randomized controlled trial enrolling dyads of mothers and their newborn babies. We will explore if the type and timing of initiation of pills is acceptable to the user with minimal side effects, impacts the supply or composition of breastmilk, and/or affects infant growth. Women will be randomly assigned to 1 of 3 groups and will be blinded to group assignment: 1. immediate initiation of drospirenone-containing progestin-only pills (d-POPs), 2. immediate initiation of norethindrone-containing progestin-only pills (n-POPs) 3. immediate initiation of a placebo pill for one month followed by d-POPs.

Interventions

  • Drug: Progestin Only Contraceptive Pills
    • Daily pill (placebo or active tablet)

Arms, Groups and Cohorts

  • Experimental: Early Initiation d-POPs
    • Initiation of d-POPs 120-160 hours after delivery. Dosing is 4mg daily for 24 days followed by 4 daily inactive tablets for 2 months.
  • Experimental: Early Initiation n-POPs
    • Initiation of n-POPs 120-160 hours after delivery. Dosing is 0.35mg daily for 28 days for 2 months.
  • Placebo Comparator: Interval Initiation of d-POPs
    • Placebo starting 120-160 hours after delivery, continuing for 28 days. Followed by 24 days of 4mg daily of d-POPs and 4 daily inactive tablets.

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of participants exclusively breastfeeding at 2 months postpartum
    • Time Frame: 8 weeks postpartum
    • Exclusive breastfeeding will be assessed at 8 weeks postpartum through an email self-reported survey. Type of infant feeding will be collected weekly beginning with enrollment to ascertain the length of time exclusively breastfeeding and date of stopping if applicable.

Secondary Measures

  • Breastfeeding supplementation type
    • Time Frame: Weeks 2-8 postpartum
    • If not exclusively breastfeeding, type of supplementation will be collected via text and email surveys.
  • Proportion of participants using progestin-only pills at 2 months postpartum
    • Time Frame: 8 weeks postpartum
    • Type of contraception being used at 8 weeks postpartum will be assessed through an email self-reported survey.
  • Vaginal bleeding
    • Time Frame: 4 and 8 weeks postpartum
    • Number of days of any bleeding and spotting in last month will be collected via self-reported email survey.
  • Satisfaction with contraception method
    • Time Frame: 4 and 8 weeks postpartum
    • Overall satisfaction and if participants would recommend the current method of contraception they are using to a friend will be ascertained from an email self-report survey.
  • Protein content of breastmilk
    • Time Frame: 4 weeks postpartum
    • Mid-feeding breastmilk samples will be collected and analyzed.
  • Carbohydrate content of breastmilk
    • Time Frame: 4 weeks postpartum
    • Mid-feeding breastmilk samples will be collected and analyzed.
  • Fat content of breastmilk
    • Time Frame: 4 weeks postpartum
    • Mid-feeding breastmilk samples will be collected and analyzed.
  • Maternal perception of milk supply
    • Time Frame: 4 and 8 weeks postpartum
    • Self-reported perception of adequacy of breastmilk supply will be collected with the 20-item Hill and Humenick Lactation Scale. Minimum scale score is 20 and maximum is 140, with higher scores representing a more positive perception of breastfeeding.
  • Change in infant weight
    • Time Frame: Baseline and 4 weeks after delivery
    • Weight in grams will be compared over 4 weeks.
  • Change in infant height
    • Time Frame: Baseline and 4 weeks after delivery
    • Length as measured on a marked board to the nearest millimeter will be compared over 4 weeks.
  • Change in infant head circumference
    • Time Frame: Baseline and 4 weeks after delivery
    • The maximum diameter through the glabella and occiput is found and measured with a tape measure and recorded to the nearest millimeter and compared over 4 weeks.

Participating in This Clinical Trial

Inclusion Criteria

  • 13 years of age and older – Desires to use POPs for 3 months – Speak English or Spanish – Had a vaginal or cesarean delivery of a singleton full term (≥37 weeks) infant less than 168 hours prior – Intends to breastfeed exclusively for 6 months Exclusion Criteria:

  • Desire another pregnancy in less than 6 months – Do not intend to exclusively breastfeed – Do not have access to a telephone – Have any medical contraindication to POPs – Have any contraindication to breastfeeding, including maternal illegal drug use, history of augmentation or reduction, infant with major congenital anomaly – Cognitively impaired – Currently incarcerated

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of California, San Diego
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sarah Averbach, MD MAS, Associate Professor – University of California, San Diego
  • Overall Official(s)
    • Sarah Averbach, MD, MAS, Principal Investigator, University of California, San Diego

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