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Completed

NCT Number: NCT04965116

Progestin-Only Pill Use and Breastfeeding Study

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.

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Key information

Conditions

Contraception Behavior Breast Feeding Breastfeeding Feeding Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of California, San Diego

La Jolla, California, 92093, United States

About this study

This is a placebo-controlled randomized controlled trial enrolling dyads of birthing people and their newborn infants. 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.

Birthing people will be randomly assigned to 1 of 3 groups and will be blinded to group assignment:

  • immediate initiation of drospirenone-containing progestin-only pills (d-POPs),
  • immediate initiation of norethindrone-containing progestin-only pills (n-POPs)
  • immediate initiation of a placebo pill for one month followed by d-POPs.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 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

Treatment and study plan

Progestin Only Contraceptive Pills

Drug

Daily pill (placebo or active tablet)

Other names: Slynd, Camila, Micronor, Errin

Primary outcomes

  1. Exclusive Lactation Among Birthing People at 8 Weeks Postpartum.

    Time frame: 8 weeks postpartum

    Lactation status will be assessed at 8 weeks postpartum through an email self-reported survey.

Secondary outcomes

  1. Proportion of Birthing People Using Progestin-only Pills at 8 Weeks Postpartum

    Time frame: 8 weeks postpartum

    Type of contraception being used at 8 weeks postpartum will be assessed through an email self-reported survey.

  2. Vaginal Bleeding

    Time frame: 8 weeks postpartum

    Number of days of any bleeding and spotting among birthing people in last week will be collected via self-reported email survey.

  3. Satisfaction With Assigned POP

    Time frame: 8 weeks postpartum

    Overall satisfaction and if birthing people would recommend the POP they were assigned to use to a friend will be ascertained from an email self-report survey. Counts are the number of birthing people who responded "yes".

  4. Protein Content of Human Milk

    Time frame: 4 weeks postpartum

    Mid-feeding milk samples will be pumped by birthing people and analyzed.

  5. Carbohydrate Content of Human Milk

    Time frame: 4 weeks postpartum

    Mid-feeding milk samples will be pumped by birthing people and analyzed.

  6. Fat Content of Human Milk

    Time frame: 4 weeks postpartum

    Mid-feeding milk samples will be pumped by birthing people and analyzed.

  7. Perception of Milk Supply

    Time frame: 8 weeks postpartum

    Self-reported perception of adequacy of milk supply will be collected with the 20-item Hill and Humenick Lactation Scale among birthing people. Minimum scale score is 20 and maximum is 140, with higher scores representing a more positive perception of breastfeeding.

  8. Change in Infant Weight

    Time frame: Baseline and 4 weeks after delivery

    Infant weight in grams will be compared over 4 weeks.

  9. Change in Infant Height

    Time frame: Baseline and 4 weeks after delivery

    Infant length as measured on a marked board to the nearest millimeter will be compared over 4 weeks.

  10. Change in Infant Head Circumference

    Time frame: Baseline and 4 weeks after delivery

    The maximum diameter through the infant's glabella and occiput is found and measured with a tape measure and recorded to the nearest millimeter and compared over 4 weeks.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 16, 2021
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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