Progestin-Only Pill Use and Breastfeeding Study

Phase 4

Completed

Conditions: Contraception
Breastfeeding

Interventions: Drug: Progestin Only Contraceptive Pills

Registration Number: NCT04965116

Lead Sponsor: University of California, San Diego

Brief Summary: 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.

Detailed Description: 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:

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 30

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Initiation d-POPs	Progestin Only Contraceptive Pills	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.
Early Initiation n-POPs	Progestin Only Contraceptive Pills	Initiation of n-POPs 120-160 hours after delivery. Dosing is 0.35mg daily for 28 days for 2 months.
Interval Initiation of d-POPs	Progestin Only Contraceptive Pills	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.

Primary Outcome Measures

Name	Time	Method
Exclusive Lactation Among Birthing People at 8 Weeks Postpartum.	8 weeks postpartum	Lactation status will be assessed at 8 weeks postpartum through an email self-reported survey.

Secondary Outcome Measures

Name	Time	Method
Satisfaction With Assigned POP	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".
Protein Content of Human Milk	4 weeks postpartum	Mid-feeding milk samples will be pumped by birthing people and analyzed.
Fat Content of Human Milk	4 weeks postpartum	Mid-feeding milk samples will be pumped by birthing people and analyzed.
Change in Infant Height	Baseline and 4 weeks after delivery	Infant length as measured on a marked board to the nearest millimeter will be compared over 4 weeks.
Carbohydrate Content of Human Milk	4 weeks postpartum	Mid-feeding milk samples will be pumped by birthing people and analyzed.
Perception of Milk Supply	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.
Proportion of Birthing People Using Progestin-only Pills at 8 Weeks Postpartum	8 weeks postpartum	Type of contraception being used at 8 weeks postpartum will be assessed through an email self-reported survey.
Vaginal Bleeding	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.
Change in Infant Head Circumference	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.
Change in Infant Weight	Baseline and 4 weeks after delivery	Infant weight in grams will be compared over 4 weeks.