Progestin-Only Pill Use and Breastfeeding Study

University of California San Diego

Status and phase: Completed; Phase 4

Conditions: Contraception; Breastfeeding

Treatments: Drug: Progestin Only Contraceptive Pills

Study type: Interventional

Funder types: Other

Identifiers

NCT04965116

210357

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups, including a placebo group

Early Initiation d-POPs

Experimental group

Description:

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.

Treatment:

Drug: Progestin Only Contraceptive Pills

Early Initiation n-POPs

Experimental group

Description:

Initiation of n-POPs 120-160 hours after delivery. Dosing is 0.35mg daily for 28 days for 2 months.

Treatment:

Drug: Progestin Only Contraceptive Pills

Interval Initiation of d-POPs

Placebo Comparator group

Description:

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.

Treatment:

Drug: Progestin Only Contraceptive Pills