Clinical trial NCT04965116: Progestin-Only Pill Use and Breastfeeding Study
Official title: Progestin-Only Pill Use and Breastfeeding Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Breastfeeding
Keywords: Minipill
Progestin-only Pill
Postpartum
Slynd
Camila
Micronor
Infant growth
Breastmilk
Drospirenone
Norethindrone
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Exclusive Lactation Among Birthing People at 8 Weeks Postpartum.
timeFrame: 8 weeks postpartum
Secondary outcomes:
measure: Proportion of Birthing People Using Progestin-only Pills at 8 Weeks Postpartum
timeFrame: 8 weeks postpartum
measure: Vaginal Bleeding
timeFrame: 8 weeks postpartum
measure: Satisfaction With Assigned POP
timeFrame: 8 weeks postpartum
measure: Protein Content of Human Milk
timeFrame: 4 weeks postpartum
measure: Carbohydrate Content of Human Milk
timeFrame: 4 weeks postpartum
measure: Fat Content of Human Milk
timeFrame: 4 weeks postpartum
measure: Perception of Milk Supply
timeFrame: 8 weeks postpartum
measure: Change in Infant Weight
timeFrame: Baseline and 4 weeks after delivery
measure: Change in Infant Height
timeFrame: Baseline and 4 weeks after delivery
measure: Change in Infant Head Circumference
timeFrame: Baseline and 4 weeks after delivery
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Sarah Averbach, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: