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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
30
Daily pill (placebo or active tablet)
University of California, San Diego
La Jolla, California, United States
Exclusive Lactation Among Birthing People at 8 Weeks Postpartum.
Lactation status will be assessed at 8 weeks postpartum through an email self-reported survey.
Time frame: 8 weeks postpartum
Proportion of Birthing People Using Progestin-only Pills at 8 Weeks Postpartum
Type of contraception being used at 8 weeks postpartum will be assessed through an email self-reported survey.
Time frame: 8 weeks postpartum
Vaginal Bleeding
Number of days of any bleeding and spotting among birthing people in last week will be collected via self-reported email survey.
Time frame: 8 weeks postpartum
Satisfaction With Assigned POP
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".
Time frame: 8 weeks postpartum
Protein Content of Human Milk
Mid-feeding milk samples will be pumped by birthing people and analyzed.
Time frame: 4 weeks postpartum
Carbohydrate Content of Human Milk
Mid-feeding milk samples will be pumped by birthing people and analyzed.
Time frame: 4 weeks postpartum
Fat Content of Human Milk
Mid-feeding milk samples will be pumped by birthing people and analyzed.
Time frame: 4 weeks postpartum
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Perception of Milk Supply
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.
Time frame: 8 weeks postpartum
Change in Infant Weight
Infant weight in grams will be compared over 4 weeks.
Time frame: Baseline and 4 weeks after delivery
Change in Infant Height
Infant length as measured on a marked board to the nearest millimeter will be compared over 4 weeks.
Time frame: Baseline and 4 weeks after delivery
Change in Infant Head Circumference
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.
Time frame: Baseline and 4 weeks after delivery