Progestin-Only Pill Use and Breastfeeding Study

Contraception Clinical Trial

Official title:

Progestin-Only Pill Use and Breastfeeding Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04965116
• Other study ID #: 210357
• Status: Completed
• Phase: Phase 4
• Start date: October 25, 2021
• Est. completion date: November 4, 2022

Study information

• Verified date: April 2024
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 4, 2022
• Est. primary completion date: November 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding
• Contraception

Intervention

Drug:
• Progestin Only Contraceptive Pills
Daily pill (placebo or active tablet)

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exclusive Lactation Among Birthing People at 8 Weeks Postpartum.	Lactation status will be assessed at 8 weeks postpartum through an email self-reported survey.	8 weeks postpartum
Secondary	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.	8 weeks postpartum
Secondary	Vaginal Bleeding	Number of days of any bleeding and spotting among birthing people in last week will be collected via self-reported email survey.	8 weeks postpartum
Secondary	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".	8 weeks postpartum
Secondary	Protein Content of Human Milk	Mid-feeding milk samples will be pumped by birthing people and analyzed.	4 weeks postpartum
Secondary	Carbohydrate Content of Human Milk	Mid-feeding milk samples will be pumped by birthing people and analyzed.	4 weeks postpartum
Secondary	Fat Content of Human Milk	Mid-feeding milk samples will be pumped by birthing people and analyzed.	4 weeks postpartum
Secondary	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.	8 weeks postpartum
Secondary	Change in Infant Weight	Infant weight in grams will be compared over 4 weeks.	Baseline and 4 weeks after delivery
Secondary	Change in Infant Height	Infant length as measured on a marked board to the nearest millimeter will be compared over 4 weeks.	Baseline and 4 weeks after delivery
Secondary	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.	Baseline and 4 weeks after delivery