This is a pilot study of early postpartum initiation of the injectable progestin contraception, depo medroxyprogesterone acetate (DMPA), among 40 postpartum people. The study aims to assess the feasibility to conduct a larger trial evaluating the effects of early postpartum initiation DMPA on lactation and infant growth outcomes in Nepal.
The primary objective of this study is to pilot the procedures necessary to demonstrate feasibility for a larger randomized trial evaluating the effects of early postpartum initiation of DMPA on time to lactogenesis (transition to mature milk), lactation continuation, and infant growth and development. The investigators will conduct a pilot study among 40 birthing people who deliver a singleton, healthy, term infant; intend to feed their infant human milk (breastfeed) exclusively for at least 6 months; and plan to use DMPA for postpartum contraception. Participants will be administered DMPA within 48 hours after birth and will be followed for 12 weeks postpartum. Time to lactogenesis, the proportion of participants exclusive feed their infant human milk at 12 weeks, any lactation and infant growth through 12 weeks will be measured. We will analyze time to onset of lactogenesis the proportion of participants exclusively feeding human milk at 12 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
40
Initiation of injectable depo medroxyprogesterone acetate (DMPA) contraception within 48 hours after birth
Provincial Hospital Janakpur of Dhanusha district
Janakpur Dham, Dhanusha District, Nepal
Enrollment feasibility
The ability of project staff to consent and enroll 40 individuals who are willing to participate in this pilot study within 12 weeks.
Time frame: 12 weeks
Time to lactogensis
Amount of time (in hours) from birth to lactogenesis
Time frame: 148 hours
Exclusive lactation
Proportion of participants who report exclusive lactation without supplementation
Time frame: 12 weeks
DMPA Continuation
The proportion of participants who use DMPA continuously for 12 weeks and return for a second dose
Time frame: 12 weeks
Change in infant weight
Infant weight in grams will be compared over 4 weeks
Time frame: Birth to 4 weeks
Change in infant length
Infant length in millimeters will be compared over 4 weeks
Time frame: Birth to 4 weeks
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: Birth to 4 weeks
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