Postpartum Contraception, Depot Medroxyprogesterone Acetate, Lactation, DMPA
Conditions
Keywords
Depo, Injectable contaception, postpartum, contraception, family planning, DMPA
Brief summary
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.
Detailed description
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.
Interventions
Initiation of injectable depo medroxyprogesterone acetate (DMPA) contraception within 48 hours after birth
Sponsors
Center for Research on Environment, Health and Population Activities
University of California, San Diego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Currently live in Nepal * Had a vaginal or cesarean delivery of a singleton full-term infant within the past 48 hours * Not yet undergone lactogenesis * Desire to use DMPA as a method of postpartum contraception
Exclusion criteria
* Desire a repeat pregnancy in less than 6 months * Do not intend to exclusively feed infant own human milk for 6 months * Do not have access to a telephone * Any medical contraindication to DMPA * Any contraindication to human milk feeding for their infant * History of breast surgery (augmentation or reduction) * Infant with a major congenital anomaly (will be excluded due to unique challenges with feeding in these populations)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment feasibility | 12 weeks | The ability of project staff to consent and enroll 40 individuals who are willing to participate in this pilot study within 12 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exclusive lactation | 12 weeks | Proportion of participants who report exclusive lactation without supplementation |
| DMPA Continuation | 12 weeks | The proportion of participants who use DMPA continuously for 12 weeks and return for a second dose |
| Time to lactogensis | 148 hours | Amount of time (in hours) from birth to lactogenesis |
| Change in infant length | Birth to 4 weeks | Infant length in millimeters will be compared over 4 weeks |
| Change in infant head circumference | Birth to 4 weeks | 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 |
| Change in infant weight | Birth to 4 weeks | Infant weight in grams will be compared over 4 weeks |
Countries
Nepal
Outcome results
None listed