Postpartum Family Planning

Postpartum women often are inadequately protected against rapid repeat pregnancy. Ensuring
adequate inter- birth intervals could prevent an estimated 9% of deaths worldwide among
children less than 5 years of age. Intramuscular injectable depot medroxyprogesterone acetate
(DMPA) is rapidly becoming the method of choice in some settings, including regions where
high maternal and child mortality make birth spacing critical. DMPA possesses many advantages
for postpartum contraception as compared to other methods. However, the World Health
Organization (WHO) advises against use of progestin-only injectables during the first six
weeks postpartum among breastfeeding women. In contrast, the Centers for Disease Control and
Prevention (CDC) recommends that progestin-only injectables generally can be started
immediately postpartum on the grounds that their known advantages, as a whole, outweigh their
unknown risks. This inconsistency in guidance reflects the lack of high-quality data for
making evidence-based decisions. Studies conducted, to date, have important limitations:
short follow-up intervals, low power, lack of consistency in using sensitive and standardized
assessments, and lack of randomized trials evaluating DMPA administration specifically in the
immediate postpartum period. Investigators propose to evaluate the effects of immediate
postpartum initiation of DMPA on breastfeeding and on child development. We will conduct a
randomized controlled trial of 429 adult women who have delivered a healthy, full-term
infant, intend to breastfeed for ≥6 months, and want to use DMPA. Women will be randomized to
receive within 48 hours of delivery: 1) DMPA ("intervention" arm), 2) placebo injection
("placebo" arm) or 3) no injection ("open control" arm). The first two arms will be blinded
while the open control arm will be unblinded. Investigators will determine the effect of
immediate postpartum initiation of DMPA on breastfeeding (Aim 1) and on contraception use
(Aim 2). The proposed trial is innovative in use of 1) a randomized, partially-blinded design
with sufficient power and follow up; 2) standardized, validated measures on lactation as well
as breastfeeding and contraception behaviors; and 3) whole-body air displacement
plethysmography to identify differences between arms in infant body composition. The findings
of a pilot study in the target population support the feasibility of the proposed trial.
Investigators expect the trial findings will permit the harmonization of the WHO and CDC
guidance on the timing of DMPA initiation among breastfeeding women. This would have
important implications for shaping global policy and practice worldwide, especially in
settings where inadequate birth spacing contributes to high maternal and infant morbidity and
mortality.

Inclusion Criteria:

1. Intend to deliver in the Labor and Delivery Unit at Ohio State University Wexner
Medical Center;

2. Are ≥18 years of age;

3. Speak English;

4. Intend to breastfeed, or express milk for their infant, for ≥6 months;

5. Do not want to become pregnant within the first 12 months after delivery;

6. Want to start use of DMPA immediately after delivery before discharge; AND

7. Intend to reside in Ohio for the first 12 months after delivery.

Exclusion Criteria:

8. Undiagnosed vaginal bleeding;

9. Known or suspected malignancy of breast;

10. Active thrombophlebitis, or current or past history of thromboembolic disorders, or
cerebral vascular disease;

11. Liver dysfunction or disease; OR

12. Known hypersensitivity to Depo-Provera.

Women who enroll prenatally will need to rescreen following delivery to confirm their
eligibility. Women enrolling after delivery or who are rescreening will need to meet
criteria 2-12 above as well as the following eligibility criteria:

1. Are a postpartum patient in the Labor and Delivery Unit at OSUWMC; AND

2. Have delivered a term, singleton infant of ≥2500 grams without any apparent health
concerns.