Trial Outcomes & Findings for Postpartum Family Planning (NCT NCT03844633)
NCT ID: NCT03844633
Last Updated: 2024-05-07
Results Overview
Self-reported time to lactogenesis stage 2 (i.e., milk "let-down")
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
49 participants
Primary outcome timeframe
within 7 days postpartum
Results posted on
2024-05-07
Participant Flow
1 enrolled participant was missing data on their assigned arm.
Participant milestones
| Measure |
Intervention Arm
Intramuscular injectable depot medroxyprogesterone acetate (1 mL of medroxyprogesterone acetate sterile aqueous suspension 150 mg/mL) provided within 48 hours of childbirth
Depo-Provera Injectable Product: Depo-Provera Injectable Product -- Shot administered within 48 hours of childbirth
|
Placebo Arm
0.9% sodium chloride injection provided within 48 hours of childbirth
Placebos: Placebos -- Shot administered within 48 hours of childbirth
|
Open Arm
No intervention provided
|
|---|---|---|---|
|
1 Week FU
STARTED
|
16
|
15
|
17
|
|
1 Week FU
COMPLETED
|
16
|
14
|
13
|
|
1 Week FU
NOT COMPLETED
|
0
|
1
|
4
|
|
12-month Follow-up
STARTED
|
16
|
15
|
17
|
|
12-month Follow-up
COMPLETED
|
9
|
10
|
9
|
|
12-month Follow-up
NOT COMPLETED
|
7
|
5
|
8
|
Reasons for withdrawal
| Measure |
Intervention Arm
Intramuscular injectable depot medroxyprogesterone acetate (1 mL of medroxyprogesterone acetate sterile aqueous suspension 150 mg/mL) provided within 48 hours of childbirth
Depo-Provera Injectable Product: Depo-Provera Injectable Product -- Shot administered within 48 hours of childbirth
|
Placebo Arm
0.9% sodium chloride injection provided within 48 hours of childbirth
Placebos: Placebos -- Shot administered within 48 hours of childbirth
|
Open Arm
No intervention provided
|
|---|---|---|---|
|
1 Week FU
Lost to Follow-up
|
0
|
1
|
4
|
|
12-month Follow-up
Lost to Follow-up
|
7
|
5
|
8
|
Baseline Characteristics
Postpartum Family Planning
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=16 Participants
Intramuscular injectable depot medroxyprogesterone acetate (1 mL of medroxyprogesterone acetate sterile aqueous suspension 150 mg/mL) provided within 48 hours of childbirth
Depo-Provera Injectable Product: Depo-Provera Injectable Product -- Shot administered within 48 hours of childbirth
|
Placebo Arm
n=15 Participants
0.9% sodium chloride injection provided within 48 hours of childbirth
Placebos: Placebos -- Shot administered within 48 hours of childbirth
|
Open Arm
n=17 Participants
No intervention provided
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Age, Continuous
|
28.9 Years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
29.3 Years
STANDARD_DEVIATION 5.9 • n=7 Participants
|
29.1 Years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
29.1 Years
STANDARD_DEVIATION 5.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Study site
Columbus, OH
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Study site
Atlanta, GA
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: within 7 days postpartumSelf-reported time to lactogenesis stage 2 (i.e., milk "let-down")
Outcome measures
| Measure |
Intervention Arm
n=16 Participants
Intramuscular injectable depot medroxyprogesterone acetate (1 mL of medroxyprogesterone acetate sterile aqueous suspension 150 mg/mL) provided within 48 hours of childbirth
Depo-Provera Injectable Product: Depo-Provera Injectable Product -- Shot administered within 48 hours of childbirth
|
Placebo Arm
n=14 Participants
0.9% sodium chloride injection provided within 48 hours of childbirth
Placebos: Placebos -- Shot administered within 48 hours of childbirth
|
Open Arm
n=13 Participants
No intervention provided
|
|---|---|---|---|
|
Time to Lactogenesis Stage 2
|
44.8 hours
Interval 11.3 to 125.6
|
47.2 hours
Interval 1.5 to 112.0
|
50.4 hours
Interval 1.0 to 103.4
|
PRIMARY outcome
Timeframe: At 12 months postpartumRates of use of a highly-effective method of contraception (defined here as DMPA, implant, IUD, sterilization, pill, patch, or ring) at 12 months post-delivery among women in the intervention or placebo arm versus those in the open control arm
Outcome measures
| Measure |
Intervention Arm
n=9 Participants
Intramuscular injectable depot medroxyprogesterone acetate (1 mL of medroxyprogesterone acetate sterile aqueous suspension 150 mg/mL) provided within 48 hours of childbirth
Depo-Provera Injectable Product: Depo-Provera Injectable Product -- Shot administered within 48 hours of childbirth
|
Placebo Arm
n=10 Participants
0.9% sodium chloride injection provided within 48 hours of childbirth
Placebos: Placebos -- Shot administered within 48 hours of childbirth
|
Open Arm
n=9 Participants
No intervention provided
|
|---|---|---|---|
|
Use of Highly-effective Contraception
|
7 Participants
|
6 Participants
|
4 Participants
|
Adverse Events
Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Open Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place