Trial Outcomes & Findings for Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression (NCT NCT01463202)
NCT ID: NCT01463202
Last Updated: 2018-08-31
Results Overview
Any breastfeeding at specific time intervals postpartum
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
184 participants
Primary outcome timeframe
2, 4, 6, 8 12, 16, 20, 24, and 28 weeks postpartum
Results posted on
2018-08-31
Participant Flow
Since participants could be recruited antepartum but may have changed their mind about breastfeeding or DMPA use post-partum, eligibility criteria were re-assessed postpartum, prior to randomization, thus the number of women enrolled in the study (184) does not equal the number of women randomized (157).
Participant milestones
| Measure |
DMPA Postpartum
Depot medroxyprogesterone acetate postpartum
Depot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)
|
DMPA at 4-6 Weeks After Delivery
Depot medroxyprogesterone acetate at 4-6 weeks after delivery
Depot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)
|
|---|---|---|
|
Overall Study
STARTED
|
79
|
78
|
|
Overall Study
COMPLETED
|
79
|
78
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression
Baseline characteristics by cohort
| Measure |
DMPA Postpartum
n=79 Participants
Depot medroxyprogesterone acetate postpartum
Depot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)
|
DMPA at 4-6 Weeks After Delivery
n=78 Participants
Depot medroxyprogesterone acetate at 4-6 weeks after delivery
Depot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.9 years
STANDARD_DEVIATION 4.9 • n=99 Participants
|
24.4 years
STANDARD_DEVIATION 4.7 • n=107 Participants
|
24.1 years
STANDARD_DEVIATION 4.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
157 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
61 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
122 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2, 4, 6, 8 12, 16, 20, 24, and 28 weeks postpartumPopulation: 1 ppt withdrawn postrandomization due to enrollment violation (did not meet eligibility criteria)
Any breastfeeding at specific time intervals postpartum
Outcome measures
| Measure |
DMPA Postpartum
n=79 Participants
Depot medroxyprogesterone acetate postpartum
Depot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)
|
DMPA at 4-6 Weeks After Delivery
n=77 Participants
Depot medroxyprogesterone acetate at 4-6 weeks after delivery
Depot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)
|
|---|---|---|
|
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
2 weeks postpartum · Any breastfeeding
|
71 Participants
|
70 Participants
|
|
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
2 weeks postpartum · Formula only
|
4 Participants
|
4 Participants
|
|
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
2 weeks postpartum · Missed call
|
4 Participants
|
3 Participants
|
|
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
4 weeks postpartum · Any breastfeeding
|
69 Participants
|
66 Participants
|
|
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
4 weeks postpartum · Formula only
|
4 Participants
|
7 Participants
|
|
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
4 weeks postpartum · Missed call
|
6 Participants
|
4 Participants
|
|
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
6 weeks postpartum · Any breastfeeding
|
61 Participants
|
63 Participants
|
|
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
6 weeks postpartum · Formula only
|
9 Participants
|
9 Participants
|
|
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
6 weeks postpartum · Missed call
|
9 Participants
|
5 Participants
|
|
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
8 weeks postpartum · Any breastfeeding
|
59 Participants
|
53 Participants
|
|
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
8 weeks postpartum · Formula only
|
14 Participants
|
16 Participants
|
|
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
8 weeks postpartum · Missed call
|
6 Participants
|
8 Participants
|
|
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
12 weeks postpartum · Any breastfeeding
|
51 Participants
|
47 Participants
|
|
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
12 weeks postpartum · Formula only
|
22 Participants
|
21 Participants
|
|
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
12 weeks postpartum · Missed call
|
6 Participants
|
8 Participants
|
|
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
16 weeks postpartum · Any breastfeeding
|
40 Participants
|
40 Participants
|
|
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
16 weeks postpartum · Formula only
|
30 Participants
|
28 Participants
|
|
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
16 weeks postpartum · Missed call
|
8 Participants
|
8 Participants
|
|
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
20 weeks postpartum · Any breastfeeding
|
39 Participants
|
31 Participants
|
|
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
20 weeks postpartum · Formula only
|
29 Participants
|
34 Participants
|
|
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
20 weeks postpartum · Missed call
|
10 Participants
|
11 Participants
|
|
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
24 weeks postpartum · Any breastfeeding
|
34 Participants
|
32 Participants
|
|
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
24 weeks postpartum · Formula only
|
32 Participants
|
34 Participants
|
|
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
24 weeks postpartum · Missed call
|
12 Participants
|
10 Participants
|
|
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
28 weeks postpartum · Any breastfeeding
|
39 Participants
|
38 Participants
|
|
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
28 weeks postpartum · Formula only
|
28 Participants
|
25 Participants
|
|
Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
28 weeks postpartum · Missed call
|
11 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 6 monthsUse of DMPA, IUD, implant, or sterilization
Outcome measures
| Measure |
DMPA Postpartum
n=79 Participants
Depot medroxyprogesterone acetate postpartum
Depot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)
|
DMPA at 4-6 Weeks After Delivery
n=78 Participants
Depot medroxyprogesterone acetate at 4-6 weeks after delivery
Depot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)
|
|---|---|---|
|
Rates of Use of Highly Effective Contraception (Defined as DMPA, IUD, Implant, Sterilization, or Lactational Amenorrhea) After Postpartum or Delayed Initiation of DMPA
DMPA, IUD, implant, or sterilization
|
43 Participants
|
44 Participants
|
|
Rates of Use of Highly Effective Contraception (Defined as DMPA, IUD, Implant, Sterilization, or Lactational Amenorrhea) After Postpartum or Delayed Initiation of DMPA
Less effective than DMPA
|
25 Participants
|
21 Participants
|
|
Rates of Use of Highly Effective Contraception (Defined as DMPA, IUD, Implant, Sterilization, or Lactational Amenorrhea) After Postpartum or Delayed Initiation of DMPA
Lost to followup
|
11 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 8 weeks postpartumPopulation: Excludes 14 participants with a missed call at 8 weeks postpartum
Edinburgh Postnatal Depression Scale (EPDS) score after postpartum or delayed initiation of DMPA: minimum possible score 0, maximum possible score 30; score of 12 or greater is a positive screen for postpartum depression
Outcome measures
| Measure |
DMPA Postpartum
n=73 Participants
Depot medroxyprogesterone acetate postpartum
Depot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)
|
DMPA at 4-6 Weeks After Delivery
n=69 Participants
Depot medroxyprogesterone acetate at 4-6 weeks after delivery
Depot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)
|
|---|---|---|
|
Rates of Postpartum Depression After Postpartum or Delayed Initiation of DMPA
|
1.0 scores on a scale
Interval 0.0 to 4.0
|
0 scores on a scale
Interval 0.0 to 5.0
|
SECONDARY outcome
Timeframe: 2, 4, 6, 8, 12, 16, 20,24 and 28 weeks postpartumPopulation: Two participants withdrew during follow-up
Exclusive breastfeeding at specific time intervals postpartum
Outcome measures
| Measure |
DMPA Postpartum
n=79 Participants
Depot medroxyprogesterone acetate postpartum
Depot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)
|
DMPA at 4-6 Weeks After Delivery
n=77 Participants
Depot medroxyprogesterone acetate at 4-6 weeks after delivery
Depot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)
|
|---|---|---|
|
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
2 weeks postpartum · Any formula
|
37 Participants
|
37 Participants
|
|
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
2 weeks postpartum · Missed call
|
4 Participants
|
3 Participants
|
|
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
20 weeks postpartum · Any formula
|
57 Participants
|
55 Participants
|
|
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
2 weeks postpartum · Exclusive breastfeeding
|
38 Participants
|
37 Participants
|
|
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
4 weeks postpartum · Exclusive breastfeeding
|
29 Participants
|
28 Participants
|
|
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
4 weeks postpartum · Any formula
|
44 Participants
|
45 Participants
|
|
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
4 weeks postpartum · Missed call
|
6 Participants
|
4 Participants
|
|
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
6 weeks postpartum · Exclusive breastfeeding
|
25 Participants
|
25 Participants
|
|
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
6 weeks postpartum · Any formula
|
45 Participants
|
47 Participants
|
|
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
6 weeks postpartum · Missed call
|
9 Participants
|
5 Participants
|
|
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
8 weeks postpartum · Exclusive breastfeeding
|
23 Participants
|
19 Participants
|
|
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
8 weeks postpartum · Any formula
|
50 Participants
|
50 Participants
|
|
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
8 weeks postpartum · Missed call
|
6 Participants
|
8 Participants
|
|
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
12 weeks postpartum · Exclusive breastfeeding
|
17 Participants
|
22 Participants
|
|
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
12 weeks postpartum · Any formula
|
56 Participants
|
46 Participants
|
|
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
12 weeks postpartum · Missed call
|
6 Participants
|
8 Participants
|
|
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
16 weeks postpartum · Exclusive breastfeeding
|
13 Participants
|
15 Participants
|
|
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
16 weeks postpartum · Any formula
|
57 Participants
|
53 Participants
|
|
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
16 weeks postpartum · Missed call
|
8 Participants
|
8 Participants
|
|
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
20 weeks postpartum · Exclusive breastfeeding
|
11 Participants
|
10 Participants
|
|
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
20 weeks postpartum · Missed call
|
10 Participants
|
11 Participants
|
|
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
24 weeks postpartum · Exclusive breastfeeding
|
9 Participants
|
10 Participants
|
|
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
24 weeks postpartum · Any formula
|
57 Participants
|
56 Participants
|
|
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
24 weeks postpartum · Missed call
|
12 Participants
|
10 Participants
|
|
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
28 weeks postpartum · Exclusive breastfeeding
|
7 Participants
|
6 Participants
|
|
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
28 weeks postpartum · Any formula
|
60 Participants
|
57 Participants
|
|
Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
28 weeks postpartum · Missed call
|
11 Participants
|
13 Participants
|
Adverse Events
DMPA Postpartum
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DMPA at 4-6 Weeks After Delivery
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
Principal Investigator
Center for Family Planning Research
Phone: 412-641-5496
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place