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Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression (DEPO-ABCD)

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ClinicalTrials.gov Identifier: NCT01463202
Recruitment Status : Completed
First Posted : November 1, 2011
Results First Posted : March 13, 2018
Last Update Posted : August 31, 2018
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Beatrice Chen, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Contraception
Postpartum Depression
Lactation
Intervention Drug: Depot medroxyprogesterone acetate
Enrollment 184

Recruitment Details  
Pre-assignment Details 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).
Arm/Group Title DMPA Postpartum DMPA at 4-6 Weeks After Delivery
Hide Arm/Group Description

Depot medroxyprogesterone acetate postpartum

Depot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)

Depot medroxyprogesterone acetate at 4-6 weeks after delivery

Depot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)

Period Title: Overall Study
Started [1] 79 78
Completed 79 78
Not Completed 0 0
[1]
27 ineligible postpartum (26 no longer eligible, 1 withdrew consent)
Arm/Group Title DMPA Postpartum DMPA at 4-6 Weeks After Delivery Total
Hide Arm/Group Description

Depot medroxyprogesterone acetate postpartum

Depot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)

Depot medroxyprogesterone acetate at 4-6 weeks after delivery

Depot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)

Total of all reporting groups
Overall Number of Baseline Participants 79 78 157
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 79 participants 78 participants 157 participants
23.9  (4.9) 24.4  (4.7) 24.1  (4.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 78 participants 157 participants
Female
79
 100.0%
78
 100.0%
157
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 78 participants 157 participants
White
11
  13.9%
9
  11.5%
20
  12.7%
Black
61
  77.2%
61
  78.2%
122
  77.7%
Other
7
   8.9%
8
  10.3%
15
   9.6%
Hispanic
3
   3.8%
6
   7.7%
9
   5.7%
1.Primary Outcome
Title Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
Hide Description Any breastfeeding at specific time intervals postpartum
Time Frame 2, 4, 6, 8 12, 16, 20, 24, and 28 weeks postpartum
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
1 ppt withdrawn postrandomization due to enrollment violation (did not meet eligibility criteria)
Arm/Group Title DMPA Postpartum DMPA at 4-6 Weeks After Delivery
Hide Arm/Group Description:

Depot medroxyprogesterone acetate postpartum

Depot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)

Depot medroxyprogesterone acetate at 4-6 weeks after delivery

Depot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)

Overall Number of Participants Analyzed 79 77
Measure Type: Count of Participants
Unit of Measure: Participants
2 weeks postpartum Number Analyzed 79 participants 77 participants
Any breastfeeding
71
  89.9%
70
  90.9%
Formula only
4
   5.1%
4
   5.2%
Missed call
4
   5.1%
3
   3.9%
4 weeks postpartum Number Analyzed 79 participants 77 participants
Any breastfeeding
69
  87.3%
66
  85.7%
Formula only
4
   5.1%
7
   9.1%
Missed call
6
   7.6%
4
   5.2%
6 weeks postpartum Number Analyzed 79 participants 77 participants
Any breastfeeding
61
  77.2%
63
  81.8%
Formula only
9
  11.4%
9
  11.7%
Missed call
9
  11.4%
5
   6.5%
8 weeks postpartum Number Analyzed 79 participants 77 participants
Any breastfeeding
59
  74.7%
53
  68.8%
Formula only
14
  17.7%
16
  20.8%
Missed call
6
   7.6%
8
  10.4%
12 weeks postpartum Number Analyzed 79 participants 76 participants
Any breastfeeding
51
  64.6%
47
  61.8%
Formula only
22
  27.8%
21
  27.6%
Missed call
6
   7.6%
8
  10.5%
16 weeks postpartum Number Analyzed 78 participants 76 participants
Any breastfeeding
40
  51.3%
40
  52.6%
Formula only
30
  38.5%
28
  36.8%
Missed call
8
  10.3%
8
  10.5%
20 weeks postpartum Number Analyzed 78 participants 76 participants
Any breastfeeding
39
  50.0%
31
  40.8%
Formula only
29
  37.2%
34
  44.7%
Missed call
10
  12.8%
11
  14.5%
24 weeks postpartum Number Analyzed 78 participants 76 participants
Any breastfeeding
34
  43.6%
32
  42.1%
Formula only
32
  41.0%
34
  44.7%
Missed call
12
  15.4%
10
  13.2%
28 weeks postpartum Number Analyzed 78 participants 76 participants
Any breastfeeding
39
  50.0%
38
  50.0%
Formula only
28
  35.9%
25
  32.9%
Missed call
11
  14.1%
13
  17.1%
2.Secondary Outcome
Title Rates of Use of Highly Effective Contraception (Defined as DMPA, IUD, Implant, Sterilization, or Lactational Amenorrhea) After Postpartum or Delayed Initiation of DMPA
Hide Description Use of DMPA, IUD, implant, or sterilization
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DMPA Postpartum DMPA at 4-6 Weeks After Delivery
Hide Arm/Group Description:

Depot medroxyprogesterone acetate postpartum

Depot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)

Depot medroxyprogesterone acetate at 4-6 weeks after delivery

Depot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)

Overall Number of Participants Analyzed 79 78
Measure Type: Count of Participants
Unit of Measure: Participants
DMPA, IUD, implant, or sterilization
43
  54.4%
44
  56.4%
Less effective than DMPA
25
  31.6%
21
  26.9%
Lost to followup
11
  13.9%
13
  16.7%
3.Secondary Outcome
Title Rates of Postpartum Depression After Postpartum or Delayed Initiation of DMPA
Hide Description 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
Time Frame 8 weeks postpartum
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Excludes 14 participants with a missed call at 8 weeks postpartum
Arm/Group Title DMPA Postpartum DMPA at 4-6 Weeks After Delivery
Hide Arm/Group Description:

Depot medroxyprogesterone acetate postpartum

Depot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)

Depot medroxyprogesterone acetate at 4-6 weeks after delivery

Depot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)

Overall Number of Participants Analyzed 73 69
Median (Inter-Quartile Range)
Unit of Measure: scores on a scale
1.0
(0 to 4)
0
(0 to 5)
4.Secondary Outcome
Title Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
Hide Description Exclusive breastfeeding at specific time intervals postpartum
Time Frame 2, 4, 6, 8, 12, 16, 20,24 and 28 weeks postpartum
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two participants withdrew during follow-up
Arm/Group Title DMPA Postpartum DMPA at 4-6 Weeks After Delivery
Hide Arm/Group Description:

Depot medroxyprogesterone acetate postpartum

Depot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)

Depot medroxyprogesterone acetate at 4-6 weeks after delivery

Depot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)

Overall Number of Participants Analyzed 79 77
Measure Type: Count of Participants
Unit of Measure: Participants
2 weeks postpartum Number Analyzed 79 participants 77 participants
Exclusive breastfeeding
38
  48.1%
37
  48.1%
Any formula
37
  46.8%
37
  48.1%
Missed call
4
   5.1%
3
   3.9%
4 weeks postpartum Number Analyzed 79 participants 77 participants
Exclusive breastfeeding
29
  36.7%
28
  36.4%
Any formula
44
  55.7%
45
  58.4%
Missed call
6
   7.6%
4
   5.2%
6 weeks postpartum Number Analyzed 79 participants 77 participants
Exclusive breastfeeding
25
  31.6%
25
  32.5%
Any formula
45
  57.0%
47
  61.0%
Missed call
9
  11.4%
5
   6.5%
8 weeks postpartum Number Analyzed 79 participants 77 participants
Exclusive breastfeeding
23
  29.1%
19
  24.7%
Any formula
50
  63.3%
50
  64.9%
Missed call
6
   7.6%
8
  10.4%
12 weeks postpartum Number Analyzed 79 participants 76 participants
Exclusive breastfeeding
17
  21.5%
22
  28.9%
Any formula
56
  70.9%
46
  60.5%
Missed call
6
   7.6%
8
  10.5%
16 weeks postpartum Number Analyzed 78 participants 76 participants
Exclusive breastfeeding
13
  16.7%
15
  19.7%
Any formula
57
  73.1%
53
  69.7%
Missed call
8
  10.3%
8
  10.5%
20 weeks postpartum Number Analyzed 78 participants 76 participants
Exclusive breastfeeding
11
  14.1%
10
  13.2%
Any formula
57
  73.1%
55
  72.4%
Missed call
10
  12.8%
11
  14.5%
24 weeks postpartum Number Analyzed 78 participants 76 participants
Exclusive breastfeeding
9
  11.5%
10
  13.2%
Any formula
57
  73.1%
56
  73.7%
Missed call
12
  15.4%
10
  13.2%
28 weeks postpartum Number Analyzed 78 participants 76 participants
Exclusive breastfeeding
7
   9.0%
6
   7.9%
Any formula
60
  76.9%
57
  75.0%
Missed call
11
  14.1%
13
  17.1%
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DMPA Postpartum DMPA at 4-6 Weeks After Delivery
Hide Arm/Group Description

Depot medroxyprogesterone acetate postpartum

Depot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge)

Depot medroxyprogesterone acetate at 4-6 weeks after delivery

Depot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)

All-Cause Mortality
DMPA Postpartum DMPA at 4-6 Weeks After Delivery
Affected / at Risk (%) Affected / at Risk (%)
Total   0/79 (0.00%)   0/78 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
DMPA Postpartum DMPA at 4-6 Weeks After Delivery
Affected / at Risk (%) Affected / at Risk (%)
Total   0/79 (0.00%)   0/78 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
DMPA Postpartum DMPA at 4-6 Weeks After Delivery
Affected / at Risk (%) Affected / at Risk (%)
Total   0/79 (0.00%)   0/78 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Principal Investigator
Organization: Center for Family Planning Research
Phone: 412-641-5496
EMail: fpr@upmc.edu
Responsible Party: Beatrice Chen, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01463202     History of Changes
Other Study ID Numbers: SFP5-1
First Submitted: October 27, 2011
First Posted: November 1, 2011
Results First Submitted: February 14, 2018
Results First Posted: March 13, 2018
Last Update Posted: August 31, 2018