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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 : June 14, 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups
  Description
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)


Participant Flow:   Overall Study
    DMPA Postpartum   DMPA at 4-6 Weeks After Delivery
STARTED [1]   79   78 
COMPLETED   79   78 
NOT COMPLETED   0   0 
[1] 27 ineligible postpartum (26 no longer eligible, 1 withdrew consent)



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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)

Total Total of all reporting groups

Baseline Measures
   DMPA Postpartum   DMPA at 4-6 Weeks After Delivery   Total 
Overall Participants Analyzed 
[Units: Participants]
 79   78   157 
Age 
[Units: Years]
Mean (Standard Deviation)
 23.9  (4.9)   24.4  (4.7)   24.1  (4.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      79 100.0%      78 100.0%      157 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White   11   9   20 
Black   61   61   122 
Other   7   8   15 
Hispanic   3   6   9 


  Outcome Measures

1.  Primary:   Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA   [ Time Frame: 2, 4, 6, 8 12, 16, 20, 24, and 28 weeks postpartum ]

2.  Secondary:   Rates of Use of Highly Effective Contraception (Defined as DMPA, IUD, Implant, Sterilization, or Lactational Amenorrhea) After Postpartum or Delayed Initiation of DMPA   [ Time Frame: 6 months ]

3.  Secondary:   Rates of Postpartum Depression After Postpartum or Delayed Initiation of DMPA   [ Time Frame: 8 weeks postpartum ]

4.  Secondary:   Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA   [ Time Frame: 2, 4, 6, 8, 12, 16, 20,24 and 28 weeks postpartum ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: 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: June 14, 2018