Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression

Study Overview
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Brief Summary
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The investigators plan to enroll 184 women who are planning to breastfeed and use DMPA after delivery to find out whether the timing of postpartum administration of DMPA (prior to hospital discharge or 4-6 weeks after delivery) affects the duration or exclusivity of breastfeeding among women who plan to breastfeed their infants.

Detailed Description
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In the United States, depot medroxyprogesterone acetate (DMPA) is given to women after delivery and before hospital discharge with the belief that women who delay starting DMPA may be more likely to become pregnant when they are not yet ready to be pregnant and that giving DMPA before discharge has little to no negative effect on breastfeeding. Administering DMPA to breastfeeding women has not been widely questioned because the limited existing studies do not show any adverse impact of DMPA on breastfeeding. However, these studies used inappropriate control groups and did not control for prior lactation experience. The investigators plan to enroll 184 women who are planning to breastfeed and use DMPA after delivery to find out whether the timing of postpartum administration of DMPA (prior to hospital discharge or 4-6 weeks after delivery) affects the duration or exclusivity of breastfeeding among women who plan to breastfeed their infants. The investigators will also look at rates of use of highly effective contraception (defined as DMPA, intrauterine device, implant, sterilization, or lactational amenorrhea) and postpartum depression.

Official Title
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Effect of Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding Continuation, Contraceptive Continuation, and Postpartum Depression: a Randomized Trial

Conditions
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Contraception, Postpartum Depression, Lactation

Intervention / Treatment
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* Drug: Depot medroxyprogesterone acetate
* Drug: Depot medroxyprogesterone acetate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years old and > 24 0/7 weeks pregnant at time of enrollment Planning to deliver at Magee-Womens Hospital and to breastfeed Plans to use DMPA for postpartum contraception for at least 6 months Willing and able to provide informed consent in English and to comply with study protocol Exclusion Criteria: Intolerance of irregular vaginal bleeding Severe coagulation disorder Severe liver disease (LFTs >2x upper limits of normal at time of randomization) Contraindications to breastfeeding: maternal HIV infection; active herpes simplex with breast lesions; active varicella; active, untreated tuberculosis; antineoplastic, thyrotoxic, or immunosuppressive medications; concern that the infant may have galactosemia History of breast cancer, reduction or augmentation surgery History of severe clinical depression Multiple gestation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DMPA postpartum<br>Depot medroxyprogesterone acetate postpartum | Drug: Depot medroxyprogesterone acetate<br>* Postpartum administration of DMPA (prior to hospital discharge)<br>* Other names: Depo Provera;|
| Active Comparator: DMPA at 4-6 weeks after delivery<br>Depot medroxyprogesterone acetate at 4-6 weeks after delivery | Drug: Depot medroxyprogesterone acetate<br>* Delayed administration of DMPA (4-6 weeks postpartum)<br>* Other names: Depo Provera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA | Any breastfeeding at specific time intervals postpartum | 2, 4, 6, 8 12, 16, 20, 24, and 28 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of Use of Highly Effective Contraception (Defined as DMPA, IUD, Implant, Sterilization, or Lactational Amenorrhea) After Postpartum or Delayed Initiation of DMPA | Use of DMPA, IUD, implant, or sterilization | 6 months | 
| Rates of Postpartum Depression After Postpartum or Delayed Initiation of DMPA | 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 | 8 weeks postpartum | 
| Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA | Exclusive breastfeeding at specific time intervals postpartum | 2, 4, 6, 8, 12, 16, 20,24 and 28 weeks postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum contraception, Contraceptive continuation, Breastfeeding, Postpartum depression, Progestins