ContraceptionPhase 4DEPO-ABCDNCT01463202
Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression
A Phase 4 study testing Depot medroxyprogesterone acetate in people with Contraception and Postpartum Depression, run by Beatrice Chen at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Postpartum Depression, Lactation
- What is being tested?
- Depot medroxyprogesterone acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to 16 Oct 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Family Planning Research, Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Effect of Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding Continuation, Contraceptive Continuation, and Postpartum Depression: a Randomized Trial
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.
Read the detailed description
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.
- Conditions
- Contraception, Postpartum Depression, Lactation
- Being tested
- Depot medroxyprogesterone acetate
- Keywords
- Postpartum contraception, Contraceptive continuation, Breastfeeding, Postpartum depression, Progestins
- Medical subject headings
- Depression, Postpartum, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depot medroxyprogesterone acetateDrug
Also called DMPA, Depo Provera
Postpartum administration of DMPA (prior to hospital discharge)
Depot medroxyprogesterone acetateDrug
Also called DMPA, Depo Provera
Delayed administration of DMPA (4-6 weeks postpartum)
| Study group | Role | What they receive |
|---|---|---|
| DMPA postpartum | Active comparator | Depot medroxyprogesterone acetate postpartum Receives: Drug: Depot medroxyprogesterone acetate |
| DMPA at 4-6 weeks after delivery | Active comparator | Depot medroxyprogesterone acetate at 4-6 weeks after delivery Receives: Drug: Depot medroxyprogesterone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2, 4, 6, 8 12, 16, 20, 24, and 28 weeks postpartum
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 2, 4, 6, 8, 12, 16, 20,24 and 28 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2011 (estimated)
- Study startNov 2011
- Primary completion13 Feb 2017
- Study completion16 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beatrice Chen
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Sponsor-investigator, Beatrice Chen, University of Pittsburgh
- Investigators
- Study Coordinator, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463202
- Sponsor's protocol ID
- SFP5-1
- Acronym
- DEPO-ABCD
- Status last verified
- Aug 2018
- First submitted
- 27 Oct 2011
- Last updated
- 31 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding Continuation, Contraceptive Continuation, and Postpartum Depression: a Randomized Trial
- ClinicalTrials.gov ID
- NCT01463202
- Acronym / sponsor ID
- DEPO-ABCD / SFP5-1
- Conditions
- Contraception, Postpartum Depression, Lactation
- Keywords
- Postpartum contraception, Contraceptive continuation, Breastfeeding, Postpartum depression, Progestins
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Beatrice ChenUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- Nov 2011
- Primary completion
- 13 Feb 2017 (actual)
- Study completion
- 16 Oct 2017 (actual)
- First posted
- 1 Nov 2011 (estimated)
- Results
- Posted 13 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DMPA postpartum | Active comparator | Drug: Depot medroxyprogesterone acetateDepot medroxyprogesterone acetate postpartum |
| DMPA at 4-6 weeks after delivery | Active comparator | Drug: Depot medroxyprogesterone acetateDepot medroxyprogesterone acetate at 4-6 weeks after delivery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Depot medroxyprogesterone acetateAlso: DMPA, Depo ProveraPostpartum administration of DMPA (prior to hospital discharge) | Drug | DMPA postpartum |
| Depot medroxyprogesterone acetateAlso: DMPA, Depo ProveraDelayed administration of DMPA (4-6 weeks postpartum) | Drug | DMPA at 4-6 weeks after delivery |
Primary outcome
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
Any breastfeeding at specific time intervals postpartum
3 secondary outcomes
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
Rates of Postpartum Depression After Postpartum or Delayed Initiation of DMPA
Time frame: 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
Time frame: 2, 4, 6, 8, 12, 16, 20,24 and 28 weeks postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Contraception
Enrolling by invitation
Flo Digital Contraceptive Study
Contraception Use
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Coordinator principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Depot medroxyprogesterone acetate in people with Contraception and Postpartum Depression, run by Beatrice Chen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.