Delay in Time to Lactogenesis Stage IIPhase 4NCT03844633
Postpartum Family Planning
A Phase 4 study testing Depo-Provera Injectable Product in people with Delay in Time to Lactogenesis Stage II, run by Ohio State University at 1 site in United States.
Trial summary
Investigators will conduct a randomized controlled trial (RCT) to evaluate the effects of immediate postpartum initiation of DMPA on breastfeeding and long-term contraceptive use. 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
- Delay in Time to Lactogenesis Stage II
- What is being tested?
- Depo-Provera Injectable Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2019to 18 Apr 2022
- 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
- Intend to deliver in the Labor and Delivery Unit at Ohio State University Wexner Medical Center, Grady Memorial Hospital or Emory University Midtown;
- Are ≥18 years of age;
- Speak English;
- Intend to breastfeed, or express milk for their infant, for ≥6 months;
- Do not want to become pregnant within the first 12 months after delivery;
- Want to start use of DMPA immediately after delivery before discharge or no hormonal contraception immediately postpartum; AND
- Intend to reside in Ohio or Georgia for the first 12 months after delivery.
Who cannot join
- Undiagnosed vaginal bleeding;
- Known or suspected malignancy of breast;
- Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease;
- Liver dysfunction or disease; OR
- Known hypersensitivity to Depo-Provera.
- Women who enroll prenatally will need to rescreen following delivery to confirm their eligibility. Women enrolling after delivery or who are rescreening will need to meet criteria 2-12 above as well as the following eligibility criteria:
- Are a postpartum patient in the Labor and Delivery Unit at OSUWMC, Grady Memorial Hospital or Emory University Midtown Hospital; AND
- Have delivered a term, singleton infant of ≥2500 grams without any apparent health concerns.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: Initiation of Injectable Contraception Immediately Postpartum Among Breastfeeding Women
Investigators will conduct a randomized controlled trial (RCT) to evaluate the effects of immediate postpartum initiation of DMPA on breastfeeding and long-term contraceptive use. Investigators will randomize approximately 429 adult women who have delivered a healthy, full-term infant at The Ohio State University Wexner Medical Center (OSUWMC), who intend to breastfeed for ≥6 months, and who want to use DMPA (Depo-Provera; Pfizer Corp.) Note that because of anticipated screening failures, investigators will enroll more than the number randomized (i.e., up to 800 women). Investigators will randomize women to receive within 48 hours of delivery: 1) DMPA ("intervention" arm), 2) placebo injection ("placebo" arm) or 3) no injection ("open control" arm). The first two arms will be blinded while the open control arm will be unblinded. Note that postpartum patients at the study site do not receive DMPA before discharge as standard care. At enrollment, women will receive condom counseling and provision and referral for contraception at 12 weeks (intervention and placebo arms) or at 6 weeks postpartum (open control arm). Investigators will collect data on lactogenesis, infant feeding and growth, and contraception use during 12 follow-up months. Investigators conducted a pilot study (N=100) in the target population, which supports the feasibility of the current trial.
Read the detailed description
Postpartum women often are inadequately protected against rapid repeat pregnancy. Ensuring adequate inter- birth intervals could prevent an estimated 9% of deaths worldwide among children less than 5 years of age. Intramuscular injectable depot medroxyprogesterone acetate (DMPA) is rapidly becoming the method of choice in some settings, including regions where high maternal and child mortality make birth spacing critical. DMPA possesses many advantages for postpartum contraception as compared to other methods. However, the World Health Organization (WHO) advises against use of progestin-only injectables during the first six weeks postpartum among breastfeeding women. In contrast, the Centers for Disease Control and Prevention (CDC) recommends that progestin-only injectables generally can be started immediately postpartum on the grounds that their known advantages, as a whole, outweigh their unknown risks. This inconsistency in guidance reflects the lack of high-quality data for making evidence-based decisions. Studies conducted, to date, have important limitations: short follow-up intervals, low power, lack of consistency in using sensitive and standardized assessments, and lack of randomized trials evaluating DMPA administration specifically in the immediate postpartum period. Investigators propose to evaluate the effects of immediate postpartum initiation of DMPA on breastfeeding and on child development. We will conduct a randomized controlled trial of 429 adult women who have delivered a healthy, full-term infant, intend to breastfeed for ≥6 months, and want to use DMPA. Women will be randomized to receive within 48 hours of delivery: 1) DMPA ("intervention" arm), 2) placebo injection ("placebo" arm) or 3) no injection ("open control" arm). The first two arms will be blinded while the open control arm will be unblinded. Investigators will determine the effect of immediate postpartum initiation of DMPA on breastfeeding (Aim 1) and on contraception use (Aim 2). The proposed trial is innovative in use of 1) a randomized, partially-blinded design with sufficient power and follow up; 2) standardized, validated measures on lactation as well as breastfeeding and contraception behaviors; and 3) whole-body air displacement plethysmography to identify differences between arms in infant body composition. The findings of a pilot study in the target population support the feasibility of the proposed trial. Investigators expect the trial findings will permit the harmonization of the WHO and CDC guidance on the timing of DMPA initiation among breastfeeding women. This would have important implications for shaping global policy and practice worldwide, especially in settings where inadequate birth spacing contributes to high maternal and infant morbidity and mortality.
- Conditions
- Delay in Time to Lactogenesis Stage II
- Being tested
- Depo-Provera Injectable Product, Placebos
- Keywords
- lactation, Depo Provera, contraception
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depo-Provera Injectable ProductDrug
Depo-Provera Injectable Product -- Shot administered within 48 hours of childbirth
PlacebosDrug
Placebos -- Shot administered within 48 hours of childbirth
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Intramuscular injectable depot medroxyprogesterone acetate (1 mL of medroxyprogesterone acetate sterile aqueous suspension 150 mg/mL) provided within 48 hours of childbirth Receives: Drug: Depo-Provera Injectable Product |
| Placebo arm | Placebo comparator | 0.9% sodium chloride injection provided within 48 hours of childbirth Receives: Drug: Placebos |
| Open arm | No intervention | No intervention provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Lactogenesis Stage 2
Self-reported time to lactogenesis stage 2 (i.e., milk "let-down")
Measured: within 7 days postpartum
Use of Highly-effective Contraception
Rates of use of a highly-effective method of contraception (defined here as DMPA, implant, IUD, sterilization, pill, patch, or ring) at 12 months post-delivery among women in the intervention or placebo arm versus those in the open control arm
Measured: At 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start21 Mar 2019
- Primary completion26 May 2021
- Study completion18 Apr 2022
Why it stopped: Because of insufficient enrollment, we closed the RCT and replaced it with an observational design
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Delay in Time to Lactogenesis Stage IIStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital, Emory University
- Responsible party
- Principal investigator, Maria F. Gallo, PhD, Ohio State University
- Investigators
- Maria Gallo, PhD, Principal investigator, The Ohio State University, College of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844633
- Sponsor's protocol ID
- 2017H0445
- Status last verified
- Apr 2024
- First submitted
- 14 Feb 2019
- Last updated
- 7 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will welcome collaboration with others who could make use of the study materials and study datasets resulting from the project. Once the primary results are accepted for publication in a peer-reviewed journal, we will make full, de-identified datasets available to individual investigators formally requesting this access.
Publications
Gallo MF, Schumacher FL, Lawley M, Keim SA, Dupper AC, Keder L. Potential effect of immediate postpartum use of injectable contraception on lactogenesis. Contraception. 2025 Feb;142:110726. doi: 10.1016/j.contraception.2024.110726. Epub 2024 Oct 17.
PubMed 39424123
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initiation of Injectable Contraception Immediately Postpartum Among Breastfeeding Women
- ClinicalTrials.gov ID
- NCT03844633
- Acronym / sponsor ID
- 2017H0445
- Conditions
- Delay in Time to Lactogenesis Stage II
- Keywords
- lactation, Depo Provera, contraception
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because of insufficient enrollment, we closed the RCT and replaced it with an observational design
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Nationwide Children's Hospital, Emory University
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- 18 Apr 2022 (actual)
- First posted
- 18 Feb 2019 (actual)
- Results
- Posted 7 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators will conduct a randomized controlled trial (RCT) to evaluate the effects of immediate postpartum initiation of DMPA on breastfeeding and long-term contraceptive use. Investigators will randomize approximately 429 adult women who have delivered a healthy, full-term infant at The Ohio State University Wexner Medical Center (OSUWMC), who intend to breastfeed for ≥6 months, and who want to use DMPA (Depo-Provera; Pfizer Corp.) Note that because of anticipated screening failures, investigators will enroll more than the number randomized (i.e., up to 800 women). Investigators will randomize women to receive within 48 hours of delivery: 1) DMPA ("intervention" arm), 2) placebo injection ("placebo" arm) or 3) no injection ("open control" arm). The first two arms will be blinded while the open control arm will be unblinded. Note that postpartum patients at the study site do not receive DMPA before discharge as standard care. At enrollment, women will receive condom counseling and provision and referral for contraception at 12 weeks (intervention and placebo arms) or at 6 weeks postpartum (open control arm). Investigators will collect data on lactogenesis, infant feeding and growth, and contraception use during 12 follow-up months. Investigators conducted a pilot study (N=100) in the target population, which supports the feasibility of the current trial.
Detailed description
Postpartum women often are inadequately protected against rapid repeat pregnancy. Ensuring adequate inter- birth intervals could prevent an estimated 9% of deaths worldwide among children less than 5 years of age. Intramuscular injectable depot medroxyprogesterone acetate (DMPA) is rapidly becoming the method of choice in some settings, including regions where high maternal and child mortality make birth spacing critical. DMPA possesses many advantages for postpartum contraception as compared to other methods. However, the World Health Organization (WHO) advises against use of progestin-only injectables during the first six weeks postpartum among breastfeeding women. In contrast, the Centers for Disease Control and Prevention (CDC) recommends that progestin-only injectables generally can be started immediately postpartum on the grounds that their known advantages, as a whole, outweigh their unknown risks. This inconsistency in guidance reflects the lack of high-quality data for making evidence-based decisions. Studies conducted, to date, have important limitations: short follow-up intervals, low power, lack of consistency in using sensitive and standardized assessments, and lack of randomized trials evaluating DMPA administration specifically in the immediate postpartum period. Investigators propose to evaluate the effects of immediate postpartum initiation of DMPA on breastfeeding and on child development. We will conduct a randomized controlled trial of 429 adult women who have delivered a healthy, full-term infant, intend to breastfeed for ≥6 months, and want to use DMPA. Women will be randomized to receive within 48 hours of delivery: 1) DMPA ("intervention" arm), 2) placebo injection ("placebo" arm) or 3) no injection ("open control" arm). The first two arms will be blinded while the open control arm will be unblinded. Investigators will determine the effect of immediate postpartum initiation of DMPA on breastfeeding (Aim 1) and on contraception use (Aim 2). The proposed trial is innovative in use of 1) a randomized, partially-blinded design with sufficient power and follow up; 2) standardized, validated measures on lactation as well as breastfeeding and contraception behaviors; and 3) whole-body air displacement plethysmography to identify differences between arms in infant body composition. The findings of a pilot study in the target population support the feasibility of the proposed trial. Investigators expect the trial findings will permit the harmonization of the WHO and CDC guidance on the timing of DMPA initiation among breastfeeding women. This would have important implications for shaping global policy and practice worldwide, especially in settings where inadequate birth spacing contributes to high maternal and infant morbidity and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Drug: Depo-Provera Injectable ProductIntramuscular injectable depot medroxyprogesterone acetate (1 mL of medroxyprogesterone acetate sterile aqueous suspension 150 mg/mL) provided within 48 hours of childbirth |
| Placebo arm | Placebo comparator | Drug: Placebos0.9% sodium chloride injection provided within 48 hours of childbirth |
| Open arm | No intervention | –No intervention provided |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Intend to deliver in the Labor and Delivery Unit at Ohio State University Wexner Medical Center, Grady Memorial Hospital or Emory University Midtown;
- Are ≥18 years of age;
- Speak English;
- Intend to breastfeed, or express milk for their infant, for ≥6 months;
- Do not want to become pregnant within the first 12 months after delivery;
Key exclusion criteria (8 listed)
- Undiagnosed vaginal bleeding;
- Known or suspected malignancy of breast;
- Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease;
- Liver dysfunction or disease; OR
- Known hypersensitivity to Depo-Provera.
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 |
|---|---|---|
| Depo-Provera Injectable ProductDepo-Provera Injectable Product -- Shot administered within 48 hours of childbirth | Drug | Intervention arm |
| PlacebosPlacebos -- Shot administered within 48 hours of childbirth | Drug | Placebo arm |
Primary outcome
Time to Lactogenesis Stage 2
Time frame: within 7 days postpartum
Self-reported time to lactogenesis stage 2 (i.e., milk "let-down")
Use of Highly-effective Contraception
Time frame: At 12 months postpartum
Rates of use of a highly-effective method of contraception (defined here as DMPA, implant, IUD, sterilization, pill, patch, or ring) at 12 months post-delivery among women in the intervention or placebo arm versus those in the open control arm
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39424123Gallo MF, Schumacher FL, Lawley M, Keim SA, Dupper AC, Keder L. Potential effect of immediate postpartum use of injectable contraception on lactogenesis. Contraception. 2025 Feb;142:110726. doi: 10.1016/j.contraception.2024.110726. Epub 2024 Oct 17.
- Individual participant dataSharing planned: Yes. We will welcome collaboration with others who could make use of the study materials and study datasets resulting from the project. Once the primary results are accepted for publication in a peer-reviewed journal, we will make full, de-identified datasets available to individual investigators formally requesting this access.
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.
Maria Gallo, PhD principal investigator
The Ohio State University, College of Public Health
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 Depo-Provera Injectable Product in people with Delay in Time to Lactogenesis Stage II, run by Ohio State University 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 7 inclusion and 8 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: stopped early, as of the sponsor's last update on 7 May 2024. 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. Some participants in this study may receive a placebo. 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 7 May 2024). 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?
Time to Lactogenesis Stage 2 (time frame: within 7 days postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03844633, which also lists 1 linked publication.
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 7 May 2024.