Postpartum HemorrhagePhase 4NCT02226588
Comparison of Primary and Secondary Prevention of Postpartum Hemorrhage at the Community Level in Egypt
A Phase 4 study testing Misoprostol in people with Postpartum Hemorrhage, run by Gynuity Health Projects at 2 sites in Egypt.
Trial summary
The objective of this study is to compare two community-level strategies: either selective, early administration of 800 mcg sublingual misoprostol to women for secondary prevention of postpartum hemorrhage (PPH) or universal use of 600 mcg oral misoprostol at the time of delivery for prophylaxis of PPH. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,827 participants
- Where
- 2 sitesEgypt
- Study dates
- Oct 2014to Jan 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Willing and able to give informed consent
- Vaginal delivery
- Agrees to participate in follow-up interview
- Agrees to have pre- and post-hemoglobin taken
- Delivery at woman's home or at the primary health unit (PHU)
Who cannot join
- Too advanced into active labor to provide consent
- Known allergy to misoprostol and/or other prostaglandin
- Pregnancy complications, such as hypertension, suspected multiple pregnancy, previous caesarean section, suspected still birth, ante-partum hemorrhage, and previous complication in the third trimester
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Primary Health Care Units
Damanhur, El Beheira
Primary Health Care Units
Kafr El Dawar, El Beheira
About this study
Official title: Two Community Strategies Comparing Use of Misoprostol for Secondary Prevention to Primary Prevention for Postpartum Hemorrhage: A Randomized Cluster Non-Inferiority Study in El Beheira Governorate, Egypt
The objective of this study is to compare two community-level strategies: either selective, early administration of 800 mcg sublingual misoprostol to women for secondary prevention of postpartum hemorrhage (PPH) or universal use of 600 mcg oral misoprostol at the time of delivery for prophylaxis of PPH. The significance of this cluster randomized non-inferiority trial is its potential to inform service delivery programs on clinical outcomes, program feasibility, cost, and acceptability of two different community models of PPH care using misoprostol.1. The study hypothesizes that a service delivery model that administers misoprostol for secondary prevention is non-inferior to a model that administers misoprostol for universal prophylaxis.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Misoprostol
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
| Study group | Role | What they receive |
|---|---|---|
| Secondary prevention | Experimental | Single sublingual dose of 800mcg (4 tablets) misoprostol administered to women with 350-500mL postpartum blood loss as estimated using a blood absorption mat or due to deteriorating postpartum condition of the woman as determined by provider's clinical judgment Receives: Drug: Misoprostol |
| Universal prophylaxis | Active comparator | Single oral prophylactic dose of 600mcg (3 tablets) misoprostol administered to all women within 1 minute of deliver of baby Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean drop in pre- to post-delivery hemoglobin level
Hemoglobin will be measured by primary health unit staff using a portable handheld Hemocue machine.
Measured: Pre-delivery hemoglobin will be measured during a third trimester antenatal care visit or during early labor. Post-delivery hemoglbin will be measured 2 to 4 days after delivery of the baby.
Secondary outcomes (7)
Proportion of women transferred to higher level care
The proportion of women transferred to higher level care will be assessed. Includes the condition of woman at time of transfer and arrival at transfer facility.
Measured: Following delivery to postpartum visit (2 to 4 days after delivery)
Proportion of women diagnosed with PPH
PPH will be diagnosed using the standard practices of PHU staff
Measured: After delivery of the baby up to 24 hours postpartum
Proportion of women receiving additional interventions for PPH
An additional intervention could include: uterotonics, manual removal of placental fragments. bimanual compression, IV fluids given to control active bleeding.
Measured: Following delivery to postpartum visit (2 to 4 days after delivery)
Proportion of women who experience side effects
Women experiencing known side effects of misoprostol, including shivering/chills and pyrexia; severity, duration, and any additional care provided will be assessed
Measured: From time of delivery to 2 hours postpartum
Proportion of women who find the intervention acceptable
Acceptability will be assessed in an exit interview with women - women will be asked if they are willing to take misoprostol in future deliveries and about the preferences what method they would prefer (primary or secondary prevention) in future deliveries.
Measured: Measured at postpartum visit (2 to 4 days after delivery)
Proportion of women who receive intervention per protocol
To assess feasibility, we will document the proportion of women for whom the intervention arm protocol is correctly followed (including correct timing of drug administration, when necessary).
Measured: within 2 hours of delivery
Proportion of women experiencing a serious adverse event
Serious adverse events include hysterectomy, blood transfusion, maternal death
Measured: Within 2 to 4 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,827 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Population, Egypt, University of Alexandria, El Galaa Teaching Hospital
- Responsible party
- Sponsor
- Investigators
- Nevine Hassanein, MD, Principal investigator, ConsultantEmad Darwish, MD, Principal investigator, Alexandria UniversityMohamed Cherine, MD, Principal investigator, El Galaa Teaching HospitalRasha Dabash, MPH, Principal investigator, Gynuity Health ProjectsHolly Anger, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226588
- Sponsor's protocol ID
- 3004
- Status last verified
- Feb 2016
- First submitted
- 25 Aug 2014
- Last updated
- 15 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Anger HA, Dabash R, Hassanein N, Darwish E, Ramadan MC, Nawar M, Charles D, Breebaart M, Winikoff B. A cluster-randomized, non-inferiority trial comparing use of misoprostol for universal prophylaxis vs. secondary prevention of postpartum hemorrhage among community level births in Egypt. BMC Pregnancy Childbirth. 2020 May 24;20(1):317. doi: 10.1186/s12884-020-03008-5.
PubMed 32448257
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Community Strategies Comparing Use of Misoprostol for Secondary Prevention to Primary Prevention for Postpartum Hemorrhage: A Randomized Cluster Non-Inferiority Study in El Beheira Governorate, Egypt
- ClinicalTrials.gov ID
- NCT02226588
- Acronym / sponsor ID
- 3004
- Conditions
- Postpartum Hemorrhage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,827 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Ministry of Health and Population, Egypt, University of Alexandria, El Galaa Teaching Hospital
- Study start
- Oct 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 27 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare two community-level strategies: either selective, early administration of 800 mcg sublingual misoprostol to women for secondary prevention of postpartum hemorrhage (PPH) or universal use of 600 mcg oral misoprostol at the time of delivery for prophylaxis of PPH. The significance of this cluster randomized non-inferiority trial is its potential to inform service delivery programs on clinical outcomes, program feasibility, cost, and acceptability of two different community models of PPH care using misoprostol.1. The study hypothesizes that a service delivery model that administers misoprostol for secondary prevention is non-inferior to a model that administers misoprostol for universal prophylaxis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Secondary prevention | Experimental | Drug: MisoprostolSingle sublingual dose of 800mcg (4 tablets) misoprostol administered to women with 350-500mL postpartum blood loss as estimated using a blood absorption mat or due to deteriorating postpartum condition of the woman as determined by provider's clinical judgment |
| Universal prophylaxis | Active comparator | Drug: MisoprostolSingle oral prophylactic dose of 600mcg (3 tablets) misoprostol administered to all women within 1 minute of deliver of baby |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Willing and able to give informed consent
- Vaginal delivery
- Agrees to participate in follow-up interview
- Agrees to have pre- and post-hemoglobin taken
- Delivery at woman's home or at the primary health unit (PHU)
Key exclusion criteria (3 listed)
- Too advanced into active labor to provide consent
- Known allergy to misoprostol and/or other prostaglandin
- Pregnancy complications, such as hypertension, suspected multiple pregnancy, previous caesarean section, suspected still birth, ante-partum hemorrhage, and previous complication in the third trimester
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 |
|---|---|---|
| Misoprostol | Drug | Secondary prevention, Universal prophylaxis |
Primary outcome
Mean drop in pre- to post-delivery hemoglobin level
Time frame: Pre-delivery hemoglobin will be measured during a third trimester antenatal care visit or during early labor. Post-delivery hemoglbin will be measured 2 to 4 days after delivery of the baby.
Hemoglobin will be measured by primary health unit staff using a portable handheld Hemocue machine.
7 secondary outcomes
Proportion of women transferred to higher level care
Time frame: Following delivery to postpartum visit (2 to 4 days after delivery)
Proportion of women diagnosed with PPH
Time frame: After delivery of the baby up to 24 hours postpartum
Proportion of women receiving additional interventions for PPH
Time frame: Following delivery to postpartum visit (2 to 4 days after delivery)
Proportion of women who experience side effects
Time frame: From time of delivery to 2 hours postpartum
Proportion of women who find the intervention acceptable
Time frame: Measured at postpartum visit (2 to 4 days after delivery)
Proportion of women who receive intervention per protocol
Time frame: within 2 hours of delivery
Proportion of women experiencing a serious adverse event
Time frame: Within 2 to 4 days after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
- Derived from this study: PubMed 32448257Anger HA, Dabash R, Hassanein N, Darwish E, Ramadan MC, Nawar M, Charles D, Breebaart M, Winikoff B. A cluster-randomized, non-inferiority trial comparing use of misoprostol for universal prophylaxis vs. secondary prevention of postpartum hemorrhage among community level births in Egypt. BMC Pregnancy Childbirth. 2020 May 24;20(1):317. doi: 10.1186/s12884-020-03008-5.
- Related InfoLink provided by the sponsor.
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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.
Nevine Hassanein, MD principal investigator
Consultant
Emad Darwish, MD principal investigator
Alexandria University
Mohamed Cherine, MD principal investigator
El Galaa Teaching Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Misoprostol in people with Postpartum Hemorrhage, run by Gynuity Health Projects at 2 sites in Egypt.
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 5 inclusion and 3 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 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean drop in pre- to post-delivery hemoglobin level (time frame: Pre-delivery hemoglobin will be measured during a third trimester antenatal care visit or during early labor. Post-delivery hemoglbin will be measured 2 to 4 days after delivery of the baby.). 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 NCT02226588, 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 15 Feb 2016.