Postpartum HemorrhageNCT01619072
Misoprostol for Treatment of Postpartum Hemorrhage at Community-level Births in Egypt
A study testing Misoprostol + referral in people with Postpartum Hemorrhage, run by Gynuity Health Projects at 1 site in Egypt.
Trial summary
This randomized controlled community-based trial will assess the effectiveness of administration of 800 mcg sublingual misoprostol with standard of care vs. placebo with standard of care for postpartum hemorrhage treatment at the community level, primarily home births attended by primary health care unit (PHU) staff… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Misoprostol + referral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2012to Oct 2013
- Phase
- Interventional
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women delivering with provider from participating primary health unit (PHU)
- willing and able to give informed consent
- vaginal delivery
Who cannot join
- women too advanced into active labor to provide informed consent
- known allergy to misoprostol and/or other prostaglandin
- women presenting with pregnancy complications, such as hypertension, suspected multiple pregnancy, previous caesarean section, suspected still birth, antepartum hemorrhage, previous complication in the third trimester (should be referred to higher level care for delivery)
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Prinary Health Units
Etay El Barood and Kafr El Dawar Districts, Beheira
About this study
Official title: A Randomized Controlled Community Study of the Effectiveness of Misoprostol for PPH Treatment at the Community Level (Home Births Attended by Primary Care Unit Staff) in Etay El Barood and Kafr El Dawar Districts (El Beheira Governorate), Egypt
This randomized controlled community-based trial will assess the effectiveness of administration of 800 mcg sublingual misoprostol with standard of care vs. placebo with standard of care for postpartum hemorrhage treatment at the community level, primarily home births attended by primary health care unit (PHU) staff in Etay El Barood and Kafr El Dawar districts (El Beheira governorate), Egypt. Standard of care per national guidelines in this setting is referral to a higher level health facility.
Read the detailed description
Hospital-based clinical trials have demonstrated misoprostol to be a safe and effective treatment option for postpartum hemorrhage (PPH). Additional research is needed to demonstrate how these findings translate into program effectiveness at lower levels of the health care system, including community home births, where access to skilled providers and treatment options are limited and misoprostol could potentially have the greatest impact on maternal health outcomes. This randomized controlled community treatment trial will assess the effectiveness of misoprostol with standard of care (i.e., referral to higher level care) vs. placebo with standard of care for PPH treatment at the community level, primarily home births attended by primary health care unit staff in Etay El Barood and Kafr El Dawar districts (El Beheira governorate), Egypt. This research will help guide decisions on how to introduce misoprostol into PPH care programs in different contexts such as primary care settings, including community-based home births.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Misoprostol + referral, Placebo + referral
- Keywords
- postpartum hemorrhage, treatment, misoprostol, home births
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol + referralOther
800 mcg of sublingual misoprostol (four tablets of 200 mcg misoprostol) + standard of care (referral to higher level care)
Placebo + referralOther
Placebo (4 tablets resembling misoprostol) + standard of care (referral to higher level care)
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol | Active comparator | 800 mcg sublingual misoprostol + referral to higher level care Receives: Other: Misoprostol + referral |
| Placebo | Placebo comparator | Placebo + referral to higher level care Receives: Other: Placebo + referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin measurement of >2 g/dL pre- to -post-delivery.
Proportion of women with a change in hemoglobin of >2 g/dL pre- to post-delivery, as measured by the HemoCue machine at both time points.
Measured: Before delivery (at onset of labor), after delivery (2 to 4 days after delivery)
Secondary outcomes (5)
Proportion of women transferred to higher level care
Proportion of women transferred to higher level care will be compared. The condition of the woman at time of transfer and arrival will also be noted.
Measured: Within 2 to 4 days after delivery
Proportion of women receiving additional interventions to treat PPH
Proportion of women who receive any additional intervention (e.g. uterotonics, manual removal of placental fragments, bimanual compression, IV fluids given, surgical procedures, blood transfusion, etc.) provided either at deliver site or upon transfer to district hospital.
Measured: Within 2 to 4 days after delivery
Proportion of women with side effects
Proportion of women with observed side effects (including shivering/chills, fever, nausea, diarrhea or fainting). Reported severity of side effects (classified by provider as "mild, "moderate," "severe," ), duration of side effects and proportion of of women receiving additional care to manage side effects will also be assessed.
Measured: Within 24 hours of delivery
Cost-effectiveness
A cost-effectiveness analysis will be done to compare the two treatment arms. The analysis will factor in the cost of materials used, procedures/interventions performed, transfers, and training of providers.
Measured: Within 2 to 4 days after delivery
Proportion of women for whom intervention was correctly administered
Proportion of women for whom treatment was administered as described in protocol (referral initiated and tablets administered to woman after PPH diagnosis made)
Measured: Within 1 hour of PPH diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startNov 2012
- Primary completionOct 2013
- Study completionOct 2013
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Population, Egypt, El Galaa Teaching Hospital, Alexandria University
- Responsible party
- Sponsor
- Investigators
- Mohamed Cherine Ramadan, MD, Principal investigator, El Galaa Teaching HospitalNevine Hassanein, MD, Principal investigator, ConsultantEmad Darwish, MD, Principal investigator, Alexandria University Faculy of MedicineEmad Ezzat, MD, Principal investigator, Ministry of health and populationRasha Dabash, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619072
- Sponsor's protocol ID
- 3001
- Status last verified
- Nov 2013
- First submitted
- 12 Jun 2012
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Parry Smith WR, Papadopoulou A, Thomas E, Tobias A, Price MJ, Meher S, Alfirevic Z, Weeks AD, Hofmeyr GJ, Gulmezoglu AM, Widmer M, Oladapo OT, Vogel JP, Althabe F, Coomarasamy A, Gallos ID. Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD012754. doi: 10.1002/14651858.CD012754.pub2.
PubMed 33232518
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Community Study of the Effectiveness of Misoprostol for PPH Treatment at the Community Level (Home Births Attended by Primary Care Unit Staff) in Etay El Barood and Kafr El Dawar Districts (El Beheira Governorate), Egypt
- ClinicalTrials.gov ID
- NCT01619072
- Acronym / sponsor ID
- 3001
- Conditions
- Postpartum Hemorrhage
- Keywords
- postpartum hemorrhage, treatment, misoprostol, home births
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Ministry of Health and Population, Egypt, El Galaa Teaching Hospital, Alexandria University
- Study start
- Nov 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 14 Jun 2012 (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.
This randomized controlled community-based trial will assess the effectiveness of administration of 800 mcg sublingual misoprostol with standard of care vs. placebo with standard of care for postpartum hemorrhage treatment at the community level, primarily home births attended by primary health care unit (PHU) staff in Etay El Barood and Kafr El Dawar districts (El Beheira governorate), Egypt. Standard of care per national guidelines in this setting is referral to a higher level health facility.
Detailed description
Hospital-based clinical trials have demonstrated misoprostol to be a safe and effective treatment option for postpartum hemorrhage (PPH). Additional research is needed to demonstrate how these findings translate into program effectiveness at lower levels of the health care system, including community home births, where access to skilled providers and treatment options are limited and misoprostol could potentially have the greatest impact on maternal health outcomes. This randomized controlled community treatment trial will assess the effectiveness of misoprostol with standard of care (i.e., referral to higher level care) vs. placebo with standard of care for PPH treatment at the community level, primarily home births attended by primary health care unit staff in Etay El Barood and Kafr El Dawar districts (El Beheira governorate), Egypt. This research will help guide decisions on how to introduce misoprostol into PPH care programs in different contexts such as primary care settings, including community-based home births.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol | Active comparator | Other: Misoprostol + referral800 mcg sublingual misoprostol + referral to higher level care |
| Placebo | Placebo comparator | Other: Placebo + referralPlacebo + referral to higher level care |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women delivering with provider from participating primary health unit (PHU)
- willing and able to give informed consent
- vaginal delivery
Key exclusion criteria (3 listed)
- women too advanced into active labor to provide informed consent
- known allergy to misoprostol and/or other prostaglandin
- women presenting with pregnancy complications, such as hypertension, suspected multiple pregnancy, previous caesarean section, suspected still birth, antepartum hemorrhage, previous complication in the third trimester (should be referred to higher level care for delivery)
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 + referral800 mcg of sublingual misoprostol (four tablets of 200 mcg misoprostol) + standard of care (referral to higher level care) | Other | Misoprostol |
| Placebo + referralPlacebo (4 tablets resembling misoprostol) + standard of care (referral to higher level care) | Other | Placebo |
Primary outcome
Change in hemoglobin measurement of >2 g/dL pre- to -post-delivery.
Time frame: Before delivery (at onset of labor), after delivery (2 to 4 days after delivery)
Proportion of women with a change in hemoglobin of >2 g/dL pre- to post-delivery, as measured by the HemoCue machine at both time points.
5 secondary outcomes
Proportion of women transferred to higher level care
Time frame: Within 2 to 4 days after delivery
Proportion of women receiving additional interventions to treat PPH
Time frame: Within 2 to 4 days after delivery
Proportion of women with side effects
Time frame: Within 24 hours of delivery
Cost-effectiveness
Time frame: Within 2 to 4 days after delivery
Proportion of women for whom intervention was correctly administered
Time frame: Within 1 hour of PPH diagnosis
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 25 Nov 2013.
- Derived from this study: PubMed 33232518Parry Smith WR, Papadopoulou A, Thomas E, Tobias A, Price MJ, Meher S, Alfirevic Z, Weeks AD, Hofmeyr GJ, Gulmezoglu AM, Widmer M, Oladapo OT, Vogel JP, Althabe F, Coomarasamy A, Gallos ID. Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD012754. doi: 10.1002/14651858.CD012754.pub2.
- Related InfoLink provided by the sponsor.
Related trials for Postpartum Hemorrhage
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
RecruitingPhase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
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.
Mohamed Cherine Ramadan, MD principal investigator
El Galaa Teaching Hospital
Nevine Hassanein, MD principal investigator
Consultant
Emad Darwish, MD principal investigator
Alexandria University Faculy of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol + referral in people with Postpartum Hemorrhage, run by Gynuity Health Projects at 1 site 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 3 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 25 Nov 2013. 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 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. 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.
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?
Change in hemoglobin measurement of >2 g/dL pre- to -post-delivery. (time frame: Before delivery (at onset of labor), after delivery (2 to 4 days after delivery)). 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 NCT01619072, 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 25 Nov 2013.