Postpartum HemorrhageNCT00120237
Misoprostol for the Prevention of Postpartum Hemorrhage in Rural Pakistan
A study testing Misoprostol in people with Postpartum Hemorrhage and Anemia, run by Gynuity Health Projects at 1 site in Pakistan.
Trial summary
This community-based trial will study misoprostol for the prevention of postpartum hemorrhage in rural Pakistan. Traditional birth attendants assisting home deliveries will administer study tablets (600 mcg oral misoprostol or placebo) in the third stage of labor to women participating in the trial. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage, Anemia
- What is being tested?
- Misoprostol
- Type of treatment
- Pill or oral medicine
- How many people
- 1,600 participants
- Where
- 1 sitePakistan
- Study dates
- Jul 2005to Jul 2008
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant women in general good health, home delivery
- Must live in one of 78 study villages
Who cannot join
- Hypertension
- Non-cephalic presentation
- Polyhydramnios
- Previous cesarean section
- Suspected multiple pregnancy
- Suspected still birth
Show all 9Show fewer
- Antepartum hemorrhage
- Previous complication in 3rd trimester
- Anemia of <8 g/dl
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo-Controlled Randomized Trial of Misoprostol in the Management of the Third Stage of Labor in the Home Delivery Setting in Rural Pakistan
This community-based trial will study misoprostol for the prevention of postpartum hemorrhage in rural Pakistan. Traditional birth attendants assisting home deliveries will administer study tablets (600 mcg oral misoprostol or placebo) in the third stage of labor to women participating in the trial. Blood loss, hemoglobin levels, side effects, and other variables will be evaluated.
- Conditions
- Postpartum Hemorrhage, Anemia
- Being tested
- Misoprostol
- Keywords
- Postpartum hemorrhage, Misoprostol, Maternal morbidity, Developing countries, Traditional birth attendants
- Medical subject headings
- Postpartum Hemorrhage, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
600 mcg oral misoprostol administered during third stage of labor
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum hemorrhage (blood loss >or= 500 mL)
Measured: Measured at 1 hour postpartum or until active bleeding has stopped
Drop in hemoglobin > 2 g/dL from pre to post-delivery
Measured: Hemoblobin (Hb) level measured 3-5 days after delivery
Secondary outcomes (4)
Intermediate and severe PPH (blood loss >or=750 mL and >or= than 1000 mL)
Measured: Blood loss measured at 1 hr postpartum or until active bleeding stopped
Mean blood loss
Measured: blood loss measured at 1 hr postpartum or until active bleeding stopped
Side effects experienced among recently delivered mothers
Measured: Interviews conducted 1 day post-delivery
Anemia (<9 g/dL and <11 g/dL)
Measured: Postpartum hemoglobin assessed 3 days post-delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2005 (estimated)
- Study startJul 2005
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Aga Khan University, Aga Khan Health Services, The Aga Khan Foundation, Family Care International
- Investigators
- Gijs Walraven, MD, Principal investigator, Aga Khan Health ServicesJuanita Hatcher, PhD, Principal investigator, Aga Khan UniversityNaushaba Mobeen, MD, Study director, Aga Khan UniversityJennifer Blum, MPH, Study director, Gynuity Health ProjectsZafar Ahmad, MD, Study director, Aga Khan Health ServicesNadeem Zuberi, MD, Study director, Aga Khan UniversityJill Durocher, Study director, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120237
- Sponsor's protocol ID
- 2.4.4
- Status last verified
- Mar 2009
- First submitted
- 7 Jul 2005
- Last updated
- 19 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled Randomized Trial of Misoprostol in the Management of the Third Stage of Labor in the Home Delivery Setting in Rural Pakistan
- ClinicalTrials.gov ID
- NCT00120237
- Acronym / sponsor ID
- 2.4.4
- Conditions
- Postpartum Hemorrhage, Anemia
- Keywords
- Postpartum hemorrhage, Misoprostol, Maternal morbidity, Developing countries, Traditional birth attendants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Aga Khan University, Aga Khan Health Services, The Aga Khan Foundation, Family Care International
- Study start
- Jul 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 15 Jul 2005 (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 community-based trial will study misoprostol for the prevention of postpartum hemorrhage in rural Pakistan. Traditional birth attendants assisting home deliveries will administer study tablets (600 mcg oral misoprostol or placebo) in the third stage of labor to women participating in the trial. Blood loss, hemoglobin levels, side effects, and other variables will be evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant women in general good health, home delivery
- Must live in one of 78 study villages
Key exclusion criteria (9 listed)
- Hypertension
- Non-cephalic presentation
- Polyhydramnios
- Previous cesarean section
- Suspected multiple pregnancy
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 |
|---|---|---|
| Misoprostol600 mcg oral misoprostol administered during third stage of labor | Drug | – |
Primary outcome
Postpartum hemorrhage (blood loss >or= 500 mL)
Time frame: Measured at 1 hour postpartum or until active bleeding has stopped
Drop in hemoglobin > 2 g/dL from pre to post-delivery
Time frame: Hemoblobin (Hb) level measured 3-5 days after delivery
4 secondary outcomes
Intermediate and severe PPH (blood loss >or=750 mL and >or= than 1000 mL)
Time frame: Blood loss measured at 1 hr postpartum or until active bleeding stopped
Mean blood loss
Time frame: blood loss measured at 1 hr postpartum or until active bleeding stopped
Side effects experienced among recently delivered mothers
Time frame: Interviews conducted 1 day post-delivery
Anemia (<9 g/dL and <11 g/dL)
Time frame: Postpartum hemoglobin assessed 3 days post-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 19 Mar 2009.
- Gynuity Health ProjectsLink 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.
Gijs Walraven, MD principal investigator
Aga Khan Health Services
Juanita Hatcher, PhD principal investigator
Aga Khan University
Naushaba Mobeen, MD study director
Aga Khan University
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 in people with Postpartum Hemorrhage and Anemia, run by Gynuity Health Projects at 1 site in Pakistan.
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 2 inclusion and 9 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 19 Mar 2009. 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 Pakistan. 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.
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?
Postpartum hemorrhage (blood loss >or= 500 mL) (time frame: Measured at 1 hour postpartum or until active bleeding has stopped). 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?
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 19 Mar 2009.