Postpartum HemorrhageNCT00116350
Misoprostol for the Treatment of Postpartum Hemorrhage
A study testing Misoprostol and Oxytocin in people with Postpartum Hemorrhage, run by Gynuity Health Projects at 6 sites in 5 countries.
Trial summary
The purpose of this study is to test whether misoprostol is as effective as oxytocin for treating primary postpartum hemorrhage (PPH) with uterine atony as the suspected cause in two circumstances: 1) where women have received prophylactic uterotonics in the third stage of labor; and 2) where no prophylactic… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Misoprostol and Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,786 participants
- Where
- 6 sitesin 5 countries
- Study dates
- Jul 2005to Jan 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Vaginal delivery
- Postpartum hemorrhage due to suspected uterine atony
- Depending on study group: administration of prophylactic uterotonics in third stage of labor
Who cannot join
- Known allergy to misoprostol or other prostaglandin
- C-section for current delivery
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Egypt2 sites
Alexandria University Hospital, Shatby Maternity Hospital
Alexandria
El-Galaa Teaching Hospital
Cairo
Burkina Faso1 site
Centre Hospitalier Universitaire Souro Sanou de Bobo Dioulasso
Bobo Diolasso
Turkey (Türkiye)1 site
Ministry of Health Ankara Etlik Maternity and Teaching-Research Hospital
Ankara, 06010
Vietnam1 site
Cu Chi Hospital, Tu Du Hospital, Hocmon Hospital, Binh Duong Hospital
Ho Chi Minh City and Binh Duong Province
About this study
Official title: Misoprostol for the Treatment of Primary Postpartum Hemorrhage
The purpose of this study is to test whether misoprostol is as effective as oxytocin for treating primary postpartum hemorrhage (PPH) with uterine atony as the suspected cause in two circumstances: 1) where women have received prophylactic uterotonics in the third stage of labor; and 2) where no prophylactic uterotonics have been given in the third stage of labor.
Read the detailed description
Postpartum hemorrhage (PPH) remains a major cause of maternal deaths worldwide. Misoprostol offers several advantages over oxytocin and ergometrine, the drugs currently used to treat PPH. For example, misoprostol is stable at high temperatures and has a shelf life of several years, it is easy to administer, it can be given to hypertensive patients, and it is inexpensive. This randomized, double-blind placebo-controlled trial will test whether misoprostol is as effective as oxytocin in treating primary PPH in hospital births, both when women have received prophylactic uterotonics in the third stage of labor and when they have not.
Blood loss will be measured for all consenting women who deliver vaginally. If PPH occurs and uterine atony is the suspected cause, women will be randomized to receive either: a) four 200 µg pills of misoprostol sublingually and an IV of saline (resembling oxytocin) or b) four placebo tablets resembling misoprostol sublingually and 40 IU oxytocin by IV. This study seeks to answer the following questions:
- Is misoprostol as effective as oxytocin for treatment of primary PPH for women who do and do not receive oxytocin prophylaxis in the third stage of labor?
- Does misoprostol have an acceptable safety profile when given as an 800 µg sublingual dose to treat PPH?
- Is the side effect profile of misoprostol acceptable to women?
This study will take place in hospitals located in Burkina Faso, Ecuador, Egypt, Turkey, and Vietnam.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Misoprostol, Oxytocin
- Keywords
- Postpartum hemorrhage, Misoprostol, Developing countries, Maternal morbidity, Randomized controlled trial
- 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
800 mcg sublingual misoprostol
OxytocinDrug
40 IU Oxytocin IV
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol | Experimental | 800 mcg sublingual misoprostol Receives: Drug: Misoprostol |
| Oxytocin | Active comparator | 40 IU Oxytocin IV Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for additional treatment after initial PPH study treatment
Measured: all additional interventions recorded following initial uterotonic treatment
Secondary outcomes (6)
Mean blood loss after PPH treatment
Measured: blood loss measured for minimum of 1 hour or until active bleeding ceases
Change in hemoglobin from pre-delivery to postpartum
Measured: Pe-delivery hemoblogin measured upon entry into labor ward; postpartum Hb measured 12-24 hrs after removal of IV
Time to bleeding cessation
Measured: Time to bleeding cessation recorded
Blood transfusion
Measured: any blood transfusion recorded after delivery and prior to discharge
Side effects
Measured: any observed or reported side effects recorded following treatment and prior to discharge
Acceptability for women
Measured: Exit interview conducted prior to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2005 (estimated)
- Study startJul 2005
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,786 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Family Care International
- Investigators
- Beverly Winikoff, MD, MPH, Principal investigator, Gynuity Health ProjectsJennifer Blum, MPH, Study director, Gynuity Health ProjectsRasha Dabash, MPH, Study director, Gynuity Health ProjectsSheila Raghavan, M.Sc., Study director, Gynuity Health ProjectsAyisha Diop, MPH, Study director, Gynuity Health ProjectsIlana Dzuba, M.H.Sc., Study director, Gynuity Health ProjectsJill Durocher, Study director, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116350
- Sponsor's protocol ID
- 2.4.1
- Other IDs
- WIRB #20041878/1063615
- Status last verified
- Mar 2009
- First submitted
- 28 Jun 2005
- Last updated
- 19 Mar 2009
- 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 33232518Blum J, Winikoff B, Raghavan S, Dabash R, Ramadan MC, Dilbaz B, Dao B, Durocher J, Yalvac S, Diop A, Dzuba IG, Ngoc NT. Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women receiving prophylactic oxytocin: a double-blind, randomised, non-inferiority trial. Lancet. 2010 Jan 16;375(9710):217-23. doi: 10.1016/S0140-6736(09)61923-1. Epub 2010 Jan 6.
PubMed 20060162Winikoff B, Dabash R, Durocher J, Darwish E, Nguyen TN, Leon W, Raghavan S, Medhat I, Huynh TK, Barrera G, Blum J. Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women not exposed to oxytocin during labour: a double-blind, randomised, non-inferiority trial. Lancet. 2010 Jan 16;375(9710):210-6. doi: 10.1016/S0140-6736(09)61924-3. Epub 2010 Jan 6.
PubMed 20060161
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
- Misoprostol for the Treatment of Primary Postpartum Hemorrhage
- ClinicalTrials.gov ID
- NCT00116350
- Acronym / sponsor ID
- 2.4.1
- Conditions
- Postpartum Hemorrhage
- Keywords
- Postpartum hemorrhage, Misoprostol, Developing countries, Maternal morbidity, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,786 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Family Care International
- Study start
- Jul 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 29 Jun 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.
The purpose of this study is to test whether misoprostol is as effective as oxytocin for treating primary postpartum hemorrhage (PPH) with uterine atony as the suspected cause in two circumstances: 1) where women have received prophylactic uterotonics in the third stage of labor; and 2) where no prophylactic uterotonics have been given in the third stage of labor.
Detailed description
Postpartum hemorrhage (PPH) remains a major cause of maternal deaths worldwide. Misoprostol offers several advantages over oxytocin and ergometrine, the drugs currently used to treat PPH. For example, misoprostol is stable at high temperatures and has a shelf life of several years, it is easy to administer, it can be given to hypertensive patients, and it is inexpensive. This randomized, double-blind placebo-controlled trial will test whether misoprostol is as effective as oxytocin in treating primary PPH in hospital births, both when women have received prophylactic uterotonics in the third stage of labor and when they have not.
Blood loss will be measured for all consenting women who deliver vaginally. If PPH occurs and uterine atony is the suspected cause, women will be randomized to receive either: a) four 200 µg pills of misoprostol sublingually and an IV of saline (resembling oxytocin) or b) four placebo tablets resembling misoprostol sublingually and 40 IU oxytocin by IV. This study seeks to answer the following questions:
- Is misoprostol as effective as oxytocin for treatment of primary PPH for women who do and do not receive oxytocin prophylaxis in the third stage of labor?
- Does misoprostol have an acceptable safety profile when given as an 800 µg sublingual dose to treat PPH?
- Is the side effect profile of misoprostol acceptable to women?
This study will take place in hospitals located in Burkina Faso, Ecuador, Egypt, Turkey, and Vietnam.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol | Experimental | Drug: Misoprostol800 mcg sublingual misoprostol |
| Oxytocin | Active comparator | Drug: Oxytocin40 IU Oxytocin IV |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Vaginal delivery
- Postpartum hemorrhage due to suspected uterine atony
- Depending on study group: administration of prophylactic uterotonics in third stage of labor
Key exclusion criteria (2 listed)
- Known allergy to misoprostol or other prostaglandin
- C-section for current 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 |
|---|---|---|
| Misoprostol800 mcg sublingual misoprostol | Drug | Misoprostol |
| Oxytocin40 IU Oxytocin IV | Drug | Oxytocin |
Primary outcome
Need for additional treatment after initial PPH study treatment
Time frame: all additional interventions recorded following initial uterotonic treatment
6 secondary outcomes
Mean blood loss after PPH treatment
Time frame: blood loss measured for minimum of 1 hour or until active bleeding ceases
Change in hemoglobin from pre-delivery to postpartum
Time frame: Pe-delivery hemoblogin measured upon entry into labor ward; postpartum Hb measured 12-24 hrs after removal of IV
Time to bleeding cessation
Time frame: Time to bleeding cessation recorded
Blood transfusion
Time frame: any blood transfusion recorded after delivery and prior to discharge
Side effects
Time frame: any observed or reported side effects recorded following treatment and prior to discharge
Acceptability for women
Time frame: Exit interview conducted prior to discharge
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.
- 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.
- Derived from this study: PubMed 20060162Blum J, Winikoff B, Raghavan S, Dabash R, Ramadan MC, Dilbaz B, Dao B, Durocher J, Yalvac S, Diop A, Dzuba IG, Ngoc NT. Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women receiving prophylactic oxytocin: a double-blind, randomised, non-inferiority trial. Lancet. 2010 Jan 16;375(9710):217-23. doi: 10.1016/S0140-6736(09)61923-1. Epub 2010 Jan 6.
- Derived from this study: PubMed 20060161Winikoff B, Dabash R, Durocher J, Darwish E, Nguyen TN, Leon W, Raghavan S, Medhat I, Huynh TK, Barrera G, Blum J. Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women not exposed to oxytocin during labour: a double-blind, randomised, non-inferiority trial. Lancet. 2010 Jan 16;375(9710):210-6. doi: 10.1016/S0140-6736(09)61924-3. Epub 2010 Jan 6.
- Gynuity Health Projects websiteLink 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.
Beverly Winikoff, MD, MPH principal investigator
Gynuity Health Projects
Jennifer Blum, MPH study director
Gynuity Health Projects
Rasha Dabash, MPH study director
Gynuity Health Projects
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol and Oxytocin in people with Postpartum Hemorrhage, run by Gynuity Health Projects at 6 sites in 5 countries.
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 2 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 6 sites in Egypt, Burkina Faso, Ecuador, Turkey (Türkiye), Vietnam. 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?
Need for additional treatment after initial PPH study treatment (time frame: all additional interventions recorded following initial uterotonic treatment). 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 NCT00116350, which also lists 3 linked publications.
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.