Postpartum HemorrhageNCT00116480
Misoprostol in the Treatment of Postpartum Hemorrhage
A study testing Misoprostol in people with Postpartum Hemorrhage, run by Gynuity Health Projects at 2 sites in Pakistan.
Trial summary
Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality, despite treatment with conventional methods. Uncontrolled reports and three small randomised controlled trials have suggested that misoprostol may have an additive effect to routine treatment, and there is a serious danger that this method… 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 2 sitesPakistan
- Study dates
- Dec 2005to Apr 2007
- 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
- All women delivering vaginally with clinically diagnosed PPH requiring uterotonics
Who cannot join
- Refusal to give consent for participation or if the woman is too distressed to give consent
- Woman is not entitled to give informed consent (e.g. minors without a guardian)
- Woman who had a caesarean section
- Delivery is regarded as abortion (gestational age < 28 weeks)
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Aga Khan University Hospital
Karachi
The Aga Khan Health Services
Karachi
About this study
Official title: Misoprostol in the Treatment of Post Partum Hemorrhage: A Placebo Randomised Controlled Trial in 4 Karachi Hospitals
Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality, despite treatment with conventional methods. Uncontrolled reports and three small randomised controlled trials have suggested that misoprostol may have an additive effect to routine treatment, and there is a serious danger that this method will be used widely without research to document the effectiveness or risks of this method. In this randomised controlled trial (RCT), we propose to test whether 600 μg of sublingually administered misoprostol in women requiring additional uterotonics after delivery, and after routine syntocinon to all women during or after delivery, has additional effects above the additional conventional uterotonics in reducing PPH. Women with measured blood loss greater than or equal to 500 mls in 4 Karachi hospitals who give consent will be given locally routine treatment for PPH. In addition, they will be enrolled by drawing the next of a series of randomised treatment packs containing misoprostol or placebo. The primary outcome measure will be blood loss greater than or equal to 500 mls after enrolment.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Misoprostol
- Keywords
- Postpartum Haemorrhage, 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
600 mcg of sublingual misoprostol
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol | Experimental | three tablets of active misoprostol (600 mcg) given sublingually Receives: Drug: Misoprostol |
| Placebo | Placebo comparator | three tablets resembling misoprostol given sublingually Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss greater than or equal to 500 mls after enrolment
Measured: Blood loss measured for minimum of 1 hour or until active bleeding ceased
Secondary outcomes (4)
Average blood loss
Measured: Blood loss measured for minimum of one hour or until active bleeding ceased
Clinical complications (need for transfusion, hysterectomy)
Measured: After delivery and prior to hospital discharge
Pre-delivery and post-delivery hemoglobin measures
Measured: Pre-delivery hemoglobin measured upon admission to hospital (during labor) and measured postpartum 12-24 hours after delivery
Side effects
Measured: observed or reported following study treatment and 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 posted30 Jun 2005 (estimated)
- Study startDec 2005
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 61 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
- Nadeem F Zuberi, MD, Principal investigator, Aga Khan University Hospital, Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116480
- Sponsor's protocol ID
- 2.4.2
- Status last verified
- Mar 2009
- First submitted
- 29 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 33232518Zuberi NF, Durocher J, Sikander R, Baber N, Blum J, Walraven G. Misoprostol in addition to routine treatment of postpartum hemorrhage: a hospital-based randomized-controlled trial in Karachi, Pakistan. BMC Pregnancy Childbirth. 2008 Aug 21;8:40. doi: 10.1186/1471-2393-8-40.
PubMed 18718007
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 in the Treatment of Post Partum Hemorrhage: A Placebo Randomised Controlled Trial in 4 Karachi Hospitals
- ClinicalTrials.gov ID
- NCT00116480
- Acronym / sponsor ID
- 2.4.2
- Conditions
- Postpartum Hemorrhage
- Keywords
- Postpartum Haemorrhage, Misoprostol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 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
- Dec 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 30 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.
Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality, despite treatment with conventional methods. Uncontrolled reports and three small randomised controlled trials have suggested that misoprostol may have an additive effect to routine treatment, and there is a serious danger that this method will be used widely without research to document the effectiveness or risks of this method. In this randomised controlled trial (RCT), we propose to test whether 600 μg of sublingually administered misoprostol in women requiring additional uterotonics after delivery, and after routine syntocinon to all women during or after delivery, has additional effects above the additional conventional uterotonics in reducing PPH. Women with measured blood loss greater than or equal to 500 mls in 4 Karachi hospitals who give consent will be given locally routine treatment for PPH. In addition, they will be enrolled by drawing the next of a series of randomised treatment packs containing misoprostol or placebo. The primary outcome measure will be blood loss greater than or equal to 500 mls after enrolment.
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: Misoprostolthree tablets of active misoprostol (600 mcg) given sublingually |
| Placebo | Placebo comparator | Drug: Misoprostolthree tablets resembling misoprostol given sublingually |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All women delivering vaginally with clinically diagnosed PPH requiring uterotonics
Key exclusion criteria (4 listed)
- Refusal to give consent for participation or if the woman is too distressed to give consent
- Woman is not entitled to give informed consent (e.g. minors without a guardian)
- Woman who had a caesarean section
- Delivery is regarded as abortion (gestational age < 28 weeks)
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 of sublingual misoprostol | Drug | Misoprostol, Placebo |
Primary outcome
Blood loss greater than or equal to 500 mls after enrolment
Time frame: Blood loss measured for minimum of 1 hour or until active bleeding ceased
4 secondary outcomes
Average blood loss
Time frame: Blood loss measured for minimum of one hour or until active bleeding ceased
Clinical complications (need for transfusion, hysterectomy)
Time frame: After delivery and prior to hospital discharge
Pre-delivery and post-delivery hemoglobin measures
Time frame: Pre-delivery hemoglobin measured upon admission to hospital (during labor) and measured postpartum 12-24 hours after delivery
Side effects
Time frame: observed or reported following study treatment and 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 18718007Zuberi NF, Durocher J, Sikander R, Baber N, Blum J, Walraven G. Misoprostol in addition to routine treatment of postpartum hemorrhage: a hospital-based randomized-controlled trial in Karachi, Pakistan. BMC Pregnancy Childbirth. 2008 Aug 21;8:40. doi: 10.1186/1471-2393-8-40.
- Related InfoLink provided by the sponsor.
Related trials for Postpartum Hemorrhage
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Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
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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.
Nadeem F Zuberi, MD principal investigator
Aga Khan University Hospital, Karachi
2 sites 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, run by Gynuity Health Projects at 2 sites 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 1 inclusion and 4 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 2 sites 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. 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?
Blood loss greater than or equal to 500 mls after enrolment (time frame: Blood loss measured for minimum of 1 hour or until active bleeding ceased). 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 NCT00116480, which also lists 2 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.