Postpartum HemorrhageNCT00124540
Misoprostol for Preventing Postpartum Hemorrhage
A study testing misoprostol in people with Postpartum Hemorrhage, run by Gynuity Health Projects at 5 sites in 3 countries.
Trial summary
This hospital-based, multicenter, randomized, placebo-controlled trial will assess the effects of misoprostol as part of active management of the third stage of labor on postpartum blood loss, complications, and side effects. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,200 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Aug 2005to Oct 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women who have given birth to 1 or more live-born infants (para 1 or more)
- Vaginal delivery
Who cannot join
- Refusal or inability to give informed consent
- Delivery regarded as abortion according to local gestational age limits
- Inability to take misoprostol sublingually
- Cesarean section
- Assisted vaginal delivery
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
South Africa3 sites
Tembisa Hospital
Johannesburg
Rob Ferreira Hospital
Mbombela
Dora Nginza Hospital
Port Elizabeth
About this study
This hospital-based, multicenter, randomized, placebo-controlled trial will assess the effects of misoprostol as part of active management of the third stage of labor on postpartum blood loss, complications, and side effects. Twelve hundred eligible women will receive routine oxytocics (oxytocin 5-10 IU) plus either 400 mcg sublingual misoprostol or placebo during or immediately after delivery. The primary outcome will be measured blood loss of =>500 mls within one hour after enrollment.
- Conditions
- Postpartum Hemorrhage
- Being tested
- misoprostol, placebo
- Keywords
- Misoprostol, Active management, Postpartum hemorrhage, Maternal morbidity, Anemia, Developing countries
- 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
placeboDrug
placebo resembling misoprosotl
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | placebo resembling misoprostol Receives: Drug: placebo |
| 2 | Experimental | misoprostol Receives: Drug: misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss =>500 mls within one hour after enrollment
Secondary outcomes (6)
Blood loss =>1000 mls within one hour after enrollment
Mean blood loss after enrollment
Blood transfusion
Hemoglobin level <8 g/dL 24 hours after delivery
Maternal morbidity and mortality
Side effects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2005 (estimated)
- Study startAug 2005
- Primary completionSep 2007
- Study completionOct 2007
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- University of Witwatersrand, South Africa, Effective Care Research Unit, Family Care International
- Investigators
- Lindeka Mangesi, Study director, Effective Care Research Unit, East London Hospital Complex, South AfricaG. J. Hofmeyr, MD, Principal investigator, Effective Care Research Unit, Frere Maternity Hospital, East London Hospital Complex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124540
- Sponsor's protocol ID
- 2.4.5
- Status last verified
- May 2008
- First submitted
- 26 Jul 2005
- Last updated
- 28 May 2008
- Results posted
- No
Publications
Hofmeyr GJ, Fawole B, Mugerwa K, Godi NP, Blignaut Q, Mangesi L, Singata M, Brady L, Blum J. Administration of 400 mug of misoprostol to augment routine active management of the third stage of labor. Int J Gynaecol Obstet. 2011 Feb;112(2):98-102. doi: 10.1016/j.ijgo.2010.08.019. Epub 2010 Dec 4.
PubMed 21130990
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Misoprostol for Preventing Postpartum Hemorrhage
- ClinicalTrials.gov ID
- NCT00124540
- Acronym / sponsor ID
- 2.4.5
- Conditions
- Postpartum Hemorrhage
- Keywords
- Misoprostol, Active management, Postpartum hemorrhage, Maternal morbidity, Anemia, Developing countries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- University of Witwatersrand, South Africa, Effective Care Research Unit, Family Care International
- Study start
- Aug 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 28 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 hospital-based, multicenter, randomized, placebo-controlled trial will assess the effects of misoprostol as part of active management of the third stage of labor on postpartum blood loss, complications, and side effects. Twelve hundred eligible women will receive routine oxytocics (oxytocin 5-10 IU) plus either 400 mcg sublingual misoprostol or placebo during or immediately after delivery. The primary outcome will be measured blood loss of =>500 mls within one hour after enrollment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: placeboplacebo resembling misoprostol |
| 2 | Experimental | Drug: misoprostolmisoprostol |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Women who have given birth to 1 or more live-born infants (para 1 or more)
- Vaginal delivery
Key exclusion criteria (5 listed)
- Refusal or inability to give informed consent
- Delivery regarded as abortion according to local gestational age limits
- Inability to take misoprostol sublingually
- Cesarean section
- Assisted vaginal 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 | Drug | 2 |
| placeboplacebo resembling misoprosotl | Drug | 1 |
Primary outcome
Blood loss =>500 mls within one hour after enrollment
6 secondary outcomes
Blood loss =>1000 mls within one hour after enrollment
Mean blood loss after enrollment
Blood transfusion
Hemoglobin level <8 g/dL 24 hours after delivery
Maternal morbidity and mortality
Side effects
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 28 May 2008.
- Derived from this study: PubMed 21130990Hofmeyr GJ, Fawole B, Mugerwa K, Godi NP, Blignaut Q, Mangesi L, Singata M, Brady L, Blum J. Administration of 400 mug of misoprostol to augment routine active management of the third stage of labor. Int J Gynaecol Obstet. 2011 Feb;112(2):98-102. doi: 10.1016/j.ijgo.2010.08.019. Epub 2010 Dec 4.
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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.
Lindeka Mangesi study director
Effective Care Research Unit, East London Hospital Complex, South Africa
G. J. Hofmeyr, MD principal investigator
Effective Care Research Unit, Frere Maternity Hospital, East London Hospital Complex
5 sites in 3 countries: 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 5 sites in 3 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 2 inclusion and 5 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 28 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Africa, Nigeria, Uganda. 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 =>500 mls within one hour after enrollment. 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 NCT00124540, 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 28 May 2008.