Post Partum HemorrhagePhase 3NCT01866241
Combating Maternal Mortality in Uganda: An Assessment of the Role of Misoprostol in Prevention of Post-Partum Hemorrhage
A Phase 3 study testing Misoprostol in people with Post Partum Hemorrhage, run by Mbarara University of Science and Technology at 1 site in Uganda.
Trial summary
Null hypothesis: 10 IU Oxytocin is better than sublingual misoprostol 600µg in management of third stage of labor Alternative hypothesis: Sublingual misoprostol 600µg is non- inferior to 10 IU oxytocin and will not be more than 6% worse [than 10 IU oxytocin] in management of third stage of labor Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Post Partum Hemorrhage
- What is being tested?
- Misoprostol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,140 participants
- Where
- 1 siteUganda
- Study dates
- Nov 2012to Oct 2013
- Phase
- Phase 3
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Complicated labor:
- confirmed intra-uterine fetal death
- self-reported maternal heart disease
- current diagnosis of severe malaria or acute bacterial infection,
- multiple pregnancy,
- induced or augmented labor,
Show all 10Show fewer
- elective Caesarean section,
- ante-partum hemorrhage,
- reported hypersensitivity to prostaglandins
- altered cognitive status (ACS) as assessed by the MRAs. -
Trial locations and contacts
1 site in 1 country.
About this study
Null hypothesis: 10 IU Oxytocin is better than sublingual misoprostol 600µg in management of third stage of labor Alternative hypothesis: Sublingual misoprostol 600µg is non- inferior to 10 IU oxytocin and will not be more than 6% worse [than 10 IU oxytocin] in management of third stage of labor
Read the detailed description
Background: In Sub- Saharan Africa, one in 35 women die in child birth, 1000 times higher than the western world and Post-Partum Hemorrhage (PPH) accounts for the biggest percentage of maternal morbidity and mortality (WHO, 2005; WHO, 2010). Maternal Mortality in Uganda is one of the highest in the world at 435 for every 100,000 and 25% of these are due to PPH happening within 24 hours after delivery. Oxytocin, the standard of care in PPH management has registered challenges like requirement of sterile injections, requirement of trained personnel, special supply chain/storage conditions like refrigeration and protection from light affecting maximum treatment outcomes especially in poorly resourced developing countries where these are not realized. It has been argued that any effort or developments based on physiological processes towards the reduction of this horrific PPH rate would greatly have a significant impact on the lives of families and women worldwide. Several scholars have thus stressed a vital need to develop simple, practical and inexpensive techniques relevant to prevent and treat PPH in developing countries.
- Conditions
- Post Partum Hemorrhage
- Being tested
- 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
Also called Prostaglandin, Cytotec
Is a prostaglandin
| Study group | Role | What they receive |
|---|---|---|
| Arm A: sublingual misoprostol 600µg | Experimental | Misoprostol is a uteretonic drug Receives: Drug: Misoprostol |
| Arm B: 10 IU Oxytocin | Placebo comparator | Oytocin is a standard of care treatment for PPH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated Blood loss
Estimated blood loss of more than or equal to 500ml
Measured: 24 hours
Secondary outcomes (3)
Blood loss of more than 1000ml
Other secondary outcomes are: Hematocrit drop, additional uteretonic use
Measured: 24 hours
1) maternal death, 2) pre and post delivery hemoglobin changes 3) pre and post delivery hematocrit changes 4) >10% hemoglobin drop 5) mean postpartum hemoglobin and hematocrit, 6) mean measured blood loss
Measured: 24 hours
7) placental retention 8) requirement for blood transfusion 9) requirement for additional therapeutic procedures or uterotonics 10) duration of the third stage of labor
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startNov 2012
- Primary completionSep 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 Post Partum 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mbarara University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University, University Ghent
- Responsible party
- Sponsor
- Investigators
- Amon Agaba, PhD, Study chair, Mbarara University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866241
- Sponsor's protocol ID
- MUST-17-2012
- Status last verified
- Sep 2014
- First submitted
- 28 May 2013
- Last updated
- 8 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Atukunda EC, Siedner MJ, Obua C, Mugyenyi GR, Twagirumukiza M, Agaba AG. Sublingual misoprostol versus intramuscular oxytocin for prevention of postpartum hemorrhage in Uganda: a double-blind randomized non-inferiority trial. PLoS Med. 2014 Nov 4;11(11):e1001752. doi: 10.1371/journal.pmed.1001752. eCollection 2014 Nov.
PubMed 25369200
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combating Maternal Mortality in Uganda: An Assessment of the Role of Misoprostol in Prevention of Post-Partum Hemorrhage
- ClinicalTrials.gov ID
- NCT01866241
- Acronym / sponsor ID
- MUST-17-2012
- Conditions
- Post Partum Hemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,140 participants (actual)
- Lead sponsor
- Mbarara University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Makerere University, University Ghent
- Study start
- Nov 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 31 May 2013 (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.
Null hypothesis: 10 IU Oxytocin is better than sublingual misoprostol 600µg in management of third stage of labor Alternative hypothesis: Sublingual misoprostol 600µg is non- inferior to 10 IU oxytocin and will not be more than 6% worse [than 10 IU oxytocin] in management of third stage of labor
Detailed description
Background: In Sub- Saharan Africa, one in 35 women die in child birth, 1000 times higher than the western world and Post-Partum Hemorrhage (PPH) accounts for the biggest percentage of maternal morbidity and mortality (WHO, 2005; WHO, 2010). Maternal Mortality in Uganda is one of the highest in the world at 435 for every 100,000 and 25% of these are due to PPH happening within 24 hours after delivery. Oxytocin, the standard of care in PPH management has registered challenges like requirement of sterile injections, requirement of trained personnel, special supply chain/storage conditions like refrigeration and protection from light affecting maximum treatment outcomes especially in poorly resourced developing countries where these are not realized. It has been argued that any effort or developments based on physiological processes towards the reduction of this horrific PPH rate would greatly have a significant impact on the lives of families and women worldwide. Several scholars have thus stressed a vital need to develop simple, practical and inexpensive techniques relevant to prevent and treat PPH in developing countries.
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 |
|---|---|---|
| Arm A: sublingual misoprostol 600µg | Experimental | Drug: MisoprostolMisoprostol is a uteretonic drug |
| Arm B: 10 IU Oxytocin | Placebo comparator | –Oytocin is a standard of care treatment for PPH |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- confirmed intra-uterine fetal death
- self-reported maternal heart disease
- current diagnosis of severe malaria or acute bacterial infection,
- multiple pregnancy,
- induced or augmented labor,
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 |
|---|---|---|
| MisoprostolAlso: Prostaglandin, CytotecIs a prostaglandin | Drug | Arm A: sublingual misoprostol 600µg |
Primary outcome
Estimated Blood loss
Time frame: 24 hours
Estimated blood loss of more than or equal to 500ml
3 secondary outcomes
Blood loss of more than 1000ml
Time frame: 24 hours
1) maternal death, 2) pre and post delivery hemoglobin changes 3) pre and post delivery hematocrit changes 4) >10% hemoglobin drop 5) mean postpartum hemoglobin and hematocrit, 6) mean measured blood loss
Time frame: 24 hours
7) placental retention 8) requirement for blood transfusion 9) requirement for additional therapeutic procedures or uterotonics 10) duration of the third stage of labor
Time frame: 24 hours
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 8 Sep 2014.
- Derived from this study: PubMed 25369200Atukunda EC, Siedner MJ, Obua C, Mugyenyi GR, Twagirumukiza M, Agaba AG. Sublingual misoprostol versus intramuscular oxytocin for prevention of postpartum hemorrhage in Uganda: a double-blind randomized non-inferiority trial. PLoS Med. 2014 Nov 4;11(11):e1001752. doi: 10.1371/journal.pmed.1001752. eCollection 2014 Nov.
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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.
Amon Agaba, PhD study chair
Mbarara University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Misoprostol in people with Post Partum Hemorrhage, run by Mbarara University of Science and Technology at 1 site in Uganda.
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 0 inclusion and 10 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 8 Sep 2014. 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Estimated Blood loss (time frame: 24 hours). 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 NCT01866241, 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 8 Sep 2014.