Postpartum HemorrhagePhase 3NCT04044287
Misoprostol in the Prevention of Postpartum Haemorrhage
A Phase 3 study testing 200 micrograms of misoprostol in people with Postpartum Hemorrhage, run by The University of The West Indies at 1 site in Jamaica.
Trial summary
Postpartum haemorrhage is a major contributor to maternal mortality in the developing world. The incidence is between 5 and 12% in Jamaica and varies depending on the route of delivery. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- 200 micrograms of misoprostol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,496 participants
- Where
- 1 siteJamaica
- Study dates
- 1 Jan 2013to 31 Dec 2019
- 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 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant women admitted to the labour wards at University Hospital of the West Indies (UHWI) and Victoria Jubilee Hospital (VJH) undergoing a vaginal delivery
- Consent given to participate in the study
Who cannot join
- Women undergoing caesarean section
- Gestational age less than 28 weeks
- Any severe allergic conditions
- Severe asthmatics
- Age <16 years
- Temperature >38 degrees Celsius
- Women not wishing to consent to join the study
Trial locations and contacts
1 site in 1 country.
Jamaica1 site, 1 recruiting
- Recruiting
University Hospital of the West Indies, Mona
Kingston, Kgn 7
Carole Rattray, DM O &G, 876.927.2556, carole.rattray@uwimona.edu.jm
About this study
Official title: Sublingual Misoprostol and Routine Third Stage Prophylaxis for the Prevention of Postpartum Haemorrhage: A Randomised Controlled Clinical Trial.
Postpartum haemorrhage is a major contributor to maternal mortality in the developing world. The incidence is between 5 and 12% in Jamaica and varies depending on the route of delivery. Misoprostol is a uterotonic agent which has the potential to augment the effects of the standard parenteral oxytocic agents used as best practice in the active management of the third stage of labour, thereby reducing the risk of postpartum haemorrhage and its attendant complications.
The Aim of the study is twofold: to show that this additive effect translates to a reduced postpartum haemorrhage rate and secondly to demonstrate reduced side effects of misoprostol resulting from the lower dose and the powdered sublingual administration.
- Conditions
- Postpartum Hemorrhage
- Being tested
- 200 micrograms of misoprostol, Placebo Oral Tablet
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
200 micrograms of misoprostolDrug
200 micrograms of powdered misoprostol applied sublingually together with standard parenteral oxytocic therapy
Placebo Oral TabletDrug
200 micrograms of powdered placebo applied sublingually together with standard parenteral oxytocic therapy
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | 200 micrograms of Misoprostol applied sublingually together with standard parenteral oxytocic therapy Receives: Drug: 200 micrograms of misoprostol |
| Placebo | Placebo comparator | 200 micrograms of powdered placebo applied sublingually together with standard parenteral oxytocic therapy micrograms of misoprostol Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of blood loss at the time of delivery
Volume (ml) of blood loss at the time of delivery will be measured using an under-buttock collection drape
Measured: 24 hours
Secondary outcomes (14)
Comparison of blood loss between intervention and control group
Volume of blood loss at delivery in the control group.
Measured: 24 hours
Measurement of Haematological indices (Haemoglobin level)
Measurement of haemoglobin level (g/dl) in blood samples obtained on admission in labour compared to 24 hours postpartum
Measured: 24 hours
Comparison of Haematological indices (Packed Cell Volume, PCV)
Measurement of the PCV (%) in blood samples obtained on admission in labour compared to 24 hours postpartum
Measured: 24 hours
Measurement of Electrolytes (Sodium)
Blood concentration of sodium (mmol/L) will be measured on admission in labour compared to 24 hours postpartum
Measured: 24 hours
Measurement of Electrolytes (Potassium)
Blood concentration of potassium (mmol/L) will be measured on admission in labour compared to 24 hours postpartum
Measured: 24 hours
Measurement of Electrolytes (Chloride)
Blood concentration of chloride (mmol/L) will be measured on admission in labour compared to 24 hours postpartum
Measured: 24 hours
Measurement of Electrolytes (Bicarbonate)
Blood concentration of bicarbonate (mmol/L) will be measured on admission in labour compared to 24 hours postpartum
Measured: 24 hours
Cardiovascular instability - Frequency of hypotension as a complication of bleeding
Presence of hypotension will be assessed as cardiovascular instability due to a complication of bleeding in each participant on admission in labour compared to 24 hours postpartum
Measured: 24 hours
Cardiovascular instability - Frequency of tachycardia as a complication of bleeding
Presence of tachycardia will be assessed as cardiovascular instability due to a complication of bleeding in each participant on admission in labour compared to 24 hours postpartum
Measured: 24 hours
Percentage of participants who receive a hysterectomy as a complication of bleeding will be assessed
Measured: 24 hours
Percentage of participants who are admitted to the ICU due to complications of bleeding will be assessed
Measured: 24 hours
Percentage of participants with fever as a complication of misoprostol administration will be assessed
Measured: 24 hours
Percentage of participants with shivering as a complication of misoprostol administration will be assessed (Shivering)
Measured: 24 hours
Percentage of participants with nausea as a complication of misoprostol administration will be assessed (Nausea)
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 posted5 Aug 2019
- Study start1 Jan 2013
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective cohort
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,496 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rattray Dr Carole, Principal investigator, University of the West Indies Mona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044287
- Sponsor's protocol ID
- ECP 200 11/12
- Status last verified
- Sep 2018
- First submitted
- 4 Apr 2019
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sublingual Misoprostol and Routine Third Stage Prophylaxis for the Prevention of Postpartum Haemorrhage: A Randomised Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT04044287
- Acronym / sponsor ID
- ECP 200 11/12
- Conditions
- Postpartum Hemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,496 participants (estimated)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 5 Aug 2019 (actual)
- 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 is a major contributor to maternal mortality in the developing world. The incidence is between 5 and 12% in Jamaica and varies depending on the route of delivery. Misoprostol is a uterotonic agent which has the potential to augment the effects of the standard parenteral oxytocic agents used as best practice in the active management of the third stage of labour, thereby reducing the risk of postpartum haemorrhage and its attendant complications.
The Aim of the study is twofold: to show that this additive effect translates to a reduced postpartum haemorrhage rate and secondly to demonstrate reduced side effects of misoprostol resulting from the lower dose and the powdered sublingual administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective cohort
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Drug: 200 micrograms of misoprostol200 micrograms of Misoprostol applied sublingually together with standard parenteral oxytocic therapy |
| Placebo | Placebo comparator | Drug: Placebo Oral Tablet200 micrograms of powdered placebo applied sublingually together with standard parenteral oxytocic therapy micrograms of misoprostol |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Pregnant women admitted to the labour wards at University Hospital of the West Indies (UHWI) and Victoria Jubilee Hospital (VJH) undergoing a vaginal delivery
- Consent given to participate in the study
Key exclusion criteria (7 listed)
- Women undergoing caesarean section
- Gestational age less than 28 weeks
- Any severe allergic conditions
- Severe asthmatics
- Age <16 years
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 |
|---|---|---|
| 200 micrograms of misoprostol200 micrograms of powdered misoprostol applied sublingually together with standard parenteral oxytocic therapy | Drug | Intervention |
| Placebo Oral Tablet200 micrograms of powdered placebo applied sublingually together with standard parenteral oxytocic therapy | Drug | Placebo |
Primary outcome
Volume of blood loss at the time of delivery
Time frame: 24 hours
Volume (ml) of blood loss at the time of delivery will be measured using an under-buttock collection drape
14 secondary outcomes
Comparison of blood loss between intervention and control group
Time frame: 24 hours
Measurement of Haematological indices (Haemoglobin level)
Time frame: 24 hours
Comparison of Haematological indices (Packed Cell Volume, PCV)
Time frame: 24 hours
Measurement of Electrolytes (Sodium)
Time frame: 24 hours
Measurement of Electrolytes (Potassium)
Time frame: 24 hours
Measurement of Electrolytes (Chloride)
Time frame: 24 hours
Measurement of Electrolytes (Bicarbonate)
Time frame: 24 hours
Cardiovascular instability - Frequency of hypotension as a complication of bleeding
Time frame: 24 hours
Cardiovascular instability - Frequency of tachycardia as a complication of bleeding
Time frame: 24 hours
Percentage of participants who receive a hysterectomy as a complication of bleeding will be assessed
Time frame: 24 hours
Percentage of participants who are admitted to the ICU due to complications of bleeding will be assessed
Time frame: 24 hours
Percentage of participants with fever as a complication of misoprostol administration will be assessed
Time frame: 24 hours
Percentage of participants with shivering as a complication of misoprostol administration will be assessed (Shivering)
Time frame: 24 hours
Percentage of participants with nausea as a complication of misoprostol administration will be assessed (Nausea)
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
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
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Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
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Prevention of Postpartum Hemorrhage With Tranexamic Acid
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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.
Rattray Dr Carole principal investigator
University of the West Indies Mona
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 200 micrograms of misoprostol in people with Postpartum Hemorrhage, run by The University of The West Indies at 1 site in Jamaica.
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 7 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: status not confirmed, as of the sponsor's last update on 5 Aug 2019. 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 Jamaica. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carole Rattray, DM (876.927.1145, carole.rattray@uwimona.edu.jm), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of blood loss at the time of delivery (time frame: 24 hours). 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 5 Aug 2019.