Misoprostol in the Prevention of Postpartum Haemorrhage
Primary Purpose
Postpartum Hemorrhage
Status
Unknown status
Phase
Phase 3
Locations
Jamaica
Study Type
Interventional
Intervention
200 micrograms of misoprostol
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Postpartum Hemorrhage
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University Hospital of the West Indies, MonaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention
Placebo
Arm Description
200 micrograms of Misoprostol applied sublingually together with standard parenteral oxytocic therapy
200 micrograms of powdered placebo applied sublingually together with standard parenteral oxytocic therapy micrograms of misoprostol
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Comparison of blood loss between intervention and control group
Volume of blood loss at delivery in the control group.
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
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
Measurement of Electrolytes (Sodium)
Blood concentration of sodium (mmol/L) will be measured on admission in labour compared to 24 hours postpartum
Measurement of Electrolytes (Potassium)
Blood concentration of potassium (mmol/L) will be measured on admission in labour compared to 24 hours postpartum
Measurement of Electrolytes (Chloride)
Blood concentration of chloride (mmol/L) will be measured on admission in labour compared to 24 hours postpartum
Measurement of Electrolytes (Bicarbonate)
Blood concentration of bicarbonate (mmol/L) will be measured on admission in labour compared to 24 hours postpartum
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
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
Percentage of participants who receive a hysterectomy as a complication of bleeding will be assessed
Percentage of participants who are admitted to the ICU due to complications of bleeding will be assessed
Percentage of participants with fever as a complication of misoprostol administration will be assessed
Percentage of participants with shivering as a complication of misoprostol administration will be assessed (Shivering)
Percentage of participants with nausea as a complication of misoprostol administration will be assessed (Nausea)
Full Information
NCT ID
NCT04044287
First Posted
April 4, 2019
Last Updated
August 2, 2019
Sponsor
The University of The West Indies
1. Study Identification
Unique Protocol Identification Number
NCT04044287
Brief Title
Misoprostol in the Prevention of Postpartum Haemorrhage
Official Title
Sublingual Misoprostol and Routine Third Stage Prophylaxis for the Prevention of Postpartum Haemorrhage: A Randomised Controlled Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of The West Indies
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Prospective cohort
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double Blind Randomised Control Trial
Allocation
Randomized
Enrollment
1496 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
200 micrograms of Misoprostol applied sublingually together with standard parenteral oxytocic therapy
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
200 micrograms of powdered placebo applied sublingually together with standard parenteral oxytocic therapy micrograms of misoprostol
Intervention Type
Drug
Intervention Name(s)
200 micrograms of misoprostol
Intervention Description
200 micrograms of powdered misoprostol applied sublingually together with standard parenteral oxytocic therapy
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
200 micrograms of powdered placebo applied sublingually together with standard parenteral oxytocic therapy
Primary Outcome Measure Information:
Title
Volume of blood loss at the time of delivery
Description
Volume (ml) of blood loss at the time of delivery will be measured using an under-buttock collection drape
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Comparison of blood loss between intervention and control group
Description
Volume of blood loss at delivery in the control group.
Time Frame
24 hours
Title
Measurement of Haematological indices (Haemoglobin level)
Description
Measurement of haemoglobin level (g/dl) in blood samples obtained on admission in labour compared to 24 hours postpartum
Time Frame
24 hours
Title
Comparison of Haematological indices (Packed Cell Volume, PCV)
Description
Measurement of the PCV (%) in blood samples obtained on admission in labour compared to 24 hours postpartum
Time Frame
24 hours
Title
Measurement of Electrolytes (Sodium)
Description
Blood concentration of sodium (mmol/L) will be measured on admission in labour compared to 24 hours postpartum
Time Frame
24 hours
Title
Measurement of Electrolytes (Potassium)
Description
Blood concentration of potassium (mmol/L) will be measured on admission in labour compared to 24 hours postpartum
Time Frame
24 hours
Title
Measurement of Electrolytes (Chloride)
Description
Blood concentration of chloride (mmol/L) will be measured on admission in labour compared to 24 hours postpartum
Time Frame
24 hours
Title
Measurement of Electrolytes (Bicarbonate)
Description
Blood concentration of bicarbonate (mmol/L) will be measured on admission in labour compared to 24 hours postpartum
Time Frame
24 hours
Title
Cardiovascular instability - Frequency of hypotension as a complication of bleeding
Description
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
Time Frame
24 hours
Title
Cardiovascular instability - Frequency of tachycardia as a complication of bleeding
Description
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
Time Frame
24 hours
Title
Percentage of participants who receive a hysterectomy as a complication of bleeding will be assessed
Time Frame
24 hours
Title
Percentage of participants who are admitted to the ICU due to complications of bleeding will be assessed
Time Frame
24 hours
Title
Percentage of participants with fever as a complication of misoprostol administration will be assessed
Time Frame
24 hours
Title
Percentage of participants with shivering as a complication of misoprostol administration will be assessed (Shivering)
Time Frame
24 hours
Title
Percentage of participants with nausea as a complication of misoprostol administration will be assessed (Nausea)
Time Frame
24 hours
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carole Rattray, DM
Phone
876.927.1145
Email
carole.rattray@uwimona.edu.jm
First Name & Middle Initial & Last Name or Official Title & Degree
Peta-Gaye Thomas Brown, PhD
Phone
876.927.2556
Email
petagaye.thomas03@uwimona.edu.jm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rattray Dr Carole
Organizational Affiliation
University of the West Indies Mona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of the West Indies, Mona
City
Kingston
ZIP/Postal Code
Kgn 7
Country
Jamaica
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carole Rattray, DM O &G
Phone
876.927.2556
Email
carole.rattray@uwimona.edu.jm
12. IPD Sharing Statement
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Misoprostol in the Prevention of Postpartum Haemorrhage
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