Misoprostol in the Prevention of Postpartum Haemorrhage

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.

Study Overview

• Status: Unknown
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Drug: 200 micrograms of misoprostol; Drug: Placebo Oral Tablet

• Study Type: Interventional
• Enrollment (Anticipated): 1496
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Carole Rattray, DM; Phone Number: 876.927.1145; Email: carole.rattray@uwimona.edu.jm
• Study Contact Backup: Name: Peta-Gaye Thomas Brown, PhD; Phone Number: 876.927.2556; Email: petagaye.thomas03@uwimona.edu.jm

Study Locations

• Jamaica
  • Kingston, Jamaica, Kgn 7
    • Recruiting
    • University Hospital of the West Indies, Mona
    • Contact: Carole Rattray, DM O &G; Phone Number: 876.927.2556; Email: carole.rattray@uwimona.edu.jm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; 200 micrograms of Misoprostol applied sublingually together with standard parenteral oxytocic therapy	Drug: 200 micrograms of misoprostol; 200 micrograms of powdered misoprostol applied sublingually together with standard parenteral oxytocic therapy
Placebo Comparator: Placebo; 200 micrograms of powdered placebo applied sublingually together with standard parenteral oxytocic therapy micrograms of misoprostol	Drug: Placebo Oral Tablet; 200 micrograms of powdered placebo applied sublingually together with standard parenteral oxytocic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of blood loss between intervention and control group	Volume of blood loss at delivery in the control group.	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	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	24 hours
Measurement of Electrolytes (Sodium)	Blood concentration of sodium (mmol/L) will be measured on admission in labour compared to 24 hours postpartum	24 hours
Measurement of Electrolytes (Potassium)	Blood concentration of potassium (mmol/L) will be measured on admission in labour compared to 24 hours postpartum	24 hours
Measurement of Electrolytes (Chloride)	Blood concentration of chloride (mmol/L) will be measured on admission in labour compared to 24 hours postpartum	24 hours
Measurement of Electrolytes (Bicarbonate)	Blood concentration of bicarbonate (mmol/L) will be measured on admission in labour compared to 24 hours postpartum	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	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	24 hours
Percentage of participants who receive a hysterectomy as a complication of bleeding will be assessed		24 hours
Percentage of participants who are admitted to the ICU due to complications of bleeding will be assessed		24 hours
Percentage of participants with fever as a complication of misoprostol administration will be assessed		24 hours
Percentage of participants with shivering as a complication of misoprostol administration will be assessed (Shivering)		24 hours
Percentage of participants with nausea as a complication of misoprostol administration will be assessed (Nausea)		24 hours

Collaborators and Investigators

• Sponsor: The University of The West Indies
• Investigators: Principal Investigator: Rattray Dr Carole, University of the West Indies Mona

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: August 2, 2019
• First Posted (Actual): August 5, 2019

Study Record Updates

• Last Update Posted (Actual): August 5, 2019
• Last Update Submitted That Met QC Criteria: August 2, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: ECP 200 11/12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No