Misoprostol in the Prevention of Postpartum Haemorrhage

Phase 3

• Conditions: Postpartum Hemorrhage
• Interventions: Drug: 200 micrograms of misoprostol; Drug: Placebo Oral Tablet

• Registration Number: NCT04044287
• Lead Sponsor: The University of The West Indies

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-01
• Status Verified: 2018-09
• Study First Submitted: 2019-04-04
• Study First Submitted QC: 2019-08-02
• Last Update Submitted: 2019-08-02
• Study First Posted: 2019-08-05
• Last Update Posted: 2019-08-05
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1496

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	200 micrograms of misoprostol	200 micrograms of Misoprostol applied sublingually together with standard parenteral oxytocic therapy
Placebo	Placebo Oral Tablet	200 micrograms of powdered placebo applied sublingually together with standard parenteral oxytocic therapy micrograms of misoprostol

Primary Outcome Measures

Name	Time	Method
Volume of blood loss at the time of delivery	24 hours	Volume (ml) of blood loss at the time of delivery will be measured using an under-buttock collection drape

Secondary Outcome Measures

Name	Time	Method
Percentage of participants with shivering as a complication of misoprostol administration will be assessed (Shivering)	24 hours
Comparison of blood loss between intervention and control group	24 hours	Volume of blood loss at delivery in the control group.
Comparison of Haematological indices (Packed Cell Volume, PCV)	24 hours	Measurement of the PCV (%) in blood samples obtained on admission in labour compared to 24 hours postpartum
Measurement of Haematological indices (Haemoglobin level)	24 hours	Measurement of haemoglobin level (g/dl) in blood samples obtained on admission in labour compared to 24 hours postpartum
Measurement of Electrolytes (Potassium)	24 hours	Blood concentration of potassium (mmol/L) will be measured on admission in labour compared to 24 hours postpartum
Measurement of Electrolytes (Sodium)	24 hours	Blood concentration of sodium (mmol/L) will be measured on admission in labour compared to 24 hours postpartum
Measurement of Electrolytes (Chloride)	24 hours	Blood concentration of chloride (mmol/L) will be measured on admission in labour compared to 24 hours postpartum
Percentage of participants with fever as a complication of misoprostol administration will be assessed	24 hours
Measurement of Electrolytes (Bicarbonate)	24 hours	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	24 hours	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	24 hours	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	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 nausea as a complication of misoprostol administration will be assessed (Nausea)	24 hours

Trial Locations

Locations (1)

University Hospital of the West Indies, Mona; 🇯🇲 Kingston, Jamaica