Misoprostol in the Prevention of Postpartum Haemorrhage

Postpartum Hemorrhage Clinical Trial

Official title:

Sublingual Misoprostol and Routine Third Stage Prophylaxis for the Prevention of Postpartum Haemorrhage: A Randomised Controlled Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04044287
• Other study ID #: ECP 200 11/12
• Status: Recruiting
• Phase: Phase 3
• Start date: January 1, 2013
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2018
• Source: The University of The West Indies
• Contact: Carole Rattray, DM
• Phone: 876.927.1145
• Email: carole.rattray[@]uwimona.edu.jm
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1496
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• 200 micrograms of misoprostol
200 micrograms of powdered misoprostol applied sublingually together with standard parenteral oxytocic therapy
• Placebo Oral Tablet
200 micrograms of powdered placebo applied sublingually together with standard parenteral oxytocic therapy

Locations

Country	Name	City	State
Jamaica	University Hospital of the West Indies, Mona	Kingston

Sponsors (1)

Lead Sponsor	Collaborator
The University of The West Indies

Country where clinical trial is conducted

Jamaica, 

Outcome

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