Clinical trial NCT04044287: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Postpartum Hemorrhage
Lead sponsor: The University of The West Indies
Sponsor class: OTHER
First posted: 2019-08-05
Enrollment: 1496
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective cohort
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Volume of blood loss at the time of delivery
timeFrame: 24 hours
Secondary outcomes:
measure: Comparison of blood loss between intervention and control group
timeFrame: 24 hours
measure: Measurement of Haematological indices (Haemoglobin level)
timeFrame: 24 hours
measure: Comparison of Haematological indices (Packed Cell Volume, PCV)
timeFrame: 24 hours
measure: Measurement of Electrolytes (Sodium)
timeFrame: 24 hours
measure: Measurement of Electrolytes (Potassium)
timeFrame: 24 hours
measure: Measurement of Electrolytes (Chloride)
timeFrame: 24 hours
measure: Measurement of Electrolytes (Bicarbonate)
timeFrame: 24 hours
measure: Cardiovascular instability - Frequency of hypotension as a complication of bleeding
timeFrame: 24 hours
measure: Cardiovascular instability - Frequency of tachycardia as a complication of bleeding
timeFrame: 24 hours
measure: Percentage of participants who receive a hysterectomy as a complication of bleeding will be assessed
timeFrame: 24 hours
measure: Percentage of participants who are admitted to the ICU due to complications of bleeding will be assessed
timeFrame: 24 hours
measure: Percentage of participants with fever as a complication of misoprostol administration will be assessed
timeFrame: 24 hours
measure: Percentage of participants with shivering as a complication of misoprostol administration will be assessed (Shivering)
timeFrame: 24 hours
measure: Percentage of participants with nausea as a complication of misoprostol administration will be assessed (Nausea)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Kingston
country: Jamaica
facility: University Hospital of the West Indies, Mona
Study officials:
affiliation: University of the West Indies Mona
name: Rattray Dr Carole
role: PRINCIPAL_INVESTIGATOR
References: