Misoprostol in the Prevention of Postpartum Haemorrhage

The University of The West Indies

Status and phase: Unknown; Phase 3

Conditions: Postpartum Hemorrhage

Treatments: Drug: 200 micrograms of misoprostol; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04044287

ECP 200 11/12

Details and patient eligibility

About

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.

Enrollment: 1,496 estimated patients

Sex: Female

Ages: 16 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

1,496 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Description:

200 micrograms of Misoprostol applied sublingually together with standard parenteral oxytocic therapy

Treatment:

Drug: 200 micrograms of misoprostol

Placebo

Placebo Comparator group

Description:

200 micrograms of powdered placebo applied sublingually together with standard parenteral oxytocic therapy micrograms of misoprostol

Treatment:

Drug: Placebo Oral Tablet