NCT04044287

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,496

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

August 5, 2019

Status Verified

September 1, 2018

Enrollment Period

7 years

First QC Date

April 4, 2019

Last Update Submit

August 2, 2019

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • Comparison of blood loss between intervention and control group

    24 hours

  • Measurement of Haematological indices (Haemoglobin level)

    24 hours

  • Comparison of Haematological indices (Packed Cell Volume, PCV)

    24 hours

  • Measurement of Electrolytes (Sodium)

    24 hours

  • Measurement of Electrolytes (Potassium)

    24 hours

  • +9 more secondary outcomes

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Drug: 200 micrograms of misoprostol

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Interventions

200 micrograms of misoprostolDRUG

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

Intervention
Placebo Oral TabletDRUG

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

Placebo

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of the West Indies, Mona

Kingston, Kgn 7, Jamaica

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rattray Dr Carole

    University of the West Indies Mona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carole Rattray, DM

CONTACT

876.927.1145carole.rattray@uwimona.edu.jm

Peta-Gaye Thomas Brown, PhD

CONTACT

876.927.2556petagaye.thomas03@uwimona.edu.jm

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double Blind Randomised Control Trial
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective cohort
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2019

First Posted

August 5, 2019

Study Start

January 1, 2013

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

August 5, 2019

Record last verified: 2018-09

Locations

JA(1)