NCT02424201

Brief Summary

Postpartum haemorrhage is the leading cause of maternal haemorrhage globally. With active management of labour 3 to 16.5% of parturients still experience postpartum haemorrhage. Hence the need for an effective oxytocic in third stage of labour.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
660

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jun 2015

Shorter than P25 for early_phase_1

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

First Submitted

Initial submission to the registry

April 18, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

April 30, 2015

Status Verified

April 1, 2015

Enrollment Period

6 months

First QC Date

April 18, 2015

Last Update Submit

April 29, 2015

Conditions

Primary Postpartum Haemorrhage

Keywords

uterine atony

Outcome Measures

Primary Outcomes (1)

  • mean blood loss

    1 hour of delivery

Secondary Outcomes (1)

  • number of participants with untowards effects

    1 hour of delivery

Study Arms (2)

study

EXPERIMENTAL

Intramuscular oxytocin 10 units, 400 micrograms of misoprostol

Drug: Misoprostol

control

OTHER

Intramuscular oxytocin 10 units, 2 tablets of placebo which will be vitamin c

Drug: vitamin c

Interventions

MisoprostolDRUG

experimental

Also known as: Cytotec
study
vitamin cDRUG

control

Also known as: ascorbic acid
control

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • singleton in longitudinal lie and cephalic presentation

You may not qualify if:

  • refusal of consents, multiple gestation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ottun TA, Adewunmi AA, Rabiu AK, Olumodeji AM, Oladipo OM, Olalere HF. Misoprostol and oxytocin versus oxytocin alone in the active management of the third stage of labour: a randomised, double-blind, placebo-controlled trial. J Obstet Gynaecol. 2022 Jul;42(5):1048-1053. doi: 10.1080/01443615.2021.1995342. Epub 2021 Dec 27.

    PMID: 34958620DERIVED

MeSH Terms

Conditions

Uterine Inertia

Interventions

MisoprostolAscorbic Acid

Condition Hierarchy (Ancestors)

DystociaObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

April 18, 2015

First Posted

April 22, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

April 30, 2015

Record last verified: 2015-04