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Comparative Study on the Effects of Sublingual Misoprostol in Addition to Standard AMTSL in Low Risk Parturients in LASUTH, Ikeja.

NCT ID: NCT02424201

Last Updated: 2015-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

660 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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This is a prospective randomized doubleblind controlled trial involving 660 consenting pregnant women. Eligible subjects will be ransomised into 2 groups of 330 participants. All patients will receive the standard oxytocin 10 units as part of the active management of third stage of labour. However, the study group will be administered sublingual 400 misoprostol while the control group will receive 2tablets of placebo (vitamin c). Measured mean blood loss will be comparee in the 2 groups using statistical analysis.

Conditions

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Primary Postpartum Haemorrhage

Keywords

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uterine atony

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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study

Intramuscular oxytocin 10 units, 400 micrograms of misoprostol

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

experimental

control

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

Group Type OTHER

vitamin c

Intervention Type DRUG

control

Interventions

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Misoprostol

experimental

Intervention Type DRUG

vitamin c

control

Intervention Type DRUG

Other Intervention Names

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Cytotec ascorbic acid

Eligibility Criteria

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Inclusion Criteria

* singleton in longitudinal lie and cephalic presentation

Exclusion Criteria

* refusal of consents, multiple gestation
Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Lagos State University

OTHER

Sponsor Role lead

Responsible Party

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Oyedeko Muyideen Oladipo

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 34958620 (View on PubMed)

Other Identifiers

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LagosSU

Identifier Type: -

Identifier Source: org_study_id