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

Primary Purpose

Primary Postpartum Haemorrhage

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Misoprostol
vitamin c
Sponsored by
Lagos State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Primary Postpartum Haemorrhage focused on measuring uterine atony

Eligibility Criteria

15 Years - 45 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • singleton in longitudinal lie and cephalic presentation

Exclusion Criteria:

  • refusal of consents, multiple gestation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    study

    control

    Arm Description

    Intramuscular oxytocin 10 units, 400 micrograms of misoprostol

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

    Outcomes

    Primary Outcome Measures

    mean blood loss

    Secondary Outcome Measures

    number of participants with untowards effects

    Full Information

    First Posted
    April 18, 2015
    Last Updated
    April 29, 2015
    Sponsor
    Lagos State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02424201
    Brief Title
    Comparative Study on the Effects of Sublingual Misoprostol in Addition to Standard AMTSL in Low Risk Parturients in LASUTH, Ikeja.
    Official Title
    Comparative Study on Effects of Sublingual Misoprostol in Addition to Standard Active Management of Third Stage of Labour in Low Risk Parturients in Lagos State University Teaching Hospital, Ikeja.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    December 2015 (Anticipated)
    Study Completion Date
    February 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Lagos State University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Postpartum Haemorrhage
    Keywords
    uterine atony

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    660 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    study
    Arm Type
    Experimental
    Arm Description
    Intramuscular oxytocin 10 units, 400 micrograms of misoprostol
    Arm Title
    control
    Arm Type
    Other
    Arm Description
    Intramuscular oxytocin 10 units, 2 tablets of placebo which will be vitamin c
    Intervention Type
    Drug
    Intervention Name(s)
    Misoprostol
    Other Intervention Name(s)
    Cytotec
    Intervention Description
    experimental
    Intervention Type
    Drug
    Intervention Name(s)
    vitamin c
    Other Intervention Name(s)
    ascorbic acid
    Intervention Description
    control
    Primary Outcome Measure Information:
    Title
    mean blood loss
    Time Frame
    1 hour of delivery
    Secondary Outcome Measure Information:
    Title
    number of participants with untowards effects
    Time Frame
    1 hour of delivery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: singleton in longitudinal lie and cephalic presentation Exclusion Criteria: refusal of consents, multiple gestation

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34958620
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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