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The Effect of Rectal and Sublingual Misoprostol Administration in Postpartum or Intrapartum Haemorrhage at Elective Caesarean Delivery: a Randomized Controlled Trial

Primary Purpose

ıntrapartum Haemorrhage, Postpartum Haemorrhage

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Misoprostol
Sponsored by
Istanbul Bakirkoy Maternity and Children Diseases Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for ıntrapartum Haemorrhage

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. live and singleton pregnancy
  2. Elective caesarean
  3. Gestational week greater than 37 weeks
  4. patient between 18-44 year old

Exclusion Criteria:

  1. -multiple pregnancy
  2. Preeclampsia
  3. Gestational diabetes
  4. Macrosomia
  5. Oligohidraamnıos
  6. Polihidraamnıos
  7. Myoma
  8. Morbid obesity
  9. Coagulatıon defect (such as HELLP syndrome)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Placebo Comparator

    No Intervention

    Arm Label

    sublingual

    rectal

    synpitan

    Arm Description

    400 microgram mısoprostol will be administered sublıngually before elective caesarean

    rectal 600 mgr misoprostol will be administered

    Outcomes

    Primary Outcome Measures

    Postpartum Haemorrhage

    Secondary Outcome Measures

    Full Information

    First Posted
    August 26, 2013
    Last Updated
    February 24, 2014
    Sponsor
    Istanbul Bakirkoy Maternity and Children Diseases Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01931410
    Brief Title
    The Effect of Rectal and Sublingual Misoprostol Administration in Postpartum or Intrapartum Haemorrhage at Elective Caesarean Delivery: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    January 2014 (Actual)
    Study Completion Date
    February 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul Bakirkoy Maternity and Children Diseases Hospital

    4. Oversight

    5. Study Description

    Brief Summary
    The investigators hypothesis in this study is that administration of rectal and sublingual misoprostol decreases intrapartum and postpartum haemorrhage.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ıntrapartum Haemorrhage, Postpartum Haemorrhage

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    618 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    sublingual
    Arm Type
    Placebo Comparator
    Arm Description
    400 microgram mısoprostol will be administered sublıngually before elective caesarean
    Arm Title
    rectal
    Arm Type
    Placebo Comparator
    Arm Description
    rectal 600 mgr misoprostol will be administered
    Arm Title
    synpitan
    Arm Type
    No Intervention
    Intervention Type
    Drug
    Intervention Name(s)
    Misoprostol
    Primary Outcome Measure Information:
    Title
    Postpartum Haemorrhage
    Time Frame
    postpartum 24 hour

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    44 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: live and singleton pregnancy Elective caesarean Gestational week greater than 37 weeks patient between 18-44 year old Exclusion Criteria: -multiple pregnancy Preeclampsia Gestational diabetes Macrosomia Oligohidraamnıos Polihidraamnıos Myoma Morbid obesity Coagulatıon defect (such as HELLP syndrome)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Berhan AŞICIOĞLU, M.D.
    Organizational Affiliation
    T.C.S.B. Kanuni Sultan Süleyman Research Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Effect of Rectal and Sublingual Misoprostol Administration in Postpartum or Intrapartum Haemorrhage at Elective Caesarean Delivery: a Randomized Controlled Trial

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