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Oxytocin Versus, Sublingual Misoprostol in the Secondary Prevention of Postpartum Hemorrhage After Vaginal Delivery

Primary Purpose

Labor Complication

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
oxytocin
misoprostol
Sponsored by
Aswan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Labor Complication

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • vaginal birth in women who had blood loss >300 ml

Exclusion Criteria:

  • <37 weeks of pregnancy,
  • genital tract injuries,
  • coagulation deficit,
  • hypertension, preeclampsia,
  • cardiac, renal, or hepatic disease,
  • epilepsy,

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    oxytocin

    misoprostol

    Arm Description

    20 unit of oxytocin infusion in 500 ml lactated ringer's solution 125 ml/h (Syntocinon, Novartis, Switzerland)

    800 µg sublingual misoprostol (Cytotec Pfizer, New York, USA)

    Outcomes

    Primary Outcome Measures

    measured excessive bleeding blood loss ≥ 300 mills after PPH treatment
    measured amount of blood loss ≥ 300 mills after PPH treatment

    Secondary Outcome Measures

    change in hemoglobin
    measure change of hemoglobin
    need for additional interventions
    number of patients need additional interventions ,like uterine aetry ligation

    Full Information

    First Posted
    October 1, 2021
    Last Updated
    October 14, 2021
    Sponsor
    Aswan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05077540
    Brief Title
    Oxytocin Versus, Sublingual Misoprostol in the Secondary Prevention of Postpartum Hemorrhage After Vaginal Delivery
    Official Title
    The Effect of Oxytocin Versus, Sublingual Misoprostol in the Secondary Prevention of Postpartum Hemorrhage After Vaginal Delivery: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2021 (Anticipated)
    Primary Completion Date
    October 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aswan University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Researchers sought to see how oxytocin versus, sublingual misoprostol affected estimated and measured blood loss during vaginal delivery in women who had blood loss >300 ml .
    Detailed Description
    The greatest cause of maternal mortality globally is postpartum hemorrhage (PPH), which is defined as a blood loss of 500 mL or more after birth. All women giving birth should be given a preventive uterotonic drug, according to the World Health Organization (WHO). Despite the use of a uterotonic drug as a preventative measure, PPH remains a frequent complication, accounting for one-quarter of all maternal fatalities worldwide. When prophylaxis fails and PPH develops, it is advised that uterotonic medicines be used as first-line therapy. However, it's unclear whether the uterotonic drug is better for treating PPH as first-line therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Labor Complication

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    double-blinded a randomized controlled trial
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    double-blinded a randomized controlled trial
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    oxytocin
    Arm Type
    Active Comparator
    Arm Description
    20 unit of oxytocin infusion in 500 ml lactated ringer's solution 125 ml/h (Syntocinon, Novartis, Switzerland)
    Arm Title
    misoprostol
    Arm Type
    Experimental
    Arm Description
    800 µg sublingual misoprostol (Cytotec Pfizer, New York, USA)
    Intervention Type
    Drug
    Intervention Name(s)
    oxytocin
    Other Intervention Name(s)
    Active Comparator
    Intervention Description
    20 unit of oxytocin infusion in 500 ml lactated ringer's solution 125 ml/h (Syntocinon, Novartis, Switzerland)
    Intervention Type
    Drug
    Intervention Name(s)
    misoprostol
    Other Intervention Name(s)
    Active Comparator
    Intervention Description
    800 µg sublingual misoprostol (Cytotec Pfizer, New York, USA)
    Primary Outcome Measure Information:
    Title
    measured excessive bleeding blood loss ≥ 300 mills after PPH treatment
    Description
    measured amount of blood loss ≥ 300 mills after PPH treatment
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    change in hemoglobin
    Description
    measure change of hemoglobin
    Time Frame
    12 hours
    Title
    need for additional interventions
    Description
    number of patients need additional interventions ,like uterine aetry ligation
    Time Frame
    24 hours

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    vaginal birth in women who had blood loss >300 ml
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: vaginal birth in women who had blood loss >300 ml Exclusion Criteria: <37 weeks of pregnancy, genital tract injuries, coagulation deficit, hypertension, preeclampsia, cardiac, renal, or hepatic disease, epilepsy,
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    hany f sallam, md
    Phone
    +201112501460
    Ext
    002
    Email
    hany.farouk@aswu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    nahla w waer, md
    Phone
    +201022336052
    Ext
    002
    Email
    nahlagyn@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Oxytocin Versus, Sublingual Misoprostol in the Secondary Prevention of Postpartum Hemorrhage After Vaginal Delivery

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