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Uterotonics Using to Reduce Bleeding at Cesarean Section

Primary Purpose

Postpartum Haemorrhage

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Misoprostol
Oxytocin
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Haemorrhage

Eligibility Criteria

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

Inclusion Criteria:

  • Gestational age 37-40 wk.
  • Elective lower segment cesarean section.
  • Under spinal anesthesia.

Exclusion Criteria:

  • Anemia (Hb> 8 g%).
  • Multiple gestation.
  • Antepartum hemorrhage.
  • Poly-hydramnios.
  • Two or more previous cesarean sections.
  • History of previous rupture uterus.
  • Current or previous history of significant disease including heart disease, liver, renal disorders or known coagulopathy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Sublingual misoprostol

    oxytocin

    Arm Description

    The patients in this arm received 400 micrograms of sublingual misoprostol, immediately after delivery of the neonate.

    The patients in this arm received 20 IU oxytocin dissolved in 1 L of Lactated Ringer's or glucose solution) at the rate of 125 ml /h , immediately after delivery of the neonate.

    Outcomes

    Primary Outcome Measures

    Blood loss in ML

    Secondary Outcome Measures

    Hematocrit value (%)

    Full Information

    First Posted
    September 27, 2015
    Last Updated
    August 10, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02562300
    Brief Title
    Uterotonics Using to Reduce Bleeding at Cesarean Section
    Official Title
    Comparative Study of Sublingual Misoprostol Versus Oxytocin in Reducing Bleeding at Cesarean Section
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    January 2015 (Actual)
    Study Completion Date
    April 2015 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    Postpartum haemorrhage continues to be a leading cause of maternal morbidity and mortality worldwide and that is according to the estimates of the World Health Organization in 1998. Average blood loss during delivery progressively increases with the type of delivery, vaginal delivery (500 ml), cesarean section (1000 ml) and emergency hysterectomy (3500 ml) of blood. A reduction of operative blood loss at cesarean section has a great benefit to the patients in terms of decreased postoperative morbidity and a decrease in risks associated with blood transfusions. The routine use of oxytocin is associated with a significant reduction in the occurrence of postpartum hemorrhage. Excessive blood loss as estimated by a 10% drop in the hematocrit value postdelivery or by need for blood transfusion, occurs in approximately 4% of vaginal deliveries and 6% of cesarean births. Although many delivery units use oxytocin as the first line agent to prevent uterine atony at cesarean section, it may not be the ideal agent for prevention of postpartum haemorrhage especially in compromised patients with preeclampsia, cardiac disease or prolonged labor. Oxytocin and specifically its preservative chlorobutanol increases the heart rate and has negative inotropic, antiplatelet and antidiuretic effects. Misoprostol, a prostaglandin E1 analogue, has been shown in many studies to be an effective myometrial stimulant of the pregnant uterus which binds to prostanoid receptors. Misoprostol administration, either by oral or rectal route, has been shown to be effective in prevention of postpartum haemorrhage and is considered as an effective alternative to other conventional oxytocics especially in developing countries as it is cheap and thermostable. Pharmacokinetic studies suggested that the bioavailability of misoprostol after sublingual administration was higher than those after oral or vaginal administration. A few studies are now available for the use of sublingual misoprostol in the prevention of postpartum haemorrhage following vaginal delivery and have reported it as an effective and convenient route of administration. However, none of the studies conducted so far have evaluated the response of sublingual misoprostol for prevention of postpartum haemorrhage during cesarean section.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sublingual misoprostol
    Arm Type
    Active Comparator
    Arm Description
    The patients in this arm received 400 micrograms of sublingual misoprostol, immediately after delivery of the neonate.
    Arm Title
    oxytocin
    Arm Type
    Active Comparator
    Arm Description
    The patients in this arm received 20 IU oxytocin dissolved in 1 L of Lactated Ringer's or glucose solution) at the rate of 125 ml /h , immediately after delivery of the neonate.
    Intervention Type
    Drug
    Intervention Name(s)
    Misoprostol
    Intervention Description
    400 micrograms of sublingual misoprostol were given immediately after delivery of the neonate.
    Intervention Type
    Drug
    Intervention Name(s)
    Oxytocin
    Intervention Description
    20 IU oxytocin dissolved in 1 L of Lactated Ringer's or glucose solution) at the rate of 125 ml /h were given immediately after delivery of the neonate.
    Primary Outcome Measure Information:
    Title
    Blood loss in ML
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Hematocrit value (%)
    Time Frame
    1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Gestational age 37-40 wk. Elective lower segment cesarean section. Under spinal anesthesia. Exclusion Criteria: Anemia (Hb> 8 g%). Multiple gestation. Antepartum hemorrhage. Poly-hydramnios. Two or more previous cesarean sections. History of previous rupture uterus. Current or previous history of significant disease including heart disease, liver, renal disorders or known coagulopathy.

    12. IPD Sharing Statement

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    Uterotonics Using to Reduce Bleeding at Cesarean Section

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