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Buccal Misoprostol Versus IV Oxytocin in Prevention of Postpartum Hemorrhage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03676621
Recruitment Status : Not yet recruiting
First Posted : September 19, 2018
Last Update Posted : September 19, 2018
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

Brief Summary:
Cesarean delivery is defined as fetal birth through incisions in the abdominal wall and the uterine wall (hysterotomy). This definition does not include removal of the fetus from the abdominal cavity in the case of uterine rupture or in the case of an abdominal pregnancy

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Drug: Misoprostol Drug: Oxytocin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Buccal Misoprostol Versus IV Oxytocin in Prevention of Postpartum Hemorrhage :a Randomized Controlled Study
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: study group
patients will receive buccal misoprostol
Drug: Misoprostol
buccal tablets

Active Comparator: control group
patients will receive intravenous oxytocin
Drug: Oxytocin
intravenous drip

Primary Outcome Measures :
  1. mean blood loss [ Time Frame: 1 hour ]
    the amount of blood in towels and suction drain

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • pregnant women
  • term pregnancy
  • singleton pregnancies
  • booked for elective cesarean section

Exclusion Criteria:

  • • Medical disorders involving the heart,liver,kidney or brain

    • Diabetes mellitus and hypertension
    • Blood disorders (e.g. coagulopathies , thrombocytopenia )
    • Patients requiring blood transfusion due to anemia
    • Risk factors for uterine atony e.g. macrosomia , polyhydramnios ,multiple pregnancies
    • Placenta previa or placental abruption
    • Previous major obstetric haemorrhage (>1000ml)in previous deliveries
    • Known fibroid or adenomyosis
    • Severe preeclampsia
    • Uterine anomalies
    • Women who received anticoagulant therapy

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Responsible Party: Ahmed Mohamed Abbas, Principal investigator, Assiut University Identifier: NCT03676621     History of Changes
Other Study ID Numbers: BMISO
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Postpartum Hemorrhage
Puerperal Disorders
Uterine Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents