Oxytocin, Carbetocin and Misopristol for Treatment of Postpartum Hemorrhage: A Multicentric Randomized Trial

Overview

Postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide, with an estimated mortality of 140 000 per year. Uterine atony is one of the most important causes of PPH. The traditional treatment of which is the use of uterotonic agents. Oxytocin is the most conventional drug which was proved effective. However, it has the shortcomings of short half life and the necessity of intravenous administration. Misopristol, and more recently Carbetocin were introduced for treatment of atonic PPP not responding to Oxytocin.

Aim of the study is to evaluate the effectiveness of Carbetocin, Misopristol, and Oxytocin for treatment of atonic PPH.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2013

Detailed Description

The study will be conducted at the departments of Obstetrics and Gynecology of Sohag, Qena, Al Azhar, and Assuit university hospitals, Egypt. All patients with atonic PPH who delivered vaginally will be invited to participate in the study. Patients who delivered by caesarean section, with retained placenta, with traumatic PPH, associated coagulopathy and those refused to participate in the study will be excluded. The patients will be randomly categorized into 3 groups; the first (n = 100) will receive 30 IU oxytocin intravenously; the second (n = 100) will receive 600 ug misopristol sublingually; the third (n = 100) will receive 100 ug Carbetocin IV. The randomization will be done using opaque sealed envelops containing computer-generated codes. The primary outcome of the study is cessation of bleeding which will be judged by visual inspection of the blood loss by the trialist and by loss of < 300 mL of blood during the first hour after enrollment. The secondary outcomes are time of control of bleeding (minutes), amount of blood loss till control of bleeding (mL), changes in the hemoglobin levels (gm) before and after treatment, Changes in the hematocrite values (%) before and after treatment, the use of additional uterotonic drugs, the rate of complications (%), and the necessity for surgical intervention, and the cost of each medication.

Written consent will be obtained from all participants and approval from the local institutional ethical committee will be included.

Interventions

  • Drug: carbetocin
    • 10 ug of carbetocin will be given intravenously to patients with atonic postpartum hemorrhage
  • Drug: misopristol
    • 600 ug of misopristol will be given sublingually to patients with atonic postpartum hemorrhage
  • Drug: oxytocin
    • 30 IU of oxytocin will be given intravenously to patients with atonic postpartum hemorrhage

Arms, Groups and Cohorts

  • Active Comparator: Oxytocin
    • 30 IU of oxytocin will be given intravenously to patients with atonic postpartum hemorrhage
  • Active Comparator: carbetocin
    • 10 ug of carbetocin will be given intravenously to patients with atonic postpartum hemorrhage
  • Active Comparator: misopristol
    • 600 ug of misopristol sublingually will be given intravenously to patients with atonic postpartum hemorrhage

Clinical Trial Outcome Measures

Primary Measures

  • control of postpartum hemorrhage
    • Time Frame: within 20 minutes of administration

Secondary Measures

  • time of control of bleeding, amount of blood loss till control of bleeding, changes in the hemoglobin and hematocrite levels, use of additional uterotonic drugs, necessity for surgical intervention, and the rate of complications.
    • Time Frame: 24 hours

Participating in This Clinical Trial

Inclusion Criteria

  • primary atonic postpartum hemorrhage after vaginal delivery

Exclusion Criteria

  • Patients who delivered by caesarean section
  • Retained placenta
  • Traumatic postpartum hemorrhage
  • Associated coagulopathy
  • Chronic medical illness (hepatic , renal diseases)
  • Refusal to participate in the study.

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sohag University
  • Collaborator
    • Al-Azhar University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Salah M Rasheed, Dr – Sohag University
  • Overall Official(s)
    • Salah M Rasheed, MD, Study Director, Department of Obstetrics and Gynecology, Sohag university, Egypt
    • magdy M Amin, MD, Study Chair, Department of obstetrics and Gynecology, Sohag university, Egypt
    • Ahmed H Abd-Ella, MD, Principal Investigator, Department of obstetrics and Gynecology, Qena university, Egypt
    • Ahmed M Abo Elhassan, MD, Principal Investigator, Department of obstetrics and Gynecology, Assuit university, Egypt
    • Mazen A El Zahry, M.D., Principal Investigator, Department of Obstetrics and Gynecology, Al Azhar university, Egypt
  • Overall Contact(s)
    • Salah M Rasheed, MD, 01224653702, salahrasheed67@yahoo.com

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