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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Sohag University
Sponsor:
Collaborator:
Al-Azhar University
Information provided by (Responsible Party):
Salah M Rasheed, Sohag University
ClinicalTrials.gov Identifier:
NCT01600612
First received: May 16, 2012
Last updated: May 30, 2013
Last verified: May 2013

May 16, 2012
May 30, 2013
September 2012
June 2013   (final data collection date for primary outcome measure)
control of postpartum hemorrhage [ Time Frame: within 20 minutes of administration ] [ Designated as safety issue: No ]
control of postpartum hemorrhage [ Time Frame: within 20 minutes of administration ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01600612 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
The secondary outcomes are time of control of bleeding, amount of blood loss till control of bleeding, the use of additional uterotonic drugs, the rate of complications, and the cost of each medication. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Oxytocin, Carbetocin and Misopristol for Treatment of Postpartum Hemorrhage: A Multicentric Randomized Trial
Oxytocin, Carbetocin and Misopristol for Treatment of Postpartum Hemorrhage: A Multicentric Randomized Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Postpartum Hemorrhage
  • Drug: carbetocin
    10 ug of carbetocin will be given intravenously to patients with atonic postpartum hemorrhage
    Other Name: pabal
  • Drug: misopristol
    600 ug of misopristol will be given sublingually to patients with atonic postpartum hemorrhage
    Other Name: Misotac
  • Drug: oxytocin
    30 IU of oxytocin will be given intravenously to patients with atonic postpartum hemorrhage
    Other Name: Oxytocin
  • Active Comparator: Oxytocin
    30 IU of oxytocin will be given intravenously to patients with atonic postpartum hemorrhage
    Intervention: Drug: oxytocin
  • Active Comparator: carbetocin
    10 ug of carbetocin will be given intravenously to patients with atonic postpartum hemorrhage
    Intervention: Drug: carbetocin
  • Active Comparator: misopristol
    600 ug of misopristol sublingually will be given intravenously to patients with atonic postpartum hemorrhage
    Intervention: Drug: misopristol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
July 2013
June 2013   (final data collection date for primary outcome measure)

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.
Female
Not Provided
No
Contact: Salah M Rasheed, MD 01224653702 salahrasheed67@yahoo.com
Egypt
 
NCT01600612
salah-1
Yes
Salah M Rasheed, Sohag University
Sohag University
Al-Azhar University
Study Director: Salah M Rasheed, MD Department of Obstetrics and Gynecology, Sohag university, Egypt
Study Chair: magdy M Amin, MD Department of obstetrics and Gynecology, Sohag university, Egypt
Principal Investigator: Ahmed H Abd-Ella, MD Department of obstetrics and Gynecology, Qena university, Egypt
Principal Investigator: Ahmed M Abo Elhassan, MD Department of obstetrics and Gynecology, Assuit university, Egypt
Principal Investigator: Mazen A El Zahry, M.D. Department of Obstetrics and Gynecology, Al Azhar university, Egypt
Sohag University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP