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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
  Purpose

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.


Condition Intervention
Postpartum Hemorrhage
Drug: carbetocin
Drug: misopristol
Drug: oxytocin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oxytocin, Carbetocin and Misopristol for Treatment of Postpartum Hemorrhage: A Multicentric Randomized Trial

Resource links provided by NLM:


Further study details as provided by Sohag University:

Primary Outcome Measures:
  • control of postpartum hemorrhage [ Time Frame: within 20 minutes of administration ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: September 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oxytocin
30 IU of oxytocin will be given intravenously to patients with atonic postpartum hemorrhage
Drug: oxytocin
30 IU of oxytocin will be given intravenously to patients with atonic postpartum hemorrhage
Other Name: Oxytocin
Active Comparator: carbetocin
10 ug of carbetocin will be given intravenously to patients with atonic postpartum hemorrhage
Drug: carbetocin
10 ug of carbetocin will be given intravenously to patients with atonic postpartum hemorrhage
Other Name: pabal
Active Comparator: misopristol
600 ug of misopristol sublingually 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
Other Name: Misotac

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01600612

Contacts
Contact: Salah M Rasheed, MD 01224653702 salahrasheed67@yahoo.com

Locations
Egypt
Sohag university Recruiting
Sohag, Egypt, 1224
Contact: Mostafa M Abdel Khalek, MD    01226534893    elgalawy@yahoo.com   
Principal Investigator: Salah M Rasheed, MD         
Sponsors and Collaborators
Sohag University
Al-Azhar University
Investigators
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
  More Information

No publications provided

Responsible Party: Salah M Rasheed, Dr, Sohag University
ClinicalTrials.gov Identifier: NCT01600612     History of Changes
Other Study ID Numbers: salah-1
Study First Received: May 16, 2012
Last Updated: May 30, 2013
Health Authority: "Egyptp':'Sohag university, Sohag faculty of medicine"

Keywords provided by Sohag University:
postpartum hemorrhage, oxytocin, carbetocin, misopristol

Additional relevant MeSH terms:
Puerperal Disorders
Hemorrhage
Postpartum Hemorrhage
Obstetric Labor Complications
Pathologic Processes
Pregnancy Complications
Uterine Hemorrhage
Carbetocin
Oxytocin
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014