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

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01600612
• Other study ID #: salah-1
• Status: Recruiting
• Phase: N/A
• First received: May 16, 2012
• Last updated: May 30, 2013
• Start date: September 2012
• Est. completion date: July 2013

Study information

• Verified date: May 2013
• Source: Sohag University
• Contact: Salah M Rasheed, MD
• Phone: 01224653702
• Email: salahrasheed67[@]yahoo.com
• Is FDA regulated: No
• Health authority: "Egyptp':'Sohag university, Sohag faculty of medicine"
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

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

Locations

Country	Name	City	State
Egypt	Sohag university	Sohag

Sponsors (2)

Lead Sponsor	Collaborator
Sohag University	Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	control of postpartum hemorrhage		within 20 minutes of administration	No
Secondary	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.		24 hours	Yes