Clinical trial NCT01600612: Oxytocin, Carbetocin and Misopristol for Treatment of Postpartum Hemorrhage: A Multicentric Randomized Trial
Official title: Oxytocin, Carbetocin and Misopristol for Treatment of Postpartum Hemorrhage: A Multicentric Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postpartum Hemorrhage
Keywords: postpartum hemorrhage, oxytocin, carbetocin, misopristol
Lead sponsor: Sohag University
Sponsor class: OTHER
Collaborators: name: Al-Azhar University
First posted: 2012-05-17
Enrollment: 300
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: control of postpartum hemorrhage
timeFrame: within 20 minutes of administration
Secondary outcomes:
measure: 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.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university
Study officials:
affiliation: Department of Obstetrics and Gynecology, Sohag university, Egypt
name: Salah M Rasheed, MD
role: STUDY_DIRECTOR
affiliation: Department of obstetrics and Gynecology, Sohag university, Egypt
name: magdy M Amin, MD
role: STUDY_CHAIR
affiliation: Department of obstetrics and Gynecology, Qena university, Egypt
name: Ahmed H Abd-Ella, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of obstetrics and Gynecology, Assuit university, Egypt
name: Ahmed M Abo Elhassan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Obstetrics and Gynecology, Al Azhar university, Egypt
name: Mazen A El Zahry, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parry Smith WR, Papadopoulou A, Thomas E, Tobias A, Price MJ, Meher S, Alfirevic Z, Weeks AD, Hofmeyr GJ, Gulmezoglu AM, Widmer M, Oladapo OT, Vogel JP, Althabe F, Coomarasamy A, Gallos ID. Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD012754. doi: 10.1002/14651858.CD012754.pub2.