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

NCT ID: NCT01600612

Last Updated: 2013-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-07-31

Brief Summary

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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

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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.

Conditions

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Postpartum Hemorrhage

Keywords

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postpartum hemorrhage, oxytocin, carbetocin, misopristol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oxytocin

30 IU of oxytocin will be given intravenously to patients with atonic postpartum hemorrhage

Group Type ACTIVE_COMPARATOR

oxytocin

Intervention Type DRUG

30 IU of oxytocin will be given intravenously to patients with atonic postpartum hemorrhage

carbetocin

10 ug of carbetocin will be given intravenously to patients with atonic postpartum hemorrhage

Group Type ACTIVE_COMPARATOR

carbetocin

Intervention Type DRUG

10 ug of carbetocin will be given intravenously to patients with atonic postpartum hemorrhage

misopristol

600 ug of misopristol sublingually will be given intravenously to patients with atonic postpartum hemorrhage

Group Type ACTIVE_COMPARATOR

misopristol

Intervention Type DRUG

600 ug of misopristol will be given sublingually to patients with atonic postpartum hemorrhage

Interventions

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carbetocin

10 ug of carbetocin will be given intravenously to patients with atonic postpartum hemorrhage

Intervention Type DRUG

misopristol

600 ug of misopristol will be given sublingually to patients with atonic postpartum hemorrhage

Intervention Type DRUG

oxytocin

30 IU of oxytocin will be given intravenously to patients with atonic postpartum hemorrhage

Intervention Type DRUG

Other Intervention Names

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pabal Misotac

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role collaborator

Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Salah M Rasheed

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Salah M Rasheed, MD

Role: STUDY_DIRECTOR

Department of Obstetrics and Gynecology, Sohag university, Egypt

magdy M Amin, MD

Role: STUDY_CHAIR

Department of obstetrics and Gynecology, Sohag university, Egypt

Ahmed H Abd-Ella, MD

Role: PRINCIPAL_INVESTIGATOR

Department of obstetrics and Gynecology, Qena university, Egypt

Ahmed M Abo Elhassan, MD

Role: PRINCIPAL_INVESTIGATOR

Department of obstetrics and Gynecology, Assuit university, Egypt

Mazen A El Zahry, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics and Gynecology, Al Azhar university, Egypt

Locations

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Sohag university

Sohag, Sohag Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Salah M Rasheed, MD

Role: CONTACT

Phone: 01224653702

Email: [email protected]

Facility Contacts

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Mostafa M Abdel Khalek, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 33232518 (View on PubMed)

Other Identifiers

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salah-1

Identifier Type: -

Identifier Source: org_study_id