NCT01600612

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

May 31, 2013

Status Verified

May 1, 2013

Enrollment Period

9 months

First QC Date

May 16, 2012

Last Update Submit

May 30, 2013

Conditions

Postpartum Hemorrhage

Keywords

postpartum hemorrhage, oxytocin, carbetocin, misopristol

Outcome Measures

Primary Outcomes (1)

  • control of postpartum hemorrhage

    within 20 minutes of administration

Secondary Outcomes (1)

  • 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

Study Arms (3)

Oxytocin

ACTIVE COMPARATOR

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

Drug: oxytocin

carbetocin

ACTIVE COMPARATOR

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

Drug: carbetocin

misopristol

ACTIVE COMPARATOR

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

Drug: misopristol

Interventions

carbetocinDRUG

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

Also known as: pabal
carbetocin
misopristolDRUG

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

Also known as: Misotac
misopristol
oxytocinDRUG

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

Oxytocin

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • primary atonic postpartum hemorrhage after vaginal delivery

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university

Sohag, Sohag Governorate, 1224, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33232518DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

carbetocinOxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Salah M Rasheed, MD

    Department of Obstetrics and Gynecology, Sohag university, Egypt

    STUDY DIRECTOR

  • magdy M Amin, MD

    Department of obstetrics and Gynecology, Sohag university, Egypt

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Salah M Rasheed, MD

CONTACT

01224653702salahrasheed67@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 16, 2012

First Posted

May 17, 2012

Study Start

September 1, 2012

Primary Completion

June 1, 2013

Study Completion

July 1, 2013

Last Updated

May 31, 2013

Record last verified: 2013-05

Locations

EG(1)