NCT02079558

Brief Summary

Postpartum hemorrhage (PPH) is a common complication of childbirth and a leading cause of maternal morbidity and mortality. The prompt and effective treatment of subjects with PPH would reduce operation risks. Hence in this study, the efficacy of Oxytocin and Carbetocin was compared in prevention of postpartum hemorrhage after cesarean sections.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 6, 2014

Completed
Last Updated

March 6, 2014

Status Verified

March 1, 2014

Enrollment Period

1 year

First QC Date

January 13, 2014

Last Update Submit

March 4, 2014

Conditions

Keywords

preventioncesarean section

Outcome Measures

Primary Outcomes (2)

  • screening of Cessation of bleeding

    screening until 24 hours after placenta disconnection

  • time duration to stop bleeding in the case of post-cesarean section

    24 hours

Study Arms (2)

Oxytocin

EXPERIMENTAL

A single 100 microgram IV dose of carbetocin after operation

Drug: Oxytocin

Carbetocin

EXPERIMENTAL

A standard 30 international units (IU) IV infusion of oxytocin during two hours

Drug: Carbetocin

Interventions

Carbetocin with single 100 microg IV dosage was used in this investigation

Also known as: Duratocin,, Pabal,, Lonactene
Carbetocin

Oxytocin with 30 international units (IU) IV infusion was used in this investigation

Also known as: Pitocin
Oxytocin

Eligibility Criteria

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

You may qualify if:

  • At least one risk for postpartum hemorrhage and lack of hypersensitivity to oxytocin and carbetocin

You may not qualify if:

  • Patients' refusal to cooperate, major therapeutic side effects, history of cardiac and renal disease or preeclampsia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Infertility and Reproductive Health Research Center

Tehran, Tehran Province, 1985717443, Iran

Location

Related Publications (1)

  • Taheripanah R, Shoman A, Karimzadeh MA, Zamaniyan M, Malih N. Efficacy of oxytocin versus carbetocin in prevention of postpartum hemorrhage after cesarean section under general anesthesia: a prospective randomized clinical trial. J Matern Fetal Neonatal Med. 2018 Nov;31(21):2807-2812. doi: 10.1080/14767058.2017.1355907. Epub 2017 Jul 25.

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

  • Robabeh Taheripanah, MD-Gyn.

    Infertility and Reproductive health Research center, Imam Hossien hospital, Shahid Beheshti Medical university, Tehran, Iran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated prof. Obstetrics & Gynecology

Study Record Dates

First Submitted

January 13, 2014

First Posted

March 6, 2014

Study Start

September 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

March 6, 2014

Record last verified: 2014-03

Locations