NCT02101567

Brief Summary

The investigators compare the effectiveness and adverse effects of I.V carbetocin versus oxytocin \& ergometrine I.V for prevention of postpartum haemorrhage following cesarean section.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2014

Shorter than P25 for phase_4

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

First Submitted

Initial submission to the registry

March 29, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2014

Completed
29 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

11 months

First QC Date

March 29, 2014

Last Update Submit

April 9, 2015

Conditions

BleedingAnemia

Keywords

Postpartum hemorrhage, Cesarean section, Uterotonics

Outcome Measures

Primary Outcomes (1)

  • Uterine tone and size

    The uterine tone and size will be assessed by using a hand resting on the fundus and palpating the anterior wall of the uterus one hour after the operation. The presence of a boggy uterus with either heavy vaginal bleeding or increasing uterine size can suspect diagnosis of uterine atony.

    One hour after the cesarean section

Secondary Outcomes (1)

  • Blood loss

    One hour after cesarean section

Other Outcomes (1)

  • Hemoglobin concentration

    Before and 24 hours after the operation

Study Arms (2)

Pabal ( carbetocin)

ACTIVE COMPARATOR

Pabal (carbetocin which is a long acting oxytocin ) given as 100 mcg slow i.v. injection over 1 minute ( Draxis/Multiph). It will be given to the patients included in the study after delivery of the fetal head.

Drug: Pabal 100 mcg iv infusion over 1 minute given after delivery of fetal head

Oxytocin and Methergine (methyl ergometrine)

ACTIVE COMPARATOR

The second group of patients included in the study will be given Oxytocin 5 IU ampoule by intravenous infusion and Methergine 0.2 mg IV after delivery of fetal head.

Drug: Oxytocin 5 IU iv infusion and Methtergine 0.2 mg iv

Interventions

Pabal 100 mcg iv infusion over 1 minute given after delivery of fetal headDRUG

In the first group of patients, carbitocin 100 mcg will be given iv infusion over one minute after delivery of the head in cesarean section.

Also known as: Carbetocin
Pabal ( carbetocin)
Oxytocin 5 IU iv infusion and Methtergine 0.2 mg ivDRUG

In the second group of patients oxytocin 5 IU will be given iv infusion and Methergine 0.2 mg iv

Also known as: Oxytocin and Methyl ergometrine
Oxytocin and Methergine (methyl ergometrine)

Eligibility Criteria

Age20 Years - 30 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women with a singleton pregnancy undergoing elective cesarean section after 37 weeks of gestation.

You may not qualify if:

  • Women undergoing cesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only.
  • women undergoing cesarean section at less than 37 weeks of gestation (likely to be emergency cesarean sections; a different smaller group from term pregnancies)
  • Hypertension with pregnancy.
  • Cardiac and coronary diseases with pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nesreen Abdel Fattah Abdullah Shehata

Cairo, Egypt

Location

Related Links

MeSH Terms

Conditions

HemorrhageAnemiaPostpartum Hemorrhage

Interventions

carbetocinOxytocinInfusions, Intravenous

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic DiseasesObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine Hemorrhage

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsAdministration, IntravenousDrug Administration RoutesDrug TherapyTherapeuticsInfusions, Parenteral

Study Officials

  • Nesreen A Shehata, MD

    Beni-Suef University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Obstetrics and Gynecology

Study Record Dates

First Submitted

March 29, 2014

First Posted

April 2, 2014

Study Start

May 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations

EG(1)