NCT03870503

Brief Summary

The objective of this study is to compare the effectiveness and safety of carbetocin vs. oxytocin plus sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH)after vaginal delivery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

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 9, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

2.2 years

First QC Date

March 9, 2019

Last Update Submit

September 27, 2021

Conditions

Postpartum Hemorrhage

Keywords

Postpartum Hemorrhagevaginal deliverycarbetocinmisoprostoloxytocin

Outcome Measures

Primary Outcomes (1)

  • The amount of blood loss

    calculation of the amount of blood loss by weighing the swabs and using pictorial charts

    6 hours post delivery

Secondary Outcomes (2)

  • The number of patients develop blood loss more than 1000 ml

    24 hours post delivery

  • The number of patient need blood transfusion

    24 hours post delivery

Study Arms (3)

oxytocin

ACTIVE COMPARATOR

The patient will be received oxytocin 20 IU by intravenous infusion

Drug: oxytocin

oxytocin plus misoprostol

ACTIVE COMPARATOR

The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mc sublingual misoprostol

Drug: oxytocinDrug: oxytocin plus misoprostol

Carbetocin

ACTIVE COMPARATOR

The patient will be received Carbetocin 100 mic gm IV

Drug: Carbetocin

Interventions

oxytocinDRUG

The patient will be received oxytocin 20 IU by intravenous infusion

Also known as: Active comparator
oxytocinoxytocin plus misoprostol
oxytocin plus misoprostolDRUG

The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mic gm sublingual misoprostol

Also known as: Active Comparator
oxytocin plus misoprostol
CarbetocinDRUG

The patient received Carbetocin 100 mic gm

Also known as: Active Comparator
Carbetocin

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAll participants had PPH defined as vaginal bleeding\>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All participants had PPH defined as vaginal bleeding\>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation

You may not qualify if:

  • gestational age\<37 weeks,
  • genital tract trauma,
  • coagulation defect,
  • women with hypertension, preeclampsia, cardiac, renal or liver diseases, epilepsy
  • known hypersensitivity to carbetocin or oxytocin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan University Hospital

Aswān, 81528, Egypt

Location

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

OxytocinMisoprostolcarbetocin

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 ProteinsProstaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • hany f allam, md

    Aswan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
This study will be a prospective double-blind randomized study
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study will be a prospective double-blind randomized study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 9, 2019

First Posted

March 12, 2019

Study Start

April 1, 2019

Primary Completion

June 30, 2021

Study Completion

August 1, 2021

Last Updated

September 29, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)