Carbetocin Versus Oxytocin for the Prevention of Postpartum Hemorrhage in Emergency Caesarean Delivery

NCT03755531 | Completed Phase 4

• 1 other identifier: 4 Al-KindyCM
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Postpartum haemorrhage keeps to be the leading cause of maternal mortality in middle and low-income countries, including Iraq. Much advancement had been made in the field of treatment for postpartum haemorrhage but no much progress had been made in the field of prevention, where one of its main component is the administration of uterotonic, preferably oxytocin, immediately after birth of the baby. In many low- and middle income countries, the efficacy of oxytocin cannot be assured since access to sustained cold-chain is unavailable. Regarding the other uterotonics; ergometrine degrades when exposed to heat or light. Misoprostol degrades rapidly when exposed to Moisture. Innovation in the manufacture of carbetocin had meet the stability requirements for hot and humid climates. This study had been accomplished to evaluate the uterotonic effect of carbetocin compared with oxytocin for the prevention of postpartum haemorrhage in emergency caesarean delivery. Looking if carbetocin is superior to oxytocin in term of reduction in the need for additional uterotonic agents or the occurrence of PPH.

Conditions

Postpartum Hemorrhage (Primary)

Keywords

Oxytocin; Carbetocin; Emergency Caesarean Section

Outcome Measures

Primary Outcomes (2)

• Blood loss equal or more than 1000 ml

  Proportion of women with blood loss equal or more than 1000 ml in both study groups

  During the first 24 hours

• Use of additional uterotonics

  Proportion of the women whom they need additional uterotonic agents

  During the first 24 hours

Secondary Outcomes (3)

• Blood pressure changes in carbetocin versus oxytocin group

  Within one hour after administration of the drugs

• Pulse rate changes in carbetocin versus oxytocin group

  Within one hour after administration of the drugs

• Blood transfusion need

  During the first 24 hours

Study Arms (2)

Carbetocin

EXPERIMENTAL

One ml of Carbitocin (100 mcg), was given as a bolus intravenous injection after labor of the baby at once.

Drug: Carbetocin

Oxytocin

ACTIVE COMPARATOR

One ml of Oxytocin (10 IU), was given as a bolus intravenous injection after labor of the baby at once.

Drug: Oxytocin

Interventions

Carbetocin DRUG

Heat stable Carbetocin, a clear colourless solution. Oxytocic activity: approximately 50 IU of oxytocin/vial. One ml of Carbitocin (100 mcg), was given as a bolus intravenous injection, slowly over 1 minute after labor of the baby at once. It was used once and no further doses were given. Drug was kept in cold storage (2 to 8°C).

Also known as: BABAL

Carbetocin

Oxytocin DRUG

Oxytocin, a clear colourless solution. One ml of oxytocin (10 IU), was given as a bolus intravenous injection over 1 minute, after labor of the baby at once. Further doses can be given accordingly. Drug was kept in cold storage (2 to 8°C).

Also known as: Pitocin

Oxytocin

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients age ≥18 years
• Singleton pregnancy
• Full term gestation
• Emergency cesarean section during labor

You may not qualify if:

• Cases of coagulopathy
• Drug hypersensitivity
• Medical diseases as; cardiac, hypertension, liver, renal or endocrine diseases
• Uterine fibroids
• Suspected placental pathology (accreta, previa or abruptio)
• General anesthesia
• Longitudinal uterine incision

Sponsors & Collaborators

• Al-Kindy College of Medicine: lead
• Elweyia Maternity Teaching Hospital: collaborator

Study Sites (1)

Al Kindy College of Medicine/ University of Baghdad

Baghdad, 10096, Iraq

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

carbetocin; Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Taghreed K Alhaidari, CABOG

  Al Kindy College of Medicine, University of Baghdad

  STUDY CHAIR

• Shayma S Al-Zubaidy, FICOG, MD

  Al- Elweyia Maternity Teaching Hospital

  PRINCIPAL INVESTIGATOR

• Alaa A Hussein, FICOG, MD

  Al- Elweyia Maternity Teaching Hospital

  PRINCIPAL INVESTIGATOR

• Ulfat M Alnakkash, CABOG

  Al- Elweyia Maternity Teaching Hospital

  PRINCIPAL INVESTIGATOR

• Ahmed S Alnuaimi, PhD

  Baghdad College of Medicine/ University of Baghdad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The anesthetist was the person in charge for giving the allocated drug after labor of the baby at once. Otherwise the operating obstetricians, the care givers, investigators and the ouctcomes assessor were all blinded to the type of the injection.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor / Consultant Obstetrician & Gynecologist / Head of Scientific Affairs Unit

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: November 24, 2018
• First Posted: November 28, 2018
• Study Start: January 4, 2018
• Primary Completion: June 10, 2018
• Study Completion: August 1, 2018
• Last Updated: November 28, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months and ending 24 months following article publication, unless otherwise stated by the publisher
• Access Criteria: The data will be available up to 24 months following article publication for anyone who wishes to access the data or for meta-analysis.

Locations

IR (1)