on-inferiority trial using carbetocin room temperature stable (RTS) for the prevention of postpartum haemorrhage in women delivering vaginally

Phase 3

Completed

• Conditions: Health Condition 1: O720- Third-stage hemorrhage

• Registration Number: CTRI/2016/05/006969
• Lead Sponsor: World Health Organization

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-06-09
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 7098

Inclusion Criteria

Trial participants will be pregnant women coming to the hospital for delivery.

Participants will be eligible for the trial if

1.They are expected to deliver vaginally

2.They have a cervical dilatation equal to or less than 6cm

3.They have a known singleton pregnancy

4.They provide written informed consent before any trial related procedures are carried out

Exclusion Criteria

Participants will be excluded from participating in the trial if they are/have

1.In an advanced first stage of labour ( >6 cm cervical dilatation) or too distressed to understand, confirm and give informed consent regardless of cervical dilatation

2.Minors

3.Scheduled for a planned caesarean section

4.A birth considered as an abortion according to local guidelines

5.Known allergies to carbetocin, other oxytocin homologues or excipients in the medicinal products used in the trial

6.Known cardiovascular disorders

7.Known hepatic or renal disease

8.Epilepsy

9.Not capable of giving consent due to other health problems such as obstetric emergencies (e.g. antepartum haemorrhage) or mental disorder

Study & Design

• Study Type: Interventional
• Study Design: Not specified