Carbetocin RTS for preventing postpartum haemorrhage: a randomized non-inferiority controlled trial.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000870651
• Date of registration: 14/08/2014
• Prospective Registration: Yes
• Primary sponsor: World Health Organization
• Public title: Carbetocin RTS for preventing postpartum haemorrhage: a randomized non-inferiority controlled trial.
• Scientific title: A phase III, randomized, double-blind, active, controlled, multinational, multicentre, non-inferiority trial using carbetocin room temperature stable (RTS) for the prevention of postpartum haemorrhage during the third stage of labour in women delivering vaginally.
• Date of first enrolment: 07/07/2015
• Target sample size: 30000
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614000870651.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Phase 3

Countries of recruitment

Argentina, Egypt, India, Kenya, Nigeria, Singapore, South Africa, Thailand, Uganda, United Kingdom

Contacts

• Name: Dr A. Metin Gulmezoglu

• Name: Dr A. Metin Gulmezoglu

Key inclusion & exclusion criteria

Inclusion criteria: *Women who are expected to deliver vaginally.
*They have a cervical dilatation equal to or less than 6cm.
*They provide written informed consent before any trial-related activities are carried out.
*Known singleton pregnancy.

Exclusion criteria: Women will be excluded from participating in the trial if they are/have:
*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.
*Non-emancipated minors (as per local regulations) without a guardian.
*Scheduled for a planned caesarean section.
*Birth considered an abortion according to local guidelines.
*Allergic to carbetocin, other oxytocin homologues or excipients.
*Serious cardiovascular disorders.
*Not capable of giving consent due to other health problems such as obstetric emergencies (e.g. antepartum haemorrhage) or mental disorder.
* Serious hepatic or renal disease
* Epilepsy

Age minimum: No limit
Age maximum: No limit
Gender: Females

Health Condition(s) or Problem(s) studied

Postpartum haemorrhage;
Postpartum haemorrhage

Reproductive Health and Childbirth - Childbirth and postnatal care

Intervention(s)

Carbetocin RTS 100 micrograms solution for intramuscular (IM) injection to be administered once during the third stage of labour.

Primary Outcome(s)

The proportion of women with blood loss of 1000 mL or more at one hour and up to two hours for women who continue to bleed after one hour.
The blood loss will be measured with a plastic drape placed under the woman's buttocks.[60 minutes after delivery or 120 minutes for women who continue to bleed after one hour]

The proportion of women with blood loss of 500 mL or more or the use of additional uterotonics at one hour and up to two hours for women who continue to bleed after one hour.
(composite primary outcome).
The blood loss will be measured with a plastic drape placed under the woman's buttocks.[60 minutes after delivery or 120 minutes for women who continue to bleed after one hour.]

Secondary Outcome(s)

Proportion of women receiving additional uterotonics within one hour (or two hours postpartum if the bleeding continues beyond one hour).
[One hour (or two hours postpartum if the bleeding continues beyond one hour).
]

Proportion of women receiving additional uterotonics up to time of discharge.[Hospital discharge]

Proportion of women with composite outcome of maternal death or severe morbidity (admission to intensive care unit, hysterectomy, blood loss of two liters or more, uterine inversion, near miss event as defined in the manual of operations) up to time of discharge.
[Hospital discharge]

Blood loss in mL within one hour (or two hours postpartum if the bleeding continues beyond one hour).
The blood loss will be measured with a plastic drape placed under the woman's buttocks.[One hour (or two hours if the bleeding continues beyond one hour).]

Proportion of maternal death.
[Hospital discharge]

proportion of women receiving blood transfusion up to time of discharge[Hospital discharge]

Proportion of women having additional surgical procedures (e.g. suturing of cervix/high vaginal tear, exploration of uterine cavity under general anaesthetic, uterine compression suture, uterine or hypogastric ligation, hysterectomy) up to time of discharge[Hospital discharge]

Proportion of women with blood loss of 500mL or more within one hour (or two hours postpartum if the bleeding continues beyond one hour).
The blood loss will be measured with a plastic drape placed under the woman's buttocks.[One hour (or two hours if the bleeding continues beyond one hour).]

Incidence and severity of adverse or serious adverse events up to time of discharge.
Adverse events will be recorded in an adverse event form specifically designed for this trial and will include any unfavourable and unintended sign, symptom or disease temporally associated with the use of the investigational medicine product (IMP), whether or not considered to be caused by the IMP.

Serious adverse events will be recorded in a serious adverse event report form and will be include any event that results in death, or it is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or is a congenital anomaly/birht defect.[Hospital discharge]

Newborn outcomes (vital status, APGAR score at 5 minutes, resuscitation of the baby, mechanical ventilation). (composite outcome)[At birth]

Proportion of women with manual removal of placenta up to time of discharge.
[Hospital discharge]

Secondary ID(s)

A65870

Source(s) of Monetary Support

Merck for Mothers (Merck Sharp & Dohme Corp.)

Ethics review

Status: Approved
Approval date:
Contact:

WHO Ethics Review Committee

Results

• Results available: Yes
• Date Posted: 09/01/2019
• Date Completed: 30/01/2018