Carbetocin for preventing excessive bleeding after birth.

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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004445-26-GB

Enrollment

30000

Registered

2015-01-30

Start date

2015-03-27

Completion date

Unknown

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum haemorrhage MedDRA version: 17.1 Level: LLT Classification code 10005128 Term: Bleeding postpartum System Organ Class: 100000004868

Interventions

Product Name: Carbotecin RTS Pharmaceutical Form: Solution for injection INN or Proposed INN: CARBETOCIN CAS Number: 37025-55-1 Current Sponsor code: FE 992097 Concentration unit: µg microgram(s) Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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. Are the trial subjects under 18? yes Number of subjects for this age range: 1290 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 28710 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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. Non-emancipated minors (as per local regulations) without a guardian 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. Serious cardiovascular disorders 7. Not capable of giving consent due to other health problems such as obstetric emergencies (e.g. antepartum haemorrhage) or mental disorder.

Design outcomes

Primary

Measure	Time frame
Main Objective: -To evaluate non-inferiority of carbetocin RTS 100 µg IM versus oxytocin 10 IU IM after vaginal delivery in the prevention of the composite endpoint “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. -To evaluate non-inferiority of carbetocin RTS 100 µg IM versus oxytocin 10 IU IM in the prevention of sPPH (=1000 mL blood loss) at one hour and up to two hours for women who continue to bleed after one hour.;Secondary Objective: Not applicable;Primary end point(s): - 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. - 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. ;Timepoint(s) of evaluation of this end point: for both end points: 60 minutes after delivery or 120 minutes for women who continue to bleed after one hour.	—

Measure

Time frame

Main Objective: -To evaluate non-inferiority of carbetocin RTS 100 µg IM versus oxytocin 10 IU IM after vaginal delivery in the prevention of the composite endpoint “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. -To evaluate non-inferiority of carbetocin RTS 100 µg IM versus oxytocin 10 IU IM in the prevention of sPPH (=1000 mL blood loss) at one hour and up to two hours for women who continue to bleed after one hour.;Secondary Objective: Not applicable;Primary end point(s): - 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. - 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. ;Timepoint(s) of evaluation of this end point: for both end points: 60 minutes after delivery or 120 minutes for women who continue to bleed after one hour.

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Secondary

Measure	Time frame
Secondary end point(s): 1 The proportion of women with blood loss of 500 mL or more at one hour (or two hours postpartum if the bleeding continues beyond one hour). 2 Blood loss in mL at one hour (or two hours postpartum if the bleeding continues beyond one hour). 3 The proportion of women receiving additional uterotonics at one hour (or two hours postpartum if the bleeding continues beyond one hour). 4 The proportion of women receiving additional uterotonics up to time of discharge. 5 The proportion of women receiving blood transfusion up to time of discharge. 6 The proportion of women with manual removal of placenta up to time of discharge. 7 The 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. 8 The proportion of maternal death. 9 The 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) up to time of discharge. 10 The incidence and severity of adverse or serious adverse events up to time of discharge. 11 Newborn outcomes (vital status, APGAR score at 5 minutes, resuscitation of the baby, mechanical ventilation). ;Timepoint(s) of evaluation of this end point: For end points 1,2,3: One hour (or two hours if the bleeding continues beyond one hour). For end points 4,5,6,7,8,9,10,11: Hospital discharge	—

Measure

Time frame

Secondary end point(s): 1 The proportion of women with blood loss of 500 mL or more at one hour (or two hours postpartum if the bleeding continues beyond one hour). 2 Blood loss in mL at one hour (or two hours postpartum if the bleeding continues beyond one hour). 3 The proportion of women receiving additional uterotonics at one hour (or two hours postpartum if the bleeding continues beyond one hour). 4 The proportion of women receiving additional uterotonics up to time of discharge. 5 The proportion of women receiving blood transfusion up to time of discharge. 6 The proportion of women with manual removal of placenta up to time of discharge. 7 The 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. 8 The proportion of maternal death. 9 The 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) up to time of discharge. 10 The incidence and severity of adverse or serious adverse events up to time of discharge. 11 Newborn outcomes (vital status, APGAR score at 5 minutes, resuscitation of the baby, mechanical ventilation). ;Timepoint(s) of evaluation of this end point: For end points 1,2,3: One hour (or two hours if the bleeding continues beyond one hour). For end points 4,5,6,7,8,9,10,11: Hospital discharge

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Countries

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

Contacts

Public ContactMariana Widmer

World Health Organization

widmerm@who.int

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 24, 2026