A study comparing three medicines used for the active management of the third stage of labour (to help deliver the placenta after your baby has been born)

Not Applicable

Completed

• Conditions: Specialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive and Sexual Medicine; UKCRC code/ Disease: Reproductive Health and Childbirth/ Complications of labour and delivery; Pregnancy and Childbirth; Reproductive Health and Childbirth/ Complications of labour and delivery

• Registration Number: ISRCTN10232550
• Lead Sponsor: orth Bristol NHS Trust

Brief Summary

2019 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30606246

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-06
• Study Completion: 2018-09-30
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 5717

Inclusion Criteria

Current inclusion criteria as of 27/06/2018:
1. =18 years of age at time of delivery
2. Vaginal birth
3. Live, singleton pregnancy
4. >24 weeks gestation

Previous inclusion criteria:
1. =18 years of age at time of baby’s birth
2. Planning to have a vaginal birth (spontaneous and instrumental)
3. Singleton pregnancy
4. Any gestational age

Exclusion Criteria

Current exclusion criteria as of 27/06/2018:
1. Significant antepartum haemorrhage (>50ml) or suspected or proven placenta abruption
2. Maternal coagulation disorder
3. Women who would decline blood products if required
4. Known or suspected hypertensive disorders
5. Peripheral, hepatic or cardiac disease
6. Epilepsy
7. Patients with an allergy or hypersensitivity to any of the active ingredients of the study drugs

Previous exclusion criteria:
1. Significant antepartum haemorrhage (>50ml) or suspected or proven placenta abruption
2. Maternal coagulation disorder
3. Multiple pregnancy (twins or higher order)
4. Intrauterine fetal death
5. Patients who would decline blood products if required (i.e., Jehovah's Witnesses - clinicians may have a lower threshold for administering additional prophylactic uterotonic drugs to these patients)
6. Known or suspected hypertensive disorders, including pre-eclampsia,
pregnancy induced hypertension, essential hypertension (even if blood pressure well controlled), and patients with hypertension in labour
7. Patients with peripheral, hepatic or cardiac disease
8. Patients with an allergy or hypersensitivity to any of the active ingredients in Carbetocin, Syntometrine or Syntocinon

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Requirement for additional uterotonic drugs. This is defined as the administration, following the administration of Imox IMP and prior to discharge from Delivery Suite (and not more than 24 hours after delivery), of any of the following: Syntocinon (IM/IV), Syntometrine (IM), Carboprost (IM), Carbetocin (IM/IV), Misoprostol (PO/PV/PR). This information is taken from the participant’s medical notes or the maternal database where the information is recorded routinely.