Combined Use of Oxytocin and Misoprostol in the Prevention of Post Partum Haemorrhage

Hemorrhage; Complicating Delivery Clinical Trial

— CYTOCINON  

Official title:

Combined Use of Oxytocin and Misoprostol in the Prevention of Post Partum Haemorrhage

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01113229
• Other study ID #: P 081104
• Secondary ID: 2009-013177-18
• Status: Terminated
• Phase: Phase 4
• First received: April 28, 2010
• Last updated: April 7, 2015
• Start date: March 2010
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

To demonstrate that the combined used of oxytocin and misoprostol prevent from post partum haemorrhage better than oxytocin alone, following vaginal birth at 36 to 42 weeks.

Description:

Objective :

To demonstrate that the combined used of oxytocin and misoprostol prevent from post partum haemorrhage better than oxytocin alone, following vaginal birth at 36 to 42 weeks'.

Method :

Double blinded Randomized controlled trial in two centers over 30 months.

Treatment :

Patients will be randomly allocated into one of the two following group :

Group A : 10 UI of oxytocin IV during delivery of the anterior shoulder of the newborn and two misoprostol tablets taken orally (400µg) following cord clamp.

Group B: 10 UI of oxytocin IV during delivery of the anterior shoulder of the newborn and two placebo tablets taken orally following cord clamp.

Number of patients:

1550 patients per group (one third reduction of occurrence with alpha and beta set at 0.05 and 0.20 respectively). Patients were included in the study during 48 hours.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1721
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women>18 years,

• during first stage of normal labor,

• at 36 to 42 weeks,

• with epidural analgesia and informed signed consent

Exclusion Criteria:

• Cesarean section delivery,

• clotting disorders,

• prostaglandin allergy,

• absent consent.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage
• Hemorrhage; Complicating Delivery
• Postpartum Hemorrhage

Intervention

Drug:
• Misoprostol
two misoprostol tablets taken orally (400µg)

Locations

Country	Name	City	State
France	Chi Poissy St Germain	Poissy

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of post partum hemorrhage > 500mL in 1 hour		1 HOUR	Yes
Secondary	Occurrence of post partum hemorrhage > 1000mL in 1 hour		1 HOUR	Yes