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

Assistance Publique - Hôpitaux de Paris

Status and phase: Terminated; Phase 4

Conditions: Hemorrhage; Complicating Delivery

Treatments: Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT01113229

2009-013177-18 (EudraCT Number)

P 081104

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,721 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,721 participants in 2 patient groups, including a placebo group

Misoprostol

Experimental group

Description:

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

Treatment:

Drug: Misoprostol

PLACEBO

Placebo Comparator group

Description:

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

Treatment:

Drug: Misoprostol