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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01113229

Acronym

CYTOCINON

Enrollment

1721

Registered

2010-04-29

Start date

2010-03-01

Completion date

2014-12-01

Last updated

2026-03-27

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

Conditions

Hemorrhage; Complicating Delivery

Keywords

Post Partum Haemorrhage,, oxytocin,, misoprostol,, prevention,, delivery.

Brief 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.

Detailed 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.

Interventions

DRUGMisoprostol

two misoprostol tablets taken orally (400µg)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Occurrence of post partum hemorrhage > 500mL in 1 hour	1 HOUR

Secondary

Measure	Time frame
Occurrence of post partum hemorrhage > 1000mL in 1 hour	1 HOUR

Countries

France

Contacts

PRINCIPAL_INVESTIGATORPatrick Rozenberg, MD

CHI POISSY ST GERMAIN

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026