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

Primary Purpose

Hemorrhage; Complicating Delivery

Status

Terminated

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

Misoprostol

About this trial

This is an interventional prevention trial for Hemorrhage; Complicating Delivery focused on measuring Post Partum Haemorrhage,, oxytocin,, misoprostol,, prevention,, delivery.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

Chi Poissy St Germain

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Misoprostol

PLACEBO

Arm 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

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

Outcomes

Primary Outcome Measures

Occurrence of post partum hemorrhage > 500mL in 1 hour

Secondary Outcome Measures

Occurrence of post partum hemorrhage > 1000mL in 1 hour

Full Information

NCT ID

NCT01113229

First Posted

April 28, 2010

Last Updated

April 7, 2015

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT01113229

Brief Title

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

Acronym

CYTOCINON

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Terminated

Why Stopped

reason of halt prematurely: futility of the trial

Study Start Date

March 2010 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemorrhage; Complicating Delivery

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1721 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Misoprostol

Arm Type

Experimental

Arm 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

Arm Title

PLACEBO

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Misoprostol

Other Intervention Name(s)

two misoprostol tablets taken orally (400µg

Intervention Description

two misoprostol tablets taken orally (400µg)

Primary Outcome Measure Information:

Title

Occurrence of post partum hemorrhage > 500mL in 1 hour

Time Frame

1 HOUR

Secondary Outcome Measure Information:

Title

Occurrence of post partum hemorrhage > 1000mL in 1 hour

Time Frame

1 HOUR

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patrick Rozenberg, MD

Organizational Affiliation

CHI POISSY ST GERMAIN

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chi Poissy St Germain

City

Poissy

ZIP/Postal Code

78300

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

27607864

Citation

Quibel T, Ghout I, Goffinet F, Salomon LJ, Fort J, Javoise S, Bussieres L, Aegerter P, Rozenberg P; Groupe de Recherche en Obstetrique et Gynecologie (GROG). Active Management of the Third Stage of Labor With a Combination of Oxytocin and Misoprostol to Prevent Postpartum Hemorrhage: A Randomized Controlled Trial. Obstet Gynecol. 2016 Oct;128(4):805-11. doi: 10.1097/AOG.0000000000001626.

Results Reference

derived

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

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