Reduction of Cesareans by Nitric Oxide (NO) Donors in Post Term Pregnancies - Full Text View

Sponsor:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00930618

Purpose

The purpose of this trial is to determine whether cervical ripening with isosorbide mononitrate reduce caesarean section in women with post term pregnancies.

Condition	Intervention	Phase
Prolonged Pregnancy "Nulliparity"	Drug: IMN Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	NOCETER, a Multicenter Double Blind Placebo-controlled Randomized Trial: Reduction of CEsareans in Post TERm Pregnancies: Impact of Outpatient Cervical Ripening With NO Donors

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section

Drug Information available for: Nitric oxide Isosorbide-5-mononitrate Isosorbide dinitrate Isosorbide

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Number of cesarean sections [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Number of labor inductions [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
Number of spontaneous labors [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
Cesarean for failed labor induction [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
Cesarean for FHR abnormalities [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
Cesarean for arrested labor [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
Bishop score at 41+2, 41+4, and labor induction [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
Isosorbide mononitrate adverse effects [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
Maternal satisfaction [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
Neonatal morbidity [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1370
Study Start Date:	June 2009
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: IMN Isosorbide mononitrate	Drug: IMN Administration of 2 x 20 mg of isosorbide mononitrate at each administration with a maximum of three administrations Other Name: IMN
Placebo Comparator: Placebo Administration of placebo of IMN	Drug: Placebo Administration of 2 X 20 mg of placebo of IMN at each administration with a maximum of three administration Other Name: Placebo

Detailed Description:

The purpose of this trial is to determine whether cervical ripening with 40 mg of isosorbide mononitrate given intravaginally at 41+0, 41+2 and 41+4 weeks reduce cesarean section in nullipara with post term pregnancies. Treatments will be administered by midwifes in the maternity wards, women will be allowed to go back home in case of Bishop score<6. Otherwise labor will be induced with oxytocin. If undelivered at 41+5, women with Bishop score<6 will be induced with prostaglandinE2 vaginal insert.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria :

Age > or = 18 years old
TAS > or = 95 mmHg
Singleton
Nulliparity
Term > or = 41 weeks + 0 day
Bishop score < or = 5
Vertex presentation
Intact membranes
No contra-indications of the study treatment
No maternal or fetal diseases which could indicate immediate labor induction
Written informed consent

Exclusion criteria :

Multiple pregnancy
Multiparity
Term < 41 weeks
Bishop score > 5
Breech presentation
Rupture of the membranes
Previous cesarean
Indication to immediate labor induction
Contraindications to isosorbide mononitrate
No co-administration of antihypertensive drugs
No social security

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00930618

Contacts

Contact: Thomas Schmitz, MD	+33(0) 1 40 03 20 00 ext 1238	thomas.schmitz@rdb.aphp.fr
Contact: Raphaël Serreau, MD, PhD	+33(0)1 58 41 11 80	raphael.serreau@cch.aphp.fr

Locations

France
Robert Debré Hospital	Recruiting
Paris, France, 75019
Principal Investigator: Thomas Schmitz, MD

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Study Director:

François Goffinet, MD, PhD

Scientific Responsible

More Information

No publications provided

Responsible Party:	Christophe Aucan, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier:	NCT00930618 History of Changes
Other Study ID Numbers:	P071212
Study First Received:	June 29, 2009
Last Updated:	April 7, 2011
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Prolonged pregnancy
Nulliparity
Cervical ripening
Induced labor
Cesarean section

Additional relevant MeSH terms:

Pregnancy, Prolonged
Pregnancy Complications
Isosorbide
Isosorbide-5-mononitrate
Isosorbide Dinitrate
Diuretics, Osmotic
Diuretics
Natriuretic Agents

Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012