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:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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

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:	September 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

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

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 58 41 21 42	thomas.schmitz@cch.aphp.fr
Contact: Raphaël Serreau, MD, PhD	+33(0)1 58 41 11 80	raphael.serreau@cch.aphp.fr

Locations

France
Hopital Cochin	Recruiting
Paris, France, 75014
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:	Department Clinical Research of Developpement ( Christophe Aucan )
Study ID Numbers:	P071212, N° EUDRACT : 2008-006328-75
Study First Received:	June 29, 2009
Last Updated:	June 29, 2009
ClinicalTrials.gov Identifier:	NCT00930618 History of Changes
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 Complications
Pregnancy, Prolonged

ClinicalTrials.gov processed this record on February 08, 2010