Reduction of Cesareans by Nitric Oxide (NO) Donors in Post Term Pregnancies (NOCETER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00930618
First received: June 29, 2009
Last updated: June 25, 2014
Last verified: June 2014

June 29, 2009
June 25, 2014
June 2009
December 2013   (final data collection date for primary outcome measure)
Number of cesarean sections [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00930618 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Mean time between randomisation and spontaneous labor [ 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 ]
  • Mean time between randomisation and delivery [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
  • Mean duration of labor [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
  • 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 ]
Not Provided
Not Provided
 
Reduction of Cesareans by Nitric Oxide (NO) Donors in Post Term Pregnancies
NOCETER, a Multicenter Double Blind Placebo-controlled Randomized Trial: Reduction of CEsareans in Post TERm Pregnancies: Impact of Outpatient Cervical Ripening With NO Donors

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

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 prostaglandins according to local protocols.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Prolonged Pregnancy
  • "Nulliparity"
  • Drug: IMN
    Administration of 2 x 20 mg of isosorbide mononitrate at each administration with a maximum of three administrations
    Other Name: 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
  • Experimental: IMN
    Isosorbide mononitrate
    Intervention: Drug: IMN
  • Placebo Comparator: Placebo
    Administration of placebo of IMN
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1409
April 2014
December 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00930618
P071212
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Study Director: François Goffinet, MD, PhD Scientific Responsible
Assistance Publique - Hôpitaux de Paris
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP