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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
  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 3

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:


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 ]
  • 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 ]

Enrollment: 1409
Study Start Date: June 2009
Study Completion Date: April 2014
Primary Completion Date: December 2013 (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 prostaglandins according to local protocols.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Robert Debré Hospital
Paris, France, 75019
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Director: François Goffinet, MD, PhD Scientific Responsible
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00930618     History of Changes
Other Study ID Numbers: P071212
Study First Received: June 29, 2009
Last Updated: June 25, 2014
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

ClinicalTrials.gov processed this record on November 27, 2014