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

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”

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 prostaglandinE2 vaginal insert.

Intervention(s) in this Clinical Trial

• Drug: IMN
  • Administration of 2 x 20 mg of isosorbide mononitrate at each administration with a maximum of three administrations
• Drug: Placebo
  • Administration of 2 X 20 mg of placebo of IMN at each administration with a maximum of three administration

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: IMN
  • Isosorbide mononitrate
• Placebo Comparator: Placebo
  • Administration of placebo of IMN

Primary Measures

• Number of cesarean sections
  • Time Frame: 10 days
    Safety Issue?: Yes

Secondary Measures

• Number of labor inductions
  • Time Frame: 10 days
    Safety Issue?: Yes
• Number of spontaneous labors
  • Time Frame: 10 days
    Safety Issue?: Yes
• Cesarean for failed labor induction
  • Time Frame: 10 days
    Safety Issue?: Yes
• Cesarean for FHR abnormalities
  • Time Frame: 10 days
    Safety Issue?: Yes
• Cesarean for arrested labor
  • Time Frame: 10 days
    Safety Issue?: Yes
• Bishop score at 41+2, 41+4, and labor induction
  • Time Frame: 10 days
    Safety Issue?: Yes
• Isosorbide mononitrate adverse effects
  • Time Frame: 10 days
    Safety Issue?: Yes
• Maternal satisfaction
  • Time Frame: 10 days
    Safety Issue?: Yes
• Neonatal morbidity
  • Time Frame: 10 days
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Assistance Publique - Hôpitaux de Paris Other

Overall Clinical Trial Officials and Contacts

François Goffinet, MD, PhD Study Director Scientific Responsible  

Overall Contact: Thomas Schmitz, MD +33(0) 1 40 03 20 00 thomas.schmitz@rdb.aphp.fr

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00930618

Study ID Number: P071212

ClinicalTrials.gov Identifier: NCT00930618

Health Authority: France: Ministry of Health