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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Do

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

Detailed Summary: 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.
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Number of cesarean sections [ Time Frame: 10 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of labor inductions [ Time Frame: 10 days ]
  • Number of spontaneous labors [ Time Frame: 10 days ]
  • Cesarean for failed labor induction [ Time Frame: 10 days ]
  • Cesarean for FHR abnormalities [ Time Frame: 10 days ]
  • Cesarean for arrested labor [ Time Frame: 10 days ]
  • Mean time between randomisation and spontaneous labor [ Time Frame: 10 days ]
  • Isosorbide mononitrate adverse effects [ Time Frame: 10 days ]
  • Maternal satisfaction [ Time Frame: 10 days ]
  • Neonatal morbidity [ Time Frame: 10 days ]
  • Mean time between randomisation and delivery [ Time Frame: 10 days ]
  • Mean duration of labor [ Time Frame: 10 days ]


Original Secondary Outcome:

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


Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: June 29, 2009
Date Started: June 2009
Date Completion:
Last Updated: December 20, 2016
Last Verified: June 2014