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

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ClinicalTrials.gov Identifier: NCT00930618
Recruitment Status : Completed
First Posted : June 30, 2009
Last Update Posted : December 21, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Prolonged Pregnancy Nulliparity Drug: IMN Drug: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1409 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : June 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : April 2014

Arm Intervention/treatment
Experimental: IMN
Isosorbide mononitrate
Drug: IMN
Administration of 2 x 20 mg of isosorbide mononitrate at each administration with a maximum of three administrations

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




Primary Outcome Measures :
  1. Number of cesarean sections [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. Number of labor inductions [ Time Frame: 10 days ]
  2. Number of spontaneous labors [ Time Frame: 10 days ]
  3. Cesarean for failed labor induction [ Time Frame: 10 days ]
  4. Cesarean for FHR abnormalities [ Time Frame: 10 days ]
  5. Cesarean for arrested labor [ Time Frame: 10 days ]
  6. Mean time between randomisation and spontaneous labor [ Time Frame: 10 days ]
  7. Isosorbide mononitrate adverse effects [ Time Frame: 10 days ]
  8. Maternal satisfaction [ Time Frame: 10 days ]
  9. Neonatal morbidity [ Time Frame: 10 days ]
  10. Mean time between randomisation and delivery [ Time Frame: 10 days ]
  11. Mean duration of labor [ Time Frame: 10 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00930618     History of Changes
Other Study ID Numbers: P071212
First Posted: June 30, 2009    Key Record Dates
Last Update Posted: December 21, 2016
Last Verified: June 2014

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
Isosorbide-5-mononitrate
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action