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Completed

NCT Number: NCT00930618

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

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

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Key information

Conditions

Prolonged Pregnancy Female Urogenital Diseases and Pregnancy Complications Nulliparity Pregnancy Complications Pregnancy, Prolonged Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Robert Debré Hospital

Paris, 75019, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IMN

Drug

Administration of 2 x 20 mg of isosorbide mononitrate at each administration with a maximum of three administrations

Placebo

Drug

Administration of 2 X 20 mg of placebo of IMN at each administration with a maximum of three administration

Primary outcomes

  1. Number of cesarean sections

    Time frame: 10 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study 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

Acronym: NOCETER

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Jun 30, 2009
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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