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

Prolonged Pregnancy Clinical Trial

— NOCETER  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00930618
• Other study ID #: P071212
• Status: Completed
• Phase: Phase 3
• First received: June 29, 2009
• Last updated: December 20, 2016
• Start date: June 2009
• Est. completion date: April 2014

Study information

• Verified date: June 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1409
• Est. completion date: April 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nulliparity
• Pregnancy, Prolonged
• Prolonged Pregnancy

Intervention

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

Locations

Country	Name	City	State
France	Robert Debré Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cesarean sections		10 days	Yes
Secondary	Number of labor inductions		10 days	Yes
Secondary	Number of spontaneous labors		10 days	Yes
Secondary	Cesarean for failed labor induction		10 days	Yes
Secondary	Cesarean for FHR abnormalities		10 days	Yes
Secondary	Cesarean for arrested labor		10 days	Yes
Secondary	Mean time between randomisation and spontaneous labor		10 days	Yes
Secondary	Isosorbide mononitrate adverse effects		10 days	Yes
Secondary	Maternal satisfaction		10 days	Yes
Secondary	Neonatal morbidity		10 days	Yes
Secondary	Mean time between randomisation and delivery		10 days	Yes
Secondary	Mean duration of labor		10 days	Yes