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

Primary Purpose

Prolonged Pregnancy, Nulliparity

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
IMN
Placebo
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prolonged Pregnancy focused on measuring Prolonged pregnancy, Nulliparity, Cervical ripening, Induced labor, Cesarean section

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Robert Debré Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IMN

Placebo

Arm Description

Isosorbide mononitrate

Administration of placebo of IMN

Outcomes

Primary Outcome Measures

Number of cesarean sections

Secondary Outcome Measures

Number of labor inductions
Number of spontaneous labors
Cesarean for failed labor induction
Cesarean for FHR abnormalities
Cesarean for arrested labor
Mean time between randomisation and spontaneous labor
Isosorbide mononitrate adverse effects
Maternal satisfaction
Neonatal morbidity
Mean time between randomisation and delivery
Mean duration of labor

Full Information

First Posted
June 29, 2009
Last Updated
December 20, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00930618
Brief Title
Reduction of Cesareans by Nitric Oxide (NO) Donors in Post Term Pregnancies
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolonged Pregnancy, Nulliparity
Keywords
Prolonged pregnancy, Nulliparity, Cervical ripening, Induced labor, Cesarean section

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1409 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMN
Arm Type
Experimental
Arm Description
Isosorbide mononitrate
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administration of placebo of IMN
Intervention Type
Drug
Intervention Name(s)
IMN
Intervention Description
Administration of 2 x 20 mg of isosorbide mononitrate at each administration with a maximum of three administrations
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administration of 2 X 20 mg of placebo of IMN at each administration with a maximum of three administration
Primary Outcome Measure Information:
Title
Number of cesarean sections
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Number of labor inductions
Time Frame
10 days
Title
Number of spontaneous labors
Time Frame
10 days
Title
Cesarean for failed labor induction
Time Frame
10 days
Title
Cesarean for FHR abnormalities
Time Frame
10 days
Title
Cesarean for arrested labor
Time Frame
10 days
Title
Mean time between randomisation and spontaneous labor
Time Frame
10 days
Title
Isosorbide mononitrate adverse effects
Time Frame
10 days
Title
Maternal satisfaction
Time Frame
10 days
Title
Neonatal morbidity
Time Frame
10 days
Title
Mean time between randomisation and delivery
Time Frame
10 days
Title
Mean duration of labor
Time Frame
10 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Goffinet, MD, PhD
Organizational Affiliation
Scientific Responsible
Official's Role
Study Director
Facility Information:
Facility Name
Robert Debré Hospital
City
Paris
ZIP/Postal Code
75019
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25415159
Citation
Schmitz T, Fuchs F, Closset E, Rozenberg P, Winer N, Perrotin F, Verspyck E, Azria E, Carbonne B, Lepercq J, Maillard F, Goffinet F; Groupe de Recherche en Obstetrique et Gynecologie (GROG). Outpatient cervical ripening by nitric oxide donors for prolonged pregnancy: a randomized controlled trial. Obstet Gynecol. 2014 Dec;124(6):1089-1097. doi: 10.1097/AOG.0000000000000544.
Results Reference
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Reduction of Cesareans by Nitric Oxide (NO) Donors in Post Term Pregnancies

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