Nulliparity, Prolonged Pregnancy
Conditions
Keywords
Prolonged pregnancy, Nulliparity, Cervical ripening, Induced labor, Cesarean section
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.
Interventions
DRUGIMN
Administration of 2 x 20 mg of isosorbide mononitrate at each administration with a maximum of three administrations
DRUGPlacebo
Administration of 2 X 20 mg of placebo of IMN at each administration with a maximum of three administration
Sponsors
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of cesarean sections | 10 days |
Secondary
| Measure | Time frame |
|---|---|
| Number of spontaneous labors | 10 days |
| Cesarean for failed labor induction | 10 days |
| Cesarean for FHR abnormalities | 10 days |
| Cesarean for arrested labor | 10 days |
| Mean time between randomisation and spontaneous labor | 10 days |
| Number of labor inductions | 10 days |
| Maternal satisfaction | 10 days |
| Neonatal morbidity | 10 days |
| Mean time between randomisation and delivery | 10 days |
| Mean duration of labor | 10 days |
| Isosorbide mononitrate adverse effects | 10 days |
Countries
France
Outcome results
None listed