The purpose of this trial is to determine whether cervical ripening with isosorbide mononitrate reduce caesarean section in women with post term pregnancies.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,409
Robert Debré Hospital
Paris, France
Number of cesarean sections
Time frame: 10 days
Number of labor inductions
Time frame: 10 days
Number of spontaneous labors
Time frame: 10 days
Cesarean for failed labor induction
Time frame: 10 days
Cesarean for FHR abnormalities
Time frame: 10 days
Cesarean for arrested labor
Time frame: 10 days
Mean time between randomisation and spontaneous labor
Time frame: 10 days
Isosorbide mononitrate adverse effects
Time frame: 10 days
Maternal satisfaction
Time frame: 10 days
Neonatal morbidity
Time frame: 10 days
Mean time between randomisation and delivery
Time frame: 10 days
Mean duration of labor
Time frame: 10 days
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