Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT02907060
Eligibility Criteria:
Inclusion Criteria:
* Pregnant women
* ≥ 18 years old
* With a singleton cephalic pregnancy between ≥41+0 weeks and ≤ 42+0 weeks of gestation
* Gestational age estimated from the first trimester ultrasound (realized between 11 and 13+6 weeks of gestation)
* With a decision of induction of labour
* Written informed consent obtained from subject
* Subject covered by or having the rights to the French Social Security system
Exclusion Criteria:
* Bishop score ≥ 6 (favourable cervix)
* Non cephalic presentation (breech, transverse)
* Severe preeclampsia defined as the presence of preeclampsia with at least one of the following items :
* Severe maternal hypertension (systolic blood pressure ≥ 160 mm Hg and/or diastolic blood pressure ≥ 110 mm Hg)
* Renal failure with oliguria (\< 500 ml/24h) or creatinine \> 135μmol/L, or proteinuria \> 5 g/day
* Pulmonary oedema, epigastric pain or HELLP syndrom (hemolysis, elevated liver enzyme, low platelets)
* Eclampsia or neurologic persisting symptoms (visual disturbances, headache, increased reflexes)
* Thrombopenia \< 100 G/L
* Prior caesarean section or uterine scar
* Placenta praevia
* Suspected genital herpes infection
* Known VIH seropositivity (confirmed by blood serology)
* Premature rupture of membranes (PROM - continual leaking of amniotic fluid or positive test in favour of PROM)
* Foetus with suspected severe congenital abnormalities
* Pathological fetal heart rate
* Contra-indications to Propess®
* Contra-indications for using Cook® Cervical Ripening Balloon
* Women under guardianship or trusteeship
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02907060
Study Brief:
Protocol Section:
NCT02907060