Mechanical cervicAl ripeninG for Women With PrOlongedPregnancies
Launched by UNIVERSITY HOSPITAL, TOURS · Sep 14, 2016
Trial Information
Current as of April 29, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
FEMALE
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
About University Hospital, Tours
The University Hospital of Tours, a leading academic medical institution in France, is dedicated to advancing healthcare through innovative clinical research and patient-centered care. With a strong emphasis on collaboration between researchers, clinicians, and community partners, the hospital fosters a dynamic environment for conducting high-quality clinical trials across various medical disciplines. Its commitment to excellence in patient safety, ethical standards, and scientific integrity positions the University Hospital of Tours as a pivotal contributor to the development of new therapies and health solutions, ultimately enhancing patient outcomes and public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Marseille, , France
Rennes, , France
Caen, , France
Toulouse, , France
Reims, , France
Poissy, , France
Tours, , France
Nantes, , France
Brest, , France
Clermont Ferrand, , France
Chartres, , France
Brest, , France
Cergy Pontoise, , France
Clermont Ferrand, , France
La Roche Sur Yon, , France
Saint Priest En Jarez, , France
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials