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Search / Trial NCT02907060

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

Prolonged Pregnancy Mechanical Cervical Ripening

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.

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

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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