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NCT Number: NCT02907060

Mechanical cervicAl ripeninG for Women With PrOlongedPregnancies

A pregnancy is considered ''prolonged'' from 41 weeks of gestation. Prolonged Pregnancies (PP) are associated with increased maternal morbidity: emergency caesarean, 3rd and 4th degree perineal lesions and postpartum haemorrhage. Foetuses are at increased risk of oligohydramnios, meconium-staining and Fetal Heart Rate (FHR) anomalies. Around 15% of all pregnancies are prolonged.

A Cochrane review on induction of labour showed that a policy of labour induction at or beyond 41 weeks was associated with significantly fewer perinatal deaths. Thus the French College of Obstetricians and Gynaecologists stated, "induction of labour can be proposed to patients between 41+0 and 41+6 weeks of gestation". In cases where labour is induced and cervix is unfavourable, cervical ripening is advised. Methods of cervical ripening include pharmacological (prostaglandins) and mechanical (Foley catheter or trans-cervical double balloon) methods. Those two methods were compared in the PROBAAT trial among women with term pregnancies (beyond 37+0). The rates of caesarean section with these two strategies were identical, however uterine hyper stimulation with FHR anomalies occurred less when cervical ripening was mechanical.

Considering pharmacological cervical ripening is associated with more uterine hyper stimulation and more FHR anomalies, it may not be the most appropriate in cases of fragile foetuses that include cases of prolonged pregnancies. Considering prolonged pregnancies are associated with a risk of FHR anomalies and that cervical ripening with a pharmacological method is another factor which increases this risk: women with prolonged pregnancies could benefit from a more "gentle" cervical ripening.

At present, no particular method is recommended in cases of cervical ripening and prolonged pregnancies. We hypothesise that, in cases of prolonged pregnancies, mechanical cervical ripening, with less uterine hyperstimulation and fewer FHR anomalies, could be more appropriate and could reduce the rate of caesarean section for suspicion of fetal distress.

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Key information

Conditions

Prolonged Pregnancy Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Pregnancy, Prolonged Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Chu Brest, Brest, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mechanical cervical ripening

Device

The mechanical cervical ripening is a double transcervical balloon. The device used in the study is the Cook® Cervical Ripening Balloon with CE marked (commercialized by the Cook® laboratory, ref JCRBS-184000). It is a silicone double balloon catheter. Maximum balloon inflation is 80 mL/balloon.

It will be used in accordance with user manual

Pharmacological cervical ripening

Drug

The comparative pharmacological procedure is a vaginal slow releasing system of dinoprostone. The form used in the study is Propess (Ferring pharmaceuticals) containing 10mg of dinoprostone (prostaglandin E2).

It will be used in accordance with Summary of Product Characteristics

Primary outcomes

  1. Caesarean section rate for non-reassuring fetal status.

    Time frame: Up to 2 days after cervical ripening

    Indication of the caesarean section will be settled by an adjudication committee at the end of the study

Secondary outcomes

  1. Time between cervical ripening and delivery in hours

    Time frame: Up to 2 days after cervical ripening

    Evaluation of time between cervical ripening and delivery in hours

  2. Delivery rate after 12 and 24 hours of cervical ripening

    Time frame: up to 2 days after cervical ripening

    Evaluation of delivery rate after 12 and 24 hours of cervical ripening

  3. Induction with oxytocin

    Time frame: up to 2 days after cervical ripening

    yes/no

  4. Total dose of oxytocin required for induction of labour

    Time frame: up to 2 days after cervical ripening

    evaluation of total dose of oxytocin required for induction of labour

  5. Uterine hyper stimulation defined as more than 6 contractions by 10 minutes over a 30 minutes period

    Time frame: up to 2 days after cervical ripening

    uterine hyperstimulation

  6. Requirement for tocolysis during cervical ripening or during labour

    Time frame: up to 2 days after cervical ripening

    requirement for tocolysis

  7. Suspicious or pathological fetal heart rate

    Time frame: up to 2 days after cervical ripening

    FIGO classification

  8. Uterine rupture

    Time frame: up to 2 days after cervical ripening

    yes/no

  9. Use of analgesics during labour

    Time frame: up to 2 days after cervical ripening

    yes/no

  10. Use of antibiotics during labour

    Time frame: up to 2 days after cervical ripening

    yes/no

  11. Indication for caesarean delivery other than non-reassuring FHR

    Time frame: up to 2 days after cervical ripening

    (failure to progress in first or second stage of labour or maternal indication)

  12. Type of vaginal delivery

    Time frame: up to 2 days after cervical ripening

    spontaneous or instrumental, indication for instrumental delivery

  13. Maternal intra partum infection

    Time frame: up to 2 days after cervical ripening

    Suspicion of maternal intra partum infection

  14. Maternal post partum infection

    Time frame: up to 2 days after cervical ripening

    Suspicion of post partum infection

  15. Maternal post partum haemorrhage

    Time frame: up to 2 days after cervical ripening

    Post partum haemorrhage defined as estimated blood loss > 500 cc

  16. Maternal blood transfusion

    Time frame: up to 2 days after cervical ripening

    Blood transfusion

  17. Neonatal apgar score

    Time frame: at 1, 3, 5 and 10 minutes after delivery

    Apgar score at 1, 3, 5 and 10 minutes

  18. Neonatal arterial ph

    Time frame: at delivery

    Arterial pH at delivery

  19. Intensive care unit for newborn

    Time frame: up to 5 days after cervical ripening

    Admission in an intensive care unit

  20. Neonatal respiratory insufficiency

    Time frame: up to 5 days after cervical ripening

    Respiratory insufficiency with necessity of any respiratory support

  21. Birth asphyxia

    Time frame: up to 5 days after cervical ripening

    Birth asphyxia defined as pH<7, Base Excess >12 mmol/l and encephalopathy.

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

Propess® Versus Double Balloon for Cervical Ripening of Prolonged Pregnancies: a Randomised Controlled Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 20, 2016
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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