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Trial · NCT02907060

Registered outcomes22

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryCaesarean section rate for non-reassuring fetal status.Up to 2 days after cervical ripeningIndication of the caesarean section will be settled by an adjudication committee at the end of the study
SecondaryTime between cervical ripening and delivery in hoursUp to 2 days after cervical ripeningEvaluation of time between cervical ripening and delivery in hours
SecondaryDelivery rate after 12 and 24 hours of cervical ripeningup to 2 days after cervical ripeningEvaluation of delivery rate after 12 and 24 hours of cervical ripening
SecondaryInduction with oxytocinup to 2 days after cervical ripeningyes/no
SecondaryTotal dose of oxytocin required for induction of labourup to 2 days after cervical ripeningevaluation of total dose of oxytocin required for induction of labour
SecondaryUterine hyper stimulation defined as more than 6 contractions by 10 minutes over a 30 minutes periodup to 2 days after cervical ripeninguterine hyperstimulation
SecondaryRequirement for tocolysis during cervical ripening or during labourup to 2 days after cervical ripeningrequirement for tocolysis
SecondarySuspicious or pathological fetal heart rateup to 2 days after cervical ripeningFIGO classification
SecondaryUterine ruptureup to 2 days after cervical ripeningyes/no
SecondaryUse of analgesics during labourup to 2 days after cervical ripeningyes/no
SecondaryUse of antibiotics during labourup to 2 days after cervical ripeningyes/no
SecondaryIndication for caesarean delivery other than non-reassuring FHRup to 2 days after cervical ripening(failure to progress in first or second stage of labour or maternal indication)
SecondaryType of vaginal deliveryup to 2 days after cervical ripeningspontaneous or instrumental, indication for instrumental delivery
SecondaryMaternal intra partum infectionup to 2 days after cervical ripeningSuspicion of maternal intra partum infection
SecondaryMaternal post partum infectionup to 2 days after cervical ripeningSuspicion of post partum infection
SecondaryMaternal post partum haemorrhageup to 2 days after cervical ripeningPost partum haemorrhage defined as estimated blood loss \> 500 cc
SecondaryMaternal blood transfusionup to 2 days after cervical ripeningBlood transfusion
SecondaryNeonatal apgar scoreat 1, 3, 5 and 10 minutes after deliveryApgar score at 1, 3, 5 and 10 minutes
SecondaryNeonatal arterial phat deliveryArterial pH at delivery
SecondaryIntensive care unit for newbornup to 5 days after cervical ripeningAdmission in an intensive care unit

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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