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Trial · NCT02980276

Registered outcomes34

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

ListOutcomeTime frameDescription
PrimaryPrimary Composite OutcomeEnrolment through delivery, an average of 16 weeks.The primary efficacy outcome was achieved if any participant experienced: * Insulin initiation * Fasting glucose value \>5.1 mmol/l at 32weeks or 38 weeks gestation.
PrimaryInsulation of InsulinEnrolment through delivery, an average of 16 weeks.Initiation of insulin treatment at any time up to delivery.
SecondaryTime to Insulin InitiationTime to Insulin Initiation, from date of randomization until the date of delivery, an average of 16 weeks..Time to Insulin Initiation, from date of randomization until the date of delivery.
SecondaryInsulin InitiatedEnrolment through delivery, an average of 16 weeks.Whether or not insulin was initiated at any time during the study.
SecondaryFasting HyperglycemiaMeasured at 32 and 38 weeks' gestation.Number of women with fasting hyperglycemia at 32wks or at 38wks gestation.
SecondaryInsulin Dose RequiredEnrolment through delivery, an average of 16 weeks.Insulin dose required in any participant requiring insulin.
SecondaryGestational Weight GainEnrolment through delivery, an average of 16 weeks.Change in weight (kg) from randomization until last visit before delivery
SecondaryPostpartum Impaired Fasting Glucose12 weeks post-partumImpaired fasting glucose at 12 weeks postpartum
SecondaryPostpartum Impaired Glucose Tolerance12 weeks postpartum
SecondaryPostpartum Metabolic Syndrome12 weeks postpartum
SecondaryGestational Age at DeliveryAt delivery, an average of 16 weeks after enrolment
SecondaryMode of Delivery - Cesarian DeliveryAt delivery, an average of 16 weeks after enrolmentDelivered by Cesarian section.
SecondaryMode of Delivery - Emergency Cesarian SectionAt delivery, an average of 16 weeks after randomization.Among those having cesarian section, count of emergency procedures.
SecondaryMode of Delivery - InducedAt time of labor, an average of 16 weeks after enrolment.Labor induced.
SecondaryMaternal Morbidity - Pregnancy-induced HypertensionFrom enrolment through 6 weeks postpartum, an average of 22 weeks.
SecondaryMaternal Morbidity - Pre-eclampsiaEnrolment through 6 weeks postpartum, an average of 22 weeks.Pre-eclampsia diagnosed during study participation
SecondaryMaternal Morbidity - Antepartum HemorrhageFrom enrolment through delivery, an average of 16 weeks.Any vaginal bleeding prior to delivery
SecondaryMaternal Morbidity - Postpartum HemorrhageFrom delivery through 6 weeks postpartum.
SecondaryBirthweightAt birth
SecondaryNeonatal Head CircumferenceAt birth

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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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