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Trial · NCT01635439

Prostin and Propess in Induction of Labor

NCT01635439, Phase 3, Completed, Ain Shams University; results first posted 2012-10-04

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Prostin and Propess in Induction of Labor. Trials, record NCT01635439. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01635439

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Prostin and Propess in Induction of Labor
NCT number
NCT01635439
Status
Completed
Phases
Phase 3
Enrollment
200 participants, actual
Lead sponsor
Ain Shams University
Conditions
Labor Pain
Interventions
Propess, Prostin E2
First posted
2012-07-09
Last updated
2014-02-06
Results first posted
2012-10-04

Source ClinicalTrials.gov

Registered outcomes5

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

ListOutcomeTime frameDescription
PrimaryInduction to Delivery Interval24 hours
SecondaryInduction to Onset of Labor Interval24 hours
SecondaryUterine Hyper-stimulation Rate24 hours
SecondaryNeed for Syntocinon Augmentation24 hours
SecondaryNormal Vaginal Delivery Rate24 hours

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYInduction to Delivery Interval24 hourshoursMEAN
SECONDARYInduction to Onset of Labor Interval24 hourshoursMEAN
SECONDARYUterine Hyper-stimulation Rate24 hoursparticipantsNUMBER
SECONDARYNeed for Syntocinon Augmentation24 hoursparticipantsNUMBER
SECONDARYNormal Vaginal Delivery Rate24 hoursparticipantsNUMBER

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Induction to Delivery IntervalPropess22.3Standard Deviation 5.7hours
Induction to Delivery IntervalProstin E221.2Standard Deviation 5.3hours
Induction to Onset of Labor IntervalPropess18.8Standard Deviation 5.3hours
Induction to Onset of Labor IntervalProstin E217.7Standard Deviation 5.4hours
Uterine Hyper-stimulation RatePropess1participants
Uterine Hyper-stimulation RateProstin E21participants
Need for Syntocinon AugmentationPropess5participants
Need for Syntocinon AugmentationProstin E210participants
Normal Vaginal Delivery RatePropess79participants
Normal Vaginal Delivery RateProstin E285participants

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDPropess100
Overall StudySTARTEDProstin E2100
Overall StudyCOMPLETEDPropess100
Overall StudyCOMPLETEDProstin E2100
Overall StudyNOT COMPLETEDPropess0
Overall StudyNOT COMPLETEDProstin E20

Adverse events8

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherMaternal adverse outcomesPregnancy, puerperium and perinatal conditionsPropess1210012
otherMaternal adverse outcomesPregnancy, puerperium and perinatal conditionsProstin E21310013
otherApgar score < 7Pregnancy, puerperium and perinatal conditionsPropess01000
otherApgar score < 7Pregnancy, puerperium and perinatal conditionsProstin E211001
otherUterine tachysystolePregnancy, puerperium and perinatal conditionsPropess21002
otherUterine tachysystolePregnancy, puerperium and perinatal conditionsProstin E231003
seriousCord pH < 7.1Pregnancy, puerperium and perinatal conditionsPropess11001
seriousCord pH < 7.1Pregnancy, puerperium and perinatal conditionsProstin E221002

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityPropess
Total, all-cause mortalityProstin E2
Total, other adverse eventsPropess14100
Total, other adverse eventsProstin E213100
Total, serious adverse eventsPropess1100
Total, serious adverse eventsProstin E22100

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
30122579DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Propess vs Prostin E2: Need for Syntocinon AugmentationTrial comparisons
Propess vs Prostin E2: Normal Vaginal Delivery RateTrial comparisons
Propess vs Prostin E2: Uterine Hyper-stimulation RateTrial comparisons
Propess vs Prostin E2: serious adverse eventsTrial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01635439

GET https://conductscience.org/api/trials/v1/NCT01635439/registered