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Comparison · NCT01973036-82f784f8

Oxytocin vs Foley Catheter and Oxytocin: Number of Participants With Confirmed Histologic Chorioamnionitis/Funisitis

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Oxytocin vs Foley Catheter and Oxytocin: Number of Participants With Confirmed Histologic Chorioamnionitis/Funisitis. Trial comparisons, record NCT01973036-82f784f8. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01973036-82f784f8

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.08330.04450.151wilson
Risk in group 20.1080.05950.187wilson
Risk difference, group 1 minus group 2-0.0242-0.1120.0587newcombe hybrid score
Risk ratio, group 1 over group 20.7750.3291.83log
Odds ratio, group 1 over group 20.7550.2931.94log
Number needed to treat, for one fewer participant with the outcome on Oxytocin than on Foley Catheter and Oxytocin41.3from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Oxytocin
This arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.~Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
9108OG000
Group 2Foley Catheter and Oxytocin
Foley Catheter: A 30cc/16 French (16F) foley catheter will be inserted. Balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.~Oxytocin: administered concurrently at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
1093OG001

Outcome

Type
SECONDARY
Title
Number of Participants With Confirmed Histologic Chorioamnionitis/Funisitis
Description
Chorioamnionitis/funisitis as determined by the pathologist examining the placenta
Time frame
Duration of hospital stay (average 3.4 days)
Population

Source ClinicalTrials.gov

Trial

Title
FOLCROM Trial: Foley Catheter in Rupture of Membranes
NCT number
NCT01973036
Phases
NA
Conditions
Premature Rupture of Membranes
Interventions
Foley Catheter, Oxytocin
Lead sponsor
Geisinger Clinic
Results first posted
2018-09-24

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
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

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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