Trial · NCT01973036
FOLCROM Trial: Foley Catheter in Rupture of Membranes
NCT01973036, Not applicable, Completed, Geisinger Clinic; results first posted 2018-09-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. FOLCROM Trial: Foley Catheter in Rupture of Membranes. Trials, record NCT01973036. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01973036
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- FOLCROM Trial: Foley Catheter in Rupture of Membranes
- NCT number
- NCT01973036
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 201 participants, actual
- Lead sponsor
- Geisinger Clinic
- Conditions
- Premature Rupture of Membranes
- Interventions
- Foley Catheter, Oxytocin
- First posted
- 2013-10-31
- Last updated
- 2018-09-24
- Results first posted
- 2018-09-24
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time From Induction of Labor Until Delivery | Time from induction to delivery (average 14.2 hours) | Time from induction (i.e., start time of Foley catheter or oxytocin) to delivery (hours), analyzed for all deliveries |
| Secondary | Number of Participants With Chorioamnionitis | Duration of Labor (average 4.8 hours) | Number of participants with chorioamnionitis excluding all those who were hospitalized with preterm premature rupture of membranes (PPROM) prior to 34 0/7 weeks. Chorioamnionitis was defined as temperature 38°C (or 100.4°F) or greater with at least two of the following: purulent discharge, maternal tachycardia (heart rate 100 beats per minute or greater), fetal tachycardia (heart rate 160 beats per minute or greater), foul odor of the amniotic fluid, or maternal leukocytosis (greater than 15,000 cells/mL3). Without Restriction = Chorioamnionitis was defined as temperature 38°C or greater and one of the following: purulent discharge, maternal tachycardia, fetal tachycardia, foul odor of the amniotic fluid, or maternal leukocytosis. With Restriction = Chorioamnionitis was defined as temperature 38°C or greater and two of the following: purulent discharge, maternal tachycardia, fetal tachycardia, foul odor of the amniotic fluid, or maternal leukocytosis. |
| Secondary | Number of Participants With Vaginal Delivery Within 12 Hours From Placement of Foley Catheter or Start Time of Oxytocin | Duration of Labor (average 4.8 hours) | |
| Secondary | Number of Participants With Vaginal Delivery Within 24 Hours From Placement of Foley Catheter or Start Time of Oxytocin | Duration of Labor (average 4.8 hours) | |
| Secondary | Duration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal Deliveries | Duration of Labor (average 4.8 hours) | |
| Secondary | Rate of Failed Induction of Labor as the Indication for Cesarean | Duration of Labor (average 4.8 hours) | This will be defined by a combination of provider documentation and cervical dilation of ≤4cm/90% effaced or ≤5cm/any effacement after a minimum of 12 hours of oxytocin in the setting of adequate contraction. One patient was missing information for failed induction. |
| Secondary | Rate of Endomyometritis | Duration of hospital stay (average 3.4 days) | Endomyometritis defined as: Temperature ≥100.4°F + one of the following: fundal tenderness, maternal tachycardia (Heart Rate ≥ 100 BPM), purulent cervical discharge and no other source of fever |
| Secondary | Maternal Length of Stay, From Admission to Discharge (Days) | Duration of hospital stay (average 3.4 days) | |
| Secondary | Rate of Five Minute Apgar Score < 5 | Duration of hospital stay (average 3.4 days) | Apgar is a test for assessing a newborn shortly after birth to determine if extra medical care or emergency care may be needed. Usually administered at 1 and 5 minutes after birth, the test includes assessment of Appearance, Pulse, Grimace, Activity and Respiration. Scores range from 0 - 10. |
| Secondary | Arterial Cord Blood Gas (pH), When Obtained | Within 1 hour of delivery |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time From Induction of Labor Until Delivery | Time from induction to delivery (average 14.2 hours) | hours | MEAN | |
| SECONDARY | Number of Participants With Chorioamnionitis | Duration of Labor (average 4.8 hours) | The number of participants analyzed excludes patients who were hospitalized with PPROM prior to 34 0/7 weeks (i.e., four patients in the Oxytocin arm and six patients in the Foley Catheter arm). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Vaginal Delivery Within 12 Hours From Placement of Foley Catheter or Start Time of Oxytocin | Duration of Labor (average 4.8 hours) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Vaginal Delivery Within 24 Hours From Placement of Foley Catheter or Start Time of Oxytocin | Duration of Labor (average 4.8 hours) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal Deliveries | Duration of Labor (average 4.8 hours) | Minutes | MEDIAN | |
| SECONDARY | Rate of Failed Induction of Labor as the Indication for Cesarean | Duration of Labor (average 4.8 hours) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Rate of Endomyometritis | Duration of hospital stay (average 3.4 days) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Maternal Length of Stay, From Admission to Discharge (Days) | Duration of hospital stay (average 3.4 days) | days | MEDIAN | |
| SECONDARY | Rate of Five Minute Apgar Score < 5 | Duration of hospital stay (average 3.4 days) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Arterial Cord Blood Gas (pH), When Obtained | Within 1 hour of delivery | pH | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time From Induction of Labor Until Delivery | Oxytocin | 14.4 | Standard Deviation 7.9 | hours | |
| Time From Induction of Labor Until Delivery | Foley Catheter and Oxytocin | 13.9 | Standard Deviation 6.9 | hours | |
| Number of Participants With Chorioamnionitis | Oxytocin | Without Restrictions | 2 | Participants | |
| Number of Participants With Chorioamnionitis | Foley Catheter and Oxytocin | Without Restrictions | 9 | Participants | |
| Number of Participants With Chorioamnionitis | Oxytocin | With Restrictions | 0 | Participants | |
| Number of Participants With Chorioamnionitis | Foley Catheter and Oxytocin | With Restrictions | 7 | Participants | |
| Number of Participants With Vaginal Delivery Within 12 Hours From Placement of Foley Catheter or Start Time of Oxytocin | Oxytocin | 46 | Participants | ||
| Number of Participants With Vaginal Delivery Within 12 Hours From Placement of Foley Catheter or Start Time of Oxytocin | Foley Catheter and Oxytocin | 34 | Participants | ||
| Number of Participants With Vaginal Delivery Within 24 Hours From Placement of Foley Catheter or Start Time of Oxytocin | Oxytocin | 80 | Participants | ||
| Number of Participants With Vaginal Delivery Within 24 Hours From Placement of Foley Catheter or Start Time of Oxytocin | Foley Catheter and Oxytocin | 61 | Participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oxytocin | 108 | |
| Overall Study | STARTED | Foley Catheter and Oxytocin | 93 | |
| Overall Study | Received Assigned Intervention | Oxytocin | 113 | |
| Overall Study | Received Assigned Intervention | Foley Catheter and Oxytocin | 88 | |
| Overall Study | COMPLETED | Oxytocin | 108 | |
| Overall Study | COMPLETED | Foley Catheter and Oxytocin | 93 | |
| Overall Study | NOT COMPLETED | Oxytocin | 0 | |
| Overall Study | NOT COMPLETED | Foley Catheter and Oxytocin | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oxytocin | 0 | 108 |
| Total, all-cause mortality | Foley Catheter and Oxytocin | 0 | 93 |
| Total, other adverse events | Oxytocin | 0 | 108 |
| Total, other adverse events | Foley Catheter and Oxytocin | 0 | 93 |
| Total, serious adverse events | Oxytocin | 0 | 108 |
| Total, serious adverse events | Foley Catheter and Oxytocin | 0 | 93 |
Source ClinicalTrials.gov
Papers16
The papers the trial lists on ClinicalTrials.gov.
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 comparisons12
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Oxytocin vs Foley Catheter and Oxytocin: Overall Cesarean Delivery | Trial comparisons |
| Oxytocin vs Foley Catheter and Oxytocin: Rate of Neonatal Sepsis | Trial comparisons |
| Oxytocin vs Foley Catheter and Oxytocin: Number of Participants With Vaginal Delivery Within 12 Hours From Placement of Foley Catheter or Start Time of Oxytocin | Trial comparisons |
| Oxytocin vs Foley Catheter and Oxytocin: Rate of Five Minute Apgar Score < 5 | Trial comparisons |
| Oxytocin vs Foley Catheter and Oxytocin: Number of Participants With Confirmed Histologic Chorioamnionitis/Funisitis | Trial comparisons |
| Oxytocin vs Foley Catheter and Oxytocin: Rate of Chorioamnionitis | Trial comparisons |
| Oxytocin vs Foley Catheter and Oxytocin: Rate of Endomyometritis | Trial comparisons |
| Oxytocin vs Foley Catheter and Oxytocin: Rate of Failed Induction of Labor as the Indication for Cesarean | Trial comparisons |
| Oxytocin vs Foley Catheter and Oxytocin: Neonatal Intensive Care Unit (NICU) Admission Rate | Trial comparisons |
| Oxytocin vs Foley Catheter and Oxytocin: deaths from any cause | Trial comparisons |
1 to 10 of 12
See all 12 trial comparisonsTests0
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.
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/NCT01973036
GET https://conductscience.org/api/trials/v1/NCT01973036/results?page=2