Trial · NCT03111316

Foley Catheter Compared to the Foley Catheter Alone for Cervical Ripening

NCT03111316, Not applicable, Completed, University of Oklahoma; results first posted 2019-05-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Foley Catheter Compared to the Foley Catheter Alone for Cervical Ripening. Trials, record NCT03111316. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03111316

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Trial

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

Title: Foley Catheter Compared to the Foley Catheter Alone for Cervical Ripening
NCT number: NCT03111316
Status: Completed
Phases: Not applicable
Enrollment: 100 participants, actual
Lead sponsor: University of Oklahoma
Conditions: Cervical Ripening, Induction of Labor
Interventions: Cervidil 10 MG Vaginal Insert, Foley Catheter
First posted: 2017-04-12
Last updated: 2021-03-24
Results first posted: 2019-05-03

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	The Median Times From Placement of Foley Catheter to Vaginal Delivery	48 hours	median time estimation for use of dinoprostone and foley catheter and foley catheter alone
Secondary	To Evaluate the Proportion of Patients That Delivered by 12 Hours and Proportion of Patients Delivered by 24 Hours	24 hours	To evaluate the proportion of patients that delivered vaginally by 12 hours and proportion of patients delivered vaginally by 24 hours.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Median Times From Placement of Foley Catheter to Vaginal Delivery	48 hours		hours	MEDIAN
SECONDARY	To Evaluate the Proportion of Patients That Delivered by 12 Hours and Proportion of Patients Delivered by 24 Hours	24 hours		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Category	Value	Spread	Units
The Median Times From Placement of Foley Catheter to Vaginal Delivery	Nulliparous Foley Catheter & Dinoprostone Insert		21.2	Inter-Quartile Range 16.6 to 38.0	hours
The Median Times From Placement of Foley Catheter to Vaginal Delivery	Nulliparous Foley Catheter Alone		31.3	Inter-Quartile Range 23.3 to 46.9	hours
The Median Times From Placement of Foley Catheter to Vaginal Delivery	Parous Foley Catheter & Dinoprostone Insert		17.1	Inter-Quartile Range 13.6 to 21.9	hours
The Median Times From Placement of Foley Catheter to Vaginal Delivery	Parous Foley Catheter Alone		14.8	Inter-Quartile Range 12.7 to 19.5	hours
To Evaluate the Proportion of Patients That Delivered by 12 Hours and Proportion of Patients Delivered by 24 Hours	Nulliparous Foley Catheter & Dinoprostone Insert	Delivered vaginally by 12 hours	2		Participants
To Evaluate the Proportion of Patients That Delivered by 12 Hours and Proportion of Patients Delivered by 24 Hours	Nulliparous Foley Catheter Alone	Delivered vaginally by 12 hours	1		Participants
To Evaluate the Proportion of Patients That Delivered by 12 Hours and Proportion of Patients Delivered by 24 Hours	Parous Foley Catheter & Dinoprostone Insert	Delivered vaginally by 12 hours	3		Participants
To Evaluate the Proportion of Patients That Delivered by 12 Hours and Proportion of Patients Delivered by 24 Hours	Parous Foley Catheter Alone	Delivered vaginally by 12 hours	6		Participants
To Evaluate the Proportion of Patients That Delivered by 12 Hours and Proportion of Patients Delivered by 24 Hours	Nulliparous Foley Catheter & Dinoprostone Insert	Delivered vaginally by 24 hours	15		Participants
To Evaluate the Proportion of Patients That Delivered by 12 Hours and Proportion of Patients Delivered by 24 Hours	Nulliparous Foley Catheter Alone	Delivered vaginally by 24 hours	6		Participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Nulliparous Foley Catheter & Dinoprostone Insert	26
Overall Study	STARTED	Nulliparous Foley Catheter Alone	24
Overall Study	STARTED	Parous Foley Catheter & Dinoprostone Insert	25
Overall Study	STARTED	Parous Foley Catheter Alone	25
Overall Study	COMPLETED	Nulliparous Foley Catheter & Dinoprostone Insert	26
Overall Study	COMPLETED	Nulliparous Foley Catheter Alone	24
Overall Study	COMPLETED	Parous Foley Catheter & Dinoprostone Insert	25
Overall Study	COMPLETED	Parous Foley Catheter Alone	25
Overall Study	NOT COMPLETED	Nulliparous Foley Catheter & Dinoprostone Insert	0
Overall Study	NOT COMPLETED	Nulliparous Foley Catheter Alone	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events20

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

Type	Event	Organ system	Group	Affected	At risk	Events
other	Neonatal ICU admission	Social circumstances	Nulliparous Foley Catheter & Dinoprostone Insert	3	26	3
other	Neonatal ICU admission	Social circumstances	Nulliparous Foley Catheter Alone	0	24	0
other	Neonatal ICU admission	Social circumstances	Parous Foley Catheter & Dinoprostone Insert	3	25	3
other	Neonatal ICU admission	Social circumstances	Parous Foley Catheter Alone	4	25	4
serious	Superimposed preeclampsia	Pregnancy, puerperium and perinatal conditions	Nulliparous Foley Catheter & Dinoprostone Insert	0	26	0
serious	Superimposed preeclampsia	Pregnancy, puerperium and perinatal conditions	Nulliparous Foley Catheter Alone	1	24	1
serious	Superimposed preeclampsia	Pregnancy, puerperium and perinatal conditions	Parous Foley Catheter & Dinoprostone Insert	0	25	0
serious	Superimposed preeclampsia	Pregnancy, puerperium and perinatal conditions	Parous Foley Catheter Alone	1	25	1
serious	Endometritis	Reproductive system and breast disorders	Nulliparous Foley Catheter & Dinoprostone Insert	0	26	0
serious	Endometritis	Reproductive system and breast disorders	Nulliparous Foley Catheter Alone	1	24	1

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nulliparous Foley Catheter & Dinoprostone Insert	0	26
Total, all-cause mortality	Nulliparous Foley Catheter Alone	0	24
Total, all-cause mortality	Parous Foley Catheter & Dinoprostone Insert	0	25
Total, all-cause mortality	Parous Foley Catheter Alone	0	25
Total, other adverse events	Nulliparous Foley Catheter & Dinoprostone Insert	3	26
Total, other adverse events	Nulliparous Foley Catheter Alone	0	24
Total, other adverse events	Parous Foley Catheter & Dinoprostone Insert	3	25
Total, other adverse events	Parous Foley Catheter Alone	4	25
Total, serious adverse events	Nulliparous Foley Catheter & Dinoprostone Insert	0	26
Total, serious adverse events	Nulliparous Foley Catheter Alone	4	24

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36996264	DERIVED

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 comparisons0

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

None in this release.

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/NCT03111316

GET https://conductscience.org/api/trials/v1/NCT03111316/registered

API reference For AI assistants