Foley Catheter Versus Cervidil for Induction of Labor at Term

• ClinicalTrials.gov Identifier: NCT01402050
• Recruitment Status: Completed
• First Posted: July 26, 2011
• Results First Posted: February 6, 2020
• Last Update Posted: March 2, 2020
• Sponsor: Pediatrix
• Information provided by (Responsible Party): Pediatrix

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Labor Induction
• Interventions: Drug: CERVIDIL (Dinoprostone); Device: FOLEY BALLOON
• Enrollment: 376

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	FOLEY BALLOON	CERVIDIL
Arm/Group Description	Comparing Foley balloon to Cervidil for decreased time from the start of the induction process to delivery is the aim of this RCT. Subjects randomized into the Foley Balloon Arm received a Foley Balloon past the cervical os filled with 30 cc of sterile water, and catheter taped to inside of maternal thigh. Catheter was removed for any of the 5 reasons: expulsion, nonreasurring fetal heart rate tracing mandating placement of internal monitors, tachysystole, spontaneous membrane rupture, or 12 hours elapsed since placement. Key words: FOLEY BALLOON: INDUCTION OF LABOR	CERVIDIL (Dinoprostone) Arm: Subjects randomized to this arm received dinoprostone controlled release vaginal insert (standard dosing Cervidil, 0.3mg/hour of dinoprostone over 12 hours). The vaginal insert was placed in the posterior fornix and was removed for any of the 5 reasons stated for the Foley catheter Arm description. Fetal heart rate and uterine contractions were continuously monitored per standard. Time of placement was noted as the time of Labor Induction initiation and time of delivery was noted as the end time of Labor Induction. Key word: INDUCTION OF LABOR
Period Title: Overall Study
Started	185	191
Completed	185	191
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		FOLEY BALLOON	CERVIDIL	Total
Arm/Group Description		Comparing foley balloon to cervidil for decreased time from the start of the induction process to delivery FOLEY BALLOON: INDUCTION OF LABOR	CERVIDIL (Dinoprostone): INDUCTION OF LABOR	Total of all reporting groups
Overall Number of Baseline Participants		185	191	376
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	185 participants	191 participants	376 participants
		28.0 (6.4)	26.9 (5.9)	27.5 (6.2)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	185 participants	191 participants	376 participants
	Female	185 100.0%	191 100.0%	376 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	185 participants	191 participants	376 participants
White		87 47.0%	81 42.4%	168 44.7%
Black		34 18.4%	33 17.3%	67 17.8%
Hispanic		44 23.8%	60 31.4%	104 27.7%
Other		20 10.8%	17 8.9%	37 9.8%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	185 participants	191 participants	376 participants
		185	191	376

Outcome Measures

1. Primary Outcome

Title	Time Of Start Of Induction Of Labor To Delivery
Description	The primary outcome variable was time (measured in hours) from first attempt at study agent placement to delivery. Time of placement of Labor Induction agent was noted as the time of Labor Induction initiation and time of delivery was noted as the end time of Labor Induction. There were no specific time points at which the outcomes were measured due to the uncertainty of the labor process. Total time duration of Labor induction was noted in hours. Key word: INDUCTION OF LABOR
Time Frame	Hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FOLEY BALLOON	CERVIDIL
Arm/Group Description:	Comparing foley balloon to cervidil for decreased time from the start of the induction process to delivery FOLEY BALLOON: INDUCTION OF LABOR	CERVIDIL (Dinoprostone): INDUCTION OF LABOR
Overall Number of Participants Analyzed	185	191
Median (Inter-Quartile Range); Unit of Measure: hours
	21.6; (15.7 to 35.1)	26.6; (19.0 to 37.8)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	FOLEY BALLOON		CERVIDIL
Arm/Group Description	Comparing foley balloon to cervidil for decreased time from the start of the induction process to delivery FOLEY BALLOON: INDUCTION OF LABOR		CERVIDIL (Dinoprostone): INDUCTION OF LABOR
All-Cause Mortality
	FOLEY BALLOON		CERVIDIL
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	FOLEY BALLOON		CERVIDIL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/185 (0.00%)		0/191 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	FOLEY BALLOON		CERVIDIL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/185 (0.00%)		2/191 (1.05%)
Gastrointestinal disorders
Neonatal event * [1]	0/185 (0.00%)	0	2/191 (1.05%)	2
* Indicates events were collected by non-systematic assessment; [1] Neonatal death due to pre-existing prenatally diagnosed diaphragmatic hernia

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Ana Braescu
• Organization: Phoenix Perinatal Associates - Mednax
• Phone: 602-614-0488
• EMail: ana_braescu@mednax.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Edwards RK, Szychowski JM, Berger JL, Petersen M, Ingersoll M, Bodea-Braescu AV, Lin MG. Foley catheter compared with the controlled-release dinoprostone insert: a randomized controlled trial. Obstet Gynecol. 2014 Jun;123(6):1280-1287. doi: 10.1097/AOG.0000000000000238.

• Responsible Party: Pediatrix
• ClinicalTrials.gov Identifier: NCT01402050
• Other Study ID Numbers: 01-10-0012
• First Submitted: April 8, 2011
• First Posted: July 26, 2011
• Results First Submitted: January 24, 2020
• Results First Posted: February 6, 2020
• Last Update Posted: March 2, 2020