Foley Catheter Compared to the Foley Catheter Alone for Cervical Ripening

• Sponsor: University of Oklahoma (Other)
• Overall Status: Completed
• CT.gov ID: NCT03111316
• Collaborator: Ferring Pharmaceuticals (Industry)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 39.5
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

In term women presenting for labor induction, combined use of the controlled release dinoprostone vaginal insert and Foley catheter for cervical ripening will decrease the median time from induction to vaginal delivery by at least four hours compared to the Foley catheter alone.

Condition or Disease	Intervention/Treatment	Phase
Cervical Ripening; Induction of Labor	Drug: Cervidil 10 MG Vaginal Insert; Device: Foley Catheter	N/A

Detailed Description

Those who provide informed consent will be allocated by an online randomization system either to placement of a transcervical Foley catheter and an intravaginal dinoprostone controlled release insert or a Foley catheter alone. Randomization will be stratified by parity (nulliparous or parous).

In both study groups, the balloon on the end of the Foley catheter will be inflated with 30 mL of sterile water, pulled back against the internal os of the cervix, and taped to the maternal thigh under minimal tension. Also in both groups, the Foley catheter will be removed if any of the following occurs: 1) expulsion, 2) fetal heart rate tracing mandating evaluation for membrane rupture and placement of internal monitors, 3) spontaneous membrane rupture, or 4) if 12 hours has elapsed since placement. The dinoprostone insert will be removed if: 1) the fetal heart rate tracing mandates evaluation for membrane rupture and placement of internal monitors, 2) tachysystole develops (more than 5 contractions per 10 minutes averaged over 30 minutes, 3) spontaneous membrane rupture, or 4) 12 hours has elapsed since placement. Though these are the criteria for insert removal, in keeping with the pragmatic design of this trial, the decision regarding removal will be left to the discretion of the attending physician.

Women will remain recumbent for 30 minutes after agent placement and, except for trips to the restroom, will undergo continuous monitoring of uterine contractions and fetal heart rate. Oxytocin, according to standard intravenous protocol, will be allowed only after removal of cervical ripening agent(s). After specified cervical ripening, labor management will be at the discretion of the attending obstetrician, in keeping with the pragmatic nature of the study design.

Antibiotics will be administered if indicated for prophylaxis against early-onset neonatal infection with group B streptococci or for treatment of chorioamnionitis. Cesarean delivery will be performed, per the discretion of the attending obstetrician, for standard maternal or fetal indications.

Medical records will be reviewed no less than 30 days after delivery. Demographic, intrapartum, and outcome data will be entered into a computerized database.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Combined Use of the Controlled Release Dinoprostone Insert and Foley Catheter Compared to the Foley Catheter Alone for Cervical Ripening and Labor Induction in Term Women: A Randomized Controlled Trial
• Actual Study Start Date: Apr 9, 2017
• Actual Primary Completion Date: Jan 5, 2018
• Actual Study Completion Date: Jul 24, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Foley Catheter & Dinoprostone Insert transcervical Foley catheter and an intravaginal dinoprostone controlled release insert	Drug: Cervidil 10 MG Vaginal Insert; Dinoprostone vaginal insert is a thin, flat, polymeric slab which is rectangular in shape with rounded corners contained within the pouch of an off-white knitted polyester retrieval system, an integral part of which is a long tape. Each slab is buff colored, semitransparent and contains 10 mg of dinoprostone in a hydrogel insert. An integral part of the knitted polyester retrieval system is a long tape designed to aid retrieval at the end of the dosing interval or earlier if clinically indicated. The finished product is a controlled release formulation which has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg/hr.; Other Names: Dinoprostone ; Device: Foley Catheter; The balloon on the end of the Foley catheter will be inflated with 30 mL of sterile water, pulled back against the internal os of the cervix, and taped to the maternal thigh under minimal tension.
Other: Foley Catheter Alone a Foley catheter alone	Device: Foley Catheter; The balloon on the end of the Foley catheter will be inflated with 30 mL of sterile water, pulled back against the internal os of the cervix, and taped to the maternal thigh under minimal tension.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Cervix ≤2 cm dilated; if 2 cm, <80% effaced

2. Gestational age 37 weeks or more

3. Singleton gestation

4. Cephalic presentation

5. Live fetus

Exclusion Criteria:

1. Contractions more frequent than every 5 minutes

2. Premature rupture of membranes

3. Prior uterine incision

4. Temperature 38C or higher

5. Fetal anomalies

6. Placenta previa

7. Suspected abruption or undiagnosed bleeding more than spotting

8. Fetal heart rate tracing prior to enrollment with no more than minimal variability, late decelerations, or more than two variable decelerations

9. HIV infection

10. Allergy to either latex or dinoprostone

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104

Sponsors and Collaborators

• University of Oklahoma
• Ferring Pharmaceuticals

Investigators

• Principal Investigator: Rodney K Edwards, MD, The University of Oklahoma Health Sciences Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 21, 2017

More Information

Publications

None provided.

• Responsible Party: University of Oklahoma
• ClinicalTrials.gov Identifier: NCT03111316
• Other Study ID Numbers: Ferring
• First Posted: Apr 12, 2017
• Last Update Posted: Mar 24, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by University of Oklahoma: Cervical Ripening; Induction of Labor
• Additional relevant MeSH terms: Dinoprostone

Study Results

Participant Flow

Arm/Group Title	Nulliparous Foley Catheter & Dinoprostone Insert	Nulliparous Foley Catheter Alone	Parous Foley Catheter & Dinoprostone Insert	Parous Foley Catheter Alone
Arm/Group Description	patients with no prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the dinoprostone insert and intracervical Foley catheter concurrently	patients with no prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the intracervical Foley catheter alone	patients with one or more prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the dinoprostone insert and intracervical Foley catheter concurrently	patients with one or more prior pregnancies at or beyond 20 weeks who were randomized to have labor induction with the intracervical Foley catheter alone
Period Title: Overall Study
STARTED	26	24	25	25
COMPLETED	26	24	25	25
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Nulliparous Foley Catheter & Dinoprostone Insert	Nulliparous Foley Catheter Alone	Parous Foley Catheter & Dinoprostone Insert	Parous Foley Catheter Alone	Total
Arm/Group Description	patients with no prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the dinoprostone insert and intracervical Foley catheter concurrently	patients with no prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the intracervical Foley catheter alone	patients with one or more prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the dinoprostone insert and intracervical Foley catheter concurrently	patients with one or more prior pregnancies at or beyond 20 weeks who were randomized to have labor induction with the intracervical Foley catheter alone	Total of all reporting groups
Overall Participants	26	24	25	25	100
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	26 100%	24 100%	25 100%	25 100%	100 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	26 100%	24 100%	25 100%	25 100%	100 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	12 46.2%	13 54.2%	11 44%	8 32%	44 44%
Black	2 7.7%	4 16.7%	2 8%	1 4%	9 9%
Hispanic	12 46.2%	6 25%	10 40%	13 52%	41 41%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%
Native American	0 0%	1 4.2%	2 8%	3 12%	6 6%
Other	0 0%	0 0%	0 0%	0 0%	0 0%
Gestational age (gestational age (weeks)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [gestational age (weeks)]	38.5 (1.5)	38.9 (1.2)	38.8 (1.3)	38.9 (1.2)	38.8 (1.3)
BMI (body mass index) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [body mass index]	33 (1.5)	35 (0.27)	33.9 (6.8)	34.8 (5.6)	34.2 (3.4)
Chronic hyptertension (Count of Participants)
Count of Participants [Participants]	3 11.5%	4 16.7%	2 8%	3 12%	12 12%
Diabetes (Count of Participants)
Count of Participants [Participants]	6 23.1%	7 29.2%	3 12%	2 8%	18 18%
Preeclampsia (Count of Participants)
Count of Participants [Participants]	5 19.2%	0 0%	1 4%	0 0%	6 6%
Gestational hypertension (Count of Participants)
Count of Participants [Participants]	5 19.2%	9 37.5%	8 32%	1 4%	23 23%
Fetal growth restriction (Count of Participants)
Count of Participants [Participants]	1 3.8%	0 0%	1 4%	1 4%	3 3%

Outcome Measures

1. Primary Outcome

Title	The Median Times From Placement of Foley Catheter to Vaginal Delivery
Description	median time estimation for use of dinoprostone and foley catheter and foley catheter alone
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nulliparous Foley Catheter & Dinoprostone Insert	Nulliparous Foley Catheter Alone	Parous Foley Catheter & Dinoprostone Insert	Parous Foley Catheter Alone
Arm/Group Description	patients with no prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the dinoprostone insert and intracervical Foley catheter concurrently	patients with no prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the intracervical Foley catheter alone	patients with one or more prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the dinoprostone insert and intracervical Foley catheter concurrently	patients with one or more prior pregnancies at or beyond 20 weeks who were randomized to have labor induction with the intracervical Foley catheter alone
Measure Participants	26	24	25	25
Median (Inter-Quartile Range) [hours]	21.2	31.3	17.1	14.8

2. Secondary Outcome

Title	To Evaluate the Proportion of Patients That Delivered by 12 Hours and Proportion of Patients Delivered by 24 Hours
Description	To evaluate the proportion of patients that delivered vaginally by 12 hours and proportion of patients delivered vaginally by 24 hours.
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nulliparous Foley Catheter & Dinoprostone Insert	Nulliparous Foley Catheter Alone	Parous Foley Catheter & Dinoprostone Insert	Parous Foley Catheter Alone
Arm/Group Description	patients with no prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the dinoprostone insert and intracervical Foley catheter concurrently	patients with no prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the intracervical Foley catheter alone	patients with one or more prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the dinoprostone insert and intracervical Foley catheter concurrently	patients with one or more prior pregnancies at or beyond 20 weeks who were randomized to have labor induction with the intracervical Foley catheter alone
Measure Participants	26	24	25	25
Delivered vaginally by 12 hours	2 7.7%	1 4.2%	3 12%	6 24%
Delivered vaginally by 24 hours	15 57.7%	6 25%	19 76%	21 84%

Adverse Events

Time Frame	adverse events data was collected beginning when the patient was randomized up until 30 days following delivery.
Arm/Group Title	Nulliparous Foley Catheter & Dinoprostone Insert		Nulliparous Foley Catheter Alone		Parous Foley Catheter & Dinoprostone Insert		Parous Foley Catheter Alone
Arm/Group Description	patients with no prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the dinoprostone insert and intracervical Foley catheter concurrently		patients with no prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the intracervical Foley catheter alone		patients with one or more prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the dinoprostone insert and intracervical Foley catheter concurrently		patients with one or more prior pregnancies at or beyond 20 weeks who were randomized to have labor induction with the intracervical Foley catheter alone
All Cause Mortality
	Nulliparous Foley Catheter & Dinoprostone Insert		Nulliparous Foley Catheter Alone		Parous Foley Catheter & Dinoprostone Insert		Parous Foley Catheter Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/24 (0%)		0/25 (0%)		0/25 (0%)
Serious Adverse Events
	Nulliparous Foley Catheter & Dinoprostone Insert		Nulliparous Foley Catheter Alone		Parous Foley Catheter & Dinoprostone Insert		Parous Foley Catheter Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		4/24 (16.7%)		0/25 (0%)		1/25 (4%)
Pregnancy, puerperium and perinatal conditions
Superimposed preeclampsia	0/26 (0%)	0	1/24 (4.2%)	1	0/25 (0%)	0	1/25 (4%)	1
Anemia	0/26 (0%)	0	1/24 (4.2%)	1	0/25 (0%)	0	0/25 (0%)	0
Pyelonephritis	0/26 (0%)	0	1/24 (4.2%)	1	0/25 (0%)	0	0/25 (0%)	0
Reproductive system and breast disorders
Endometritis	0/26 (0%)	0	1/24 (4.2%)	1	0/25 (0%)	0	0/25 (0%)	0
Other (Not Including Serious) Adverse Events
	Nulliparous Foley Catheter & Dinoprostone Insert		Nulliparous Foley Catheter Alone		Parous Foley Catheter & Dinoprostone Insert		Parous Foley Catheter Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/26 (11.5%)		0/24 (0%)		3/25 (12%)		4/25 (16%)
Social circumstances
Neonatal ICU admission	3/26 (11.5%)	3	0/24 (0%)	0	3/25 (12%)	3	4/25 (16%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Ferring shall have the right to review all clinical data arising from the research project. Sponsor/investigator shall provide any manuscript to Ferring prior to submission to permit at least 30 days for comment. Sponsor/investigator may incorporate the written suggestions or comments from Ferring in his/her own discretion. Ferring reserves the right to delay publication of clinical data arising from the research project, not to exceed 90 days to permit any intellectual property to be protected.