Trial Outcomes & Findings for Foley Catheter Compared to the Foley Catheter Alone for Cervical Ripening (NCT NCT03111316)

NCT ID: NCT03111316

Last Updated: 2021-03-24

Results Overview

median time estimation for use of dinoprostone and foley catheter and foley catheter alone

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2021-03-24

Participant Flow

Participant milestones

Measure	Nulliparous Foley Catheter & Dinoprostone Insert 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	Nulliparous Foley Catheter Alone patients with no prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the intracervical Foley catheter alone	Parous Foley Catheter & Dinoprostone Insert 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	Parous Foley Catheter Alone 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
Overall Study STARTED	26	24	25	25
Overall Study COMPLETED	26	24	25	25
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Foley Catheter Compared to the Foley Catheter Alone for Cervical Ripening

Baseline characteristics by cohort

Measure	Nulliparous Foley Catheter & Dinoprostone Insert n=26 Participants 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	Nulliparous Foley Catheter Alone n=24 Participants patients with no prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the intracervical Foley catheter alone	Parous Foley Catheter & Dinoprostone Insert n=25 Participants 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	Parous Foley Catheter Alone n=25 Participants 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 n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants	24 Participants n=7 Participants	25 Participants n=5 Participants	25 Participants n=4 Participants	100 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	24 Participants n=7 Participants	25 Participants n=5 Participants	25 Participants n=4 Participants	100 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized White	12 Participants n=5 Participants	13 Participants n=7 Participants	11 Participants n=5 Participants	8 Participants n=4 Participants	44 Participants n=21 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	9 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic	12 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants	13 Participants n=4 Participants	41 Participants n=21 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Native American	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Gestational age	38.5 gestational age (weeks) STANDARD_DEVIATION 1.5 • n=5 Participants	38.9 gestational age (weeks) STANDARD_DEVIATION 1.2 • n=7 Participants	38.8 gestational age (weeks) STANDARD_DEVIATION 1.3 • n=5 Participants	38.9 gestational age (weeks) STANDARD_DEVIATION 1.2 • n=4 Participants	38.8 gestational age (weeks) STANDARD_DEVIATION 1.3 • n=21 Participants
BMI	33 body mass index STANDARD_DEVIATION 1.5 • n=5 Participants	35 body mass index STANDARD_DEVIATION 0.27 • n=7 Participants	33.9 body mass index STANDARD_DEVIATION 6.8 • n=5 Participants	34.8 body mass index STANDARD_DEVIATION 5.6 • n=4 Participants	34.2 body mass index STANDARD_DEVIATION 3.4 • n=21 Participants
Chronic hyptertension	3 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	12 Participants n=21 Participants
Diabetes	6 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	18 Participants n=21 Participants
Preeclampsia	5 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants
Gestational hypertension	5 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	1 Participants n=4 Participants	23 Participants n=21 Participants
Fetal growth restriction	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants

PRIMARY outcome

Timeframe: 48 hours

median time estimation for use of dinoprostone and foley catheter and foley catheter alone

Outcome measures

Measure	Nulliparous Foley Catheter & Dinoprostone Insert n=26 Participants 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	Nulliparous Foley Catheter Alone n=24 Participants patients with no prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the intracervical Foley catheter alone	Parous Foley Catheter & Dinoprostone Insert n=25 Participants 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	Parous Foley Catheter Alone n=25 Participants 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
The Median Times From Placement of Foley Catheter to Vaginal Delivery	21.2 hours Interval 16.6 to 38.0	31.3 hours Interval 23.3 to 46.9	17.1 hours Interval 13.6 to 21.9	14.8 hours Interval 12.7 to 19.5

SECONDARY outcome

Timeframe: 24 hours

To evaluate the proportion of patients that delivered vaginally by 12 hours and proportion of patients delivered vaginally by 24 hours.

Outcome measures

Measure	Nulliparous Foley Catheter & Dinoprostone Insert n=26 Participants 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	Nulliparous Foley Catheter Alone n=24 Participants patients with no prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the intracervical Foley catheter alone	Parous Foley Catheter & Dinoprostone Insert n=25 Participants 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	Parous Foley Catheter Alone n=25 Participants 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
To Evaluate the Proportion of Patients That Delivered by 12 Hours and Proportion of Patients Delivered by 24 Hours Delivered vaginally by 12 hours	2 Participants	1 Participants	3 Participants	6 Participants
To Evaluate the Proportion of Patients That Delivered by 12 Hours and Proportion of Patients Delivered by 24 Hours Delivered vaginally by 24 hours	15 Participants	6 Participants	19 Participants	21 Participants

Adverse Events

Nulliparous Foley Catheter & Dinoprostone Insert

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Nulliparous Foley Catheter Alone

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Parous Foley Catheter & Dinoprostone Insert

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Parous Foley Catheter Alone

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Nulliparous Foley Catheter & Dinoprostone Insert n=26 participants at risk 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	Nulliparous Foley Catheter Alone n=24 participants at risk patients with no prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the intracervical Foley catheter alone	Parous Foley Catheter & Dinoprostone Insert n=25 participants at risk 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	Parous Foley Catheter Alone n=25 participants at risk 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
Pregnancy, puerperium and perinatal conditions Pyelonephritis	0.00% 0/26 • adverse events data was collected beginning when the patient was randomized up until 30 days following delivery.	4.2% 1/24 • Number of events 1 • adverse events data was collected beginning when the patient was randomized up until 30 days following delivery.	0.00% 0/25 • adverse events data was collected beginning when the patient was randomized up until 30 days following delivery.	0.00% 0/25 • adverse events data was collected beginning when the patient was randomized up until 30 days following delivery.
Pregnancy, puerperium and perinatal conditions Superimposed preeclampsia	0.00% 0/26 • adverse events data was collected beginning when the patient was randomized up until 30 days following delivery.	4.2% 1/24 • Number of events 1 • adverse events data was collected beginning when the patient was randomized up until 30 days following delivery.	0.00% 0/25 • adverse events data was collected beginning when the patient was randomized up until 30 days following delivery.	4.0% 1/25 • Number of events 1 • adverse events data was collected beginning when the patient was randomized up until 30 days following delivery.
Reproductive system and breast disorders Endometritis	0.00% 0/26 • adverse events data was collected beginning when the patient was randomized up until 30 days following delivery.	4.2% 1/24 • Number of events 1 • adverse events data was collected beginning when the patient was randomized up until 30 days following delivery.	0.00% 0/25 • adverse events data was collected beginning when the patient was randomized up until 30 days following delivery.	0.00% 0/25 • adverse events data was collected beginning when the patient was randomized up until 30 days following delivery.
Pregnancy, puerperium and perinatal conditions Anemia	0.00% 0/26 • adverse events data was collected beginning when the patient was randomized up until 30 days following delivery.	4.2% 1/24 • Number of events 1 • adverse events data was collected beginning when the patient was randomized up until 30 days following delivery.	0.00% 0/25 • adverse events data was collected beginning when the patient was randomized up until 30 days following delivery.	0.00% 0/25 • adverse events data was collected beginning when the patient was randomized up until 30 days following delivery.

Other adverse events

Measure	Nulliparous Foley Catheter & Dinoprostone Insert n=26 participants at risk 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	Nulliparous Foley Catheter Alone n=24 participants at risk patients with no prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the intracervical Foley catheter alone	Parous Foley Catheter & Dinoprostone Insert n=25 participants at risk 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	Parous Foley Catheter Alone n=25 participants at risk 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
Social circumstances Neonatal ICU admission	11.5% 3/26 • Number of events 3 • adverse events data was collected beginning when the patient was randomized up until 30 days following delivery.	0.00% 0/24 • adverse events data was collected beginning when the patient was randomized up until 30 days following delivery.	12.0% 3/25 • Number of events 3 • adverse events data was collected beginning when the patient was randomized up until 30 days following delivery.	16.0% 4/25 • Number of events 4 • adverse events data was collected beginning when the patient was randomized up until 30 days following delivery.

Additional Information

Director of Women's Health Research

University of Oklahoma Health Sciences Center

Phone: 4052718001

Email: christy-zornes@ouhsc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER