Trial Outcomes & Findings for Foley Catheter for Induction of Labor (NCT NCT02044458)

Results Overview

Difference in insertion times between women randomly allocated to ridged stylette or no ridged stylette. Patient's may have experienced multiple insertions only if a patient failed initial randomized insertion method. Subsequent treatment methods were used when a patient failed and time was summarized as length of time of attempt. Failure was defined as either inadvertent amniotomy, excessive time in placement (subjectively determined by the provider using the catheter), or excessive patient pain (subjectively defined by the provider but based on patient response).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

134 participants

Primary outcome timeframe

Followed throughout patient's hospital stay, approximately 10 days

Results posted on

2024-10-03

Participant Flow

Participant milestones

Participant milestones
Measure	Stylette Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter. Stylette: use of stylette for successful insertion of foley catheter for induction of labor	No Stylette No Stylette: 22 French Foley catheter placed without stylette or guide.
Overall Study STARTED	65	69
Overall Study COMPLETED	62	61
Overall Study NOT COMPLETED	3	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Stylette Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter. Stylette: use of stylette for successful insertion of foley catheter for induction of labor	No Stylette No Stylette: 22 French Foley catheter placed without stylette or guide.
Overall Study Protocol Violation	3	8

Baseline Characteristics

Foley Catheter for Induction of Labor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stylette n=62 Participants Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter. Stylette: use of stylette for successful insertion of foley catheter for induction of labor	No Stylette n=61 Participants No Stylette: 22 French Foley catheter placed without stylette or guide.	Total n=123 Participants Total of all reporting groups
Age, Continuous	26.9 years STANDARD_DEVIATION 5.56 • n=5 Participants	26.9 years STANDARD_DEVIATION 6.98 • n=7 Participants	26.9 years STANDARD_DEVIATION 6.28 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	61 Participants n=7 Participants	123 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White non-Hispanic	15 participants n=5 Participants	8 participants n=7 Participants	23 participants n=5 Participants
Race/Ethnicity, Customized African-American non-Hispanic	38 participants n=5 Participants	41 participants n=7 Participants	79 participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latina	6 participants n=5 Participants	10 participants n=7 Participants	16 participants n=5 Participants
Race/Ethnicity, Customized Other	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment United States	62 participants n=5 Participants	61 participants n=7 Participants	123 participants n=5 Participants

PRIMARY outcome

Timeframe: Followed throughout patient's hospital stay, approximately 10 days

Population: The insertion time of two failed attempts with no stylette were not recorded.

Difference in insertion times between women randomly allocated to ridged stylette or no ridged stylette. Patient's may have experienced multiple insertions only if a patient failed initial randomized insertion method. Subsequent treatment methods were used when a patient failed and time was summarized as length of time of attempt. Failure was defined as either inadvertent amniotomy, excessive time in placement (subjectively determined by the provider using the catheter), or excessive patient pain (subjectively defined by the provider but based on patient response).

Outcome measures

Outcome measures
Measure	Stylette n=62 Participants Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter. Stylette: use of stylette for successful insertion of foley catheter for induction of labor	No Stylette n=59 Participants No Stylette: 22 French Foley catheter placed without stylette or guide.
Duration of Insertion Between Foley Catheter Groups With and Without a Stylette. Successful insertion attempts	1.72 minutes Interval 1.25 to 3.3	1.88 minutes Interval 1.33 to 3.12
Duration of Insertion Between Foley Catheter Groups With and Without a Stylette. Failed insertion attempts	6.55 minutes Interval 3.8 to 11.6	5.00 minutes Interval 3.0 to 7.18

SECONDARY outcome

Timeframe: Followed throughout patient's hospital stay, approximately 10 days

Population: The pain level of one successful attempt with stylette was not recorded.

To compare the pain assessed by visual analogue scale(VAS), in women randomly allocated to ridged stylette or no ridged stylette. Patient-assessed pain level was determined by verbally asking patients to assess their pain (on a scale from 0-10 \[no pain-worst pain\]) following taping of the catheter tail. Pain was only assessed once.

Outcome measures

Outcome measures
Measure	Stylette n=61 Participants Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter. Stylette: use of stylette for successful insertion of foley catheter for induction of labor	No Stylette n=61 Participants No Stylette: 22 French Foley catheter placed without stylette or guide.
Pain Assessed by Visual Analog Scale (VAS)	4.90 units on a scale Interval 4.22 to 5.58	4.43 units on a scale Interval 3.59 to 5.27

OTHER_PRE_SPECIFIED outcome

Timeframe: Followed throughout patient's hospital stay, approximately 10 days

To compare the failure rate of the placement of a Foley catheter for the induction of labor in women randomly allocated to rigid stylette or no stylette

Outcome measures

Outcome measures
Measure	Stylette n=62 Participants Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter. Stylette: use of stylette for successful insertion of foley catheter for induction of labor	No Stylette n=61 Participants No Stylette: 22 French Foley catheter placed without stylette or guide.
Failure Rates of the Placement of a Foley Catheter	7 failed attempt	9 failed attempt

Adverse Events

Stylette

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Stylette

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jessica J F Kram, MPH

Aurora Health Care, Inc.

Phone: 414-219-5594

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place