Trial Outcomes & Findings for Induction of Labor in Women With Unfavorable Cervix: Dilapan Versus Foley Bulb (NCT NCT02899689)

NCT ID: NCT02899689

Last Updated: 2020-11-18

Results Overview

Proportion of patients that delivered vaginal. (%)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 419 participants
• Primary outcome timeframe: Through study completion, an average of 1-2 years
• Results posted on: 2020-11-18

Participant Flow

From November 2016 to February 2018 at UTMB Galveston

Participant milestones

Measure	Foley Bulb Group Patients will have a Foley catheter inserted into the internal cervical os. Foley Catheter: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl.	Dilapan Group Patients will have Dilapan sticks inserted into the internal cervical os. Dilapan: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os.
Overall Study STARTED	209	210
Overall Study COMPLETED	209	208
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Induction of Labor in Women With Unfavorable Cervix: Dilapan Versus Foley Bulb

Baseline characteristics by cohort

Measure	Foley Bulb Group n=209 Participants Patients will have a Foley catheter inserted into the internal cervical os. Foley Catheter: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl.	Dilapan Group n=210 Participants Patients will have Dilapan sticks inserted into the internal cervical os. Dilapan: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os.	Total n=419 Participants Total of all reporting groups
Age, Continuous	25 years n=93 Participants	25 years n=4 Participants	25 years n=27 Participants
Sex: Female, Male Female	209 Participants n=93 Participants	210 Participants n=4 Participants	419 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	147 Participants n=93 Participants	153 Participants n=4 Participants	300 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	62 Participants n=93 Participants	57 Participants n=4 Participants	119 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	209 participants n=93 Participants	210 participants n=4 Participants	419 participants n=27 Participants
Gestational age	39.0 weeks n=93 Participants	39 weeks n=4 Participants	39 weeks n=27 Participants
Nulliparous	98 Participants n=93 Participants	88 Participants n=4 Participants	186 Participants n=27 Participants
Bishop score at randomization	3 scores on a scale n=93 Participants	3 scores on a scale n=4 Participants	3 scores on a scale n=27 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 1-2 years

Proportion of patients that delivered vaginal. (%)

Outcome measures

Measure	Foley Bulb Group n=209 Participants Patients will have a Foley catheter inserted into the internal cervical os. Foley Catheter: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl.	Dilapan Group n=208 Participants Patients will have Dilapan sticks inserted into the internal cervical os. Dilapan: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os.
Rate of Vaginal Delivery	169 Participants	159 Participants

SECONDARY outcome

Timeframe: 2-4 days

Delivery time frame in mins from cervical dilator insertion

Outcome measures

Measure	Foley Bulb Group n=209 Participants Patients will have a Foley catheter inserted into the internal cervical os. Foley Catheter: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl.	Dilapan Group n=208 Participants Patients will have Dilapan sticks inserted into the internal cervical os. Dilapan: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os.
Time of Vaginal Delivery	1291 minutes Interval 1203.0 to 1408.0	1441 minutes Interval 1343.0 to 1521.0

SECONDARY outcome

Timeframe: 1-2 days

time from hospital admission to reach active stage of labor defined as ≥ 6 cm (mins)

Outcome measures

Measure	Foley Bulb Group n=209 Participants Patients will have a Foley catheter inserted into the internal cervical os. Foley Catheter: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl.	Dilapan Group n=208 Participants Patients will have Dilapan sticks inserted into the internal cervical os. Dilapan: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os.
Time to Reach Active Stage of Labor as ≥ 6cm Cervical Dilation	1011 minutes Interval 913.0 to 1074.0	1152 minutes Interval 1092.0 to 1205.0

SECONDARY outcome

Timeframe: 12-24 hrs

Change in Bishop score from insertion to extraction of device. The total score is calculated by assessing the following five components on manual vaginal examination by a trained professional: Cervical dilation in centimeters. Cervical effacement as a percentage. Cervical consistency by provider assessment/judgement.

The highest possible score is 13 and the lowest possible score is 0. Bishop scores of less than 6 usually require that a cervical ripening method (pharmacologic or physical, such as a foley bulb) be used before other method

Outcome measures

Measure	Foley Bulb Group n=209 Participants Patients will have a Foley catheter inserted into the internal cervical os. Foley Catheter: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl.	Dilapan Group n=208 Participants Patients will have Dilapan sticks inserted into the internal cervical os. Dilapan: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os.
Change in Bishop Scores	3 score on a scale Interval -3.0 to 9.0	2 score on a scale Interval -2.0 to 11.0

SECONDARY outcome

Timeframe: 1-4 days

Proportion of patients that delivered vaginal by forceps assistance or vacuum (%) assistance.

Outcome measures

Measure	Foley Bulb Group n=209 Participants Patients will have a Foley catheter inserted into the internal cervical os. Foley Catheter: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl.	Dilapan Group n=208 Participants Patients will have Dilapan sticks inserted into the internal cervical os. Dilapan: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os.
Operative Deliveries	6 Participants	9 Participants

SECONDARY outcome

Timeframe: 1-4 days

Proportion of patients that delivered by cesarean (%).

Outcome measures

Measure	Foley Bulb Group n=209 Participants Patients will have a Foley catheter inserted into the internal cervical os. Foley Catheter: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl.	Dilapan Group n=208 Participants Patients will have Dilapan sticks inserted into the internal cervical os. Dilapan: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os.
Cesarean Deliveries	50 Participants	39 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1-2 days

Rate of women who require any analgesia used during insertion of the device

Outcome measures

Measure	Foley Bulb Group n=209 Participants Patients will have a Foley catheter inserted into the internal cervical os. Foley Catheter: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl.	Dilapan Group n=208 Participants Patients will have Dilapan sticks inserted into the internal cervical os. Dilapan: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os.
Analgesia Requirement	38 Participants	34 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1-4 days

Rate of women underwent spontaneous labor (%)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1-2 days

Rate of women that required pharmacological cervical ripening agents (%) requirement (%)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1-2 days

Rate of women that had artificial rupture of membranes (AROM) (%)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1-2 days

Rate of epidural/spinal analgesia (%)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1-2 days

Total duration of Dilapan-S® /Foley catheter insertion (mins)

Outcome measures

Measure	Foley Bulb Group n=209 Participants Patients will have a Foley catheter inserted into the internal cervical os. Foley Catheter: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl.	Dilapan Group n=208 Participants Patients will have Dilapan sticks inserted into the internal cervical os. Dilapan: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os.
Device Insertion Time	666 minutes Standard Deviation 319	774.1 minutes Standard Deviation 295

OTHER_PRE_SPECIFIED outcome

Timeframe: 1-4 days

Interval from device placement to delivery (mins)

Outcome measures

Measure	Foley Bulb Group n=209 Participants Patients will have a Foley catheter inserted into the internal cervical os. Foley Catheter: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl.	Dilapan Group n=208 Participants Patients will have Dilapan sticks inserted into the internal cervical os. Dilapan: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os.
Device Placement to Delivery Interval	1291 minutes Interval 1203.0 to 1408.0	1441 minutes Interval 1343.0 to 1521.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 1-2 days

Induction (Oxytocin/Prostaglandin initiation) to delivery interval (mins)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1-2 days

Labor curves using Kaplan Meier method comparing Dilapan-S to Foley balloon

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1-2 days

Rates of complications resulting from device insertion (%):

Vaginal bleeding Vaso-vagal reaction from manipulation of the cervix Cervical laceration Retraction into the uterine cavity Rupture of membranes (Date/Time) Entrapment of the device Fragmentation of the device in the genital tract Rates of complications associated with cervical ripening(%) Uterine tachysystole/hypertonus Non reassuring fetal status Systemic adverse events (nausea, vomiting, diarrhea, fever, hypotension, tachycardia)

Outcome measures

Outcome data not reported

Adverse Events

Foley Bulb Group

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Dilapan Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Foley Bulb Group n=209 participants at risk Patients will have a Foley catheter inserted into the internal cervical os. Foley Catheter: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl.	Dilapan Group n=208 participants at risk Patients will have Dilapan sticks inserted into the internal cervical os. Dilapan: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os.
Skin and subcutaneous tissue disorders Serious Adverse event	0.48% 1/209 • Number of events 1 • Duration of the trial: up to 2 weeks after discharge from hospital	0.00% 0/208 • Duration of the trial: up to 2 weeks after discharge from hospital
Musculoskeletal and connective tissue disorders Motor vehicle collision	0.48% 1/209 • Number of events 1 • Duration of the trial: up to 2 weeks after discharge from hospital	0.00% 0/208 • Duration of the trial: up to 2 weeks after discharge from hospital

Other adverse events

Adverse event data not reported

Additional Information

Antonio F Saad

UTMB

Phone: 4097720982

Email: afsaad@utmb.edu

Results disclosure agreements

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