Trial Outcomes & Findings for Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor (NCT NCT04573517)

NCT ID: NCT04573517

Last Updated: 2025-03-04

Results Overview

Total time from initiation of labor induction to reaching 6 cm cervical dilation

Recruitment status

COMPLETED

Study phase

Target enrollment

150 participants

Primary outcome timeframe

At delivery

Results posted on

2025-03-04

Participant Flow

150 subjects were enrolled between October 2020 and March 2023.

Participant milestones

Participant milestones
Measure	Early Amniotomy Subjects randomized to this arm will undergo amniotomy within 2 hours of removal of Foley balloon. Amniotomy: Artificial rupture of amniotic membranes Foley balloon: The Foley balloon is inserted transcervically and inflated to a volume of 60 cc. It may be spontaneously expelled or manually removed if in place for 12 hours.	Delayed Amniotomy Subjects randomized to this arm will undergo amniotomy at least 4 hours after removal of Foley balloon. Amniotomy: Artificial rupture of amniotic membranes Foley balloon: The Foley balloon is inserted transcervically and inflated to a volume of 60 cc. It may be spontaneously expelled or manually removed if in place for 12 hours.
Overall Study STARTED	75	75
Overall Study COMPLETED	75	74
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Early Amniotomy n=75 Participants Subjects randomized to this arm will undergo amniotomy within 2 hours of removal of Foley balloon. Amniotomy: Artificial rupture of amniotic membranes Foley balloon: The Foley balloon is inserted transcervically and inflated to a volume of 60 cc. It may be spontaneously expelled or manually removed if in place for 12 hours.	Delayed Amniotomy n=74 Participants Subjects randomized to this arm will undergo amniotomy at least 4 hours after removal of Foley balloon. Amniotomy: Artificial rupture of amniotic membranes Foley balloon: The Foley balloon is inserted transcervically and inflated to a volume of 60 cc. It may be spontaneously expelled or manually removed if in place for 12 hours.	Total n=149 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	75 Participants n=99 Participants	74 Participants n=107 Participants	149 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	24 years n=99 Participants	24 years n=107 Participants	24 years n=206 Participants
Sex: Female, Male Female	75 Participants n=99 Participants	74 Participants n=107 Participants	149 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	14 Participants n=99 Participants	11 Participants n=107 Participants	25 Participants n=206 Participants
Race (NIH/OMB) White	60 Participants n=99 Participants	61 Participants n=107 Participants	121 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants

PRIMARY outcome

Timeframe: At delivery

Total time from initiation of labor induction to reaching 6 cm cervical dilation

Outcome measures

Outcome measures
Measure	Early Amniotomy n=75 Participants Subjects randomized to this arm will undergo amniotomy within 2 hours of removal of Foley balloon. Amniotomy: Artificial rupture of amniotic membranes Foley balloon: The Foley balloon is inserted transcervically and inflated to a volume of 60 cc. It may be spontaneously expelled or manually removed if in place for 12 hours.	Delayed Amniotomy n=74 Participants Subjects randomized to this arm will undergo amniotomy at least 4 hours after removal of Foley balloon. Amniotomy: Artificial rupture of amniotic membranes Foley balloon: The Foley balloon is inserted transcervically and inflated to a volume of 60 cc. It may be spontaneously expelled or manually removed if in place for 12 hours.
Time to Active Phase of Labor	885 minutes Interval 161.0 to 2340.0	975 minutes Interval 250.0 to 2760.0

SECONDARY outcome

Timeframe: At delivery

Total time from initiation of labor induction to delivery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At delivery

Rate of vaginal delivery within 24, 36, and 48 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At delivery

Rate of cesarean section and indications

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From admission to discharge, up to 2 weeks

Includes isolated maternal fever, chorioamnionitis, endometritis, wound infection

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At delivery

Rates of umbilical cord prolapse

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From admission to discharge, up to 2 weeks

Neonatal outcome composite including NICU admission, respiratory support, hypoxic ischemic encephalopathy, seizures, sepsis, meconium aspiration syndrome, birth trauma, intracranial or subgaleal hemorrhage, hypotension requiring pressors, and perinatal death.

Outcome measures

Outcome data not reported

Adverse Events

Early Amniotomy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Delayed Amniotomy

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

Dr. Marissa Berry

University of Texas Medical Branch

Phone: 402-772-4099

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place