Trial Outcomes & Findings for Foley Bulb With Oral Misoprostol for Induction of Labor (NCT NCT03407625)

NCT ID: NCT03407625

Last Updated: 2020-11-04

Results Overview

vaginal delivery at first induction

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

2227 participants

Primary outcome timeframe

at delivery

Results posted on

2020-11-04

Participant Flow

Participant milestones

Participant milestones
Measure
Foley Bulb Plus Oral Misoprostol
Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Foley bulb plus Oral Misoprostol: Although labeled "experimental" for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States.
Oral Misoprostol
Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Oral Misoprostol: Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.
Overall Study
STARTED
1117
1110
Overall Study
COMPLETED
1117
1110
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Foley Bulb With Oral Misoprostol for Induction of Labor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Foley Bulb Plus Oral Misoprostol
n=1117 Participants
Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Foley bulb plus Oral Misoprostol: Although labeled "experimental" for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States.
Oral Misoprostol
n=1110 Participants
Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Oral Misoprostol: Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.
Total
n=2227 Participants
Total of all reporting groups
Age, Continuous
26.8 years
STANDARD_DEVIATION 6.6 • n=5 Participants
26.6 years
STANDARD_DEVIATION 6.7 • n=7 Participants
26.7 years
STANDARD_DEVIATION 6.6 • n=5 Participants
Sex: Female, Male
Female
1117 Participants
n=5 Participants
1110 Participants
n=7 Participants
2227 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
Black, non-Hispanic
192 Participants
n=5 Participants
186 Participants
n=7 Participants
378 Participants
n=5 Participants
Race/Ethnicity, Customized
White, non-Hispanic
41 Participants
n=5 Participants
40 Participants
n=7 Participants
81 Participants
n=5 Participants
Race/Ethnicity, Customized
Hispanic
840 Participants
n=5 Participants
860 Participants
n=7 Participants
1700 Participants
n=5 Participants
Race/Ethnicity, Customized
Other
44 Participants
n=5 Participants
24 Participants
n=7 Participants
68 Participants
n=5 Participants
Region of Enrollment
United States
1117 Participants
n=5 Participants
1110 Participants
n=7 Participants
2227 Participants
n=5 Participants
Parity
Parity = 0
591 Participants
n=5 Participants
584 Participants
n=7 Participants
1175 Participants
n=5 Participants
Parity
Parity = 1
219 Participants
n=5 Participants
208 Participants
n=7 Participants
427 Participants
n=5 Participants
Parity
Parity = 2
158 Participants
n=5 Participants
155 Participants
n=7 Participants
313 Participants
n=5 Participants
Parity
Parity = > 2
149 Participants
n=5 Participants
163 Participants
n=7 Participants
312 Participants
n=5 Participants
Body mass index (kg/m2)
29.7 kg/m^2
STANDARD_DEVIATION 6.7 • n=5 Participants
30.1 kg/m^2
STANDARD_DEVIATION 7.2 • n=7 Participants
29.9 kg/m^2
STANDARD_DEVIATION 7.0 • n=5 Participants
Diabetes
None
977 Participants
n=5 Participants
952 Participants
n=7 Participants
1929 Participants
n=5 Participants
Diabetes
Gestational
99 Participants
n=5 Participants
115 Participants
n=7 Participants
214 Participants
n=5 Participants
Diabetes
Pregestational
41 Participants
n=5 Participants
43 Participants
n=7 Participants
84 Participants
n=5 Participants
Gestational age at delivery (weeks)
39 weeks
n=5 Participants
39 weeks
n=7 Participants
39 weeks
n=5 Participants

PRIMARY outcome

Timeframe: at delivery

vaginal delivery at first induction

Outcome measures

Outcome measures
Measure
Foley Bulb Plus Oral Misoprostol
n=1 Participants
Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Foley bulb plus Oral Misoprostol: Although labeled "experimental" for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States.
Oral Misoprostol
n=1 Participants
Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Oral Misoprostol: Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.
Number of Participants With Vaginal Delivery
869 Participants
860 Participants

SECONDARY outcome

Timeframe: from start of induction agent to time of delivery

Population: This number represents women delivered at first induction

Time (in hours) from start of induction agent to delivery at first induction

Outcome measures

Outcome measures
Measure
Foley Bulb Plus Oral Misoprostol
n=1088 Participants
Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Foley bulb plus Oral Misoprostol: Although labeled "experimental" for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States.
Oral Misoprostol
n=1075 Participants
Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Oral Misoprostol: Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.
Time to Delivery
17.3 hours
Standard Deviation 9.2
18.2 hours
Standard Deviation 9.2

SECONDARY outcome

Timeframe: at delivery

Among women delivered by cesarean, the indication for cesarean

Outcome measures

Outcome measures
Measure
Foley Bulb Plus Oral Misoprostol
n=1117 Participants
Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Foley bulb plus Oral Misoprostol: Although labeled "experimental" for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States.
Oral Misoprostol
n=1110 Participants
Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Oral Misoprostol: Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.
Indication for Cesarean Delivery
Labor dystocia
122 Participants
110 Participants
Indication for Cesarean Delivery
Abnormal fetal heart rate tracing
110 Participants
115 Participants
Indication for Cesarean Delivery
Malpresentation
3 Participants
3 Participants
Indication for Cesarean Delivery
No cesarean delivery
882 Participants
882 Participants

SECONDARY outcome

Timeframe: at delivery

Population: Total dose of oxytocin was not found to be meaningful, thus data were not collected.

Total dose of oxytocin given for induction as calculated by volume infused, concentration of solution and rate of infusion

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From time of documented insertion until the time of documented expulsion or removal, whichever came first, assessed up to 24 hours.

Population: Number of women with successful Foley bulb placement

time (in hours) from insertion to removal or expulsion of foley bulb

Outcome measures

Outcome measures
Measure
Foley Bulb Plus Oral Misoprostol
n=945 Participants
Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Foley bulb plus Oral Misoprostol: Although labeled "experimental" for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States.
Oral Misoprostol
Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Oral Misoprostol: Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.
Time With Foley Bulb in Place
5.3 hours
Interval 4.6 to 8.3

SECONDARY outcome

Timeframe: at delivery

Intrapartum fever (temp equal or greater than 38C) with no other identified cause

Outcome measures

Outcome measures
Measure
Foley Bulb Plus Oral Misoprostol
n=1117 Participants
Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Foley bulb plus Oral Misoprostol: Although labeled "experimental" for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States.
Oral Misoprostol
n=1110 Participants
Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Oral Misoprostol: Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.
Presence of Chorioamnionitis
203 Participants
155 Participants

SECONDARY outcome

Timeframe: at delivery

Population: Intravenous analgesia was not clinically meaningful and was not collected

Intravenous analgesia used between the start of induction and delivery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: from start of induction to delivery

Regional or neuraxial analgesia (labor epidural or spinal) used between the start of induction and delivery

Outcome measures

Outcome measures
Measure
Foley Bulb Plus Oral Misoprostol
n=1117 Participants
Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Foley bulb plus Oral Misoprostol: Although labeled "experimental" for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States.
Oral Misoprostol
n=1110 Participants
Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Oral Misoprostol: Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.
Number of Participants Used Neuraxial Analgesia During Labor
949 Participants
935 Participants

SECONDARY outcome

Timeframe: at delivery

General anesthesia administered for delivery

Outcome measures

Outcome measures
Measure
Foley Bulb Plus Oral Misoprostol
n=1117 Participants
Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Foley bulb plus Oral Misoprostol: Although labeled "experimental" for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States.
Oral Misoprostol
n=1110 Participants
Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Oral Misoprostol: Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.
Number of Participants Used General Anesthesia for Delivery
29 Participants
24 Participants

SECONDARY outcome

Timeframe: At the time of rupture of membranes and at delivery

Identification of any meconium (green tinge) in the amniotic fluid before or during delivery by a healthcare provider's assessment of gross fluid color.

Outcome measures

Outcome measures
Measure
Foley Bulb Plus Oral Misoprostol
n=1117 Participants
Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Foley bulb plus Oral Misoprostol: Although labeled "experimental" for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States.
Oral Misoprostol
n=1110 Participants
Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Oral Misoprostol: Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.
Number of Participants With Meconium-stained Amniotic Fluid
227 Participants
234 Participants

SECONDARY outcome

Timeframe: at delivery

Population: Terbutaline use was not felt to be clinically meaningful, and thus data were not collected

Administration of terbutaline, a tocolytic agent, for tetanic contractions with or without fetal heart rate decelerations

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at delivery

6 or more contractions in 10 minutes or tetanic contraction of 120 seconds or longer

Outcome measures

Outcome measures
Measure
Foley Bulb Plus Oral Misoprostol
n=1117 Participants
Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Foley bulb plus Oral Misoprostol: Although labeled "experimental" for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States.
Oral Misoprostol
n=1110 Participants
Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Oral Misoprostol: Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.
Number of Participants With Tachysystole
325 Participants
313 Participants

SECONDARY outcome

Timeframe: at delivery

Tachysystole accompanied by fetal heart rate decelerations

Outcome measures

Outcome measures
Measure
Foley Bulb Plus Oral Misoprostol
n=1117 Participants
Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Foley bulb plus Oral Misoprostol: Although labeled "experimental" for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States.
Oral Misoprostol
n=1110 Participants
Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Oral Misoprostol: Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.
Number of Participants With Uterine Hyperstimulation Syndrome
184 Participants
147 Participants

SECONDARY outcome

Timeframe: at delivery

Maternal excess blood loss is defined as \>500ml for vaginal and \>1000ml for cesarean delivery

Outcome measures

Outcome measures
Measure
Foley Bulb Plus Oral Misoprostol
n=1117 Participants
Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Foley bulb plus Oral Misoprostol: Although labeled "experimental" for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States.
Oral Misoprostol
n=1110 Participants
Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Oral Misoprostol: Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.
Number of Participants With Excess Blood Loss
215 Participants
223 Participants

SECONDARY outcome

Timeframe: at delivery

administration of blood products related to delivery blood loss

Outcome measures

Outcome measures
Measure
Foley Bulb Plus Oral Misoprostol
n=1117 Participants
Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Foley bulb plus Oral Misoprostol: Although labeled "experimental" for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States.
Oral Misoprostol
n=1110 Participants
Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Oral Misoprostol: Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.
Number of Participants With Blood Transfusion
37 Participants
33 Participants

SECONDARY outcome

Timeframe: at delivery

spontaneous separation of myometrium in a previously intact, unscarred uterus

Outcome measures

Outcome measures
Measure
Foley Bulb Plus Oral Misoprostol
n=1117 Participants
Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Foley bulb plus Oral Misoprostol: Although labeled "experimental" for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States.
Oral Misoprostol
n=1110 Participants
Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Oral Misoprostol: Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.
Number of Participants With Uterine Rupture
0 Participants
1 Participants

SECONDARY outcome

Timeframe: at discharge from the hospital following delivery

unplanned removal of the uterus following delivery of the fetus

Outcome measures

Outcome measures
Measure
Foley Bulb Plus Oral Misoprostol
n=1117 Participants
Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Foley bulb plus Oral Misoprostol: Although labeled "experimental" for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States.
Oral Misoprostol
n=1110 Participants
Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Oral Misoprostol: Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.
Number of Participants With Unplanned Hysterectomy
1 Participants
0 Participants

SECONDARY outcome

Timeframe: Following delivery and prior to discharge

Fever recorded in the time after delivery but prior to discharge from the hospital, with clinical assessment of endometritis

Outcome measures

Outcome measures
Measure
Foley Bulb Plus Oral Misoprostol
n=1117 Participants
Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Foley bulb plus Oral Misoprostol: Although labeled "experimental" for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States.
Oral Misoprostol
n=1110 Participants
Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Oral Misoprostol: Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.
Number of Participants With Postpartum Fever
11 Participants
3 Participants

SECONDARY outcome

Timeframe: at delivery

Population: This number represents available umbilical cord blood gas

Arterial or venous cord blood pH defined as \<7.0

Outcome measures

Outcome measures
Measure
Foley Bulb Plus Oral Misoprostol
n=1085 Participants
Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Foley bulb plus Oral Misoprostol: Although labeled "experimental" for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States.
Oral Misoprostol
n=1088 Participants
Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Oral Misoprostol: Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.
Number of Participants With Umbilical Cord Blood pH <7.0
3 Participants
4 Participants

SECONDARY outcome

Timeframe: 5 minutes after time of birth

Appearance, Pulse, Grimace, Activity, Respirations - scored from 0 to 2 for each component, added to make a total score and used as an assessment of initial response to newborn resuscitation, lower scores associated with poor outcomes. Here defined as Apgar less than 4 at 5 minutes.

Outcome measures

Outcome measures
Measure
Foley Bulb Plus Oral Misoprostol
n=1117 Participants
Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Foley bulb plus Oral Misoprostol: Although labeled "experimental" for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States.
Oral Misoprostol
n=1110 Participants
Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Oral Misoprostol: Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.
Number of Participants With an 5-minute Apgar Score Less Than 4
4 Participants
4 Participants

SECONDARY outcome

Timeframe: at delivery

Intubation with mechanical support or control of neonatal breathing in delivery room

Outcome measures

Outcome measures
Measure
Foley Bulb Plus Oral Misoprostol
n=1117 Participants
Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Foley bulb plus Oral Misoprostol: Although labeled "experimental" for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States.
Oral Misoprostol
n=1110 Participants
Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Oral Misoprostol: Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.
Number of Participants That Needed Mechanical Ventilation in Delivery Room (Yes/No)
2 Participants
4 Participants

SECONDARY outcome

Timeframe: From time of birth until the time of discharge or up to 7 days of life, whichever comes first.

Administration of neonatal antibiotics and/or neonatal blood cultures

Outcome measures

Outcome measures
Measure
Foley Bulb Plus Oral Misoprostol
n=1117 Participants
Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Foley bulb plus Oral Misoprostol: Although labeled "experimental" for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States.
Oral Misoprostol
n=1110 Participants
Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Oral Misoprostol: Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.
Number of Participants Administered Neonatal Antibiotics and/or Neonatal Blood Cultures
277 Participants
237 Participants

SECONDARY outcome

Timeframe: From time of birth until the time of discharge or up to 7 days of life, whichever comes first.

Neonatal bacteremia as defined by bacterial growth in blood cultures

Outcome measures

Outcome measures
Measure
Foley Bulb Plus Oral Misoprostol
n=1117 Participants
Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Foley bulb plus Oral Misoprostol: Although labeled "experimental" for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States.
Oral Misoprostol
n=1110 Participants
Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Oral Misoprostol: Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.
Number of Participants With Neonatal Sepsis
2 Participants
1 Participants

SECONDARY outcome

Timeframe: From time of birth until the time of discharge or up to 7 days of life, whichever comes first.

Admission order to neonatal intensive care unit (NICU) placed between the time of delivery and infant discharge

Outcome measures

Outcome measures
Measure
Foley Bulb Plus Oral Misoprostol
n=1117 Participants
Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Foley bulb plus Oral Misoprostol: Although labeled "experimental" for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States.
Oral Misoprostol
n=1110 Participants
Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses. Oral Misoprostol: Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.
Number of Participants With NICU Admission Order
16 Participants
17 Participants

Adverse Events

Foley Bulb Plus Oral Misoprostol

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Oral Misoprostol

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

Emily Adhikari, MD

University of Texas Southwestern Medical Center

Phone: 214-648-7825

Results disclosure agreements

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