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
COMPLETED
NA
2227 participants
at delivery
2020-11-04
Participant Flow
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
| 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 deliveryvaginal delivery at first induction
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 deliveryPopulation: This number represents women delivered at first induction
Time (in hours) from start of induction agent to delivery at first induction
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 deliveryAmong women delivered by cesarean, the indication for cesarean
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 deliveryPopulation: 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
| 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 deliveryIntrapartum fever (temp equal or greater than 38C) with no other identified cause
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 deliveryPopulation: 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 deliveryRegional or neuraxial analgesia (labor epidural or spinal) used between the start of induction and delivery
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 deliveryGeneral anesthesia administered for delivery
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 deliveryIdentification 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
| 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 deliveryPopulation: 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 delivery6 or more contractions in 10 minutes or tetanic contraction of 120 seconds or longer
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 deliveryTachysystole accompanied by fetal heart rate decelerations
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 deliveryMaternal excess blood loss is defined as \>500ml for vaginal and \>1000ml for cesarean delivery
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 deliveryadministration of blood products related to delivery blood loss
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 deliveryspontaneous separation of myometrium in a previously intact, unscarred uterus
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 deliveryunplanned removal of the uterus following delivery of the fetus
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 dischargeFever recorded in the time after delivery but prior to discharge from the hospital, with clinical assessment of endometritis
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 deliveryPopulation: This number represents available umbilical cord blood gas
Arterial or venous cord blood pH defined as \<7.0
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 birthAppearance, 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
| 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 deliveryIntubation with mechanical support or control of neonatal breathing in delivery room
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
| 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
| 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
| 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
Oral Misoprostol
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place