Trial Outcomes & Findings for Pitocin or Oral Misoprostol for PROM IOL (NCT NCT04028765)
NCT ID: NCT04028765
Last Updated: 2024-04-30
Results Overview
Time (hours) from start of IOL (As defined by receipt of first medication for induction of labor) to delivery of infant.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
108 participants
Primary outcome timeframe
Time (hours) from start of IOL (As defined by receipt of first medication for induction of labor) to delivery of infant.
Results posted on
2024-04-30
Participant Flow
Began: August 2019 End: May 2023 (Last participant follow-up completed 1/8/2023. Additional subjects were screened/approached for participation through 5/2023.) Location: Labor and Delivery
Participant milestones
| Measure |
Oral Misoprostol
Misoprostol: Oral misoprostol 50 mcg every 4 hours for up to 6 doses or until cervical ripening is no longer indicated
|
Oxytocin
Oxytocin: IV Oxytocin 2 milliunits (mU)/min, increased by 2mU/min q15 minutes per hospital protocol. Max 40 mU/min
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
56
|
|
Overall Study
COMPLETED
|
52
|
56
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pitocin or Oral Misoprostol for PROM IOL
Baseline characteristics by cohort
| Measure |
Oral Misoprostol
n=52 Participants
Misoprostol: Oral misoprostol 50 mcg every 4 hours for up to 6 doses or until cervical ripening is no longer indicated
|
Oxytocin
n=56 Participants
Oxytocin: IV Oxytocin 2 milliunits (mU)/min, increased by 2mU/min q15 minutes per hospital protocol. Max 40 mU/min
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.0 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
28.5 years
STANDARD_DEVIATION 5.9 • n=7 Participants
|
29.2 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
108 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
Race · Black
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic, not otherwise specified
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Public Insurance
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
BMI
|
31.9 kg/m^2
n=5 Participants
|
31.9 kg/m^2
n=7 Participants
|
31.9 kg/m^2
n=5 Participants
|
|
Prenatal Visit Number
|
9 Visits
n=5 Participants
|
9 Visits
n=7 Participants
|
9 Visits
n=5 Participants
|
|
Gestational age at Rupture of Membranes
|
39.7 Weeks
n=5 Participants
|
39.3 Weeks
n=7 Participants
|
39.4 Weeks
n=5 Participants
|
|
Starting Cervical Dilation
|
1.1 Centimeters
STANDARD_DEVIATION 0.6 • n=5 Participants
|
1.1 Centimeters
STANDARD_DEVIATION 0.5 • n=7 Participants
|
1.1 Centimeters
STANDARD_DEVIATION 0.5 • n=5 Participants
|
|
Starting Bishop Score
|
3.6 Units on a scale.
STANDARD_DEVIATION 1.5 • n=5 Participants
|
3.9 Units on a scale.
STANDARD_DEVIATION 1.7 • n=7 Participants
|
3.8 Units on a scale.
STANDARD_DEVIATION 1.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Time (hours) from start of IOL (As defined by receipt of first medication for induction of labor) to delivery of infant.Time (hours) from start of IOL (As defined by receipt of first medication for induction of labor) to delivery of infant.
Outcome measures
| Measure |
Oral Misoprostol
n=52 Participants
Misoprostol: Oral misoprostol 50 mcg every 4 hours for up to 6 doses or until cervical ripening is no longer indicated
|
Oxytocin
n=56 Participants
Oxytocin: IV Oxytocin 2 milliunits (mU)/min, increased by 2mU/min q15 minutes per hospital protocol. Max 40 mU/min
|
|---|---|---|
|
Time From Induction of Labor (IOL) to Delivery
|
18.1 Hours
Interval 12.2 to 24.0
|
14.9 Hours
Interval 10.9 to 18.9
|
SECONDARY outcome
Timeframe: Enrollment to DeliverySuspected intraamniotic infection
Outcome measures
| Measure |
Oral Misoprostol
n=52 Participants
Misoprostol: Oral misoprostol 50 mcg every 4 hours for up to 6 doses or until cervical ripening is no longer indicated
|
Oxytocin
n=56 Participants
Oxytocin: IV Oxytocin 2 milliunits (mU)/min, increased by 2mU/min q15 minutes per hospital protocol. Max 40 mU/min
|
|---|---|---|
|
Infection
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Time (hours) from PROM (as reported by patient) to delivery of infantOutcome measures
| Measure |
Oral Misoprostol
n=52 Participants
Misoprostol: Oral misoprostol 50 mcg every 4 hours for up to 6 doses or until cervical ripening is no longer indicated
|
Oxytocin
n=56 Participants
Oxytocin: IV Oxytocin 2 milliunits (mU)/min, increased by 2mU/min q15 minutes per hospital protocol. Max 40 mU/min
|
|---|---|---|
|
Time From Premature Rupture of Membranes (PROM) to Delivery
|
25.8 Hours
Interval 18.5 to 33.2
|
22.1 Hours
Interval 17.3 to 26.9
|
SECONDARY outcome
Timeframe: Time from IOL (as defined by receipt of first medication for induction) to vaginal deliveryOutcome measures
| Measure |
Oral Misoprostol
n=52 Participants
Misoprostol: Oral misoprostol 50 mcg every 4 hours for up to 6 doses or until cervical ripening is no longer indicated
|
Oxytocin
n=56 Participants
Oxytocin: IV Oxytocin 2 milliunits (mU)/min, increased by 2mU/min q15 minutes per hospital protocol. Max 40 mU/min
|
|---|---|---|
|
Time From IOL to Vaginal Delivery
|
17.9 Hours
Interval 11.7 to 24.1
|
12.9 Hours
Interval 9.2 to 16.4
|
SECONDARY outcome
Timeframe: Time (hours) from PROM (as reported by patient) to vaginal deliveryOutcome measures
| Measure |
Oral Misoprostol
n=52 Participants
Misoprostol: Oral misoprostol 50 mcg every 4 hours for up to 6 doses or until cervical ripening is no longer indicated
|
Oxytocin
n=56 Participants
Oxytocin: IV Oxytocin 2 milliunits (mU)/min, increased by 2mU/min q15 minutes per hospital protocol. Max 40 mU/min
|
|---|---|---|
|
Time From PROM to Vaginal Delivery
|
24.9 Hours
Interval 16.9 to 32.9
|
21.6 Hours
Interval 17.4 to 25.8
|
SECONDARY outcome
Timeframe: Enrollment to DeliveryCesarean section rate
Outcome measures
| Measure |
Oral Misoprostol
n=52 Participants
Misoprostol: Oral misoprostol 50 mcg every 4 hours for up to 6 doses or until cervical ripening is no longer indicated
|
Oxytocin
n=56 Participants
Oxytocin: IV Oxytocin 2 milliunits (mU)/min, increased by 2mU/min q15 minutes per hospital protocol. Max 40 mU/min
|
|---|---|---|
|
Cesarean Delivery
|
13 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Enrollment to 4 weeks postpartumComposite maternal morbidity: postpartum hemorrhage, blood transfusion, endometritis, wound infection, venous thromboembolism (VTE), hysterectomy, Intensive care unit (ICU) admission, readmission within 4 weeks, death
Outcome measures
| Measure |
Oral Misoprostol
n=52 Participants
Misoprostol: Oral misoprostol 50 mcg every 4 hours for up to 6 doses or until cervical ripening is no longer indicated
|
Oxytocin
n=56 Participants
Oxytocin: IV Oxytocin 2 milliunits (mU)/min, increased by 2mU/min q15 minutes per hospital protocol. Max 40 mU/min
|
|---|---|---|
|
Maternal Morbidity
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Enrollment to hospital discharge (On average 2-4 days)Composite neonatal morbidity: NICU admission \> 48 hours, neonatal blood transfusion, hypoxic ischemic encephalopathy, intraventricular hemorrhage grade III or IV, headcooling, severe respiratory distress syndrome, necrotizing enterocolitis, sepsis, death
Outcome measures
| Measure |
Oral Misoprostol
n=52 Participants
Misoprostol: Oral misoprostol 50 mcg every 4 hours for up to 6 doses or until cervical ripening is no longer indicated
|
Oxytocin
n=56 Participants
Oxytocin: IV Oxytocin 2 milliunits (mU)/min, increased by 2mU/min q15 minutes per hospital protocol. Max 40 mU/min
|
|---|---|---|
|
Neonatal Morbidity
|
1 Participants
|
2 Participants
|
Adverse Events
Oral Misoprostol-Mothers
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Oxytocin-Mothers
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Oral Misoprostol-Fetus/Neonate
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Oxytocin-Fetus/Neonate
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oral Misoprostol-Mothers
n=52 participants at risk
Misoprostol: Oral misoprostol 50 mcg every 4 hours for up to 6 doses or until cervical ripening is no longer indicated Adverse Maternal Events Only
|
Oxytocin-Mothers
n=56 participants at risk
Oxytocin: IV Oxytocin 2 milliunits (mU)/min, increased by 2mU/min q15 minutes per hospital protocol. Max 40 mU/min Adverse Maternal Events only
|
Oral Misoprostol-Fetus/Neonate
n=52 participants at risk
Misoprostol: Oral misoprostol 50 mcg every 4 hours for up to 6 doses or until cervical ripening is no longer indicated Adverse Neonatal Events Only
|
Oxytocin-Fetus/Neonate
n=56 participants at risk
Oxytocin: IV Oxytocin 2 milliunits (mU)/min, increased by 2mU/min q15 minutes per hospital protocol. Max 40 mU/min Adverse Neonatal Events only
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Neonatal Hypoxic Ischemic Encephalopathy
|
0.00%
0/52 • From trial enrollment to one month post-delivery (Maternal) or hospital discharge (Neonatal)
Adverse events as described per maternal and neonatal subject. Described adverse event numbers are per event (ie. subject may have experienced more than one event).
|
0.00%
0/56 • From trial enrollment to one month post-delivery (Maternal) or hospital discharge (Neonatal)
Adverse events as described per maternal and neonatal subject. Described adverse event numbers are per event (ie. subject may have experienced more than one event).
|
1.9%
1/52 • Number of events 1 • From trial enrollment to one month post-delivery (Maternal) or hospital discharge (Neonatal)
Adverse events as described per maternal and neonatal subject. Described adverse event numbers are per event (ie. subject may have experienced more than one event).
|
0.00%
0/56 • From trial enrollment to one month post-delivery (Maternal) or hospital discharge (Neonatal)
Adverse events as described per maternal and neonatal subject. Described adverse event numbers are per event (ie. subject may have experienced more than one event).
|
Other adverse events
| Measure |
Oral Misoprostol-Mothers
n=52 participants at risk
Misoprostol: Oral misoprostol 50 mcg every 4 hours for up to 6 doses or until cervical ripening is no longer indicated Adverse Maternal Events Only
|
Oxytocin-Mothers
n=56 participants at risk
Oxytocin: IV Oxytocin 2 milliunits (mU)/min, increased by 2mU/min q15 minutes per hospital protocol. Max 40 mU/min Adverse Maternal Events only
|
Oral Misoprostol-Fetus/Neonate
n=52 participants at risk
Misoprostol: Oral misoprostol 50 mcg every 4 hours for up to 6 doses or until cervical ripening is no longer indicated Adverse Neonatal Events Only
|
Oxytocin-Fetus/Neonate
n=56 participants at risk
Oxytocin: IV Oxytocin 2 milliunits (mU)/min, increased by 2mU/min q15 minutes per hospital protocol. Max 40 mU/min Adverse Neonatal Events only
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
NICU Admission > 48 hours
|
—
0/0 • From trial enrollment to one month post-delivery (Maternal) or hospital discharge (Neonatal)
Adverse events as described per maternal and neonatal subject. Described adverse event numbers are per event (ie. subject may have experienced more than one event).
|
—
0/0 • From trial enrollment to one month post-delivery (Maternal) or hospital discharge (Neonatal)
Adverse events as described per maternal and neonatal subject. Described adverse event numbers are per event (ie. subject may have experienced more than one event).
|
1.9%
1/52 • Number of events 1 • From trial enrollment to one month post-delivery (Maternal) or hospital discharge (Neonatal)
Adverse events as described per maternal and neonatal subject. Described adverse event numbers are per event (ie. subject may have experienced more than one event).
|
3.6%
2/56 • Number of events 2 • From trial enrollment to one month post-delivery (Maternal) or hospital discharge (Neonatal)
Adverse events as described per maternal and neonatal subject. Described adverse event numbers are per event (ie. subject may have experienced more than one event).
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum Readmission
|
0.00%
0/52 • From trial enrollment to one month post-delivery (Maternal) or hospital discharge (Neonatal)
Adverse events as described per maternal and neonatal subject. Described adverse event numbers are per event (ie. subject may have experienced more than one event).
|
3.6%
2/56 • Number of events 2 • From trial enrollment to one month post-delivery (Maternal) or hospital discharge (Neonatal)
Adverse events as described per maternal and neonatal subject. Described adverse event numbers are per event (ie. subject may have experienced more than one event).
|
—
0/0 • From trial enrollment to one month post-delivery (Maternal) or hospital discharge (Neonatal)
Adverse events as described per maternal and neonatal subject. Described adverse event numbers are per event (ie. subject may have experienced more than one event).
|
—
0/0 • From trial enrollment to one month post-delivery (Maternal) or hospital discharge (Neonatal)
Adverse events as described per maternal and neonatal subject. Described adverse event numbers are per event (ie. subject may have experienced more than one event).
|
|
Pregnancy, puerperium and perinatal conditions
Blood transfusion
|
5.8%
3/52 • Number of events 3 • From trial enrollment to one month post-delivery (Maternal) or hospital discharge (Neonatal)
Adverse events as described per maternal and neonatal subject. Described adverse event numbers are per event (ie. subject may have experienced more than one event).
|
1.8%
1/56 • Number of events 1 • From trial enrollment to one month post-delivery (Maternal) or hospital discharge (Neonatal)
Adverse events as described per maternal and neonatal subject. Described adverse event numbers are per event (ie. subject may have experienced more than one event).
|
—
0/0 • From trial enrollment to one month post-delivery (Maternal) or hospital discharge (Neonatal)
Adverse events as described per maternal and neonatal subject. Described adverse event numbers are per event (ie. subject may have experienced more than one event).
|
—
0/0 • From trial enrollment to one month post-delivery (Maternal) or hospital discharge (Neonatal)
Adverse events as described per maternal and neonatal subject. Described adverse event numbers are per event (ie. subject may have experienced more than one event).
|
Additional Information
Dr. Whitney Bender
Thomas Jefferson University Health System
Phone: 4342948416
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place