Trial Outcomes & Findings for Cervical Ripening in Premature Rupture of Membranes (NCT NCT02314728)
NCT ID: NCT02314728
Last Updated: 2021-08-10
Results Overview
Mode of delivery via cesarean section or vaginal delivery
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
230 participants
Primary outcome timeframe
within 48 hours
Results posted on
2021-08-10
Participant Flow
Women with PROM, Bishop Score \<6, singleton, \>/=34 weeks of gestation
Calculated Sample size of 208-104 per each arm. Recruited 230 women out of 294 admitted with PROM and assessed for eligibility.
Participant milestones
| Measure |
Vaginal Misoprostol
PROM \>/= 34 weeks
Those randomized to the prostaglandin arm will receive PGE1 (misoprostol) in a dose of 25mcg placed vaginally every 4 hours as per hospital protocol.
Misoprostol: Patients who are randomized to receive misoprostol will have 25mcg placed vaginally.
|
Oxytocin Alone
PROM \>/= 34 weeks
Those randomized to the oxytocin arm will receive infusion of oxytocin, which will then be titrated per hospital protocol or until adequate contractions.
Oxytocin: Patients who are randomized to receive oxytocin alone will receive intravenous administration of oxytocin as designated by the hospital protocol. Protocol begins with 2 milliunits of oxytocin that is then titrated over time. Titration is based on hospital protocol, clinical exam and clinical judgment of the provider and is continued until there are adequate uterine contractions to delivery.
|
|---|---|---|
|
Overall Study
STARTED
|
117
|
113
|
|
Overall Study
COMPLETED
|
116
|
112
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Vaginal Misoprostol
PROM \>/= 34 weeks
Those randomized to the prostaglandin arm will receive PGE1 (misoprostol) in a dose of 25mcg placed vaginally every 4 hours as per hospital protocol.
Misoprostol: Patients who are randomized to receive misoprostol will have 25mcg placed vaginally.
|
Oxytocin Alone
PROM \>/= 34 weeks
Those randomized to the oxytocin arm will receive infusion of oxytocin, which will then be titrated per hospital protocol or until adequate contractions.
Oxytocin: Patients who are randomized to receive oxytocin alone will receive intravenous administration of oxytocin as designated by the hospital protocol. Protocol begins with 2 milliunits of oxytocin that is then titrated over time. Titration is based on hospital protocol, clinical exam and clinical judgment of the provider and is continued until there are adequate uterine contractions to delivery.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Cervical Ripening in Premature Rupture of Membranes
Baseline characteristics by cohort
| Measure |
Vaginal Misoprostol
n=116 Participants
PROM greater than or equal to 34 weeks of gestation with unfavorable cervical examination (Bishop score \</= 6.
Women with PROM randomized to the prostaglandin arm will receive PGE1 (misoprostol) in a dose of 25 mcg transvaginal every 4 hours as per hospital protocol.
Misoprostol: Women with PROM who are randomized to receive misoprostol will have 25 mcg placed vaginally.
|
Oxytocin Alone
n=112 Participants
PROM greater than or equal to 34 weeks of gestation with unfavorable cervical examination (Bishop score \</= 6.
Women randomized to the oxytocin arm will receive infusion of oxytocin that is titrated as per hospital protocol, and until adequate uterine contractions are achieved.
Oxytocin: Women with PROM who are randomized to receive oxytocin alone will receive intravenous administration of oxytocin as designated by the hospital protocol. The hospital protocol begins with 2 milliunits of oxytocin that is then titrated upward by 2 millunits every 20-30 minutes until adequate contractions that cause cervical change is obtained. Titration is based on hospital protocol, clinical examination and clinical judgment of the provider, and is continued until there are adequate uterine contractions that cause the cervix to change until delivery.
|
Total
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
114 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
220 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
25.5 years
n=5 Participants
|
26 years
n=7 Participants
|
26.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
228 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
Caucasian
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
64 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
116 participants
n=5 Participants
|
112 participants
n=7 Participants
|
228 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 48 hoursMode of delivery via cesarean section or vaginal delivery
Outcome measures
| Measure |
Vaginal Misoprostol
n=116 Participants
PROM greater than or equal to 34 weeks of gestation
Those randomized to the prostaglandin arm will receive PGE1 (misoprostol) in a dose of 25mcg placed vaginally every 4 hours as per hospital protocol.
Misoprostol: Patients who are randomized to receive misoprostol will have 25mcg placed vaginally.
|
Oxytocin Alone
n=112 Participants
PROM greater than or equal to 34 weeks of gestation
Those randomized to the oxytocin arm will receive infusion of oxytocin, which will then be titrated per hospital protocol or until adequate contractions.
Oxytocin: Patients who are randomized to receive oxytocin alone will receive intravenous administration of oxytocin as designated by the hospital protocol. Protocol begins with 2 milliunits of oxytocin that is then titrated over time. Titration is based on hospital protocol, clinical exam and clinical judgment of the provider and is continued until there are adequate uterine contractions to delivery.
|
|---|---|---|
|
Rate of Cesarean Section
Vaginal Delivery
|
89 participants
|
86 participants
|
|
Rate of Cesarean Section
Cesarean Delivery
|
27 participants
|
26 participants
|
SECONDARY outcome
Timeframe: within 72 hoursPopulation: Women induced for PROM at greater than, or equal to 34 weeks of gestation with unfavorable cervical examination (Bishop score \</= 6 and their neonates.
Maternal infection defined as fever \>100.4 on at least two occasions during labor, continued antibiotic treatment on or after PPD#1, histologic confirmation of chorioamnionitis. Dose of Oxytocin, Tachysystole, Estimated blood loss at delivery, maternal length of stay, Epidural use, Indication for cesarean delivery Neonatal infection defined as WBC \<5000 and absolute neutrophil count \<1000 or positive blood cultures and neonatal fever, NICU admission, Apgar score less than 7 at 5 minutes,
Outcome measures
| Measure |
Vaginal Misoprostol
n=116 Participants
PROM greater than or equal to 34 weeks of gestation
Those randomized to the prostaglandin arm will receive PGE1 (misoprostol) in a dose of 25mcg placed vaginally every 4 hours as per hospital protocol.
Misoprostol: Patients who are randomized to receive misoprostol will have 25mcg placed vaginally.
|
Oxytocin Alone
n=112 Participants
PROM greater than or equal to 34 weeks of gestation
Those randomized to the oxytocin arm will receive infusion of oxytocin, which will then be titrated per hospital protocol or until adequate contractions.
Oxytocin: Patients who are randomized to receive oxytocin alone will receive intravenous administration of oxytocin as designated by the hospital protocol. Protocol begins with 2 milliunits of oxytocin that is then titrated over time. Titration is based on hospital protocol, clinical exam and clinical judgment of the provider and is continued until there are adequate uterine contractions to delivery.
|
|---|---|---|
|
Maternal and Neonatal Infectious Morbidity
NICU Admission
|
13 Participants
|
15 Participants
|
|
Maternal and Neonatal Infectious Morbidity
Histologic Chorioamnionitis
|
9 Participants
|
13 Participants
|
Adverse Events
Misoprostol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oxytocin Alone
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
Kafui A. Demasio, MD, MPH, Maternal Fetal Medicine, Dept of Obstetrics/Gynecology and Women's Health
Montefiore Medical Center
Phone: 718-920-2767
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place