Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-01-07 @ 10:54 AM
Study NCT ID:
NCT00598260
Status:
TERMINATED
Last Update Posted:
2011-05-10
First Post:
2008-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Active Management Of Risk In Pregnancy At Term to Reduce Rate of Cesarean Deliveries
Sponsor:
Albert Einstein Healthcare Network
Organization:
Study Overview
Official Title:
Active Management Of Risk In Pregnancy At Term - a Prospective Study
Status:
TERMINATED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective randomized cohort study of obstetric patients from Paley clinic at AEMC and from other affiliated obstetric clinics.
This study will try to determine if active management of risks in pregnancy at term by inducing patients will not decrease the cesarean delivery rate or change neonatal outcomes.
The outcomes that will be measured include cesarean delivery rate, meconium, Apgar scores and admissions to the NICU.
This study will try to determine if active management of risks in pregnancy at term by inducing patients will not decrease the cesarean delivery rate or change neonatal outcomes.
The outcomes that will be measured include cesarean delivery rate, meconium, Apgar scores and admissions to the NICU.
Detailed Description:
The study will include patients who have their prenatal care at the Paley clinic in AEMC, where the residents provide the prenatal care with supervision of OBGYN attending physicians, or at other affiliated clinics that are staffed by care givers from our OBGYN department.
Patients at our obstetric clinics are scheduled for weekly visits starting at 36 weeks. At 36 to 37 weeks of gestation, or earlier, each patient will be offered to participate in the study. Those who refuse will continue to have the standard care and will not be considered as part of the study. Those who wish to participate in the study will be consented and will then be randomly assigned to the control group or to the AMOR-IPAT group with a ratio of 2:1.
Risk factors will be identified for each patient participating in the study at the gestational age of 36 to 37 weeks (using the digichart system, the medical records and questioners) and the upper limit of the optimal time of delivery will be calculated for each patient, according to the method used by the UPenn group, with the time always being at least 38 weeks and no more then 41 weeks.
Patients from the AMOR-IPAT group will be scheduled for induction of labor on the morning of the day of the calculated upper limit (plus or minus 2 days).
To try and eliminate biases, a uniform method of induction will be applied to all the patients participating in the study, no matter the group or the reason for the induction. The induction will be performed with misoprostol 25mcg intravaginally every four hours (to a maximum of three doses) for a Bishop score of 4 or less and as long as there is no tachysystole which will be defined as six or more uterine contractions in ten minutes in consecutive ten minute intervals. The misoprostol will be followed by a foley bulb inflated with 80 cc of fluid if the cervix is still not favorable after three doses or when tachysystole develops. Once the cervix is favorable induction will be continued with high dose oxytocin (starting dose of six milliunits with increments of four milliunits every thirty minutes), which is associated with less cesarean deliveries for dystocia than the low dose.
Anesthesia will be applied according to the patient's wish, without limiting epidural anesthesia to a certain degree of dilatation.
After delivery information will be collected from the charts and the two groups will be compared regarding the incidence of cesarean deliveries, but also regarding intrapartum variables and major outcomes.
The Student t test and the Wilcoxon rank sum test will be used to compare continuous demographic characteristics, past medical and surgical historic features and obstetric risk factors that will be present in the two study groups. Universal chi squared tests will be used to compare levels of various dichotomous variables.
Statistical significance is defined as a probability value of less than 0.05. Using a power analysis and by assuming a cesarean delivery rate of 20% in the control group and a change of 13% (as shown in the original study) we will need 191 patients in the control group and 96 in the study group.
All data will be collected by staff of the OBGYN department and maintained on departmental secured password limited database. Obstetrical prenatal data is maintained on HIPPA compliant password protected electronic medical records.
Patients at our obstetric clinics are scheduled for weekly visits starting at 36 weeks. At 36 to 37 weeks of gestation, or earlier, each patient will be offered to participate in the study. Those who refuse will continue to have the standard care and will not be considered as part of the study. Those who wish to participate in the study will be consented and will then be randomly assigned to the control group or to the AMOR-IPAT group with a ratio of 2:1.
Risk factors will be identified for each patient participating in the study at the gestational age of 36 to 37 weeks (using the digichart system, the medical records and questioners) and the upper limit of the optimal time of delivery will be calculated for each patient, according to the method used by the UPenn group, with the time always being at least 38 weeks and no more then 41 weeks.
Patients from the AMOR-IPAT group will be scheduled for induction of labor on the morning of the day of the calculated upper limit (plus or minus 2 days).
To try and eliminate biases, a uniform method of induction will be applied to all the patients participating in the study, no matter the group or the reason for the induction. The induction will be performed with misoprostol 25mcg intravaginally every four hours (to a maximum of three doses) for a Bishop score of 4 or less and as long as there is no tachysystole which will be defined as six or more uterine contractions in ten minutes in consecutive ten minute intervals. The misoprostol will be followed by a foley bulb inflated with 80 cc of fluid if the cervix is still not favorable after three doses or when tachysystole develops. Once the cervix is favorable induction will be continued with high dose oxytocin (starting dose of six milliunits with increments of four milliunits every thirty minutes), which is associated with less cesarean deliveries for dystocia than the low dose.
Anesthesia will be applied according to the patient's wish, without limiting epidural anesthesia to a certain degree of dilatation.
After delivery information will be collected from the charts and the two groups will be compared regarding the incidence of cesarean deliveries, but also regarding intrapartum variables and major outcomes.
The Student t test and the Wilcoxon rank sum test will be used to compare continuous demographic characteristics, past medical and surgical historic features and obstetric risk factors that will be present in the two study groups. Universal chi squared tests will be used to compare levels of various dichotomous variables.
Statistical significance is defined as a probability value of less than 0.05. Using a power analysis and by assuming a cesarean delivery rate of 20% in the control group and a change of 13% (as shown in the original study) we will need 191 patients in the control group and 96 in the study group.
All data will be collected by staff of the OBGYN department and maintained on departmental secured password limited database. Obstetrical prenatal data is maintained on HIPPA compliant password protected electronic medical records.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: