Active Management Of Risk In Pregnancy At Term to Reduce Rate of Cesarean Deliveries

NCT ID: NCT00598260

Last Updated: 2011-05-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2009-10-31

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.

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.

Conditions

Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1- study group

study group - induction of labor at optimal time of delivery between 38 weeks and 41 weeks.

Group Type: EXPERIMENTAL

induction of labor

Intervention Type: PROCEDURE

study group - induction of labor at optimal time of delivery between 38 weeks and 41 weeks.

2 - control group

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

induction of labor

study group - induction of labor at optimal time of delivery between 38 weeks and 41 weeks.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• patients with singleton pregnancies
• at least one prenatal visit at one of our clinics
• an ultrasonogram confirming the dates within the first 22 weeks
• no maternal or fetal problems before 37 weeks and 5 days of gestation that mandated cesarean delivery.

Exclusion Criteria

• a delivery before 37 weeks and 5 days of gestation
• a previous cesarean delivery (one or more)
• a history of any other uterine surgeries that are a contraindication for a vaginal delivery.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Albert Einstein Healthcare Network

OTHER

Sponsor Role: lead

Responsible Party

Albert Einstein Medical Center

Principal Investigators

Arnold Cohen, MD

Role: STUDY_CHAIR

Albert Einstein Medical Center

Shai M Pri-Paz, MD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein Medical Center

Locations

Albert Einstein Medical Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

(H)N-2957

Identifier Type: -

Identifier Source: org_study_id