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

May 9, 2011 updated by: Albert Einstein Healthcare Network

Active Management Of Risk In Pregnancy At Term - a Prospective Study

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

222

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1- study group
study group - induction of labor at optimal time of delivery between 38 weeks and 41 weeks.
Procedure: induction of labor
study group - induction of labor at optimal time of delivery between 38 weeks and 41 weeks.
No Intervention: 2 - control group
control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cesarean delivery rate
Time Frame: prospective: 06.2006 to 06.2008
prospective: 06.2006 to 06.2008

Secondary Outcome Measures

Outcome Measure
Time Frame
admissions to NICU during same hospitalization
Time Frame: prospective. 06.2006 - 06.2008
prospective. 06.2006 - 06.2008
APGAR scores at one and five minutes
Time Frame: prospective. 06.2006 - 06.2008
prospective. 06.2006 - 06.2008
meconium
Time Frame: prospective. 06.2006 - 06.2008
prospective. 06.2006 - 06.2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Einstein Healthcare Network

Investigators

  • Study Chair: Arnold Cohen, MD, Albert Einstein Medical Center
  • Principal Investigator: Shai M Pri-Paz, MD, Albert Einstein Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

January 10, 2008

First Submitted That Met QC Criteria

January 18, 2008

First Posted (Estimate)

January 21, 2008

Study Record Updates

Last Update Posted (Estimate)

May 10, 2011

Last Update Submitted That Met QC Criteria

May 9, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • (H)N-2957

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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