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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00598260
Recruitment Status : Terminated
First Posted : January 21, 2008
Last Update Posted : May 10, 2011
Information provided by:
Albert Einstein Healthcare Network

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.

Condition or disease Intervention/treatment Phase
Pregnancy Procedure: induction of labor Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Active Management Of Risk In Pregnancy At Term - a Prospective Study
Study Start Date : June 2006
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

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

Primary Outcome Measures :
  1. cesarean delivery rate [ Time Frame: prospective: 06.2006 to 06.2008 ]

Secondary Outcome Measures :
  1. admissions to NICU during same hospitalization [ Time Frame: prospective. 06.2006 - 06.2008 ]
  2. APGAR scores at one and five minutes [ Time Frame: prospective. 06.2006 - 06.2008 ]
  3. meconium [ Time Frame: prospective. 06.2006 - 06.2008 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00598260

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United States, Pennsylvania
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Sponsors and Collaborators
Albert Einstein Healthcare Network
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Study Chair: Arnold Cohen, MD Albert Einstein Medical Center
Principal Investigator: Shai M Pri-Paz, MD Albert Einstein Medical Center

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Responsible Party: Shai Pri-Paz, Albert Einstein Medical Center Identifier: NCT00598260    
Other Study ID Numbers: (H)N-2957
First Posted: January 21, 2008    Key Record Dates
Last Update Posted: May 10, 2011
Last Verified: May 2011
Keywords provided by Albert Einstein Healthcare Network:
active management
induction of labor
cesarean delivery