NCT00598260

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Jun 2006

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 21, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

May 10, 2011

Status Verified

May 1, 2011

Enrollment Period

3.3 years

First QC Date

January 10, 2008

Last Update Submit

May 9, 2011

Conditions

Pregnancy

Keywords

active managementinduction of laborcesarean deliveryCesarean

Outcome Measures

Primary Outcomes (1)

  • cesarean delivery rate

    prospective: 06.2006 to 06.2008

Secondary Outcomes (3)

  • admissions to NICU during same hospitalization

    prospective. 06.2006 - 06.2008

  • APGAR scores at one and five minutes

    prospective. 06.2006 - 06.2008

  • meconium

    prospective. 06.2006 - 06.2008

Study Arms (2)

1- study group

EXPERIMENTAL

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

Procedure: induction of labor

2 - control group

NO INTERVENTION

control group

Interventions

induction of laborPROCEDURE

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

1- study group

Eligibility Criteria

Age16 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

MeSH Terms

Interventions

Labor, Induced

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Arnold Cohen, MD

    Albert Einstein Medical Center

    STUDY CHAIR

  • Shai M Pri-Paz, MD

    Albert Einstein Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2008

First Posted

January 21, 2008

Study Start

June 1, 2006

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

May 10, 2011

Record last verified: 2011-05

Locations

US(1)