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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

Sonographic Assessment for Prediction of Labor Induction Success

Clinicaltrials.gov identifier NCT03944187

Recruitment Status Recruiting

First Posted May 9, 2019

Last update posted September 15, 2020

Study Description

Brief summary:

The study is conducted to assess several sonographic parameters for prediction of labor induction success. These parameters include cervical length, fetal head circumference, and fetal head to cervix angle.

  • Condition or Disease:Induction of Labor Affected Fetus / Newborn
  • Intervention/Treatment: Diagnostic Test: Transvaginal sonography
  • Phase: N/A
Detailed Description

Pregnant women at term over 37 weeks' gestation visiting the obstetric emergency room for various obstetric indications will be assessed. Women with obstetric or medical indication for induction will receive an explanation regarding the study protocol and will sign an informed consent. After recruitment and during the evaluation in the obstetric emergency room, patients will undergo transvaginal sonography during which, cervical length, fetal head circumference and fetal head to cervix angle will be measured. Relevant demographic and obstetric information will be collected from a computerized database.

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 200 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Sonographic Assessment of Fetal Head Circumference, Cervical Length and Fetal Head to Cervix Angle for Prediction of Labor Induction Success
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: April 2021
Outcome Measures
  • Primary Outcome Measures: 1. Success in induction of labor [ Time Frame: From admission to the obstetric emergency room up to 24 hours postpartum ]
    Vaginal delivery rate after labor induction
Eligibility Criteria
  • Ages Eligible for Study: 18 to 45 Years (Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers:
  • Sampling Method: Non-Probability Sample
  • Study Population: Pregnant women with singleton pregnancy over 37 weeks' gestation
Criteria

Inclusion Criteria:

- Singleton pregnancy.

- Term pregnancy.

Exclusion Criteria:

- Multiple gestation.

- Fetal anomalies and malformations.

- Preterm pregnancy.

Contacts and Locations
Contacts

Contact: Roy Lauterbach, MD 0529432416 r_lauterbach@rambam.health.gov.il

Locations

Israel
Rambam health care campus
Haifa

Sponsors and Collaborators

Rambam Health Care Campus

Investigators

Principal Investigator: Roy Lauterbach, MD Rambam healthcare campus

More Information
  • Responsible Party: Rambam Health Care Campus
  • ClinicalTrials.gov Identifier: NCT03944187 History of Changes
  • Other Study ID Numbers: 0529-18-RMB
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: September 15, 2020
  • Last Verified: September 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No