Value of Measuring Cervical Angle and Length by Ultrasound in Prediction of Successful Induction of Delivery

July 13, 2017 updated by: Eman Omran, Cairo University

Diagnostic Accuracy of Posterior Cervical Angle and Cervical Length in Prediction of Successful Induction of Labor

Seventy ladies indicated for induction of delivery will be recruited. Two ways of assessment of their cervices will be done before actual induction of labor. First, ultrasound will be done to assess the angle and the length of the cervix. Then vaginal examination will be done to assess the characteristics of cervix. Analysis will be done to identify the best predictor of successful induction of labour.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Seventy patients indicated for induction of labor will be recruited. Two ways of assessment of their cervices will be done before actual induction of labor. First, transvaginal ultrasound will be done to assess the posterior angle and the length of the cervix. Then vaginal examination will be done to measure the Bishop score. Analysis will be done to identify the best predictor of successful induction of labour.

Study Type

Interventional

Enrollment (Actual)

70

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

  • Egypt
    • Greater Cairo
      • Cairo, Greater Cairo, Egypt, 11956
        • Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital

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

18 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Singleton pregnancy
  • Gestational age between 35 and 42
  • Presence of an indication for induction of labour as post-term pregnancy or rupture of membranes
  • The fetus is living
  • Cephalic presentation

Exclusion Criteria:

  • Estimated fetal weight more than 4 kilograms
  • Malpresentation
  • Oligohydramnios
  • Polyhydramnios
  • Non-reassuring non-stress test before induction of labor
  • Cephalo-pelvic disproportion
  • Previous operation on the cervix as cautery or cerclage
  • Previous cesarean section
  • Any contraindication to vaginal delivery including placenta previa
  • Anomalous fetus
  • Morbid obesity

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: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Successful Induction of labor group
Both transvaginal ultrasound and vaginal examination will be done for that group
Diagnostic test: Transvaginal ultrasound
Transvaginal ultrasound will be made for assessment of posterior cervical angle and cervical length
Diagnostic test: Vaginal examination
Vaginal examination will be done for assessment of Bishop score
Active Comparator: Failed induction of labor group
Both transvaginal ultrasound and vaginal examination will be done for that group
Diagnostic test: Transvaginal ultrasound
Transvaginal ultrasound will be made for assessment of posterior cervical angle and cervical length
Diagnostic test: Vaginal examination
Vaginal examination will be done for assessment of Bishop score

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Value of posterior cervical angle
Time Frame: At around 10 minutes from admission to hospital
Value of posterior cervical angle will be measured by an investigator
At around 10 minutes from admission to hospital

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of the cervix
Time Frame: At around 10 minutes from admission to hospital
Length of the cervix will be measured by an investigator
At around 10 minutes from admission to hospital
Bishop score
Time Frame: At around 30 minutes from admission to hospital
Bishop score will be measured by an investigator
At around 30 minutes from admission to hospital

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Eman Omran, M.D., Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

April 15, 2017

Primary Completion (Actual)

July 9, 2017

Study Completion (Actual)

July 9, 2017

Study Registration Dates

First Submitted

April 10, 2017

First Submitted That Met QC Criteria

April 10, 2017

First Posted (Actual)

April 13, 2017

Study Record Updates

Last Update Posted (Actual)

July 17, 2017

Last Update Submitted That Met QC Criteria

July 13, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5355

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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