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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT03113227

Collaborator

(none)

Enrollment

Location

Arms

2.8

Actual Duration (Months)

25.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Induced; Birth	Diagnostic Test: Transvaginal ultrasound Diagnostic Test: Vaginal examination	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Apr 15, 2017

Actual Primary Completion Date :

Jul 9, 2017

Actual Study Completion Date :

Jul 9, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Value of posterior cervical angle [At around 10 minutes from admission to hospital]
Value of posterior cervical angle will be measured by an investigator

Secondary Outcome Measures

Length of the cervix [At around 10 minutes from admission to hospital]
Length of the cervix will be measured by an investigator
Bishop score [At around 30 minutes from admission to hospital]
Bishop score will be measured by an investigator

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 37 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital	Cairo	Greater Cairo	Egypt	11956

Sponsors and Collaborators

Cairo University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eman Omran, Principal investigator, Cairo University

ClinicalTrials.gov Identifier:

NCT03113227

Other Study ID Numbers:

5355

First Posted:

Apr 13, 2017

Last Update Posted:

Jul 17, 2017

Last Verified:

Jul 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Eman Omran, Principal investigator, Cairo University

induction of labor

Bishop score

posterior cervical angle

cervical length

Study Results

No Results Posted as of Jul 17, 2017