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

NCT ID: NCT03113227

Last Updated: 2017-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-15

Study Completion Date

2017-07-09

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Induced; Birth

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Successful Induction of labor group

Both transvaginal ultrasound and vaginal examination will be done for that group

Group Type ACTIVE_COMPARATOR

Transvaginal ultrasound

Intervention Type DIAGNOSTIC_TEST

Transvaginal ultrasound will be made for assessment of posterior cervical angle and cervical length

Vaginal examination

Intervention Type DIAGNOSTIC_TEST

Vaginal examination will be done for assessment of Bishop score

Failed induction of labor group

Both transvaginal ultrasound and vaginal examination will be done for that group

Group Type ACTIVE_COMPARATOR

Transvaginal ultrasound

Intervention Type DIAGNOSTIC_TEST

Transvaginal ultrasound will be made for assessment of posterior cervical angle and cervical length

Vaginal examination

Intervention Type DIAGNOSTIC_TEST

Vaginal examination will be done for assessment of Bishop score

Interventions

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Transvaginal ultrasound

Transvaginal ultrasound will be made for assessment of posterior cervical angle and cervical length

Intervention Type DIAGNOSTIC_TEST

Vaginal examination

Vaginal examination will be done for assessment of Bishop score

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Eman Omran

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eman Omran, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital

Cairo, Greater Cairo, Egypt

Site Status

Countries

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Egypt

References

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Al-Adwy AM, Sobh SM, Belal DS, Omran EF, Hassan A, Saad AH, Afifi MM, Nada AM. Diagnostic accuracy of posterior cervical angle and cervical length in the prediction of successful induction of labor. Int J Gynaecol Obstet. 2018 Apr;141(1):102-107. doi: 10.1002/ijgo.12425. Epub 2018 Jan 18.

Reference Type DERIVED
PMID: 29224196 (View on PubMed)

Other Identifiers

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5355

Identifier Type: -

Identifier Source: org_study_id

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