NCT03430804

Brief Summary

Transvaginal sonographic measurement of cervical length versus Bishop score in labour induction at term for prediction of Caesarean delivery. This study is prospective study. This study will be carried out in Ain-shams maternity hospital. Sample size of 320 parturients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 14, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2018

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 31, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
Last Updated

February 14, 2018

Status Verified

February 1, 2018

Enrollment Period

4 months

First QC Date

January 31, 2018

Last Update Submit

February 12, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Cervical length

    median cervical length measured by transvaginal ultrasound in centimetres.

    24 hours

  • Bishop score

    median Bishop score assessed by digital vaginal examination as follows: Cervical dilatation in centimeters will be given a score of zero if closed, a score of 1 if 1-2 cm dilated, a score of 2 if 3-4 cm dilated and a score of 3 if 5 cm or more dilatation. Effacement of the cervix will be given a score of zero if 0-30%, a score of 1 if 40-50%, a score of 2 if 60-70% and a score of 3 if 80% or more. Station of fetal head will be given a score of zero if -3, a score of 1 if -2, a score of 2 if -1 to zero and a score of 3 if 1 or more. Consistency of the cervix will be given a score of zero if firm, a score of 1 if medium and a score of 2 if soft. Position of the cervix will be given a score of zero if posterior, a score of 1 if mid position and a score of 2 if anterior. So, a total score (sum of all scores) of zero at a minimum to 10 at a maximum can be estimated. Note that a score more than 10 means patient is in labor not needing induction of labor.

    72

Study Arms (1)

Single gruop320 parturients

Measurement of cervical length and digital examination of Bishop score in 320 women undergoing induction of labour will be carried out in ain shams university maternity hospital.

Other: Bishop score calculation of modified Bishop score in numbers by digital vaginal examination

Interventions

Measurement of cervical length by transvaginal ultrasound and digital examination of Bishop score in 320 parturients undergoing labour induction at term

Also known as: cervical length measuring cervical length by trans-vaginal ultrasound
Single gruop320 parturients

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Single group 320 parturients udergoing induction of labour at term

You may qualify if:

  • \. Age (18-35) years. 2. Singleton pregnancy. 3. (37-42) weeks gestation. 4. Living fetus. 5. Cephalic presentation. 6. Absence of active labour. 7. No contraindication to vaginal delivery. 8. Average amount of clear liquor. 9. No history of uterine scar (myomectomy or previous C.S(.

You may not qualify if:

  • \. Malpresentation. 2. Major fetal congenital anomalies as hydrocephalous \& dead fetus. 3. Patient received any pre induction ripping methods for example: (Acetic Acid-Prostaglandins).
  • \. Any medical history contraindicating vaginal delivery. 5. Assessment meconium staining to liquor or any evidence of chorioamnionitis. 6. Previous uterine surgery. 7. Multiple gestations. 8. Women with allergy to prostaglandins.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed adel mazroa

Tanta, Egypt

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr resident of obstetrics and gynecology

Study Record Dates

First Submitted

January 31, 2018

First Posted

February 13, 2018

Study Start

August 14, 2017

Primary Completion

December 14, 2017

Study Completion

January 12, 2018

Last Updated

February 14, 2018

Record last verified: 2018-02

Locations