NCT02694315

Brief Summary

Comparison between Sonographic Cervical Length and Bishop Score in Preinduction Cervical Assessment prior to induction of labor as regards induction success.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

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

October 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 29, 2016

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
8 months until next milestone

Results Posted

Study results publicly available

November 7, 2016

Completed
Last Updated

November 7, 2016

Status Verified

September 1, 2016

Enrollment Period

1.4 years

First QC Date

February 23, 2016

Results QC Date

March 11, 2016

Last Update Submit

September 19, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • Cervical Length Prior to Labor Induction

    median cervical length measured by transvaginal ultrasound in centimetres

    24 hours

  • Bishop Score Prior to Induction of Labor

    median Bishop score assessed by digital vaginal examination as follows: 1. 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 dilataion. 2. 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. 3. 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. 4. 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. 5. 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 hours

Study Arms (1)

Induction of labor

200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.

Other: Bishop scoreOther: cervical length

Interventions

calculation of modified Bishop score in numbers by digital vaginal examination

Induction of labor

measuring cervical length by trans-vaginal ultrasound

Induction of labor

Eligibility Criteria

Age17 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital

You may qualify if:

  • Nulliparous patients.
  • Singleton pregnancy.
  • Living fetus with cephalic presentation.
  • Absence of labor pain.
  • Gestational age 37-42 weeks.
  • No previous uterine surgical procedures.
  • No Liquor abnormalities.
  • Fetal weight less than 4 kilograms.

You may not qualify if:

  • Non-vertex presentation.
  • Previous uterine surgery.
  • Multiple pregnancy.
  • Fetal or maternal complications that might cause cesarean section.
  • Liquor abnormalities.
  • Fetal weight more than 4 kilograms.
  • Abnormal umbilical artery Doppler indices or non-stress test.
  • Asthmatic patients or women with allergy to prostaglandins.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams maternity hospital

Cairo, Egypt

Location

Results Point of Contact

Title
amr ahmed mahmoud riad
Organization
Ain Shams Maternity hospital

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

February 23, 2016

First Posted

February 29, 2016

Study Start

October 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

November 7, 2016

Results First Posted

November 7, 2016

Record last verified: 2016-09

Locations