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CompletedNCT03430804Updated Feb 14, 2018

Transvaginal Sonographic Measurement of Cervical Length Versus Bishop Score in Induction of Labour for Prediction of Caesarean Delivery.

An observational study in Failed Induction and Cervical Dystocia, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-14.

Sponsored by Ain Shams University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
320
Ages
18 Years to 35 Years
Sex
Female
01

Study 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.

Read the detailed description

Patients and Methods

Study design:

This study is prospective study, comparative clinical trial for a test against a gold standard with blinding of the evaluator

Study setting:

This study will be carried out in Ain-Shams university maternity hospital.

Methods:

  • All patients recruited were given an oral consent.
  • All patients were subjected to the following:

History of the patient:

  • Detailed and careful history was taken from the patient as the following:

    1. Personal history: name, age, occupation, residence and special habit of medical importance.
    2. Obstetric history: including last menstrual period, Gestation age and regular Antenatal care.
    3. Past history: including any medical disorder e.g. Diabetes mellitus, hypertension or any surgical procedure
    4. History of present pregnancy: duration of pregnancy from last menstrual period, any complications occurred or any medication used during pregnancy.

      Examination of the patient:

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    1. General examination: as regard level of consciousness, vital data, and complexion.
    2. Abdominal examination: as regard fundal level, lie of the fetus, detection of any uterine contractions and fetal heart rate.
    3. Pelvic Examination: as regard pelvic capacity, presenting part, presence of rupture of membranes and cervical assessment as regard cervical dilation, station and presenting part.
  • Investigations. Complete blood count , Rh, transvaginal ultra sound and non-stress test.
  • All patients had vaginal examination for assessing the (Bishop Score,1964) before induction of labour.
  • All women had transvaginal ultrasound for assessment of cervical length using (median digital GAIA) Ultrasonic machine.

Protocol of transvaginal ultrasound will be done as follow:

  1. Patient will be asked to void.
  2. Vaginal probe will be inserted using direct visualization with K-Y gel.
  3. Identification of bladder, amniotic fluid and fetal presenting part.
  4. Identification of abnormal findings as placenta pervia or absence of fetal heart motion.
  5. Identification of midline sagittal plane of the cervix and looking in the proximal one third of the image for the internal os then pulling back the probe until the lightest touch provides good image of the cervical canal and moving the probe slightly to get the best long axis of the cervix then measuring the cervical length by placing the calipers appropriately and recording the distance between internal and external cervical os.

    • Transvaginal ultrasound will be done to assess cervical length using medison sonoace 8800 (median digital GAIA) ultrasound machine equipped with a 7.5 m hertz by vaginal probe in Ain-Shams University Maternity Hospital.
    • Induction of labour will be done using intravaginal misoprostol (25 microgram) then digital examination will be made 6 h after the first intravaginal administration; if necessary, 3 doses were given at 6 hours interval. External Cardiotocography will be regularly performed to monitor the condition of the fetus.
    • Continuous Cardiotocography will be used in all cases. If necessary, amniotomy will be performed. Intravenous oxytocin administration will be started when there is an arrest of dilatation, starting at 1milli-international unit/minute and increasing 1 mIU every 30 min as necessary. For analgesia, intramuscular pethidine will be offered.
    • Caesarean delivery will be done due to pathological fetal heart rate trace, arrest the fetal head for at least one hour despite adequate uterine contractions.
02

Conditions studied

  • Failed Induction
  • Cervical Dystocia

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03

In context

Dystocia

55 studies on the registry are indexed under Dystocia; 12 are open to participants now.

This study's enrollment of 320 is above the median of 212 across 12 observational studies indexed under Dystocia.

Browse Dystocia studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Single group 320 parturients udergoing induction of labour at term

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    1. 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 to vaginal delivery. 8. Average amount of clear liquor. 9. No history of uterine scar (myomectomy or previous C.S(.

Exclusion criteria

Exclusion Criteria:

    1. Malpresentation. 2. Major fetal congenital anomalies as hydrocephalous \& dead fetus. 3. Patient received any pre induction ripping methods for example: (Acetic Acid-Prostaglandins).

      1. 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
320 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherBishop score calculation of modified Bishop score in numbers by digital vaginal examination

    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

06

What researchers measure

Primary outcomes

  1. Cervical length

    median cervical length measured by transvaginal ultrasound in centimetres.

    Time frame: 24 hours

  2. 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.

    Time frame: 72

07

Study locations

1 site
  • Mohamed adel mazroa
    Tanta, Egypt
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2017 to primary completion in Dec 2017, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 31, 2018
First posted
Feb 13, 2018
StartActual
Aug 14, 2017
Primary completionActual
Dec 14, 2017
CompletionActual
Jan 12, 2018
Last update
Feb 14, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03430804
Responsible party
Mohamed Adel Mazroa (Dr resident of obstetrics and gynecology, Ain Shams University) — Principal investigator
First posted
Feb 13, 2018
Start date
Aug 14, 2017
Primary completion
Dec 14, 2017
Completion
Jan 12, 2018
Last update
Feb 14, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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