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CompletedNCT02694315Updated Nov 7, 2016Results posted

Cervical Length and Bishop Score in Preinduction Cervical Assessment Prior to Induction of Labor

An observational study in Cervical Dystocia, sponsored by Ain Shams Maternity Hospital. Completed at 1 site in Egypt. Open to female participants aged 17 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-07.

Sponsored by Ain Shams Maternity Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
17 Years to 40 Years
Sex
Female
01

Study summary

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

Read the detailed description

Type of the study:

assessment of accuracy of diagnostic test.

Study setting:

The study will be performed at Ain Shams university Maternity hospital on nulliparous women at term admitted to causality for induction of labor.

Study population:

The study will be held on 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 patients will have cervical assessment by modified Bishop score and cervical length measurement by ultrasound.

Plan for induction of labor:

  • Detailed and careful history will be taken from the participants as follows:

    1. Personal history: including name, age, occupation, residence and special habits of medical importance.
    2. Obstetric history: including gestational 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 participants:

    1. General examination: level of consciousness, vital data, complexion.
    2. Abdominal examination: fundal level, lie of the fetus, detection of any uterine contractions and fetal heart rate.
    3. Pelvic Examination : presenting part, presence of ruptured membranes and cervical assessment as regard cervical dilation, effacement, station and presenting part to calculate the modified Bishop Score.
  • Investigations: complete blood count, blood group, non stress test.
  • All women will have trans-vaginal ultrasound sound for assessment of cervical length.
  • Protocol of trans-vaginal ultrasound will be as follows:

    1. Patient will be asked to void.
    2. Vaginal probe will be inserted using direct visualization.
    3. Identification of bladder and fetal presenting part.
    4. Identification of abnormal findings as placenta previa or absence of fetal heart motion.
    5. Identification of mid-line sagittal plane of the cervix and looking in the proximal one third of the image for the internal cervical 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 three times by placing the calibers appropriately and recording the distance between internal and external os then at last recording the measurement of the best image .
  • If cervical length assessed by trans-vaginal ultrasound is less than 28 mm or modified Bishop Value is less than 7, the patient will receive 3mg prostaglandin E2 for pre-induction cervical ripening to be repeated after 6 hours with maximum of 2 doses. If failed cervical ripening, Cesarean section will be done.
  • All Patients will be tested by antepartum fetal heart monitoring "Non stress test".This will be considered reactive if there are two or more fetal heart rate accelerations peaking at least by 15 beats/min above the baseline and lasting for 15 seconds or more from baseline, within a 20 minutes period, with or without fetal movement felt by the mother. A non-reactive tracing will be one without sufficient fetal heart rate accelerations over a 40 minutes period. Any patient with non-reassuring non stress test will be excluded.
  • Successful induction will be defined as vaginal delivery within 24 hours.
  • Failed induction after 24 hours will indicate lower segment cesarean section. Failed induction will be defined as an inability to achieve the active phase of labor corresponding to a cervical dilatation ≥4 cm within 12 hours of initiating oxytocin. Failure of progress was defined as no cervical dilatation during the active phase of labor for at least 2 hours or no descent of the fetal head during the second stage of labor for at least 1 hour despite adequate uterine contraction. This will be considered an indication for cesarean delivery.
  • No further induction agent will be given when uterine contractions reach frequency of three in ten minutes each lasting 30-60 seconds with cervical changes. Amniotomy and oxytocin augmentation will begin when cervical dilation becomes > 3 cm.
  • Oxytocin infusion will be prepared by placing 5 IU ampoule in 500 ml Ringer or Saline to achieve concentration of 10 ml\minute.
  • The rate of infusion will be started at a rate of 5 miu/ml (about 10 drops per minute) and will be increased at same increment every 20 minutes according to uterine contractions.
  • When the patient become in the active phase of labor, vaginal examination will be repeated every 1-2 hours to know the rate of cervical dilation.
  • If patient requests pain relieve, epidural analgesia will be used.
  • Fetal heart rate will be recorded every half an hour.
  • Labor progress will be plotted on partogram.
02

Conditions studied

  • Cervical Dystocia
03

In context

Lead sponsor

Ain Shams Maternity Hospital is the lead sponsor of 139 studies on the registry; 8 are open to participants now.

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

04

Who can participate

Ages eligible
17 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability 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

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

Exclusion criteria

Exclusion Criteria:

  1. Non-vertex presentation.
  2. Previous uterine surgery.
  3. Multiple pregnancy.
  4. Fetal or maternal complications that might cause cesarean section.
  5. Liquor abnormalities.
  6. Fetal weight more than 4 kilograms.
  7. Abnormal umbilical artery Doppler indices or non-stress test.
  8. Asthmatic patients or women with allergy to prostaglandins.
05

Study design

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

Groups and cohorts

  • 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 score · Other: cervical length

Interventions

  • OtherBishop score

    calculation of modified Bishop score in numbers by digital vaginal examination

  • Othercervical length

    measuring cervical length by trans-vaginal ultrasound

06

What researchers measure

Primary outcomes

  1. Cervical Length Prior to Labor Induction

    median cervical length measured by transvaginal ultrasound in centimetres

    Time frame: 24 hours

  2. 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.

    Time frame: 72 hours

07

Results

Posted Nov 7, 2016

Participant flow

Participant flow — Overall Study
MilestoneInduction of Labor
Started200
Completed200
Not completed0

Outcome measures

PrimaryCervical Length Prior to Labor Induction

median cervical length measured by transvaginal ultrasound in centimetres

Time frame:
24 hours
Reported as:
Median · centimetres
Cervical Length Prior to Labor Induction
centimetresInduction of Labor
successful induction of labor2.9 (2.8 to 3.1)
failed induction of labor3 (2.8 to 3.2)
PrimaryBishop 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.

Time frame:
72 hours
Reported as:
Median · units on a scale
Bishop Score Prior to Induction of Labor
units on a scaleInduction of Labor
successful induction of labor4 (3 to 5)
failed induction of labor3 (3 to 4)

Adverse events

Collected over All participants and their livebirths were followed for 72 hours following delivery for adverse events. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Induction of Labor—0/200 (0%)19/200 (9.5%)
Most frequent other events
Most frequent other events
EventInduction of Labor
low APGAR scorePregnancy, puerperium and perinatal conditions10/200
neonatal ICU admissionPregnancy, puerperium and perinatal conditions5/200
maternal traumatic birth injuryPregnancy, puerperium and perinatal conditions3/200
low birth weightPregnancy, puerperium and perinatal conditions1/200

Baseline characteristics

Raslan et al., 2013 reported accuracy of cervical length or Bishop score was 72% vs 63%. So, proportion of discordant pairs is 0.37. A sample of 200 would achieve a power of 80% to detect statistical significance for an effect size equivalent to odds ratio of 1.9. Two sided McNemar test was used with a confidence level 95%.

Age, Continuous
Age, Continuous(years)Induction of Labor
Median23.5 (21 to 27)
Sex: Female, Male
Sex: Female, Male(Participants)Induction of Labor
Female200
Male0
Gestational age
Gestational age(weeks)Induction of Labor
Median39.8 (38.2 to 40.4)
Previous abortions
Previous abortions(participants)Induction of Labor
no abortions173
one abortion22
two abortions4
three abortions1
Indication of induction of labor
Indication of induction of labor(participants)Induction of Labor
severe pre-eclampsia8
mild pre-eclampsia11
intrauterine growth restriction3
oligohydramnios17
postdate89
term rupture of membranes72
Need for oxytocin
Need for oxytocin(participants)Induction of Labor
needed oxytocin116
did not need oxytocin84
Outcome of induction of labor
Outcome of induction of labor(participants)Induction of Labor
successful vaginal delivery114
need for cesarean section86
08

Study locations

1 site
  • Ain Shams maternity hospital
    Cairo, Egypt
09

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2014, a primary completion of Mar 2016 and a completion of Mar 2016. It does not say whether these dates are actual or estimated.

Results were first posted in Nov 2016, 8 months after primary completion.

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

Registered
Feb 23, 2016
First posted
Feb 29, 2016
Start
Oct 2014
Primary completionActual
Mar 2016
CompletionActual
Mar 2016
Results first posted
Nov 7, 2016
Last update
Nov 7, 2016
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 Nov 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02694315
Responsible party
Amr Ahmed Mahmoud Riad (Lecturer of obstetrics and gynecology, Ain Shams Maternity Hospital) — Principal investigator
First posted
Feb 29, 2016
Start date
Oct 2014
Primary completion
Mar 2016
Completion
Mar 2016
Results posted
Nov 7, 2016
Last update
Nov 7, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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