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Cervical DystociaNCT02694315

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

An observational study of Cervical Dystocia, run by Ain Shams Maternity Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 17 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Cervical Dystocia
What is being tested?
Bishop score and cervical length
How many people
200 participants
Where
1 siteEgypt
Study dates
Oct 2014to Mar 2016
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Ain Shams maternity hospital

    Cairo

Other trials in Egypt

About this study

Official title: Comparison Between Sonographic Cervical Length and Bishop Score in Preinduction Cervical Assessment Prior to Induction of Labor as Regards Induction Success

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.
Being tested
Bishop score, cervical length

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bishop scoreOther

    calculation of modified Bishop score in numbers by digital vaginal examination

  • cervical lengthOther

    measuring cervical length by trans-vaginal ultrasound

Study groups in NCT02694315
Study groupRoleWhat they receive
Induction of labor200 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.
Receives: Other: Bishop score; Other: cervical length

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cervical Length Prior to Labor Induction

    median cervical length measured by transvaginal ultrasound in centimetres

    Measured: 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.

    Measured: 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Feb 2016 (estimated)
  2. Study startOct 2014
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02694315
Sponsor's protocol ID
sonographic cervical length
Status last verified
Sep 2016
First submitted
23 Feb 2016
Last updated
7 Nov 2016
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Dystocia, run by Ain Shams Maternity Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cervical Length Prior to Labor Induction (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2016.

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