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Failed Induction of LaborNCT02314260

Modifying Cervical Bishop Scoring System

An observational study of Failed Induction of Labor, run by Kasr El Aini 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

To have an early more precise way to predict failed induction in patients undergoing elective termination of pregnancy \& those more likely to undergo caesarian section,this will Spare patients with decreased chances of favorable induction a long and exhausting trial of labour with increased probability of… Read more about this study

Who is it for?
Ages 20 to 34 years, women onlyHealthy volunteers can take part
Conditions the study is for
Failed Induction of Labor
What is being tested?
bishop score calculation, Trans-vaginal ultrasound and Modified bishop score calculation
Type of treatment
Surgery or procedure
How many people
80 participants
Where
1 siteEgypt
Study dates
Jul 2014to Dec 2014
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 20 to 34 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: 80 primigravidas undergoing induction of labour at our hospital in a prospective study were subjected to history taking, examination, investigations \& ultrasonography. Indication for pregnancy termination was explained to each patient and a written consent was obtained.

Who may be able to join

  • Primigravida Singleton pregnancy with mature fetus at term indicated for termination of pregnancy.
  • Cephalic presentation.
  • Medical indications for termination of pregnancy e.g.: Pre-eclampsia, uncontrolled diabetes at term..e.t.c,
  • Post-term pregnancy.
  • Fetal indication: signs of fetal compromise e.g.: decreased biophysical profile, poor umbilical Doppler indices, diminished liquor.
  • premature rupture of membranes (PROM) not going into spontaneous labor within 24 hours since onset.
  • Intrauterine fetal death (IUFD).

Who cannot join

  • they had true labor pains or clear onset of labor as diagnosed by cervical changes.
  • Previous uterine surgery (scared uterus).
  • Cephalo-pelvic disproportion.
  • Mal-presentations
  • Severe oligo-hydramnios i.e.: amniotic fluid index Less than 5.
  • Twin pregnancy.
  • Fetal macrosomia. -Growth beyond a specific threshold (weight above 4000g) 8) Placenta previa.
  • 9) Fetal bradycardia in case of living fetus.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • 11562

    Ḩadā’iq al Qubbah, Cairo Governorate, 11562

Other trials in Egypt

About this study

Official title: Bishop Score; Are Further Modifications Needed?

To have an early more precise way to predict failed induction in patients undergoing elective termination of pregnancy \& those more likely to undergo caesarian section,this will Spare patients with decreased chances of favorable induction a long and exhausting trial of labour with increased probability of complications and an emergency caesarian

Read the detailed description

After approval of the ethical \& scientific committees of the OBGYN department of Kasr El Aini hospital, 80 primigravidas undergoing induction of labour at our hospital in a prospective blind study were subjected to history taking, examination, investigations \& ultrasonography. Indication for pregnancy termination was explained to each patient and a written consent was obtained.

Clinical examination \& assessment:

Patients were examined vaginally by the attending physician and a Bishop score was assigned and recorded according to the original bishop scoring system 1964 (Bishop EH, 1964) as seen in table 1.

Table 1: The Bishop score (Bishop EH, 1964):

0 points : for no dilation, effacement 0-30%, station -3, firm consistency \& posterior position of cervix

  1. point : for dilation 1-2 cm, effacement 40-50%, station -2, medium consistency \& mid position of cervix.
  2. points: for dilation 3-4 cm, effacement 60-70%, station -1, soft consistency \& Anterior position of cervix.
  3. points: for dilation 5-6 cm, effacement 80%, station +1 or +2.

Sum of the points in each criteria assessed will be the bishop score.

Trans-vaginal ultrasound assessment of cervical length was performed using the same machine each time Sonoace x4 (samsung Medison Co., Ltd. Seoul, South Korea) following a standardized technique in which the bladder was emptied \& the vaginal probe 6.5MHz was introduced into the vagina and manipulated so that the main anatomical landmarks (bladder, fetal presentation, cervical canal, internal and external cervical os) were identified. The hyper echoic line extending from the internal os to external os, was identified by fine manipulations of the probe. The cervical canal length was measured as the distance between the internal and external os, while presence of funneling was recorded. Funneling was defined as a (V)or (U) shaped indentation of the internal os. In the presence of funneling, the length of an associated funnel was not included as part of the cervical length, and the measurement was taken from the apex of the funnel to the external os.

A modified bishop score was devised for the purpose of this study, which aimed to incorporate cervical length into the bishop scoring system. This score was calculated by addition or subtraction of the figure obtained respectively for cervical length in table 2 from the original bishop score.

Table 2: Scoring System for respective cervical length

Score: -2 for Cervical length > 2.5cm by trans-vaginal ultrasound. Score: -1 for Cervical length 2 - 2.5 cm by trans-vaginal ultrasound.

Score: 0 for Cervical length 1.6 - 1.9 cm by trans-vaginal ultrasound.

Score: +1 for Cervical length 1 - 1.5 cm by trans-vaginal ultrasound.

Score: +2 for Cervical length < 1 cm by trans-vaginal ultrasound.

We think an unfavorable score should decrease the value of the bishop score, and not just fail to increase it (in comparison to the original score) \& hence our negative value for unfavorable cervical length. The values used to set the figures for the max and min score for cervical length in table 2 were based on our observation of how several studies displayed the range of their results for cervical length and how we think that it should impact the bishop score. There is no exact pre-set cut off value for what a favorable cervical length should be.

Labour induction and Monitoring:

Induction of labor was carried out as per our hospital's standard protocol, in which patients with unfavorable cervical examination i.e. bishop score of 4 or less were given dinoprostone 3mg (Dinoglandin E2 ® Egypharma Nasr City Cairo Egypt) vaginal tablet, with re-dosing intervals every six hours if no significant cervical changes were noted.

In cases where the initial bishop score was 5 or more, or improvement was seen after dinoprostone, Oxytocin was initiated for induction. In cases already having one or more dinoprostone vaginal tablets, oxytocin was started four hours after the final dinoprostone dose, using the low-dose protocol beginning with 2 mU/min (and increase by 2 mU/min) at incremental time intervals (15 - 30 minutes). The goal was to reach satisfactory contractions (3-5 per ten minutes with each contraction lasting 45 seconds), \& to avoid uterine hyperstimulation.

All through induction \& labor fetal heart rate was measured every 30 minutes in first stage of labor and every 10 minutes in second stage of labor. Progress of labor was observed \& recorded, the total amount of oxytocin used, fetal weight and Apgar score for each baby were recorded. The total time taken till reaching active phase of labor, total time taken till delivery \& mode of delivery were recorded. Any decision to proceed to caesarean was reviewed by a senior consultant and the indication was noted. Any case undergoing caesarean for any indication other than failure of progress will be omitted from the results.

Being tested
bishop score calculation, Trans-vaginal ultrasound, Modified bishop score calculation, labour induction
Keywords
labour induction, cervical length, trans-vaginal assessment of cervical length, Bishop score

What participants receive

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

  • bishop score calculationOther

    Assessment of bishop score by vaginal examination

  • Trans-vaginal ultrasoundOther

    trans-vaginal ultrasound assessment of cervical length.

  • Modified bishop score calculationOther

    using the cervical length and the original bishop score to calculate modified bishop score

  • labour inductionProcedure or surgery

    Induction of labor was carried out as per our hospital's standard protocol.

Study groups in NCT02314260
Study groupRoleWhat they receive
Labour Induction80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length \&, Modified bishop score calculation, then induction of labour at our hospital.
Receives: Other: bishop score calculation; Other: Trans-vaginal ultrasound; Other: Modified bishop score calculation; Procedure: labour induction

What is being measured

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

  1. Area Under Receiver Operating Characteristic Curve (ROC) for Modified Bishop Score

    to predict failed induction and comparing it to the area under curve for bishop score to find out which test is more accurate in predicting caesarean section, The positive actual state is failed induction and performing Caesarean Section.The positive actual state is failed induction, the true positive rate (Sensitivity) is plotted in function of the false positive rate (100-Specificity). So as the numbers approaches 1, induction fails, the Y-axis of the curve is sensitivity and the x- axis is (1-specificity).

    Measured: 5 months

Secondary outcomes (3)
  1. Area Under Curve for The Bishop Score

    to predict failed induction and comparing it to the area under curve for modified bishop score to find out which test is more accurate in predicting caesarean section, The positive actual state is failed induction and performing Caesarean Section. The positive actual state is failed induction, the true positive rate (Sensitivity) is plotted in function of the false positive rate (100-Specificity), So as the numbers approaches 1, induction fails, the Y-axis of the curve is sensitivity and the x- axis is (1-specificity).

    Measured: 5 months

  2. Cut Off Value for The Modified Bishop Score

    the value at which there a high sensitivity and specificity to predict failed labour induction

    Measured: 5 months

  3. Cut Off Value for Bishop Score

    the value at which there a high sensitivity and specificity to predict failed labour induction

    Measured: 5 months

Timeline

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

  1. First posted11 Dec 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionDec 2014
  4. Study completionDec 2014

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
Case only
Time perspective
Prospective
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02314260
Sponsor's protocol ID
A13802022
Status last verified
Jan 2015
First submitted
6 Dec 2014
Last updated
16 Jan 2015
Data monitoring committee
No

Publications

  • BISHOP EH. PELVIC SCORING FOR ELECTIVE INDUCTION. Obstet Gynecol. 1964 Aug;24:266-8. No abstract available.

    PubMed 14199536

Questions about this trial

What is this clinical trial studying?

An observational study of Failed Induction of Labor, run by Kasr El Aini 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 7 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 16 Jan 2015. 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 16 Jan 2015). 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?

Area Under Receiver Operating Characteristic Curve (ROC) for Modified Bishop Score (time frame: 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02314260, which also lists 1 linked publication.

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 16 Jan 2015.

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