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.
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.
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
- point : for dilation 1-2 cm, effacement 40-50%, station -2, medium consistency \& mid position of cervix.
- points: for dilation 3-4 cm, effacement 60-70%, station -1, soft consistency \& Anterior position of cervix.
- 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.
- Conditions
- Failed Induction of Labor
- 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 group | Role | What they receive |
|---|---|---|
| Labour Induction | 80 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.
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)
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
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
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.
- First posted11 Dec 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Failed Induction of LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M.Kamel, Kasr El Aini Hospital
- Investigators
- Ahmed M Kamel, M.D, Principal investigator, Lecturer of obstetrics & Gynecology
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
BISHOP EH. PELVIC SCORING FOR ELECTIVE INDUCTION. Obstet Gynecol. 1964 Aug;24:266-8. No abstract available.
PubMed 14199536
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bishop Score; Are Further Modifications Needed?
- ClinicalTrials.gov ID
- NCT02314260
- Acronym / sponsor ID
- A13802022
- Conditions
- Failed Induction of Labor
- Keywords
- labour induction, cervical length, trans-vaginal assessment of cervical length, Bishop score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Dec 2014 (estimated)
- Results
- Posted 16 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- point : for dilation 1-2 cm, effacement 40-50%, station -2, medium consistency \& mid position of cervix.
- points: for dilation 3-4 cm, effacement 60-70%, station -1, soft consistency \& Anterior position of cervix.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Labour Induction | – | Other: bishop score calculation, Other: Trans-vaginal ultrasound, Other: Modified bishop score calculation, Procedure: 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. |
Who may qualify
- Ages
- 20 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bishop score calculationAssessment of bishop score by vaginal examination | Other | Labour Induction |
| Trans-vaginal ultrasoundtrans-vaginal ultrasound assessment of cervical length. | Other | Labour Induction |
| Modified bishop score calculationusing the cervical length and the original bishop score to calculate modified bishop score | Other | Labour Induction |
| labour inductionInduction of labor was carried out as per our hospital's standard protocol. | Procedure or surgery | Labour Induction |
Primary outcome
Area Under Receiver Operating Characteristic Curve (ROC) for Modified Bishop Score
Time frame: 5 months
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).
3 secondary outcomes
Area Under Curve for The Bishop Score
Time frame: 5 months
Cut Off Value for The Modified Bishop Score
Time frame: 5 months
Cut Off Value for Bishop Score
Time frame: 5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14199536BISHOP EH. PELVIC SCORING FOR ELECTIVE INDUCTION. Obstet Gynecol. 1964 Aug;24:266-8. No abstract available.
Related trials for Failed Induction of Labor
Recruiting
Oxytocin Rest to Reduce Cesarean Delivery
Prolonged Labor, Failed Induction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed M Kamel, M.D principal investigator
Lecturer of obstetrics & Gynecology
1 site in 1 country: see every site and its status.
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.