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Modifying Cervical Bishop Scoring System

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ClinicalTrials.gov Identifier: NCT02314260
Recruitment Status : Completed
First Posted : December 11, 2014
Results First Posted : January 16, 2015
Last Update Posted : January 16, 2015
Sponsor:
Information provided by (Responsible Party):
Ahmed M.Kamel, Kasr El Aini Hospital

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Failed Induction of Labor
Interventions Other: bishop score calculation
Other: Trans-vaginal ultrasound
Other: Modified bishop score calculation
Procedure: labour induction
Enrollment 80
Recruitment Details started July 2014 till December 2014 & recruited 80 primigravidas undergoing scheduled for pregnancy termination at Kasr El Aini Hospital
Pre-assignment Details  
Arm/Group Title Labour Induction
Hide Arm/Group Description

80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.

bishop score calculation: Assessment of bishop score by vaginal examination

Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.

Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score

labour induction: Induction of labor was carried out as per our hospital’s standard protocol.

Period Title: Overall Study
Started 80
Completed 80
Not Completed 0
Arm/Group Title Labour Induction
Hide Arm/Group Description

80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.

bishop score calculation: Assessment of bishop score by vaginal examination

Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.

Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score

labour induction: Induction of labor was carried out as per our hospital’s standard protocol.

Overall Number of Baseline Participants 80
Hide Baseline Analysis Population Description
80 primigravidas undergoing induction of labour at our hospital
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants
24.31  (3.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants
Female
80
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Egypt Number Analyzed 80 participants
80
Gestational Age  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 80 participants
39.70  (1.50)
Bishop Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 80 participants
5.71  (1.20)
[1]
Measure Description:

A score of 5 or less suggests that labour is unlikely to start without induction. A score of 9 or more indicates that labour will most likely commence spontaneously.

The score can range between (0 -13) A low Bishop's score often indicates that induction is unlikely to be successful, however there is no set value

Cervical Length  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 80 participants
2.06  (0.56)
New Modified Bishop Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 80 participants
5.28  (1.88)
[1]
Measure Description:

The modified bishop score, is tailored by criteria we added to incorporate cervical length into the old bishop score.

it can have a range between (-2 & 15). low scores bellow 5 are associated with failed induction , while high scores are associated with successful vaginal delivery.

there are no set cut-off value for failed induction

Time to active Phase  
Mean (Standard Deviation)
Unit of measure:  Hours
Number Analyzed 80 participants
11.87  (3.25)
Induction to delivery time  
Mean (Standard Deviation)
Unit of measure:  Hours
Number Analyzed 80 participants
17.38  (4.29)
rupture of membraned duration  
Mean (Standard Deviation)
Unit of measure:  Hours
Number Analyzed 80 participants
9.93  (4.50)
Fetal weight (kilograms)  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 80 participants
3.02  (0.267)
Apgar score at 5 minutes   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 80 participants
8.45  (1.82)
[1]
Measure Description:

Apgar score is a method to assess the health of a newborn immediately after birth.

It is determined by evaluating the newborn baby on 5 simple criteria on a scale from 0-2, then adding the five values obtained.

The resulting Apgar score ranges from 0-10. The 5 criteria are summarized using words chosen to form a backronym (Appearance,Pulse,Grimace,Activity,Respiration).

The test is generally done at 1 & 5 minutes after birth. Scores 7 & above are normal, 4-6 fairly low,and 3 and below are critically low.A low score on the one-minute test, may indicate neonate requires medical attention

1.Primary Outcome
Title Area Under Receiver Operating Characteristic Curve (ROC) for Modified Bishop Score
Time Frame 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
the area under the modified bishop score was 0.916 (95% [confidence interval ] 0.85–0.97). The positive actual state is failed induction and performing Caesarean Section, So as the numbers approaches 1, induction fails, the Y-axis of the curve is sensitivity and the x- axis is (1-specificity).
Arm/Group Title Labour Induction
Hide Arm/Group Description:

80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.

bishop score calculation: Assessment of bishop score by vaginal examination

Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.

Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score

labour induction: Induction of labor was carried out as per our hospital’s standard protocol.

Overall Number of Participants Analyzed 80
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability
0.916
(0.85 to 0.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Labour Induction
Comments Null hypothesis: true area = 0.5 The positive actual state is failed induction, the true positive rate (Sensitivity) is plotted in function of the false positive rate (100-Specificity)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments Under the nonparametric assumption. P-value <0.05, means statistical significance
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.917
Confidence Interval (2-Sided) 95%
0.854 to 0.979
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0318
Estimation Comments The positive actual state is failed induction and performing Caesarean Section, So as the numbers approaches 1, induction fails. the Y-axis of the curve is sensitivity and the x- axis is (1-Specificity).
2.Secondary Outcome
Title Area Under Curve for The Bishop Score
Time Frame 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
The positive actual state is failed induction and performing Caesarean Section, So as the numbers approaches 1, induction of labour fails, the Y-axis of the curve is (sensitivity) and the x- axis is (1-specificity).
Arm/Group Title Labour Induction
Hide Arm/Group Description:

80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.

bishop score calculation: Assessment of bishop score by vaginal examination

Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.

Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score

labour induction: Induction of labor was carried out as per our hospital’s standard protocol.

Overall Number of Participants Analyzed 80
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability
0.806
(0.69 to 0.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Labour Induction
Comments Null hypothesis: true area = 0.5 The positive actual state is failed induction, the true positive rate (Sensitivity) is plotted in function of the false positive rate (100-Specificity)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments Under the nonparametric assumption P value <0.05 is statistically significant
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.806
Confidence Interval (2-Sided) 95%
0.693 to 0.919
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0578
Estimation Comments The positive actual state is failed induction and performing Caesarean Section, 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 Outcome
Title Cut Off Value for The Modified Bishop Score
Hide Description the value at which there a high sensitivity and specificity to predict failed labour induction
Time Frame 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
sensitivity of 83% and a specificity of 87% for failed induction.
Arm/Group Title Labour Induction
Hide Arm/Group Description:

80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.

bishop score calculation: Assessment of bishop score by vaginal examination

Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.

Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score

labour induction: Induction of labor was carried out as per our hospital’s standard protocol.

Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: probability
4.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Labour Induction
Comments The smallest cutoff value is the minimum observed test value minus 1, and the largest cutoff value is the maximum observed test value plus 1. All the other cutoff values are the averages of two consecutive ordered observed test values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments P<0.05 is significant
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 4.5
Confidence Interval (2-Sided) 95%
0.00 to 10
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0318
Estimation Comments at a cutoff value of 4.5, the sensitivity for failure to labour induction is 0.83 (83%), with a specificity of 0.87(87%).
4.Secondary Outcome
Title Cut Off Value for Bishop Score
Hide Description the value at which there a high sensitivity and specificity to predict failed labour induction
Time Frame 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
sensitivity of 83% & specificity was 73% to failed induction
Arm/Group Title Labour Induction
Hide Arm/Group Description:

80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.

bishop score calculation: Assessment of bishop score by vaginal examination

Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.

Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score

labour induction: Induction of labor was carried out as per our hospital’s standard protocol.

Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: probability
5.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Labour Induction
Comments The smallest cutoff value is the minimum observed test value minus 1, and the largest cutoff value is the maximum observed test value plus 1. All the other cutoff values are the averages of two consecutive ordered observed test values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments P<0.05 is significant
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.5
Confidence Interval (2-Sided) 95%
0.00 to 10
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0578
Estimation Comments at a cutoff value of 5.5, the sensitivity for failure to labour induction is 0.83 (83%), with a specificity of 0.73 (73%).
Time Frame 5 months. total time to complete study, other adverse events not related to successful labour induction were not recorded e.g postpartum hemorrhage, wound infection e.t.c
Adverse Event Reporting Description In our study the only serious adverse event recorded was Caesarean section, which occurred when labour progress stopped,& labour induction was considered to be a failure. In the 5 months total time to complete study, other adverse events not related to successful labour induction were not recorded e.g postpartum hemorrhage, wound infection e.t.c
 
Arm/Group Title Labour Induction
Hide Arm/Group Description

80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.

bishop score calculation: Assessment of bishop score by vaginal examination

Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.

Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score

labour induction: Induction of labor was carried out as per our hospital’s standard protocol.

All-Cause Mortality
Labour Induction
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Labour Induction
Affected / at Risk (%)
Total   18/80 (22.50%) 
Pregnancy, puerperium and perinatal conditions   
failed labour induction  [1]  18/80 (22.50%) 
Indicates events were collected by systematic assessment
[1]
caesarean section was performed due to failed progress of labour
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Labour Induction
Affected / at Risk (%)
Total   0/80 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Ahmed Kamel
Organization: kasr EL alini
Phone: 0201120022332
EMail: dr.ahmed.m.kamel@gmail.com
Layout table for additonal information
Responsible Party: Ahmed M.Kamel, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT02314260     History of Changes
Other Study ID Numbers: A13802022
First Submitted: December 6, 2014
First Posted: December 11, 2014
Results First Submitted: December 15, 2014
Results First Posted: January 16, 2015
Last Update Posted: January 16, 2015