Trial Outcomes & Findings for Modifying Cervical Bishop Scoring System (NCT NCT02314260)
NCT ID: NCT02314260
Last Updated: 2015-01-16
Results Overview
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).
COMPLETED
80 participants
5 months
2015-01-16
Participant Flow
started July 2014 till December 2014 \& recruited 80 primigravidas undergoing scheduled for pregnancy termination at Kasr El Aini Hospital
Participant milestones
| Measure |
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.
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.
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|---|---|
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Overall Study
STARTED
|
80
|
|
Overall Study
COMPLETED
|
80
|
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Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Modifying Cervical Bishop Scoring System
Baseline characteristics by cohort
| Measure |
Labour Induction
n=80 Participants
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.
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|---|---|
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Age, Continuous
|
24.31 years
STANDARD_DEVIATION 3.65 • n=99 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
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0 Participants
n=99 Participants
|
|
Region of Enrollment
Egypt
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80 participants
n=99 Participants
|
|
Gestational Age
|
39.70 Weeks
STANDARD_DEVIATION 1.50 • n=99 Participants
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Bishop Score
|
5.71 units on a scale
STANDARD_DEVIATION 1.20 • n=99 Participants
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|
Cervical Length
|
2.06 Cm
STANDARD_DEVIATION 0.56 • n=99 Participants
|
|
New Modified Bishop Score
|
5.28 units on a scale
STANDARD_DEVIATION 1.88 • n=99 Participants
|
|
Time to active Phase
|
11.87 Hours
STANDARD_DEVIATION 3.25 • n=99 Participants
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Induction to delivery time
|
17.38 Hours
STANDARD_DEVIATION 4.29 • n=99 Participants
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rupture of membraned duration
|
9.93 hours
STANDARD_DEVIATION 4.50 • n=99 Participants
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Fetal weight (kilograms)
|
3.02 kilograms
STANDARD_DEVIATION 0.267 • n=99 Participants
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Apgar score at 5 minutes
|
8.45 units on a scale
STANDARD_DEVIATION 1.82 • n=99 Participants
|
PRIMARY outcome
Timeframe: 5 monthsPopulation: 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).
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).
Outcome measures
| Measure |
Labour Induction
n=80 Participants
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.
|
|---|---|
|
Area Under Receiver Operating Characteristic Curve (ROC) for Modified Bishop Score
|
0.916 probability
Interval 0.85 to 0.97
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SECONDARY outcome
Timeframe: 5 monthsPopulation: 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).
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).
Outcome measures
| Measure |
Labour Induction
n=80 Participants
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.
|
|---|---|
|
Area Under Curve for The Bishop Score
|
0.806 probability
Interval 0.69 to 0.91
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SECONDARY outcome
Timeframe: 5 monthsPopulation: sensitivity of 83% and a specificity of 87% for failed induction.
the value at which there a high sensitivity and specificity to predict failed labour induction
Outcome measures
| Measure |
Labour Induction
n=80 Participants
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.
|
|---|---|
|
Cut Off Value for The Modified Bishop Score
|
4.5 probability
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SECONDARY outcome
Timeframe: 5 monthsPopulation: sensitivity of 83% \& specificity was 73% to failed induction
the value at which there a high sensitivity and specificity to predict failed labour induction
Outcome measures
| Measure |
Labour Induction
n=80 Participants
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.
|
|---|---|
|
Cut Off Value for Bishop Score
|
5.5 probability
|
Adverse Events
Labour Induction
Serious adverse events
| Measure |
Labour Induction
n=80 participants at risk
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.
|
|---|---|
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Pregnancy, puerperium and perinatal conditions
failed labour induction
|
22.5%
18/80 • 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
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
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place