Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-02-25 @ 11:06 PM
Study NCT ID:
NCT02314260
Status:
COMPLETED
Last Update Posted:
2015-01-16
First Post:
2014-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Modifying Cervical Bishop Scoring System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007751', 'term': 'Labor, Induced'}], 'ancestors': [{'id': 'D036861', 'term': 'Delivery, Obstetric'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dr.ahmed.m.kamel@gmail.com', 'phone': '0201120022332', 'title': 'Dr Ahmed Kamel', 'organization': 'kasr EL alini'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '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', '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', 'eventGroups': [{'id': 'EG000', 'title': 'Labour Induction', '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.\n\nbishop score calculation: Assessment of bishop score by vaginal examination\n\nTrans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.\n\nModified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score\n\nlabour induction: Induction of labor was carried out as per our hospital's standard protocol.", 'otherNumAtRisk': 80, 'otherNumAffected': 0, 'seriousNumAtRisk': 80, 'seriousNumAffected': 18}], 'seriousEvents': [{'term': 'failed labour induction', 'notes': 'caesarean section was performed due to failed progress of labour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 18}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under Receiver Operating Characteristic Curve (ROC) for Modified Bishop Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Labour Induction', '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.\n\nbishop score calculation: Assessment of bishop score by vaginal examination\n\nTrans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.\n\nModified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score\n\nlabour induction: Induction of labor was carried out as per our hospital's standard protocol."}], 'classes': [{'categories': [{'measurements': [{'value': '0.916', 'groupId': 'OG000', 'lowerLimit': '0.85', 'upperLimit': '0.97'}]}]}], 'analyses': [{'pValue': '0.000', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.917', 'ciLowerLimit': '0.854', 'ciUpperLimit': '0.979', 'pValueComment': 'Under the nonparametric assumption. P-value \\<0.05, means statistical significance', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0318', 'estimateComment': '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).', 'groupDescription': '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)', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '5 months', 'description': '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).', 'unitOfMeasure': 'probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Area Under Curve for The Bishop Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Labour Induction', '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.\n\nbishop score calculation: Assessment of bishop score by vaginal examination\n\nTrans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.\n\nModified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score\n\nlabour induction: Induction of labor was carried out as per our hospital's standard protocol."}], 'classes': [{'categories': [{'measurements': [{'value': '0.806', 'groupId': 'OG000', 'lowerLimit': '0.69', 'upperLimit': '0.91'}]}]}], 'analyses': [{'pValue': '0.000', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.806', 'ciLowerLimit': '0.693', 'ciUpperLimit': '0.919', 'pValueComment': 'Under the nonparametric assumption P value \\<0.05 is statistically significant', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0578', 'estimateComment': '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).', 'groupDescription': '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)', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '5 months', 'description': '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).', 'unitOfMeasure': 'probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Cut Off Value for The Modified Bishop Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Labour Induction', '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.\n\nbishop score calculation: Assessment of bishop score by vaginal examination\n\nTrans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.\n\nModified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score\n\nlabour induction: Induction of labor was carried out as per our hospital's standard protocol."}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.000', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.5', 'ciLowerLimit': '0.00', 'ciUpperLimit': '10', 'pValueComment': 'P\\<0.05 is significant', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0318', 'estimateComment': '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%).', 'groupDescription': '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.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '5 months', 'description': 'the value at which there a high sensitivity and specificity to predict failed labour induction', 'unitOfMeasure': 'probability', 'reportingStatus': 'POSTED', 'populationDescription': 'sensitivity of 83% and a specificity of 87% for failed induction.'}, {'type': 'SECONDARY', 'title': 'Cut Off Value for Bishop Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Labour Induction', '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.\n\nbishop score calculation: Assessment of bishop score by vaginal examination\n\nTrans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.\n\nModified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score\n\nlabour induction: Induction of labor was carried out as per our hospital's standard protocol."}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.000', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.5', 'ciLowerLimit': '0.00', 'ciUpperLimit': '10', 'pValueComment': 'P\\<0.05 is significant', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0578', 'estimateComment': '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%).', 'groupDescription': '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.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '5 months', 'description': 'the value at which there a high sensitivity and specificity to predict failed labour induction', 'unitOfMeasure': 'probability', 'reportingStatus': 'POSTED', 'populationDescription': 'sensitivity of 83% \\& specificity was 73% to failed induction'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Labour Induction', '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.\n\nbishop score calculation: Assessment of bishop score by vaginal examination\n\nTrans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.\n\nModified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score\n\nlabour induction: Induction of labor was carried out as per our hospital's standard protocol."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'started July 2014 till December 2014 \\& recruited 80 primigravidas undergoing scheduled for pregnancy termination at Kasr El Aini Hospital'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Labour Induction', '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.\n\nbishop score calculation: Assessment of bishop score by vaginal examination\n\nTrans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.\n\nModified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score\n\nlabour induction: Induction of labor was carried out as per our hospital's standard protocol."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.31', 'spread': '3.65', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '80', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Egypt', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gestational Age', 'classes': [{'categories': [{'measurements': [{'value': '39.70', 'spread': '1.50', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Bishop Score', 'classes': [{'categories': [{'measurements': [{'value': '5.71', 'spread': '1.20', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', '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.\n\nThe 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", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cervical Length', 'classes': [{'categories': [{'measurements': [{'value': '2.06', 'spread': '0.56', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'New Modified Bishop Score', 'classes': [{'categories': [{'measurements': [{'value': '5.28', 'spread': '1.88', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The modified bishop score, is tailored by criteria we added to incorporate cervical length into the old bishop score.\n\nit 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.\n\nthere are no set cut-off value for failed induction', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time to active Phase', 'classes': [{'categories': [{'measurements': [{'value': '11.87', 'spread': '3.25', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Hours', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Induction to delivery time', 'classes': [{'categories': [{'measurements': [{'value': '17.38', 'spread': '4.29', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Hours', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'rupture of membraned duration', 'classes': [{'categories': [{'measurements': [{'value': '9.93', 'spread': '4.50', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'hours', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fetal weight (kilograms)', 'classes': [{'categories': [{'measurements': [{'value': '3.02', 'spread': '0.267', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Apgar score at 5 minutes', 'classes': [{'categories': [{'measurements': [{'value': '8.45', 'spread': '1.82', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Apgar score is a method to assess the health of a newborn immediately after birth.\n\nIt is determined by evaluating the newborn baby on 5 simple criteria on a scale from 0-2, then adding the five values obtained.\n\nThe resulting Apgar score ranges from 0-10. The 5 criteria are summarized using words chosen to form a backronym (Appearance,Pulse,Grimace,Activity,Respiration).\n\nThe 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', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': '80 primigravidas undergoing induction of labour at our hospital'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-08', 'studyFirstSubmitDate': '2014-12-06', 'resultsFirstSubmitDate': '2014-12-15', 'studyFirstSubmitQcDate': '2014-12-10', 'lastUpdatePostDateStruct': {'date': '2015-01-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-01-08', 'studyFirstPostDateStruct': {'date': '2014-12-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under Receiver Operating Characteristic Curve (ROC) for Modified Bishop Score', 'timeFrame': '5 months', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Area Under Curve for The Bishop Score', 'timeFrame': '5 months', 'description': '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).'}, {'measure': 'Cut Off Value for The Modified Bishop Score', 'timeFrame': '5 months', 'description': 'the value at which there a high sensitivity and specificity to predict failed labour induction'}, {'measure': 'Cut Off Value for Bishop Score', 'timeFrame': '5 months', 'description': 'the value at which there a high sensitivity and specificity to predict failed labour induction'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['labour induction', 'cervical length', 'trans-vaginal assessment of cervical length', 'Bishop score'], 'conditions': ['Failed Induction of Labor']}, 'referencesModule': {'references': [{'pmid': '14199536', 'type': 'BACKGROUND', 'citation': 'BISHOP EH. PELVIC SCORING FOR ELECTIVE INDUCTION. Obstet Gynecol. 1964 Aug;24:266-8. No abstract available.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': "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.\n\nClinical examination \\& assessment:\n\nPatients 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.\n\nTable 1: The Bishop score (Bishop EH, 1964):\n\n0 points : for no dilation, effacement 0-30%, station -3, firm consistency \\& posterior position of cervix\n\n1. point : for dilation 1-2 cm, effacement 40-50%, station -2, medium consistency \\& mid position of cervix.\n2. points: for dilation 3-4 cm, effacement 60-70%, station -1, soft consistency \\& Anterior position of cervix.\n3. points: for dilation 5-6 cm, effacement 80%, station +1 or +2.\n\nSum of the points in each criteria assessed will be the bishop score.\n\nTrans-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.\n\nA 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.\n\nTable 2: Scoring System for respective cervical length\n\nScore: -2 for Cervical length \\> 2.5cm by trans-vaginal ultrasound. Score: -1 for Cervical length 2 - 2.5 cm by trans-vaginal ultrasound.\n\nScore: 0 for Cervical length 1.6 - 1.9 cm by trans-vaginal ultrasound.\n\nScore: +1 for Cervical length 1 - 1.5 cm by trans-vaginal ultrasound.\n\nScore: +2 for Cervical length \\< 1 cm by trans-vaginal ultrasound.\n\nWe 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.\n\nLabour induction and Monitoring:\n\nInduction 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.\n\nIn 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.\n\nAll 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '34 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Primigravida Singleton pregnancy with mature fetus at term indicated for termination of pregnancy.\n2. Cephalic presentation.\n3. Medical indications for termination of pregnancy e.g.: Pre-eclampsia, uncontrolled diabetes at term..e.t.c,\n4. Post-term pregnancy.\n5. Fetal indication: signs of fetal compromise e.g.: decreased biophysical profile, poor umbilical Doppler indices, diminished liquor.\n6. premature rupture of membranes (PROM) not going into spontaneous labor within 24 hours since onset.\n7. Intrauterine fetal death (IUFD).\n\nExclusion Criteria:\n\n1. they had true labor pains or clear onset of labor as diagnosed by cervical changes.\n2. Previous uterine surgery (scared uterus).\n3. Cephalo-pelvic disproportion.\n4. Mal-presentations\n5. Severe oligo-hydramnios i.e.: amniotic fluid index Less than 5.\n6. Twin pregnancy.\n7. Fetal macrosomia. -Growth beyond a specific threshold (weight above 4000g) 8) Placenta previa.\n\n9\\) Fetal bradycardia in case of living fetus.'}, 'identificationModule': {'nctId': 'NCT02314260', 'briefTitle': 'Modifying Cervical Bishop Scoring System', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Bishop Score; Are Further Modifications Needed?', 'orgStudyIdInfo': {'id': 'A13802022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Labour Induction', '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.', 'interventionNames': ['Other: bishop score calculation', 'Other: Trans-vaginal ultrasound', 'Other: Modified bishop score calculation', 'Procedure: labour induction']}], 'interventions': [{'name': 'bishop score calculation', 'type': 'OTHER', 'description': 'Assessment of bishop score by vaginal examination', 'armGroupLabels': ['Labour Induction']}, {'name': 'Trans-vaginal ultrasound', 'type': 'OTHER', 'description': 'trans-vaginal ultrasound assessment of cervical length.', 'armGroupLabels': ['Labour Induction']}, {'name': 'Modified bishop score calculation', 'type': 'OTHER', 'description': 'using the cervical length and the original bishop score to calculate modified bishop score', 'armGroupLabels': ['Labour Induction']}, {'name': 'labour induction', 'type': 'PROCEDURE', 'description': "Induction of labor was carried out as per our hospital's standard protocol.", 'armGroupLabels': ['Labour Induction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Ḩadā’iq al Qubbah', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': '11562', 'geoPoint': {'lat': 30.08843, 'lon': 31.28351}}], 'overallOfficials': [{'name': 'Ahmed M Kamel, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer of obstetrics & Gynecology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer Of obstetrics & Gynecology', 'investigatorFullName': 'Ahmed M.Kamel', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}