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CTRI Number  CTRI/2024/03/064115 [Registered on: 14/03/2024] Trial Registered Prospectively
Last Modified On: 13/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   To assess the Role of Transvaginal Sonographic cervical score and Bishop’s score in prediction of successful labor induction at a Tertiary Care Centre 
Scientific Title of Study   To assess the Role of Transvaginal Sonographic cervical score and Bishop’s score in prediction of successful labor induction at a Tertiary Care Centre 
Trial Acronym  TVS cervical and Bishops score in TVS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Divya Shah 
Designation  JUNIOR RESIDENT 
Affiliation  MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL 
Address  A-503 VASANT VAIBHAV 150 FEET ROAD OPPOSITE HDFC BANK NEAR FLYOVER BHAYANDER WEST

Thane
MAHARASHTRA
401101
India 
Phone  9920613101  
Fax    
Email  SHAHDIVYAR26@GMAIL.COM  
 
Details of Contact Person
Scientific Query
 
Name  Dr Usha Shekhawat 
Designation  PROFESSOR AND HEAD OF THE DEPARTMENT OF OBSTETRICS AND GYNECOLOGY 
Affiliation  MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITA 
Address  RIICO Institutional Area,Sitapura, Tonk Road, Jaipur - 302 022 (Rajasthan) INDIA

Jaipur
RAJASTHAN
302022
India 
Phone  9828011930  
Fax    
Email  shekhawat_usha@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Usha Shekhawat 
Designation  PROFESSOR AND HEAD OF THE DEPARTMENT OF OBSTETRICS AND GYNECOLOGY 
Affiliation  MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITA 
Address  RIICO Institutional Area,Sitapura, Tonk Road, Jaipur - 302 022 (Rajasthan) INDIA

Jaipur
RAJASTHAN
302022
India 
Phone  9828011930  
Fax    
Email  shekhawat_usha@yahoo.co.in  
 
Source of Monetary or Material Support  
MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL 
 
Primary Sponsor  
Name  MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL 
Address  RIICO Institutional Area,Sitapura, Tonk Road, Jaipur - 302 022 (Rajasthan) INDIA 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Divya Shah  mahatma gandhi medical college and hospital  RIICO Institutional Area,Sitapura, Tonk Road, Jaipur - 302 022 (Rajasthan) INDIA
Jaipur
RAJASTHAN 
9920613101

shahdivyar26@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DR RAJENDRA SUREKHA, MEMBER SECRETARY IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bishop score  The Bishop scoring system is based on a digital cervical exam of a patient with a zero point minimum and 13 point maximum.  The scoring system utilizes cervical dilation, position, effacement, consistency of the cervix, and fetal station. Cervical dilation, effacement, and station are scored 0 to 3 points, while cervical position and consistency are scored 0 to 2 points 
Comparator Agent  Trans vaginal sonography  Transvaginal sonography (TVS) as an objective method of assessment of cervix. TVS cervical score comprises of five different parameters; cervical length, funneling at the internal os, distance from the presenting part to the external os, and cervix position  
 
Inclusion Criteria  
Age From  22.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Patients with history of uterine surgeries like previous LSCS, myomectomy.
Placental Abnormalities like placenta previa and suspected placenta accreta etc.
Systemic diseases like liver dysfunction, kidney dysfunction and heart disease.
Women with major fetal anomalies
Patients having Fetal distress before onset of active labor after Induction.
Patients with ruptured Membranes
Patients who have any contraindication for vaginal delivery Patients who refuse to give consent.
 
 
ExclusionCriteria 
Details  Patients with history of uterine surgeries like previous LSCS, myomectomy.
Placental Abnormalities like placenta previa and suspected placenta accreta etc.
Systemic diseases like liver dysfunction, kidney dysfunction and heart disease.
Women with major fetal anomalies
Patients having Fetal distress before onset of active labor after Induction.
Patients with ruptured Membranes
Patients who have any contraindication for vaginal delivery Patients who refuse to give consent.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
TO ASSESS THE BISHOP SCORE PARAMETER AND COMPARE THEM WITH SONOGRAPHIC PARAMETERS.  To identify an objective method for prediction of successful induction of labour
 
 
Secondary Outcome  
Outcome  TimePoints 
Transvaginal Sonographic cervical score & Bishop’s score in prediction of successful labor induction  To identify an objective method for prediction of successful induction of labour 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Induction of labor is an artificial method of initiating uterine contractions before the onset of spontaneous labour, leading to progressive cervical dilatation and effacement followed by delivery. Until now Modified Bishops score was the most commonly used method for evaluation of preindicting favourability of cervix but now TVS is becoming more reliable because the supravaginal portion of the cervix is hard to assess digitally. Hence to avoid subjective variations, role of TVS parameters are taken into consideration in Predicting outcomes of Labor Induction.  Most common indications include post-term pregnancy (27%), Rupture of membranes prior to labour (26%) 3. Appropriate selection of cases is crucial prior to induction, out of those, cervical status is one of the most important factors in predicting the likelyhood of successful induction of labour.

The Bishop scoring system is based on a digital cervical exam of a patient with a zero point minimum and 13 point maximum.  The scoring system utilizes cervical dilation, position, effacement, consistency of the cervix, and fetal station. Cervical dilation, effacement, and station are scored 0 to 3 points, while cervical position and consistency are scored 0 to 2 points 4. A Bishop score of 8 or greater is considered to be favourable for induction, or the chance of a vaginal delivery with induction is similar to spontaneous labor.  A score of 6 or less is considered to be unfavourable if an induction is indicated cervical ripening agents may be utilized.

Transvaginal sonography (TVS) as an objective method of assessment of cervix.  TVS cervical score comprises of five different parameters; cervical length, funneling at the internal os, distance from the presenting part to the external os, and cervix position 5.

These parameters were selected to match the components of Bishop’s Score—cervical length was comparable to effacement of cervix; cervical station was represented as distance of the presenting part to the external os and cervical dilatation was assessed by measurement of width and length of the funnel. The cervical funneling is an important predictor of successful induction as its presence may associated with reduction of delivery time [5]

Based on the description above, this study will aim to compare the success of labor induction with Cervical assessment using a Transvaginal ultrasonography and Bishop score assessment.
A randomised clinical compare study on patients aged 22–40 years, ANC patients in the time period between April 2023- October 2024 will be conducted. Data will be collected by using self design questionnaire. Entire data would be entered into a microsoft office software and appropriate statistical test will be applied and results will be calculated.

 
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