| 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
|
|
|
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
|
|
|
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. Â 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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