| CTRI Number |
CTRI/2025/08/093496 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Diagnostic |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Preinduction transvaginal ultrasound helps doctors predict how likely it is that labour induction will work by giving clear images of the cervix and baby’s position, which can guide better decisions about delivery in full term patients who needs induction of labour. |
|
Scientific Title of Study
|
Role of preinduction transvaginal sonography in predicting outcomes of labour induction |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kumudini Rajora |
| Designation |
Post graduate resident |
| Affiliation |
Kasturba Hospital Delhi |
| Address |
112-113, first floor, pocket D14, sector 8, rohini, delhi
Central
DELHI
110085
India |
| Phone |
9990827000 |
| Fax |
|
| Email |
rajorakumudini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr vinita Sarbhai |
| Designation |
Senior Specialist, SAG |
| Affiliation |
Kasturba Hospital Delhi |
| Address |
Department of Obstetrics and Gynecology, Kasturba hospital, Delhi
Central
DELHI
110006
India |
| Phone |
9810359546 |
| Fax |
|
| Email |
vinitasarbhai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr vinita Sarbhai |
| Designation |
Senior Specialist, SAG |
| Affiliation |
Kasturba Hospital Delhi |
| Address |
Department of Obstetrics and Gynecology, Kasturba hospital, Delhi
DELHI
110006
India |
| Phone |
9810359546 |
| Fax |
|
| Email |
vinitasarbhai@gmail.com |
|
|
Source of Monetary or Material Support
|
| self, PG resident kasturba hospital, delhi, 110006 |
|
|
Primary Sponsor
|
| Name |
Dr Kumudini Rajora |
| Address |
Kasturba Hospital Delhi |
| Type of Sponsor |
Other [self] |
|
|
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 Kumudini Rajora |
Kasturba Hospital |
Gate No.1, J6XQ+H5G Metro Station, Near, Kasturba Hospital Marg, Jama Masjid, Old Delhi, New Delhi, Delhi, 110006
Central
DELHI |
09990827000
rajorakumudini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Transvaginal Ultrasonography
Induction of labour |
Transvaginal sonographic (TVS) can be used for measuring Cervical length, posterior cervical angle and fetal head position which can help in prediction of outcomes of induction.
•Hence, it may provide a more accurate and objective assessment for prediction of success of labour Induction compared to digital examination. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Period of gestation greater than 37 weeks
2.Single live fetus
3.Vertex presentation
4.Indication of induction of labour for example post-term, gestational hypertension, oligohydramnios.
5.Normal Reactive Non stress Test
6.Intact membranes
|
|
| ExclusionCriteria |
| Details |
Previous surgical scar
Malpresentation
Multiple pregnancy
Cephalopelvic disproportion
Major fetal anomalies or IUD
Ante partum haemorrhage
Premature labour
Rupture of membranes
Women in active labour
Contraindication to vaginal delivery or booked for elective LSCS
Patient refusal |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Success of induction of labour - defined as vaginal delivery within 24 hours of induction
2. Labour Outcome -Mode of delivery- Normal/Instrumental/Caesarean
|
1.Success of induction of labour - defined as vaginal delivery within 24 hours of induction
2. Labour Outcome -Mode of delivery- Normal/Instrumental/Caesarean
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation of TVS Findings ( Cervical length, posterior cervical angle & position of fetal head) & Bishop Score with respect to
a. Induction to active labour duration
b.Induction to delivery interval
c.Failed Induction rate -Defined as inability to enter active labour despite adequate uterine activity
d.The need of agent for induction in terms of number of Dinoprostone gel, amount of oxytocin & amniotomy.
e.Maternal & fetal outcomes
|
TVS will be done in full term patients of more than 37 weeks of gestation in whom induction of labour is indicated |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
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)
|
01/09/2025 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
TVS will be done for cervical length, position of fetal head, and posterior cervical angle •then digitally cervical condition will be accessed by Modified Bishop Score. •All women will be induced as per hospital protocol. •The prediction of successful labor will be assessed for all parameters of TVS( Cervical length, posterior cervical angle and position of fetal head) and Bishop score. Foloowing are the methods that will be used for measuring TVS parameters
CERVICAL LENGTH : Cervical distortion will be avoided by placing the transducer away from the cervix. A sagittal view of the cervix and echogenic endocervical mucosa will be visualised along the length of the endocervical canal. The image of the cervix is magnified to about 75% of the screen. The length of the cervix will be measured from the internal osto the external os. •POSTERIOR CERVICAL ANGLE : The posterior cervical angle will be measured with a protractor applied to a hard copy picture taken in a sagittal plane at the level of the internal os and approximated to the nearest 10° . •FOETAL HEAD POSITION : For determination of foetal head position, the ultrasound transducer will first be placed transversely in the suprapubic region of the maternal abdomen. The foetal orbits in the case of Occiput Posterior (OP) position, the midline cerebral echo in the case of Occiput Transverse (OT) positions and the cerebellum or occiput in the case of Occiput Anterior (OA) position will serve as landmarks for foetal head position. |