| CTRI Number |
CTRI/2025/08/093156 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
15/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
OBSERVATIONAL LONGITUDINAL |
| Study Design |
Other |
|
Public Title of Study
|
Role of artificial intelligence during labor to predict labor outcome |
|
Scientific Title of Study
|
Role of intrapartum AI in predicting labor outcome |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Radhika Maheshwari |
| Designation |
Post graduate |
| Affiliation |
Kasturba medical college |
| Address |
Department of Obstetrics and gynecology, Women and child block, Kasturba hospital Manipal, Udupi District
Udupi
KARNATAKA
576104
India |
| Phone |
8169995927 |
| Fax |
|
| Email |
radhika11398@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyothi Shetty |
| Designation |
Professor and head of unit |
| Affiliation |
Kasturba medical college |
| Address |
Department of Obstetrics and gynecology, Women and child block, Kasturba hospital Manipal, Udupi District
Udupi
KARNATAKA
576104
India |
| Phone |
9845973697 |
| Fax |
|
| Email |
jyothi.shetty@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Radhika Maheshwari |
| Designation |
Post graduate |
| Affiliation |
Kasturba medical college |
| Address |
Department of Obstetrics and gynecology, Women and child block, Kasturba hospital Manipal, Udupi District
Udupi
KARNATAKA
576104
India |
| Phone |
8169995927 |
| Fax |
|
| Email |
radhika11398@gmail.com |
|
|
Source of Monetary or Material Support
|
| Material provided by Kasturba Hospital- Ultrasound machine.
Manipal, Karnataka, India, 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Department of Obstetrics and gynecology, Women and child block, Kasturba hospital Manipal, Udupi District, Udupi, KARNATAKA, 576104, 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 Radhika Maheshwari |
Kasturba Hospital |
Labour room, 1st floor, Department of obstetrics and gynecology, Women and child block, Kasturba Hospital, Manipal-576104
Udupi
KARNATAKA |
8169995927
radhika11398@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee, Kasturba N=Medical College, Manipla, 576104 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Singleton pregnancy
Term pregnancy (37-41 weeks)
Cervical dilatation 4-10cm |
|
| ExclusionCriteria |
| Details |
Mulifetal pregnancy
VBAC |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation between Intrapartum AI and traditional assessment of labor . Hence helps in reducing unnecessary interventions such as prolonged labor, cesarean section. |
At term (37weeks- 41 weeks), during labor |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="61"
Sample Size from India="61"
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)
|
27/08/2025 |
| 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="0"
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
|
This prospective observational study will be conducted in Kasturba Hospital, Manipal. Ethical clearance by Institutional ethical committee (IEC), Kasturba Hospital, Manipal will be taken. Pregnant women who will be admitted to the hospital will be screened based on the inclusion and exclusion criteria, as mentioned in the proforma and thereafter, baseline demographic characteristics will be obtained. Written and informed consent will be taken from the participants after a brief explanation of the procedure. Intrapartum AI is Digital assessment of labor progress, where 8 maternal parameters such as BMI, Parity index, gestational age, Duration of labor, Cervical dilatation, Head-Perineum distance, fetal position and caput will be taken into account to predict labor outcome. Based on these 8 parameters intrapartum AI will predict likelihood of normal vaginal delivery. We will conduct parallel traditional clinical assessment and wait for the outcome- vaginal delivery or c-section. From all the data collected we will employ statistical analysis to know the accuracy of Intrapartum AI in predicting labor outcome. |