| CTRI Number |
CTRI/2026/02/103454 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
“Study on First-Time Caesarean Deliveries in Low-Risk Pregnancies (NTSV: First-Time Mothers with Full-Term, Single, Head-Down Babies) at a Tertiary Care Hospital” |
|
Scientific Title of Study
|
Analysis of Primary Caesarean Section in NTSV (Nulliparous, Term, Single, Vertex) Pregnancy at a Tertiary Care Hospital. |
| 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 hinal shah |
| Designation |
post graduate |
| Affiliation |
jawaharlal nehru medical college belgavi |
| Address |
kles dr Prabhakar kore hospital
g -1 labour room Nehru nagar Belgaum Karnataka
Belgaum
KARNATAKA
590001
India |
| Phone |
9725663186 |
| Fax |
|
| Email |
hinalshah0407@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Dalal |
| Designation |
professor |
| Affiliation |
jawaharlal nehru medical college belgavi |
| Address |
kles dr Prabhakar kore hospital
g -1 labour room Nehru nagar Belgaum Karnataka
Belgaum
KARNATAKA
590001
India |
| Phone |
9448140343 |
| Fax |
|
| Email |
anitamgan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
dr hinal shah |
| Designation |
post graduate |
| Affiliation |
jawaharlal nehru medical college belgavi |
| Address |
kles dr Prabhakar kore hospital
g -1 labour room Nehru nagar Belgaum Karnataka
Belgaum
KARNATAKA
590001
India |
| Phone |
9725663186 |
| Fax |
|
| Email |
hinalshah0407@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr Prabhakar kore hospital, Belgaum,590001 |
|
|
Primary Sponsor
|
| Name |
DR HINAL SHAH primary investigator |
| Address |
kles dr Prabhakar kore hospital,
g -1 , labour room, Nehru nagar, belagavi |
| 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 |
| hinal shah |
kles dr Prabhakar kore hospital Belgaum |
G-1 floor, labour room, department of obstretics and gynaecology
Belgaum
KARNATAKA |
9725663186
hinalshah0407@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| jnmc institutional ethics committee |
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 |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
nulliparous women
term pregnancy
singleton
vertex presentation |
|
| ExclusionCriteria |
| Details |
multiparous women
abnormal lie
multiple pregnancy
preteen pregnancy
non vertex presentation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess the factors contributing to the caesarean section in nulliparous, term, singleton, vertex group of pregnancies |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to study maternal & neonatal outcome |
1 year |
|
|
Target Sample Size
|
Total Sample Size="345"
Sample Size from India="345"
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)
|
12/02/2026 |
| 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 document is about Dr Hinal Shah postgraduate research study at JN Medical College. The study looks at why first-time mothers, who are otherwise low-risk and expected to have a normal delivery , end up having a caesarean section.
Such cases are called NTSV pregnancies which means Nulliparous = first pregnancy, Term = full-term, Single = one baby, Vertex = head-first position. Normally, these women should deliver vaginally. The rise is a concern because unnecessary caesareans can cause more health problems for mothers, longer recovery, higher costs, and also increase the chances of repeat caesareans in future pregnancies.
The study will take place at a tertiary care hospital in Belagavi over one year. About 345 women will be studied. Their pregnancy details, reasons for caesarean, and outcomes for both mother and baby will be recorded and analyzed. The aim is to find out the main reasons for caesareans in this group and see if some of them can be avoided.
The project has ethical clearance, informed consent will be taken, and no extra risk or cost is involved for the patients.
In short, the research is trying to answer: “Why are so many low-risk first-time mothers having caesareans, and how can we reduce unnecessary ones?” |