| CTRI Number |
CTRI/2019/01/017020 [Registered on: 09/01/2019] Trial Registered Prospectively |
| Last Modified On: |
08/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
ultrasound scan done to measure babys head circumference and weight and the ability of that scan in predicting whether normal delivery can be done or cesarean delivery. |
|
Scientific Title of Study
|
Performance of sonographically estimated fetal head circumference and estimated fetal weight in predicting the risk of unplanned cesarean and instrumental delivery in term nulliparous women |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ramya |
| Designation |
Junior resident |
| Affiliation |
KMC manipal |
| Address |
Department of OBG, KMC manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8762981674 |
| Fax |
|
| Email |
ramyamunnur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vidyashree poojari |
| Designation |
Assistant professor |
| Affiliation |
KMC manipal |
| Address |
Department of OBG, KMC Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
drvidyaganesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vidyashree poojari |
| Designation |
Assistant professor |
| Affiliation |
KMC manipal |
| Address |
Department of OBG, KMC Manipal, Udupi
Hassan
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
drvidyaganesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba medical college, manipal |
|
|
Primary Sponsor
|
| Name |
KMC Manipal |
| Address |
Madhav nagar, manipal, Udupi |
| 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 |
| Ramya |
Kasturba Medical College, Manipal |
Madhav nagara, Manipal, Udupi
Udupi
KARNATAKA |
8762981674
ramyamunnur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Hospital Manipal |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Term nulliparous mothers with singleton pregnancy (>37 completed weeks)- spontaneous labor/ induced |
|
| ExclusionCriteria |
| Details |
1. Elective cesarean section (eg: placenta previa, maternal
request, CPD)
2. Emergency cesarean/ Instrumental delivery for fetal distress
3. Any unanticipated event in labor like abruption, cord prolapse
4. Any CNS anomaly |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| cesarean section done for prolonged, protracted labor |
within 6 hours of active labor |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Better predictor of labor outcome - Fetal HC or traditional
method of prediction?
Neonatal outcomes |
post delivery |
|
|
Target Sample Size
|
Total Sample Size="315"
Sample Size from India="315"
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)
|
11/02/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/02/2019 |
| 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
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
High rates of cesarean delivery, particularly primary cesarean delivery, are a concern for women and their care providers. In the present obstetric practise, estimated fetal weight by ultrasound is one of the determinants for the likelihood of operative vaginal delivery. There are growing body of evidence showing that the fetal head, as the part directly interfacing with the maternal pelvis, plays a significant role when compared to fetal weight, in the progress and outcome of labor. |