| CTRI Number |
CTRI/2021/02/030936 [Registered on: 02/02/2021] Trial Registered Prospectively |
| Last Modified On: |
25/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A CLINICAL TRIAL TO STUDY THE COMPARISON BETWEEN ULTRASOUND PARAMETERS AND DIGITAL VAGINAL EXAMINATION TO ASSESS FETAL HEAD STATION IN LABOR |
|
Scientific Title of Study
|
COMPARISON BETWEEN TRANSPERINEAL ULTRASOUND PARAMETERS AND CLINICAL EXAMINATION TO ASSESS FETAL HEAD STATION IN LABOR |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr NIPASA SARMA |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College |
| Address |
Dept of Obstetrics and Gynaecology, Kasturba Hospital, Manipal, Udupi
Kasturba Medical College, Manipal- 576104, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8810457450 |
| Fax |
|
| Email |
nipasasharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr JYOTHI SHETTY |
| Designation |
PROF AND HOU, OBG- 4 |
| Affiliation |
Kasturba Medical College |
| Address |
Dept of Obstetrics and Gynaecology, Kasturba Hospital, Manipal, Udupi
Kasturba Medical College, Manipal- 576104, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9845973697 |
| Fax |
|
| Email |
jyothi.shetty@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr NIPASA SARMA |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College |
| Address |
Dept of Obstetrics and Gynaecology, Kasturba Hospital, Manipal, Udupi
Kasturba Medical College, Manipal- 576104, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8810457450 |
| Fax |
|
| Email |
nipasasharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Kasturba Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
KASTURBA HOSPITAL |
| Address |
Dept of Obstetrics and gynaecology, Kasturba hospital, Kasturba Medical College, 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 |
| Dr Jyothi Shetty |
Kasturba Hospital |
Room no- 4, OBG OPD,
Dept of obstetrics and gynaecology,
Kasturba Hospital,
Kasturba Medical College,
Manipal, Udupi, Karnataka
Udupi
KARNATAKA |
9845973697
jyothi.shetty@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital 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 |
| Comparator Agent |
nil |
nil |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant women who are scheduled for induction of labor or with spontaneous onset of labor
2. Singleton pregnancy at gestational age 36 to 40 weeks
3. Women in labor and regular uterine contractions and changes in cervical dilatation of more than 2 cm
|
|
| ExclusionCriteria |
| Details |
1. Previous LSCS
2. Multiple pregnancy
3. Cephalopelvic Disproportion
4. Abnormal cardiotocography at enrollment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Correlation between the ultrasound parameters
2. Correlation between the ultrasound parameters and digitally palpated fetal head station |
22 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Outcome of labor |
22 months |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
05/02/2021 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Prospective observational study will be conducted in Kasturba Hospital, Manipal. Ethical clearance by Institutional ethical committee (IEC), Kasturba hospital is taken. Pregnant women admitted in the hospital will be screened for inclusion and exclusion criteria through proforma where baseline demographic characteristics will be obtained. A written informed consent from the participants will be taken after a brief explanation about the procedure. Ultrasound probe is enclosed in a powder free latex glove will be placed in the maternal perineum in midsaggital plane between the labia. Head perineum distance will be measured by holding transducer transversely over the ischial tuberosity. Ultrasound parameters will be measured and recorded in a data sheet. Ultrasound parameters are- i. Intrapartum trans perineal ultrasound fatal head station ii. Head perineum distance iii. Angle of descent Vaginal examination will be done by the managing clinician and will be blinded to the ultrasound data and will coincide with TPU assessments. All the above mentioned findings will be recorded in a data sheet to evaluate the correlation coefficient( r). |