| CTRI Number |
CTRI/2021/05/033345 [Registered on: 04/05/2021] Trial Registered Prospectively |
| Last Modified On: |
03/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Use of doppler ultrasound and progesterone in predicting outcome in women with threatened miscarriage |
|
Scientific Title of Study
|
Ultrasound parameters, Doppler and Serum Progesterone level for prediction of early pregnancy outcome in women experiencing threatened miscarriage |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavitha D Nayak |
| Designation |
Junior resident |
| Affiliation |
KMC MANIPAL |
| Address |
Department of OBG
KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448655487 |
| Fax |
|
| Email |
kavithanayak1507@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIDYASHREE G POOJARY |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
KMC MANIPAL |
| Address |
DEPARTMENT OF OBG
KMC MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
9901731619 |
| Fax |
|
| Email |
vidyashree.g@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Kavitha D Nayak |
| Designation |
Junior resident |
| Affiliation |
KMC MANIPAL |
| Address |
Department of OBG
KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448655487 |
| Fax |
|
| Email |
kavithanayak1507@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kavitha D Nayak |
| Address |
Department of OBG
KMC MANIPAL |
| 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 |
| Kavitha D Nayak |
KMC MANIPAL |
DEPARTMENT OF OBG , WOMEN AND CHILD BLOCK
Udupi
KARNATAKA |
9448655487
kavithanayak1507@gmail.com |
|
|
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: O200||Threatened abortion, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women with signs and symptoms of threatened miscarriage between 8 and 14 weeks of pregnancy -both spontaneous and ART conception (according to a documented early ultrasonography scan and the date of the last menstrual period given by the participant ) |
|
| ExclusionCriteria |
| Details |
Missed Miscarriage , Multiple Pregnancy ,Molar pregnancy ,Maternal history of a systemic disease , Uterine anatomic anomalies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Early pregnancy outcome up to 20 weeks |
10 weeks -12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complications in pregnancy beyond 20 weeks ,late pregnancy outcome |
18 weeks to 20 weeks |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
10/05/2021 |
| 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="2"
Months="0"
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
|
This is a Prospective observational study . This study involves pregnant women between 8 to 14 weeks presenting with symptoms and signs of threatened abortion . Their demographic characteristics ,obstetric history and Period of gestation are noted .Transvaginal ultrasound performed to determine gestational age , parameters like G sac, yolk sac ,CRL ,sub chorionic hematoma are noted . Uterine artery dopplers on both sides and mean values are calculated .Serum progesterone level is estimated . Each patient continues her treatment as per her assigned obstetrician .Pregnancy outcome is documented until 20 weeks . This is the primary outcome . Secondary outcome includes complications developing in pregnancy beyond 20 weeks and late pregnancy outcome . |