| CTRI Number |
CTRI/2024/03/063845 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
07/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Placental volume by three-dimensional ultrasound in first trimester as a predictor of low birth weight infant: A prospective Cohort Study |
|
Scientific Title of Study
|
Placental volume by three-dimensional ultrasound in first trimester as a predictor of low birth weight infant: A prospective Cohort Study |
| 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.Termtem Waidee |
| Designation |
lecturer |
| Affiliation |
Srinagarind Hospital |
| Address |
Room no.1
Department of Obstetrics and Gynecology.
Khon kaen university.
123/16 Nai Mueang, Mueang Khon Kaen District, Khon Kaen
Thailand
40000
40000
Other |
| Phone |
695672807 |
| Fax |
|
| Email |
termwa@kku.ac.th |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Termtem Waidee |
| Designation |
lecturer |
| Affiliation |
Srinagarind Hospital |
| Address |
Room no.1
Department of Obstetrics and Gynecology.
Khon kaen university.
123/16 Nai Mueang, Mueang Khon Kaen District, Khon Kaen
Thailand
40000
40000
Other |
| Phone |
695672807 |
| Fax |
|
| Email |
termwa@kku.ac.th |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Termtem Waidee |
| Designation |
lecturer |
| Affiliation |
Srinagarind Hospital |
| Address |
Room no.1
Department of Obstetrics and Gynecology.
Khon kaen university.
123/16 Nai Mueang, Mueang Khon Kaen District, Khon Kaen
Thailand
40000
40000
Other |
| Phone |
6956728072 |
| Fax |
|
| Email |
termwa@kku.ac.th |
|
|
Source of Monetary or Material Support
|
| Srinagarind Hospital is a university teaching hospital, affiliated to the Faculty of Medicine of Khon Kaen University |
|
|
Primary Sponsor
|
| Name |
Srinagarind Hospital |
| Address |
123/16 Nai Mueang, Mueang Khon Kaen District, Khon Kaen 40000
Thailand |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| Srinagarind Hospital |
123/16 Nai Mueang, Mueang Khon Kaen District, Khon Kaen 40000 |
|
|
Countries of Recruitment
|
Thailand |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrTermtem Waidee |
Srinagarind Hospital |
Room no.1
Department of Obstetrics and Gynecology.
Khon kaen university.
123/16 Nai Mueang, Mueang Khon Kaen District, Khon Kaen
Thailand
40000
|
0956728072
termwa@kku.ac.th |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Center for Ethics in Human Research, Khon Kaen University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
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
- Gestational age less than 14 weeks gestation |
|
| ExclusionCriteria |
| Details |
- Pregnant woman who has history of fetal abnormality
- Pregnant woman who has history of placental tumor
- Pregnant woman who has history of myoma uteri |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Low birth weight |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| APGAR score of newborn |
After delivery |
|
|
Target Sample Size
|
Total Sample Size="163"
Sample Size from India="0"
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)
|
22/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/03/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [termwa@kku.ac.th].
- For how long will this data be available start date provided 31-01-2024 and end date provided 01-01-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Low birth weight is defined as a birth weight less than 2500 grams, and this is a global problem. Factors that can contribute to low birth weight, including maternal, fetal, and placental factors, involve placental pathology. Therefore, investigating placental volume might help describe or predict low birth weight. |