| CTRI Number |
CTRI/2018/08/015286 [Registered on: 13/08/2018] Trial Registered Retrospectively |
| Last Modified On: |
02/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Comparitive study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of outcome of normal pregnancy and pregnancy with complications based on cerebroplacental ratio detected by ultrasound scan |
|
Scientific Title of Study
|
Comparison of outcome of Low-risk and High-risk pregnancies based on fetal cerebroplacental ratio assessed by Doppler studies |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shemini Saleem |
| Designation |
Resident Obstetrics and Gynecology |
| Affiliation |
Kerala Institute of Medical Science |
| Address |
Kerala Institute of Medical Science
PB No. 1
Anayara
Trivandrum
Thiruvananthapuram KERALA 695029 India |
| Phone |
9846634057 |
| Fax |
|
| Email |
drshemini@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Vidyalekshmy R |
| Designation |
Coordinator High risk OBG and Consultant Perinatology |
| Affiliation |
Kerala Institute of Medical Science |
| Address |
Kerala Institute of Medical Science
PB No. 1
Anayara
Trivandrum
Thiruvananthapuram KERALA 695029 India |
| Phone |
9495959496 |
| Fax |
|
| Email |
drvidyalekshmy@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Shemini Saleem |
| Designation |
Resident Obstetrics and Gynecology |
| Affiliation |
Kerala Institute of Medical Science |
| Address |
Kerala Institute of Medical Science
PB No. 1
Anayara
Trivandrum
Thiruvananthapuram KERALA 695029 India |
| Phone |
9846634057 |
| Fax |
|
| Email |
drshemini@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kerala Institute of Medical Science |
|
|
Primary Sponsor
|
| Name |
Kerala Institute of Medical Science |
| Address |
PB No.1
Anayara P.O
Trivandrum |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Shemini Saleem |
Kerala Institute of Medical Science |
Department of Obstetrics and Gynecolog
Kerala Institute of Medical Science
PB No. 1
Anayara P.O
Trivandrum Thiruvananthapuram KERALA |
9846634057
drshemini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee Kerala Institute of Medical Science Trivandrum |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pregnant women 28 to 36 weeks, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Low-risk Pregnancy
a.Singleton pregnancy
b.Gestational age of patient should be between 30 and 38 weeks
2.High-risk Pregnancy
a.Singleton pregnancy
b.Gestational age of patient should be between 30 and 38 weeks
c.At least one of the following risk factor was present in study group pregnant women.
i.Gestational hypertension
ii.Essential hypertension
iii.Prior neonatal death
iv.Diabetes mellitus
v.Malnutrition
vi.Anemia |
|
| ExclusionCriteria |
| Details |
1.Multiple Pregnancy
2.Congenital anomalies in fetus
3.Not willing to participate
|
|
|
Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
Perinatal outcome - Admission in NICU
|
Up to two week post delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Obstetrical outcome - Mode of Delivery
|
Till Delivery |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
12/04/2018 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not Yet completed |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
FGR
is normally used to refer to small fetuses with higher risk for fetal inutero
deterioration, stillbirth and overall poorer perinatal outcome as compared with
normally grown fetuses. They are associated with Doppler signs suggesting
hemodynamic redistribution as a reflection of fetal adaptation to under
nutrition /hypoxia, histological and biochemical signs of placental disease and
a higher risk of preeclampsia. The term SGA has been used to differentiate a
subgroup of small fetuses that do not present the changes described above. While
the concepts of FGR and SGA may be clear, distinction of ‘True FGR’ in clinical
practice can be challenging.
Population based series
show that prenatal identification of SGA babies’ results in a reduction of
adverse perinatal outcome and stillbirth. However, most SGA babies remain
unnoticed until birth, even when routine third trimester ultrasound is
performed. In late SGA fetuses, abnormal CPR is present before delivery
in 20-25% of the cases. We propose that low fetal CPR is associated with
adverse perinatal outcome. This study aims to evaluate the Cerebro Placental
Ratio, which is the ratio of Pulsatality Index of fetal middle cerebral and Umbilical
Artery, in normal and high-risk pregnancies during 28 – 36 weeks of gestation
and compare the fetal and neonatal outcome.
|