| CTRI Number |
CTRI/2025/06/089323 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Alterations in the placenta in pregnant mothers with gestational diabetes mellitus. |
|
Scientific Title of Study
|
Placental changes in women with Gestational Diabetes Mellitus : A cross sectional 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. Nipunika Singh |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand Medical College and Hospital , Pilibhit Bypass Road,Bareilly |
| Address |
Department of Obstetrics and Gynaecology Room No: 2029,Rohilkhand Medical College and Hospital , Pilibhit Bypass Road,Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7338236050 |
| Fax |
|
| Email |
nipunikasingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Ranjana Gupta |
| Designation |
Professor of Obstetrics and Gynaecology |
| Affiliation |
Rohilkhand Medical College and Hospital , Pilibhit Bypass Road,Bareilly |
| Address |
Department of Obstetrics And Gynaecology, Room No: 2029 Rohilkhand Medical College, Pilibhit Bypass Road, Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7351326155 |
| Fax |
|
| Email |
ranj2036@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Nipunika Singh |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand Medical College and Hospital , Pilibhit Bypass Road,Bareilly |
| Address |
Department of Obstetrics and Gynaecology Room No: 2029,Rohilkhand Medical College and Hospital , Pilibhit Bypass Road,Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7338236050 |
| Fax |
|
| Email |
nipunikasingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand Medical College and Hospital , Pilibhit Bypass Road,Bareilly 243006, India |
|
|
Primary Sponsor
|
| Name |
Dr Nipunika Singh |
| Address |
Rohilkhand Medical College and Hospital , Pilibhit Bypass Road,Bareilly,243006, India |
| 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 Nipunika Singh |
Rohilkhand Medical College and Hospital , Pilibhit Bypass Road,Bareilly |
Department of Obstetrics and Gynaecology Room No: 2029,Rohilkhand Medical College and Hospital , Pilibhit Bypass Road,Bareilly
Bareilly
UTTAR PRADESH |
7338236050
nipunikasingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O098||Supervision of other high risk pregnancies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
ALL pregnant women with gestational diabetes mellitus who give consent. |
|
| ExclusionCriteria |
| Details |
Pregnant women with Type 1 diabetes mellitus.
Pregnant women with Type 2 diabetes mellitus.
Pregnant women with genetic or drug induced glucose intolerance.
Pregnant women with MODY (Maturity onset diabetes of the youth). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Radiological Examination of Placenta:
Placental thickness
Cord thickness
Gross Examination of Placenta
Placental weight
Cord length
Cord insertion site
Histopathological Examination of Placenta:
Diameter
Area
Circumference
Central thickness
Villous immaturity
Fibrinoid degeneration
Syncytial knots or Peinatal Outcome:
Fetal weight
APGAR Score 1min/5min
NICU admission
sprouts
|
At 28 weeks period of gestation, at term and post delivery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Outdoor patient visit followed by duration of stay during delivery. |
1 week after delivery. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
07/07/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The data will be collected from
obstetric cases of gestational diabetes that will be presenting at RMCH. The
study subject will be recruited in the study after approval of study of
Institutional Ethics committee, RMCH Bareilly. An Informed written consent will
be taken from the study participants. All data regarding patient’s name, age,
parity, socio-economic status, address, time, date, place and current obstetric
history, past obstetric history, past menstrual history, family history and
personal history, medical comorbities,
ultrasonographical investigation including
placental
thickness and cord
thickness
performed in the 3rd
trimester of the pregnancy and any
investigations if needed and mode of delivery. Gross
examination including placental weight, cord length, site of cord insertion.
Histopathological examination including diameter, area, circumference, central
thickness, villous immaturity, fibrinoid degeneration and syncytial knots and
sprouts. Neonatal birth weight,
APGAR score at 1min and 5min, need for NICU admissions, its indications and
outcome.
Objectives:
·To study the various gross and histomorphological placental changes in women with
gestational diabetes mellitus.
·To study the radiological placental
alterations in mothers with gestational diabetes mellitus considering placental
thickness and cord thickness.
·To assess foetal outcome in terms
of birth weight, APGAR score and need for NICU admission. |