| CTRI Number |
CTRI/2024/04/066375 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Prospective and comparative study of perinatal outcomes among monochorionic and dichorionic twins at tertiary care centre at GMC Aurangabad. |
|
Scientific Title of Study
|
Prospective and comparative study of perinatal outcomes among monochorionic and dichorionic twins at tertiary care centre at GMC Aurangabad |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sumit Jeena |
| Designation |
DM Senior Resident Neonatology |
| Affiliation |
GMC Aurangabad Neonatology Department |
| Address |
room no.2 A block MARD Hostel Ghati Hospital Aurangabad
NICU Neonatology department Ghati hospital Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
09756216477 |
| Fax |
|
| Email |
sumit.jeena@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
L S Deshmukh |
| Designation |
Professor and Head Dept. Neonatology GMC Aurangabad |
| Affiliation |
GMC Aurangabad |
| Address |
Department of Neonatology GMC Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9822478275 |
| Fax |
|
| Email |
deshmukhls@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sumit Jeena |
| Designation |
DM Senior Resident Neonatology |
| Affiliation |
GMC Aurangabad |
| Address |
room no.2 A block MARD Hostel Ghati Hospital Aurangabad
NICU Department of Neonatology Ghati hospital Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
09756216477 |
| Fax |
|
| Email |
sumit.jeena@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Sumit Jeena GMC Aurangabad |
|
|
Primary Sponsor
|
| Name |
Sumit Jeena |
| Address |
room no.2 A block MARD Hostel Ghati Hospital Aurangabad |
| Type of Sponsor |
Government 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 |
| Sumit Jeena |
GMC Aurangabad |
Department of Neonatology 2nd floor
Aurangabad
MAHARASHTRA |
9756216477
sumit.jeena@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: P015||Newborn affected by multiple pregnancy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Twin pregnancies |
Monochorionic and Dichorionic pregnancies |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
all twin neonates born in NICU Aurangabad |
|
| ExclusionCriteria |
| Details |
Age more than 28 days |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| neonatal outcomes in twins gestation with relation to chorionicity |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Influence of chorionicity on neonatal mortality and morbidity
in twin gestation |
1year |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "365"
Final Enrollment numbers achieved (India)="365" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/05/2024 |
| Date of Study Completion (India) |
31/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/07/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Abstract
Objective
:- The aim of this study was to evaluate chorionicity
in twin pregancies and its impact on perinatal outcomes
Design
:- This is a prospective observational study
Setting:- This study
was conducted in Department of Neonatology in
Government Medical College Chhatrapati Sambhaji Nagar, a tertiary care public
hospital for a period of 18 months, between January2024 to July 2025
Participants
:- 251 mothers with DCDA and 114 mothers with
uncomplicated MCDA twins were enrolled and followed till discharge including
those admitted in NICU.Chorionicity was confirmed at delivery by examination of
placenta and membranes
Main
Outcome Measures :- Monochorionic
twins have higher perinatal morbidity and mortality than dichorionic twins
Results:- In our hospital, 365 patients presented with
multiple pregnancy. The incidence of twin pregnancy in our study was 1.42%. Mean maternal age of
patients in our study was 25.3 years.
With respect to chorionicity, 68.77% of women were dichorionic, 30.09% were
monochorionic diamniotic and 0.54% patients were monochorionic monoamniotic.
There was no maternal mortality in our study. In our study 10.68% of patients
conceived following ovulation induction, IUI or IVF. In our cohort, significant
association between low birth weight and chorionicity was established. The most
common cause for neonatal intensive care admission was prematurity in both
dichorionic 303/410 (73.90%) and monochorionic twins, 189/208 (90.86%) babies.
Respiratory distress syndrome was more common among monochorionic babies (41.82%
vs 26.83%). Neonatal deaths occurred in 50/502 (9.96%) babies of dichorionic
babies, while in 29/228 (13.94%) monochorionic babies died. Perinatal mortality
rate is 17.10% in monochorionic twins and 11.55% in dichorionic twins.
Conclusions:- MC twins are at more risk to develop various
complications. Chorionicity should be determined on ultrasound in all twins
preferably in first trimester.
Early diagnosis of twin pregnancy and proper
follow up throughout pregnancy improves perinatal outcome.
|