| CTRI Number |
CTRI/2021/06/033963 [Registered on: 03/06/2021] Trial Registered Prospectively |
| Last Modified On: |
02/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
correlation between Umbilical Cord Coiling in pregnancy and post delivery outcome of the baby
|
|
Scientific Title of Study
|
Antenatal Umbilical Cord Coiling Index
and Perinatal Outcome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr D Suma |
| Designation |
junior resident |
| Affiliation |
kasturba medical college, Manipal |
| Address |
Department of OBG
kasturba medical college, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9652472730 |
| Fax |
|
| Email |
sumadaliparthy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyamala G |
| Designation |
Professor |
| Affiliation |
kasturba medical college, Manipal |
| Address |
Room no 1; Department of OBG
kasturba medical college, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844551037 |
| Fax |
|
| Email |
shyamaladoc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr D Suma |
| Designation |
junior resident |
| Affiliation |
kasturba medical college, Manipal |
| Address |
Department of OBG
kasturba medical college, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9652472730 |
| Fax |
|
| Email |
sumadaliparthy@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kasturba medical college |
| Address |
Department of OBG
Kasturba medical college
Manipal |
| 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 |
| D Suma |
Kasturba hospital, Manipal |
Room number 1 ,women and child block. Department of OBG
Udupi
KARNATAKA |
9652472730
sumadaliparthy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC and KH IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Healthy women with singleton live foetuses with no maternal and fetal complications detected at late second trimester(18-28 weeks)and early 3rd trimester for doppler evaluation(28-32 weeks) with no gross fetal anomalies
|
|
| ExclusionCriteria |
| Details |
Multiple gestations
Pregnancy with medical disorders (chronic hypertension, overt diabetes, cardiac disease, hepatic and renal impairment)
Low AFI (<5cm) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Intrauterine growth retardation (IUGR)
Preterm delivery
Presence of meconium-stained amniotic fluid
Delivery intervention due to fetal distress(Instrumental/caesarean section)
APGAR scores 7 at 5min
Small for gestational age
|
at 18 weeks period of gestation i will measure umbilical cord coiling via ultrasound and i will measure velocity of blood flow in umbilical vein at 28 weeks of gestation and correlate with outcome variables immediate post delivery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
10/06/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
AFTER COMPLETION OF STUDY I WOULD LIKE TO PUBLISH |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Umbilical cord is a narrow cord of tissue that connects a developing foetus with the placenta
One important feature of the umbilical cord is its coiling index (UCI).
A coil is defined as completed 360 degrees spiral course of umbilical vessels around Wharton’s jelly.
The cause of abnormal cord coiling is not known.
Abnormal cord coiling was associated with thrombosis of chorionic plate vessels, umbilical venous thrombosis, and cord stenosis. Umbilical coiling affects the venous return to the fetus, Hypo-coiling leads to reduced venous return and is associated with reduced flow indices in the umbilical vein Effects on fetal well-being are chronic (growth retardation) and acute (fetal intolerance to labor and fetal demise). |