| CTRI Number |
CTRI/2021/04/032988 [Registered on: 22/04/2021] Trial Registered Prospectively |
| Last Modified On: |
20/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [Phototherapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of treatment with UDCA vs UDCA & Phototherapy in patients of jaundice of Pregnancy |
|
Scientific Title of Study
|
A Comparative Study Of Selected Outcomes Of Treatment With Ursodeoxycolic Acid (UDCA) Vs UDCA+ Phototherapy In Patients With Intrahepatic Cholestasisof Pregnancy - Randomized Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Apphia Saphir Kathi |
| Designation |
JR |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Obstetrics And Gynecology
AFMC
PUNE
Sholapur Road
Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
8075766341 |
| Fax |
|
| Email |
apphiasaphirk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr AK Srivastava |
| Designation |
Professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Obstetrics and GYnecology
AFMC
Pune
Sholapur Road
Oune
Pune
MAHARASHTRA
411040
India |
| Phone |
8075766341 |
| Fax |
|
| Email |
ajaidoc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Apphia Saphir Kathi |
| Designation |
JR |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Obstetrics and Gynecology
AFMC
PUNE
Sholapur Road
Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
8075766341 |
| Fax |
|
| Email |
apphiasaphirk@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Armef Forces Medical College |
| Address |
Sholapur Road
Pune |
| 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 |
| Dr Apphia |
Family ward, Command Hospital Pune |
Department of Obstetrics and Gynecology
Command Hospital Pune
Wanwadi
Pune
MAHARASHTRA |
8075766341
apphiasaphirk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical Research and ethical committee, AFMC Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O266||Liver and biliary tract disordersin pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
UDCA |
Group 1 will receive UDCA 10-15 mg per kg per day, daily BD or TDS till 37 weeks period of gestation |
| Comparator Agent |
UDCA and Phototherapy |
Group 2 will receive UDCA 10-15 mg per kg per day daily and UV B phototherapy at 400- 500 mJ per sq cm twice weekly upto 37 wks period of gestation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
All ANC cases with IHCP |
|
| ExclusionCriteria |
| Details |
Women with pruritic skin diseases and other liver pathologies wh are already on treatment for IHCP
Lethal fetal anomalies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| additional benefit of Phototherapy in treatment of IHCP |
at baseline and weekly till delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
5D Pruritus Scale for assessment of Pruritus
Lab Parameters
ALT and AST
Serum Alkaline Phosphatase
Gamma Glutamyl Transferase
Serum Bilirubin
|
1 yr |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
25/04/2021 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Intrahepatic cholestasis of pregnancy is a reversible form of hormonally triggered cholestasis that typically develops in genetically predisposed individuals in late pregnancy. The aim of treatment is the reduction of serum bile acid levels in order to prolong pregnancy and reduce both fetal risks and maternal symptoms. Ursodeoxycholic acid (UDCA) not only reduces maternal pruritus but to also improves fetal prognosis.Both narrowband (NBUVB) and broadband (BBUVB) ultraviolet B light phototherapy are considered safe options in pregnancy. Phototherapy to the skin with ultraviolet (UV) light B is used by some clinicians to treat the pruritus of cholestasis. UVB has been variably helpful in IHCP. My aim is to compare the selected outcomes of treatment with URSODEOXYCHOLIC ACID (UDCA) vs UDCA+PHOTOTHERAPY in patients with Intrahepatic Cholestasis of Pregnancy |