| CTRI Number |
CTRI/2018/10/016128 [Registered on: 24/10/2018] Trial Registered Prospectively |
| Last Modified On: |
24/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To investigate the correlation between serum bile acid level less than 40 micro mol/L in pregnancies affected with intrahepatic cholestasis of pregnancy(liver problem associated to pregnancy) and maternal and fetal outcomes |
|
Scientific Title of Study
|
To investigate correlation between raised serum bile acid levels in pregnancies affected with Intrahepatic Cholestasis of Pregnancy and adverse perinatal outcome. |
| Trial Acronym |
IHCP40 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kiranjeet Kaur |
| Designation |
Senior Consultant |
| Affiliation |
A unit of Gujramal Modi hospital and Research Centre for Medical Sciences |
| Address |
Max Smart Super Speciality Hospital,
Mandir Marg, Press Enclave Road, Saket, New Delhi
South
DELHI
110017
India |
| Phone |
9811253669 |
| Fax |
|
| Email |
kiranjeet.kaur@maxhealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiranjeet Kaur |
| Designation |
Senior Consultant |
| Affiliation |
A unit of Gujramal Modi hospital and Research Centre for Medical Sciences |
| Address |
Max Smart Super Speciality Hospital,
Mandir Marg, Press Enclave Road, Saket, New Delhi
South
DELHI
110017
India |
| Phone |
9811253669 |
| Fax |
|
| Email |
kiranjeet.kaur@maxhealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiranjeet Kaur |
| Designation |
Senior Consultant |
| Affiliation |
A unit of Gujramal Modi hospital and Research Centre for Medical Sciences |
| Address |
Max Smart Super Speciality Hospital,
Mandir Marg, Press Enclave Road, Saket, New Delhi
South
DELHI
110017
India |
| Phone |
9811253669 |
| Fax |
|
| Email |
kiranjeet.kaur@maxhealthcare.com |
|
|
Source of Monetary or Material Support
|
| Max Smart Super Speciality hospital, Mandir Marg, Press enclave Road, Saket, New Delhi- 110017 |
|
|
Primary Sponsor
|
| Name |
Max Smart Super Speciality Hospital |
| Address |
Max Smart Super Speciality Hospital,A unit of Gujramal Modi hospital and Research Centre for Medical Sciences,Mandir Marg, Press Enclave Road,Saket, New Delhi |
| 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 |
| Dr Kiranjeet Kaur |
Max Smart Super Speciality Hospital |
Department of Obstetrics and Gynecology, Mother and Child OPD, Room number G3. A unit of Gujramal Modi hospital and Research Centre for Medical Sciences
Mandir Marg, Press Enclave Road, Saket, New Delhi
South
DELHI |
9811253669
kiranjeet.kaur@maxhealthcare.com |
|
Details of Ethics Committee
Modification(s)
|
| 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: O266||Liver and biliary tract disordersin pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women presenting with pruritis with elevated liver enzymes
Primigravida or Multigravida
Spontaneous or IVF conception
Singleton or Twins |
|
| ExclusionCriteria |
| Details |
History of cholelithiasis
Chronic liver disease
Hepatitis A,B,C,E
Any other cause of raised liver function tests
Dermatological cause of pruritis
Allergic disorder
Pre eclampsia and HELLP
Patient refusal
Patient with pruritis but no elevation of liver enzymes
Pregnancy ending before 24 weeks gestation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate maternal and neonatal outcomes in Intrahepatic Cholestasis of pregnancy with Serum Bile Acids less than 40 micro mol per litre
|
Until delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the frequency of serum bile acid measurement in these patients |
2 weeks |
| To determine the optimal timing of delivery with close monitoring in these patients |
40 weeks gestation |
|
|
Target Sample Size
|
Total Sample Size="174"
Sample Size from India="174"
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)
|
01/11/2018 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
None yet, as and when if there is any publication it will be informed |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Patients fulfilling the inclusion and exclusion criteria for intrahepatic cholestasis of pregnancy will be recruited in the study followed by monitoring of serum bile acids and liver function tests every fortnightly. The decision for deliver will be taken on the basis of serum bile acid level and maternal , fetal or other complication. The patients will be followed until delivery and maternal and neonatal outcomes would be recorded.
24/11/19 the study is still in the recruiting phase as the desired sample size has not been achieved. |