Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00471575
Status:
UNKNOWN
Last Update Posted:
2007-05-15
First Post:
2007-05-09
Brief Title:
Fatty Liver in Pregnancy
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Assaf-Harofeh Medical Center
Study Overview
Official Title:
Prospective Observational Study
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Non alcoholic fatty liver disease NAFLD is one of the main causes of development of chronic liver disease and cirrhosis There are no published studies which have investigated the incidence of NAFLD in pregnant women or the correlation between the metabolic changes in pregnancy and this phenomenon
We aimed in our study to explore the incidence of NAFLD in pregnancy by ultrasonography US during the end of the pregnancy or immediately after birth after 36 weeks and to look for a correlation between fatty liver and demographic clinical nutritional and laboratory data during pregnancy
We aimed in our study to explore the incidence of NAFLD in pregnancy by ultrasonography US during the end of the pregnancy or immediately after birth after 36 weeks and to look for a correlation between fatty liver and demographic clinical nutritional and laboratory data during pregnancy
Detailed Description:
Fatty liver in pregnancy-protocol
Non alcoholic fatty liver disease NAFLD is one of the main causes of development of chronic liver disease and cirrhosis The incidence of NAFLD among the general population is about 17-30 There are no published studies which have investigated the incidence of NAFLD in pregnant women or the correlation between the metabolic changes in pregnancy and this phenomenon
We aimed in our study to explore the incidence of NAFLD in pregnancy by ultrasonography US during the end of the pregnancy or immediately after birth after 36 weeks and to look for a correlation between fatty liver and demographic clinical nutritional and laboratory data during pregnancy
Methods US examination will be performed by an experienced technician The liver will be scanned by B mode US using a 2-5 MHZ transducer In those with fatty liver as seen by US a repeat examination will be performed after 6 weeks and 24 weeks For women with the diagnosis of fatty liver serum lipid profile glucose liver function tests and insulin will be done Homa score as well as BMI will be calculated for each woman with fatty liver All participants will sign an informed consent which has been approved by the hospital ethical committee
Non alcoholic fatty liver disease NAFLD is one of the main causes of development of chronic liver disease and cirrhosis The incidence of NAFLD among the general population is about 17-30 There are no published studies which have investigated the incidence of NAFLD in pregnant women or the correlation between the metabolic changes in pregnancy and this phenomenon
We aimed in our study to explore the incidence of NAFLD in pregnancy by ultrasonography US during the end of the pregnancy or immediately after birth after 36 weeks and to look for a correlation between fatty liver and demographic clinical nutritional and laboratory data during pregnancy
Methods US examination will be performed by an experienced technician The liver will be scanned by B mode US using a 2-5 MHZ transducer In those with fatty liver as seen by US a repeat examination will be performed after 6 weeks and 24 weeks For women with the diagnosis of fatty liver serum lipid profile glucose liver function tests and insulin will be done Homa score as well as BMI will be calculated for each woman with fatty liver All participants will sign an informed consent which has been approved by the hospital ethical committee
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None