Gallbladder Functions & Serum Cholecystokinin Levels in Pregnant Women Diagnosed With Hyperemesis Gravidarum
Conditions: Hyperemesis Gravidarum, Pregnancy Related
Sponsor: Müge Keskin

 
September 26, 2021 
Evaluation of Plasma Cholecystokinin (CCK) Levels and Gallbladder (GB) Functions in 
Hyperemesis Gravidarum 
NCT 03950167. 
 
 

Background: The pathophysiology of hyperemesis gravidarum (HG)  remains poorly 
understood. A multifactorial origin, including infective, anatomical and psychological factors, 
and hormonal changes of pregnancy has been proposed. Altered cholecystokinin (CCK) levels 
may have potential consequences on gastric emptying, which may be related to nausea and 
vomiting. In this context, alterations in CCK secretion in women diagnosed with HG have been 
previously reported, and alterations in CCK levels lead to impaired gallbladder (GB) functions. 
 
Objective: In this study, we aimed to evaluate fasting and post-prandial CCK levels, and GB 
function in HG patients. 
 
Design: Prospective cohort study 
 
Methods: HG patients who present before the end of the 14th week of gestation at our obstetrics 
outpatient clinic, with persistent vomiting and routine prenatal visits, will  be  recruited. The 
required evaluations, including the collection of venous blood samples and sonographic 
evaluation of GB functions, will be performed at the initial assessment.  
After a 12-hour overnight fasting period, venous blood samples will be collected for routine 
haematological, biochemical, hormonal tests and CCK levels. Transabdominal ultrasonography 
(US) will be performed to assess GB functions. Subsequently, a fatty test meal (100 g of milk 
chocolate) will be administered to the patients. The postprandial CCK concentrations at 15 min 
after meal intake will be measured. The postprandial GB volume (PGv) will be measured using 
the same US equipment by the same radiologist for each patient at the 45th minute after the 
meal  
 
Statistical analysis: 
 
Statistical analyses will be performed using SPSS for Windows, version 22.0 (SPSS Inc., 
Chicago, IL, United States). Since this is the first study comparing both CCK levels and GB 
functions in patients diagnosed with HG and healthy pregnant women, a power analysis is not 
feasible. The distribution of continuous variables (normal or skewed) will be determined with 
the Shapiro-Wilks test. Levene’s test will be used for the evaluation of the homogeneity of 
variances. Unless specified otherwise, continuous data will be described as mean ± SD for 
normal distributions, and median (inter-quartile range) for skewed distributions. The two 
groups will be compared with Student’s t-test for normally distributed variables and the Mann- 
Whitney U test for the data that were not normally distributed. Degrees of relation between the 
variables will be evaluated with the Pearson or Spearman correlation analysis. A p value of 
<0.05 will be accepted as significant in all statistical analyses.