Hyperemesis Gravidarum, Pregnancy Related
Conditions
Keywords
gallbladder functions, cholecystokinin, hyperemesis gravidarum
Brief summary
This study evaluates the gallbladder functions and serum cholecystokinin levels in pregnant women diagnosed with hyperemesis gravidarum. Half of the participants are healthy pregnant women and half of the participants are pregnant women diagnosed with hyperemesis gravidarum. Two groups will be compared by means of gallbladder functions and serum cholecystokinin levels.
Detailed description
Previously gallbladder functions have been observed in human with gallbladder disease. However it has never been evaluated whether there is any difference in gallbladder functions between healthy pregnant women and pregnant women diagnosed with hyperemesis gravidarum. Moreover correlation between hyperemesis gravidarum symptom scores and gallbladder functions has never been assessed. There is also few data comparing serum cholecystokinin levels between healthy pregnant women and those diagnosed with hyperemesis gravidarum. The investigators will measure serum cholecystokinin levels after a fatty meal (100 g chocolate) and compare two groups. In this study the investigators would like to evaluate gallbladder functions and serum cholecystokinin levels in women with hyperemesis gravidarum and compare these with healthy subjects.
Interventions
None listed
Sponsors
Müge Keskin
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* gestation week between 6 and 14 weeks, * singleton pregnancy with a live embryo, * healthy women without any medical disorders,
Exclusion criteria
* any systemic disease, * gallbladder disease * any psychological disorder that can cause vomiting, * multiple gestation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Cholecystokinin (CCK) Levels | Fasting (baseline) and postprandial (15 minutes after the test meal) CCK level | a gut hormone released, its level can be measured in blood as fasting level and postprandial |
| Gallbladder (GB) Wall Thickness | fasting and postprandial 45th minute | GB wall thickening measured with abdominal ultrasound at fasting and postprandial |
| Gallbladder (GB) Volume | fasting and postprandial 45th minute | volume of GB measured with abdominal ultrasound at fasting and postprandial |
| Gallbladder (GB) Ejection Fraction | The fasting and postprandial 45th minute | GB ejection fraction measures how much bile gallbladder releases at one time, expressed as percentage |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
This is a prospective cohort study conducted in Ufuk University hospital, Ankara, Turkey (a tertiary center) between March 2019 and May 2020.
Pre-assignment details
Excluded (n=275) * Not meeting inclusion criteria (n=163) Inclusion criteria were: gestation week between 6 and 14 weeks, singleton pregnancy with a live embryo, age range between 18 and 40 years, healthy women without any medical disorders, Women with any systemic disease, gallbladder disease or any psychological disorder that can cause vomiting, multiple gestation were excluded. * Declined to participate (n=112)
Participants by arm
| Arm | Count |
|---|---|
| Hyperemesis Gravidarum pregnant women before 14 weeks of pregnancy diagnosed with hyperemesis gravidarum will be assessed in terms of gallbladder functions and serum cholecystokinin levels after a fatty meal. | 24 |
| Healthy Pregnant Women Healthy pregnant women before 14 weeks of pregnancy without hyperemesis gravidarum will be assessed in terms of gallbladder functions and serum cholecystokinin levels after a fatty meal. | 22 |
| Total | 46 |
Baseline characteristics
| Characteristic | Healthy Pregnant Women | Hyperemesis Gravidarum | Total |
|---|---|---|---|
| age | 30.08 years STANDARD_DEVIATION 4.03 | 30.91 years STANDARD_DEVIATION 4.2 | 30.49 years STANDARD_DEVIATION 4.11 |
| Age, Continuous | 30.91 years STANDARD_DEVIATION 4.2 | 30.08 years STANDARD_DEVIATION 4.03 | 30.49 years STANDARD_DEVIATION 2.11 |
| body mass index (BMI) | 24.55 kg/m² STANDARD_DEVIATION 4.72 | 23.95 kg/m² STANDARD_DEVIATION 3.53 | 24.25 kg/m² STANDARD_DEVIATION 4.125 |
| Gestational age | 8.92 weeks | 9.07 weeks | 8.995 weeks |
| gravidity | 2 gravidity | 2 gravidity | 2 gravidity |
| parity | 1 parity | 1 parity | 1 parity |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 22 Participants | 24 Participants | 46 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Turkey | 22 participants | 24 participants | 46 participants |
| Sex: Female, Male Female | 22 Participants | 24 Participants | 46 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 22 |
| other Total, other adverse events | 0 / 24 | 0 / 22 |
| serious Total, serious adverse events | 0 / 24 | 0 / 22 |
Outcome results
Primary
Blood Cholecystokinin (CCK) Levels
a gut hormone released, its level can be measured in blood as fasting level and postprandial
Time frame: Fasting (baseline) and postprandial (15 minutes after the test meal) CCK level
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hyperemesis Gravidarum | Blood Cholecystokinin (CCK) Levels | fasting CCK | 53.13 picogram/mililiters (pg/ml) | Standard Deviation 25.3 |
| Hyperemesis Gravidarum | Blood Cholecystokinin (CCK) Levels | postprandial CCK | 73.61 picogram/mililiters (pg/ml) | Standard Deviation 30.29 |
| Healthy Pregnant Women | Blood Cholecystokinin (CCK) Levels | fasting CCK | 54.55 picogram/mililiters (pg/ml) | Standard Deviation 25.32 |
| Healthy Pregnant Women | Blood Cholecystokinin (CCK) Levels | postprandial CCK | 81.24 picogram/mililiters (pg/ml) | Standard Deviation 29.89 |
p-value: 0.05t-test, 2 sided
Comparison: Since this is the first study comparing both CCK levels and GB functions in patients diagnosed with hyperemesis gravidarum (HG) and healthy pregnant women, a power analysis was not feasible.p-value: 0.05t-test, 2 sided
Primary
Gallbladder (GB) Ejection Fraction
GB ejection fraction measures how much bile gallbladder releases at one time, expressed as percentage
Time frame: The fasting and postprandial 45th minute
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyperemesis Gravidarum | Gallbladder (GB) Ejection Fraction | 52.06 Percantage (%) | Standard Deviation 19.45 |
| Healthy Pregnant Women | Gallbladder (GB) Ejection Fraction | 45.46 Percantage (%) | Standard Deviation 16.59 |
p-value: 0.05t-test, 2 sided
p-value: 0.05t-test, 2 sided
Primary
Gallbladder (GB) Volume
volume of GB measured with abdominal ultrasound at fasting and postprandial
Time frame: fasting and postprandial 45th minute
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hyperemesis Gravidarum | Gallbladder (GB) Volume | fasting GB volume | 36.9 mililiter (ml) | Standard Deviation 13.8 |
| Hyperemesis Gravidarum | Gallbladder (GB) Volume | postprandial GB volume | 17.29 mililiter (ml) | Standard Deviation 8.14 |
| Healthy Pregnant Women | Gallbladder (GB) Volume | fasting GB volume | 33.69 mililiter (ml) | Standard Deviation 12.54 |
| Healthy Pregnant Women | Gallbladder (GB) Volume | postprandial GB volume | 18.33 mililiter (ml) | Standard Deviation 6.98 |
p-value: 0.05t-test, 2 sided
p-value: 0.05t-test, 2 sided
Primary
Gallbladder (GB) Wall Thickness
GB wall thickening measured with abdominal ultrasound at fasting and postprandial
Time frame: fasting and postprandial 45th minute
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hyperemesis Gravidarum | Gallbladder (GB) Wall Thickness | fasting GB wall thickness | 2.10 milimeters (mm) | Standard Deviation 0.57 |
| Hyperemesis Gravidarum | Gallbladder (GB) Wall Thickness | postprandial GB wall thickness | 2.51 milimeters (mm) | Standard Deviation 0.51 |
| Healthy Pregnant Women | Gallbladder (GB) Wall Thickness | fasting GB wall thickness | 2.11 milimeters (mm) | Standard Deviation 0.47 |
| Healthy Pregnant Women | Gallbladder (GB) Wall Thickness | postprandial GB wall thickness | 2.74 milimeters (mm) | Standard Deviation 0.76 |
p-value: 0.05t-test, 2 sided
p-value: 0.05t-test, 2 sided