Trial Outcomes & Findings for Gallbladder Functions & Serum Cholecystokinin Levels in Women Diagnosed With Hyperemesis Gravidarum (NCT NCT03950167)
NCT ID: NCT03950167
Last Updated: 2021-11-30
Results Overview
a gut hormone released, its level can be measured in blood as fasting level and postprandial
Recruitment status
COMPLETED
Target enrollment
325 participants
Primary outcome timeframe
Fasting (baseline) and postprandial (15 minutes after the test meal) CCK level
Results posted on
2021-11-30
Participant Flow
This is a prospective cohort study conducted in Ufuk University hospital, Ankara, Turkey (a tertiary center) between March 2019 and May 2020.
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)
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
24
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gallbladder Functions & Serum Cholecystokinin Levels in Women Diagnosed With Hyperemesis Gravidarum
Baseline characteristics by cohort
| Measure |
Hyperemesis Gravidarum
n=24 Participants
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.
|
Healthy Pregnant Women
n=22 Participants
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.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.08 years
STANDARD_DEVIATION 4.03 • n=5 Participants
|
30.91 years
STANDARD_DEVIATION 4.20 • n=7 Participants
|
30.49 years
STANDARD_DEVIATION 2.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
24 participants
n=5 Participants
|
22 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
age
|
30.91 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
30.08 years
STANDARD_DEVIATION 4.03 • n=7 Participants
|
30.49 years
STANDARD_DEVIATION 4.11 • n=5 Participants
|
|
body mass index (BMI)
|
23.95 kg/m²
STANDARD_DEVIATION 3.53 • n=5 Participants
|
24.55 kg/m²
STANDARD_DEVIATION 4.72 • n=7 Participants
|
24.25 kg/m²
STANDARD_DEVIATION 4.125 • n=5 Participants
|
|
gravidity
|
2 gravidity
n=5 Participants
|
2 gravidity
n=7 Participants
|
2 gravidity
n=5 Participants
|
|
Gestational age
|
9.07 weeks
n=5 Participants
|
8.92 weeks
n=7 Participants
|
8.995 weeks
n=5 Participants
|
|
parity
|
1 parity
n=5 Participants
|
1 parity
n=7 Participants
|
1 parity
n=5 Participants
|
PRIMARY outcome
Timeframe: Fasting (baseline) and postprandial (15 minutes after the test meal) CCK levela gut hormone released, its level can be measured in blood as fasting level and postprandial
Outcome measures
| Measure |
Hyperemesis Gravidarum
n=24 Participants
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.
|
Healthy Pregnant Women
n=22 Participants
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.
|
|---|---|---|
|
Blood Cholecystokinin (CCK) Levels
fasting CCK
|
53.13 picogram/mililiters (pg/ml)
Standard Deviation 25.3
|
54.55 picogram/mililiters (pg/ml)
Standard Deviation 25.32
|
|
Blood Cholecystokinin (CCK) Levels
postprandial CCK
|
73.61 picogram/mililiters (pg/ml)
Standard Deviation 30.29
|
81.24 picogram/mililiters (pg/ml)
Standard Deviation 29.89
|
PRIMARY outcome
Timeframe: fasting and postprandial 45th minuteGB wall thickening measured with abdominal ultrasound at fasting and postprandial
Outcome measures
| Measure |
Hyperemesis Gravidarum
n=24 Participants
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.
|
Healthy Pregnant Women
n=22 Participants
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.
|
|---|---|---|
|
Gallbladder (GB) Wall Thickness
fasting GB wall thickness
|
2.10 milimeters (mm)
Standard Deviation 0.57
|
2.11 milimeters (mm)
Standard Deviation 0.47
|
|
Gallbladder (GB) Wall Thickness
postprandial GB wall thickness
|
2.51 milimeters (mm)
Standard Deviation 0.51
|
2.74 milimeters (mm)
Standard Deviation 0.76
|
PRIMARY outcome
Timeframe: fasting and postprandial 45th minutevolume of GB measured with abdominal ultrasound at fasting and postprandial
Outcome measures
| Measure |
Hyperemesis Gravidarum
n=24 Participants
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.
|
Healthy Pregnant Women
n=22 Participants
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.
|
|---|---|---|
|
Gallbladder (GB) Volume
fasting GB volume
|
36.9 mililiter (ml)
Standard Deviation 13.8
|
33.69 mililiter (ml)
Standard Deviation 12.54
|
|
Gallbladder (GB) Volume
postprandial GB volume
|
17.29 mililiter (ml)
Standard Deviation 8.14
|
18.33 mililiter (ml)
Standard Deviation 6.98
|
PRIMARY outcome
Timeframe: The fasting and postprandial 45th minuteGB ejection fraction measures how much bile gallbladder releases at one time, expressed as percentage
Outcome measures
| Measure |
Hyperemesis Gravidarum
n=24 Participants
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.
|
Healthy Pregnant Women
n=22 Participants
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.
|
|---|---|---|
|
Gallbladder (GB) Ejection Fraction
|
52.06 Percantage (%)
Standard Deviation 19.45
|
45.46 Percantage (%)
Standard Deviation 16.59
|
Adverse Events
Hyperemesis Gravidarum
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Pregnant Women
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hyperemesis Gravidarum
n=24 participants at risk
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.
|
Healthy Pregnant Women
n=22 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea and vomitting
|
0.00%
0/24 • 1 year 6 months
a fatty test meal (100 g milk chocolate) was given to all participants for the evaluation of postprandial cholecystokinin levels and gallbladder parameters including volume and gallbladder wall thickness. Nausea and vomiting are the possible adverse events that may have been observed.
|
0.00%
0/22 • 1 year 6 months
a fatty test meal (100 g milk chocolate) was given to all participants for the evaluation of postprandial cholecystokinin levels and gallbladder parameters including volume and gallbladder wall thickness. Nausea and vomiting are the possible adverse events that may have been observed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place