To show that the human secondary yolk sac follows a dynamic pattern during the day by the investigation of:1.) size and volume of the human secondary yolk sac at several time points during one day2.) the relationship between size and volume of the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
geen aandoening; fysiologie van de dooierzak in het eerste trimester van de zwnagerschap
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Biometry of the yolk sac during the day (YSD, YSV) and blood glucose levels of
the pregnant women preceding the ultrasound examinations. Time-dependent
relationship, if any, between YS parameters (YSD and YSV) and blood glucose
levels.
Secondary outcome
n.a.
Background summary
The variation in size and volume of the humane secondary yolk sac is large and
an HbA1c related larger size of the yolk sac is found in diabetes type 1
patients. By measuring yolk sac parameters combined with blood glucose levels
changes in yolk sac size and volume during the day can be detected.
Study objective
To show that the human secondary yolk sac follows a dynamic pattern during the
day by the investigation of:
1.) size and volume of the human secondary yolk sac at several time points
during one day
2.) the relationship between size and volume of the human secondary yolk sac
and blood glucose levels
Study design
This study is a prospective, exploratory, follow-up study which will be
embedded in the ongoing Predict study (METC Erasmus MC 2004-277), a hospital
bases birth cohort study from preconception onwards at the Erasmus MC in
Rotterdam. Predict study participants who volunteered for a longitudinal 3D
ultrasound evaluation of early pregnancy will be included for another series of
examinations.
We have an annual inclusion of 250 pregnancies in the Predict study. In
approximately one year we will measure in 20 pregnancies, equally distributed
over the gestational weeks 8-10, yolk sac size and volume five times during one
day and as well determine blood glucose levels preceding these ultrasound
examinations.
Intervention
Standardized breakfast.
Study burden and risks
The women who volunteered for the ultrasound scans in the first trimester are
asked to visit the Erasmus MC for four extra ultrasound scans during one
morning. The regular weekly visit of the Predict study will also be performed
this morning; ending up with five measurement moments. These four extra
ultrasound scans will take about 15 minutes per scan. The first scan will be
performed at 8:00 a.m. after determing a fasting glucose and is followed by a
standardized breakfast. Then every hour an ultrasound scan is performed until
12:00 p.m. preceded by a determination of blood glucose levels. The techniques
that we will be used are safe and harmless. The patients will receive a picture
of their unborn child obtained by 3D ultrasound.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
Predict study participants who volunteered for a longitudinal 3D ultrasound evaluation in early pregnancy and who were willing to volunteer for one additional series of four ultrasound scans and for five additional determinations of blood glucose levels preceding the extra ultrasound scans. Their gestational age has to be in the range of 7+4 to 10+3 weeks based on last menstrual period or conception date.
Exclusion criteria
- Women < 18 years of age
- A gestational age of < 7+4 or > 10+3 weeks
- Clinically unstable women
- Clinically unstable fetuses
- Women with diabetus mellitus
- Multiple pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL42414.078.12 |