Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2019-06-01
2020-09-01
Brief Summary
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Children of these women are in risk of developing obesity during childhood which again leads to overweight during adult life resulting in life-style related diseases such as diabetes and cardio-vascular disease.
Overweight and diabetic women are currently advised to substitute sugar sweetened beverages with artificially sweetened beverages to lower caloric intake and avoid fluctuations in blood glucose to avoid complications during pregnancy for both mother and child.
Recent studies suggest that high intake of artificial sweeteners during pregnancy increases the risk of the child developing obesity. If this is indeed true, the current guidelines have the opposite of the wanted and children already in risk of overweight are exposed to extra risk.
To investigate if artificial sweeteners can affect the foetus, the investigators wish to examine whether artificial sweeteners can cross the placenta.
The study is a clinical trial in which 40 women will be enrolled. 30 participants will drink a diet soft drink 2 hours before a caesarean section and 10 controls will refrain from intake. After birth the investigators will obtain a blood sample from the mother and from the umbilical cord and a placental biopsy and measure the contents of artificial sweeteners. Furthermore, the investigators will obtain a sample of amniotic fluid to examine if the sweeteners are excreted into the amniotic fluid.
The results ultimately have the potential to change the current guidelines on diet for overweight and diabetic women during pregnancy.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
10 women with IUGR-child, 10 women with diabetes, 10 healthy women. We will use a control group of 10 healthy women who will refrain from intake.
The participants will drink an artificially sweetened soft drink 2 to 4 hours before planned c-section.
BASIC_SCIENCE
NONE
Study Groups
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Intervention group
Participants will drink an artificially sweetened drink 2-4 hours before elective caesarean section.
Acesulfame K, cyclamate, saccharine, aspartame
Intervention group receives a combination of multiple artificial sweeteners
Control group
Participants in the control group will refrain from intake of artificial sweeteners.
No interventions assigned to this group
Interventions
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Acesulfame K, cyclamate, saccharine, aspartame
Intervention group receives a combination of multiple artificial sweeteners
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Child with IUGR (10 subjects)
* Diabetes (10 subjects)
* Other reasons for caesarean section(10 healthy subjects in intervention + 10 healthy controls)
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Locations
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Obstetrics and Gynecology
Aarhus, , Denmark
Countries
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Other Identifiers
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MM_PO_MP_2019
Identifier Type: -
Identifier Source: org_study_id
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