Clinical trial NCT03954418: Transport of Artificial Sweeteners During Pregnancy
Official title: Trans-placental Transport and Foetal Accumulation of Artificial Sweeteners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Diabetes
IUGR
Keywords: Artificial sweeteners
Non-nutritive sweeteners
Caesarean section
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2019-05-17
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: We wish to conduct an interventional, open-label study in which 40 women undergoing planned caesarean section will be included. In the intervention-group divided between:

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.
Primary purpose: BASIC_SCIENCE

Brief summary: With obesity on the rise worldwide more and more young women are also affected, leading to a higher prevalence of obese pregnant women and pregnant women with diabetes.

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.


Eligibility criteria: Inclusion Criteria:

* Elective caesarean section
* Child with IUGR (10 subjects)
* Diabetes (10 subjects)
* Other reasons for caesarean section(10 healthy subjects in intervention + 10 healthy controls)

Exclusion Criteria:

* Acute caesarean section

Primary outcomes:
measure: Mothers blood
timeFrame: Time of birth
measure: Placenta
timeFrame: Time of birth
measure: Umbilical cord
timeFrame: Time of birth
measure: Amniotic fluid
timeFrame: Time of birth
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Obstetrics and Gynecology
Study officials:
affiliation: per.ovesen@clin.au.dk
name: Per Ovesen, DMSc
role: STUDY_DIRECTOR
References: