Plain English Summary
Background and study aims
Maternal obesity during pregnancy has been linked with higher fetal fat mass, which could be related to higher incorporation of circulating fatty acids into fetal adipose (fat) tissue, promoting fetal programming of obesity. However, the role of the placenta in the selective transfer of specific fatty acids is unknown. Previous studies on women with gestational diabetes have found disturbed fatty acid transfer to the fetus which might also affect the neurodevelopment of the newborn. Similar results could also occur in maternal obesity but it is unknown. The aim of this study is to assess the transfer of the different fatty acids in obese mothers compared to healthy pregnant women.
Who can participate?
Pregnant women aged 18-40 who are planning to undergo an elective caesarean section at term
What does the study involve?
Ten obese and ten normal weight pregnant women take labelled fatty acids orally 12 hours before they undergo a caesarean section. Maternal plasma (blood) samples are taken at different timepoints until delivery, when cord blood and placenta samples are collected. Fatty acid levels are then measured.
What are the possible benefits and risks of participating?
This study attempts to provide better knowledge on the transfer of fatty acids with the aim of improving dietary recommendations for obese pregnant women. Participants might benefit from the results of this study in future pregnancies, as well as the whole population of women of reproductive age. There are no risks for the participating pregnant women or their babies. Labelled fatty acids have been used in previous studies without any side effects. Nevertheless, a medical insurance is signed in order to cover any unlikely negative event.
Where is the study run from?
1. "Virgen de la Arrixaca" Clinical Hospital (Spain)
2. University of Murcia (Spain)
3. Dr. von Hauner Children's Hospital, Ludwig-Maximilians-University Munich (Germany)
When is the study starting and how long is it expected to run for?
February 2012 to October 2017
Who is funding the study?
This work is financially supported in part by the Commission of the European Communities, Projects Early Nutrition, DYNAHEALTH and LIFECYCLE, the European Research Council Advanced Grant META-GROWTH, and the Excellence Network for Maternal and Child Health and Development
Who is the main contact?
Prof. Elvira Larque
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
KBBE.2011.2.2-03
Study information
Scientific title
In vivo materno-fetal fatty acid transfer in normal and obese pregnancy
Acronym
Study hypothesis
Maternal obesity at conception is considered a major predictor of offspring obesity. The pathophysiological mechanisms involved in the early programming of obesity are not fully understood. This study aimed to investigate the role of materno-fetal transfer of fatty acids in obese pregnant women using stable isotopes.
Ethics approval
Ethics Committee of the Virgen de la Arrixaca Clinical Hospital, 29/04/2013, ref: 04/13
Study design
Observational case-control study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Obesity
Intervention
Ten obese and ten normal weight pregnant women (control) received orally 13C-labelled fatty acids 12h before elective caesarean section: oleic acid, linoleic acid and docosahexaenoic acid. Maternal plasma samples were taken before tracer administration and at different timepoints until delivery, when cord blood and placenta samples were collected. 13C-enrichment and 13C-fatty acid concentrations were determined by gas chromatography combustion isotope ratio mass spectrometry.
Intervention type
Other
Phase
Drug names
Primary outcome measures
13C-enrichment and 13C-fatty acid concentrations in samples of plasma, placenta and cord blood, measured by gas chromatography combustion isotope ratio mass spectrometry at baseline and during the 12h before the cesarean section
Secondary outcome measures
13C-enrichment and 13C-fatty acid concentrations in maternal plasma lipoproteins, measured by gas chromatography combustion isotope ratio mass spectrometry at baseline and during the 12h before the cesarean section
Overall trial start date
01/02/2012
Overall trial end date
30/10/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Singleton pregnancy
2. Age 18-40 years
3. Plan to undergo elective caesarean section at term
4. Omnivorous diet
5. No DHA supplements (last trimester)
6. Non-smoking
7. Normal fetal Doppler scan within the normal reference range (24) on the day before caesarean section
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
20
Participant exclusion criteria
Any health problem of the mother or fetus, diabetes, gestational diabetes, preeclampsia
Recruitment start date
13/05/2013
Recruitment end date
15/04/2015
Locations
Countries of recruitment
Germany, Spain
Trial participating centre
"Virgen de la Arrixaca" Clinical Hospital
Murcia
30120
Spain
Trial participating centre
Department of Physiology, University of Murcia
Murcia
30100
Spain
Trial participating centre
Division of Metabolic and Nutritional Medicine, Dr. von Hauner Children's Hospital, Ludwig-Maximilians-University Munich
Munich
80337
Germany
Funders
Funder type
Government
Funder name
This work is financially supported in part by the Commission of the European Communities, Projects Early Nutrition (FP7-289346), DYNAHEALTH (H2020-633595) and LIFECYCLE (H2020-SC1-2016-RTD), the European Research Council Advanced Grant META-GROWTH (ERC-2012-AdG 322605), and the Excellence Network for Maternal and Child Health and Development (RED SAMID III, RD 16/0022/0009)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication of the results in peer-reviewed journals in 2018-2019. The protocol and statistical analyses will be published together with the results of the project.
IPD sharing statement
According to the Spanish law of Personal Data Protection, the individual data collected are only available for partners on the repository intranet from the European project Early Nutrition (FP7-289346).
Intention to publish date
30/10/2018
Participant level data
Stored in repository
Results - basic reporting
Publication summary