In vivo materno-fetal fatty acid transfer in normal and obese pregnancy
| ISRCTN | ISRCTN69794527 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69794527 |
| Secondary identifying numbers | KBBE.2011.2.2-03 |
- Submission date
- 28/11/2017
- Registration date
- 12/12/2017
- Last edited
- 23/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
Department of Physiology
School of Biology
Campus de Espinardo
Murcia
30100
Spain
Study information
| Study design | Observational case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | In vivo materno-fetal fatty acid transfer in normal and obese pregnancy |
| Study objectives | 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(s) | Ethics Committee of the Virgen de la Arrixaca Clinical Hospital, 29/04/2013, ref: 04/13 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/02/2012 |
| Completion date | 30/10/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | Female |
| Target number of participants | 20 |
| Total final enrolment | 20 |
| Key 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 |
| Key exclusion criteria | Any health problem of the mother or fetus, diabetes, gestational diabetes, preeclampsia |
| Date of first enrolment | 13/05/2013 |
| Date of final enrolment | 15/04/2015 |
Locations
Countries of recruitment
- Germany
- Spain
Study participating centres
30120
Spain
30100
Spain
80337
Germany
Sponsor information
Government
EU
Murcia
30100
Spain
"ROR" |
https://ror.org/00k4n6c32 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/10/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| 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 plan | 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2020 | 23/11/2020 | Yes | No |
Editorial Notes
23/11/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
