To establish a functional working protocol to analyze, characterize and determine the microbiome (including the virome) and its metabolome of the placenta, neonate and periconceptional semen and vaginal/cervical/uterine/rectal environment.
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To establish a functional work protocol for analyzing, characterization and
determination of the periconceptional, placental and neonatal microbiome and
metabolome.
Secondary outcome
Not applicable.
Background summary
Placental-related pregnancy complications (preeclampsia, preterm birth, fetal
growth restriction) originate in the first weeks of pregnancy and are due to
suboptimal implantation and placentation. In order to improve the perinatal and
maternal outcome of placental-related complications, we need to understand the
combined periconceptional microbiome and its metabolome. By linking different
microbiome compositions and its metabolome to different pregnancy outcomes, we
want to develop novel biomarkers to predict optimal implantation and
placentation.
Study objective
To establish a functional working protocol to analyze, characterize and
determine the microbiome (including the virome) and its metabolome of the
placenta, neonate and periconceptional semen and
vaginal/cervical/uterine/rectal environment.
Study design
Part 1a+b: An observational cohort study as pilot in periconceptional women and
men and women after elective caesarean section (aged 18 - 45 years) and
neonates delivered by an elective caesarean section.
Study burden and risks
For all participants the risks involve primarily the burden of participating in
a study, which usually means additional hospital visits and assessments.
Secondly, all participating men will be asked to produce a semen specimen by
masturbation. All women have to participate in a physical examination (a
speculum exam to obtain vagina/cervical and/or uterine swabs) ) and a rectum
swab (this could be collected by the self-collection if preferred by the
patient). Women participating have to deliver in the Erasmus MC in order to
collect the placental microbiome. Extra information can be obtained from
residual material, questionnaires, and extra material (blood, urine, saliva
from the participants). The risks of participation are considered to be minor
and the potential benefit outweighs the risks. From the above, it is clear that
there are no obvious risks associated with participation in the study. The
establishment of a safe and rapid work protocol to determine the placental,
neonatal and periconceptional microbiome and metabolome could be used in the
future to predict pregnancy outcome and will have a high impact on current
clinical practice. The assessment and determination of an optimal
periconceptional microbiome in combination with the metabolome may lead to the
use of new biomarkers to assess placental function and might provide future
intervention strategies eventually leading to life-long reduced risk of
non-communicable diseases. Therefore, this project will have an impact on
research, clinical care individual and public health as well as on future
medical health care costs.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
1) Part 1a: Men and women >= 18 and 45 <= years of age, healthy and in the
periconceptional period or couples contemplating pregnancy and visiting the
preconception and reproductive life planning clinics at the Erasmus MC.
2) Part 1b: Women >= 18 and 45 <= years of age who will undergo an elective term
caesarean section.
3) Understanding of Dutch in speaking and reading.
4) Part 1a: Willingness to undergo a speculum examination (female) or produce a
semen specimen (male).
5) Written informed consent.
Exclusion criteria
1) Men and women unable or unwilling to agree with the physical examination and
procedures.
2) Men and women unable or unwilling to give written informed consent.
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 | NL61077.078.17 |