The aim of this study is to study risk factors (in the field of public health and occupation as well as medical technical factors) to enable early detection of pregnant women at increased risk and to integrate these risk factors in a risk prognostic…
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
- Lifestyle issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is spontaneous preterm delivery before 37 weeks (expected
incidence is approximately 5%)
Secondary outcome
Secondary outcome measures are:
- preterm delivery before 28, 32 and 34 weeks
- the number of women that present for signs and symptoms of preterm birth
- referral to secondary/tertiary care for threatened preterm birth
- administration of corticosteroids and tocolysis
- maternal admission days for preterm labour and costs
- time to delivery
- maternal morbidity
- perinatal mortality
- perinatal morbidity (respiratory distress syndrome (RDS), broncho pulmonal
dysplasia (BPD), intraventricular haemorrhage (IVH) grade 3 or worse,
necrotizing enterocolitis (NEC) stage 2B or higher, periventricular
leucomalacia (PVL), rethinopathy of prematurity (ROP), and culture proven
sepsis)
- days of admission in neonatal intensive care unit
- financial costs
- long term neonatal outcome (developmentscores)
Background summary
Preterm birth is the most important cause of neonatal mortality in the
Netherlands. In the region around the AMC, we already study, in a
multidisciplinary setting, preterm birth in studies and evaluate treatments for
threathening preterm labour.
In this study, risk factors for preterm birth will be studied in nulliparous
women at present considered to have low risk pregnancies. These risk factors
will be linked to the occurence of preterm birth as well as subsequent neonatal
outcome. The project is unique in the sense that it integrates factors in the
field of public health, factors on labour and physical activity, clinical
factors and the subsequent course of pregnancy.
The data will be used to develop and validate a prediction model for preterm
birth. This model can be used for the design of intervention studies. This
project facilitates a next multidisciplinary step in the prediction and primary
prevention of preterm birth.
Study objective
The aim of this study is to study risk factors (in the field of public health
and occupation as well as medical technical factors) to enable early detection
of pregnant women at increased risk and to integrate these risk factors in a
risk prognostic model to enable the identification of pregnant women at
increased risk for preterm birth. The data will be collected in an unselected
population and their offspring, both short term and long term.
This will then result in answering the following questions:
1. What is the risk of spontaneous preterm birth in the regions Noord-Holland,
Flevoland, Gooi- en Vechtstreek en Kennemerland in terms of
- spontaneous preterm birth before 37 weeks?
- spontaneous preterm birth before 34 weeks?
- spontaneous preterm birth before 32 weeks?
2. What is the neonatal mortality and morbidity due to spontaneous preterm
birth?
3. Which risk factors contribute to spontaneous preterm birth?
- socioeconomic factors
- ethnic factors
- regional factors
- occupational health, labour and physical activity
- nutrition
- medical history
- biomarkers, including serum samples, bacteriuria and cervical length
4. How do these risk factors interact? Can differences in biomarkers be
explained by ethnic, socioeconomic, regional, occupational health and other
factors?
Study design
Observational cohort study in the catchment area of the Regional Perinatal
Network Northwest Netherlands (Netwerk Geboortezorg Noordwest Nederland).
Study burden and risks
This study is an observational study, so no interventions will take place. Two
extra serum samples will be taken, a vaginal and rectal swab will be collected
and an extra transvaginal ultrasound measure will be performed. The performed
tests are widely used in common obstetrical care, so the extra burden and risks
for the women remain very low. Also women will be asked to complete a web-based
questionnaires, one in each trimester. In the first trimester filling in takes
30 minutes, the next questionnaires take 10 minutes.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Nulliparous women
First visit in midwifery practice before a gestational age of 24 weeks
Low risk pregnancy
Maternal age > 18 years
Exclusion criteria
Multiparous women
First visit in midwifery practice and hospital beyond a gestational age of 24 weeks
High risk pregnancy (indication for referral to 2nd or 3rd line)
Multiple pregnancy
Maternal age < 18 years
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 | NL43414.018.13 |