The objective of this study is to test the hypothesis that healthy obese pregnant women at increased risk for obesity-related pregnancy complications can be identified by a subgroup-specific screening program at twelve weeks amenorrhea.
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome variable of this study is a complicated pregnancy defined
by the presence of at least one of the following complications: a hypertensive
disorder, gestational diabetes, dysmaturity, macrosomia, preterm birth,
prolonged pregnancy, placental abruption and/or intrauterine death.
Secondary outcome
The secondary outcome variable is the presence of labor complications.
Background summary
Obese pregnant women have an increased risk to develop both complications in
pregnancy and during labor. The obstetrical care system in the Netherlands
offers the opportunity for home delivery in healthy low-risk pregnant women.
However, save and thus adequate functioning of this system depends on the
selection procedure to timely identify and refer high-risk women to the
so-called *second-line* care, provided by gynecologists in community hospitals.
The objective of this study is to improve early identification of high-risk
women among healthy obese pregnant women.
Study objective
The objective of this study is to test the hypothesis that healthy obese
pregnant women at increased risk for obesity-related pregnancy complications
can be identified by a subgroup-specific screening program at twelve weeks
amenorrhea.
Study design
The screening test at 12 weeks pregnancy consists of measuring some
anthropometric parameters, the (standardized) registration of eating habits and
- physical activities, the performance of a fitness test and the measurement of
a number of variables in a blood sample. Afterwards, the midwife will perform
the check-ups throughout pregnancy without being informed about the outcome of
the test. After childbirth, we will collect the information on pregnancy course
and outcome of all participants in the two groups and evaluate the
possibilities and limitations of this new 12-weeks screening test to be
implemented in daily practice.
Study burden and risks
This study design has no direct risks for the participants. Participants will
receive a screeningtest during one morning. The tests are non-invasive.
Postbus 5800 (P. Debyelaan 25)
6202 AZ Maastricht
Nederland
Postbus 5800 (P. Debyelaan 25)
6202 AZ Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
BMI >30 kg.m-2 or BMI 20-25 kg.m-2
nulliparus
singleton pregnancy
Exclusion criteria
age <18 years
preexistant disease
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL17877.068.07 |
| OMON | NL-OMON20635 |