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Obesity in pregnancy.


- candidate number2947
- NTR NumberNTR1163
- ISRCTNWordt niet aangevraagd/Observational study
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-dec-2007
- Secondary IDs07-2-067. MEC
- Public TitleObesity in pregnancy.
- Scientific TitleThe obstetric risk profile of obese nulliparous women in a low risk population.
- ACRONYMN/A
- hypothesisObesity-related factors rather than obesity itself predispose to complications in pregnancy.
- Healt Condition(s) or Problem(s) studiedPregnancy, Obesity
- Inclusion criteria1. Nulliparous;
2. >18 years;
3. Dutch speaking.
- Exclusion criteriaAn indication for hospital care present at booking.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2008
- planned closingdate1-jan-2010
- Target number of participants180
- InterventionsNone. Observational study in which an experimental group of 90 obese pregnant women will be compared to a reference group of 90 non-obese pregnant women.
- Primary outcomeA complicated pregnancy defined by the presence of one of the following complications:
1. gestational diabetes;
2. macrosomia;
3. prolonged pregnancy;
4. hypertensive disorder;
5. dysmaturity;
6. preterm birth and/or intrauterine death.
- Secondary outcomeLabor complications.
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. J. Spaan
- CONTACT for SCIENTIFIC QUERIESDr. L.L.H. Peeters
- Sponsor/Initiator Academic Hospital Maastricht (AZM)
- Funding
(Source(s) of Monetary or Material Support)
Academic Hospital Maastricht
- PublicationsN/A
- Brief summaryObese 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. Therefor, 90 obese and 90 non-obese nulliparous women will be invited to participate at the time of booking for their prenatal check-ups in a midwifery practice. At twelve weeks of gestation we will perform a couple of measures, consisting of anthropometric parameters, standardized questionnaires on food intake and physical activity, a submaximal fitness test and the measurement of a number of variables in a blood sample.
- Main changes (audit trail)
- RECORD14-dec-2007 - 12-nov-2008


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