Norwegian University of Science and Technology
Trondheim, 7489, Norway
NCT Number: NCT01243554
Observational studies demonstrate that overweight in pregnancy is a risk factor for adverse pregnancy outcomes as fetal macrosomia, prolonged labor, low Apgar score, shoulder dystocia, nerve plexus injuries, increased proportion of instrumental deliveries and perineal ruptures. There is a 2.6 fold risk for gestational diabetes mellitus (fourfold in morbidly obese women) and a recent study has shown that fetuses of obese mothers develop insulin resistance in uterus.
Main aims of this study are to assess if regular exercise in pregnancy among obese women can prevent or influence weight gain; impaired cardiac function in mother and fetus/newborn; impaired vascular function in mother; insulin resistance/sensitivity; body composition in mother and offspring; lumbopelvic pain; urinary and/or fecal incontinence; prolonged labor
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Notify Me18 year and older
Female
Interventional
Not applicable
Trondheim, 7489, Norway
Women with a self-reported pre-pregnancy BMI of 28 or more will be eligible for our study. Woman are eligible if they are 18 years or older, with a singleton live fetus at an early (week 12-14) ultrasound scan. Exclusion criteria are pregnancy complications with high risk for preterm labour or diseases that could interfere with participation.
Primary outcome measure is weight increase based on weight measured at 14 weeks and immediately before labour. Assessments are done at baseline at 14 (12-18) weeks of pregnancy, and again in week 38, as well as 3 months postpartum. Some measurements are also done at other points in time. The maternal secondary outcome measurements include fasting glucose, glucose tolerance assessed by 2-h, 75 mg per-oral glucose tolerance test, insulin resistance assessed by HOMA-IR, weight, height, body composition estimated by skinfold measurements in pregnancy and by dual energy x-ray absorptiometry postpartum, blood markers, lumbopelvic pain, urin- and fecal incontinence, quality of life, psychological wellbeing, depression, and diet.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exercise training at the hospital
Other names: Training
Time frame: From 14 weeks pregnancy to delivery
Measured in kg
Time frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
Blood samples to determine the fasting glucose after an overnight fast (>10 hours)
Time frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
2 hour 75 mg per-oral glucose tolerance test. Gestational diabetes is diagnosed as fasting glucose = or > 6.9 mmol/L or 2h concentration = or > 7.8 mmol/L.
Time frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
Homeostasis model assessment (HOMA-IR)
Time frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
Skinfold measurements, done by an experienced investigator using Harpenden kaliper. At the 3 months postpartum testing, also dual energy x-ray absorptiometry (DEXA scan) will be used.
Time frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
Inflammation markers, cytokines (leptin, resistin, adiponectin, tnf-alfa). Blood will be collected and stored for later analyses.
Time frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
Clinical assessment (active straight leg raising, pelvic provocation test), and validated questionnaire.
Time frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
Pelvic floor muscle function will be assessed by clinical assessment and by 2D and 3D ultrasound. The prevalence and severity of urin- and fecal incontinence will also be assessed by a validated questionnaire
Time frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
Validated questionnaire
Time frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
Epworth sleepiness scale
Time frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
Level of physical activity will be assessed by activity registration (armbands) and by validated questionnaires
Time frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
Validated questionnaire: Norkost
Time frame: At delivery
As recorded by the hospital
Time frame: At delivery
Vaginal or caesarean delivery, and recorded complications during the delivery
Time frame: At delivery
Cord blood will be sampled and stored for later analysis of relevant markers of inflammation and metabolism (including resistin, leptin, adiponectin)
Norwegian University of Science and Technology
Other
Exercise Training in Pregnancy. Good for the Mother - Good for the Child?
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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