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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01243554
Other study ID # ETiP-Ob
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2010
Est. completion date June 2016

Study information

Verified date June 2018
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 91
Est. completion date June 2016
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Pre-pregnancy body mass index of 28 or more

- 18 years or more

- singleton live fetus at the routine ultrasound scan

Exclusion Criteria:

- high risk for preterm labor or diseases that could interfere with participation

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise
Exercise training at the hospital

Locations

Country Name City State
Norway Norwegian University of Science and Technology Trondheim

Sponsors (5)

Lead Sponsor Collaborator
Norwegian University of Science and Technology Harvard Medical School, Karolinska Institutet, Norwegian School of Sport Sciences, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (5)

Garnæs KK, Helvik AS, Stafne SN, Mørkved S, Salvesen K, Salvesen Ø, Moholdt T. Effects of supervised exercise training during pregnancy on psychological well-being among overweight and obese women: secondary analyses of the ETIP-trial, a randomised contro — View Citation

Garnæs KK, Mørkved S, Salvesen KÅ, Salvesen Ø, Moholdt T. Exercise training during pregnancy reduces circulating insulin levels in overweight/obese women postpartum: secondary analysis of a randomised controlled trial (the ETIP trial). BMC Pregnancy Child — View Citation

Garnæs KK, Mørkved S, Salvesen Ø, Moholdt T. Exercise Training and Weight Gain in Obese Pregnant Women: A Randomized Controlled Trial (ETIP Trial). PLoS Med. 2016 Jul 26;13(7):e1002079. doi: 10.1371/journal.pmed.1002079. eCollection 2016 Jul. — View Citation

Garnæs KK, Nyrnes SA, Salvesen KÅ, Salvesen Ø, Mørkved S, Moholdt T. Effect of supervised exercise training during pregnancy on neonatal and maternal outcomes among overweight and obese women. Secondary analyses of the ETIP trial: A randomised controlled — View Citation

Nyrnes SA, Garnæs KK, Salvesen Ø, Timilsina AS, Moholdt T, Ingul CB. Cardiac function in newborns of obese women and the effect of exercise during pregnancy. A randomized controlled trial. PLoS One. 2018 Jun 1;13(6):e0197334. doi: 10.1371/journal.pone.019 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Weight gain during pregnancy Measured in kg From 14 weeks pregnancy to delivery
Secondary Fasting glucose Blood samples to determine the fasting glucose after an overnight fast (>10 hours) From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
Secondary Glucose tolerance 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. From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
Secondary Insulin resistance Homeostasis model assessment (HOMA-IR) From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
Secondary Body composition 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. From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
Secondary Blood markers for cardiovascular disease Inflammation markers, cytokines (leptin, resistin, adiponectin, tnf-alfa). Blood will be collected and stored for later analyses. From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
Secondary Lumbopelvic pain Clinical assessment (active straight leg raising, pelvic provocation test), and validated questionnaire. From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
Secondary Urin- and fecal incontinence 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 From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
Secondary Quality of life Validated questionnaire From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
Secondary Sleep Epworth sleepiness scale From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
Secondary Physical activity Level of physical activity will be assessed by activity registration (armbands) and by validated questionnaires From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
Secondary Diet Validated questionnaire: Norkost From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum
Secondary Offspring birth weight, length and head circumference As recorded by the hospital At delivery
Secondary Delivery complications Vaginal or caesarean delivery, and recorded complications during the delivery At delivery
Secondary Markers of inflammation and metabolism in cord blood Cord blood will be sampled and stored for later analysis of relevant markers of inflammation and metabolism (including resistin, leptin, adiponectin) At delivery
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