Exercise During Pregnancy: Effects on the Maternal-Fetal Unit
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intervention.
- Who it may be relevant to
- Registry conditions: Pregnancy. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Benefits of Exercise for the Maternal-Fetal Unit During Pregnancy
Overview
Metabolic alterations during pregnancy have been associated with adverse maternal-fetal outcomes, including low birth weight and pregnancy complications. Maternal endothelial dysfunction, oxidative stress, insulin resistance, and placental mitochondrial dysfunction are thought to contribute to fetal metabolic disturbances. Lifestyle changes, such as structured exercise during pregnancy, may modulate maternal and placental factors. This randomized controlled trial will evaluate the effects of a multicomponent exercise program during the second and third trimester on maternal functional capacity, vascular health, anthropometry, metabolic biomarkers, placental function, and newborn health outcomes.
Detailed description
To investigate the effects of a multicomponent supervised exercise program during pregnancy on the maternal-fetal unit.
Interventions
- Behavioral Intervention
Exercise
Primary outcome measures
- Cardiorespiratory fitness (Vo2max) [Time frame: at the 16th and 34-36th week of gestation]
- Maternal weight gain (kg) [Time frame: 34-36th week of gestation]
Secondary outcome measures (12)
- Systolic and diastolic blood pressure (mmHg) [Time frame: at the 16th and 34-36th week of gestation]
- Resting heart rate (bpm) [Time frame: at the 16th and 34-36th week of gestation]
- Muscle strength (kg) [Time frame: at the 16th and 34-36th week of gestation]
- Whole bone mineral density (g/cm2) [Time frame: at the 16th to 34-36th week of gestation]
- Fat free mass [Time frame: at the 16th to 34-36th week of gestation]
- Lean mass/fat mass ratio [Time frame: at the 16th to 34-36th week of gestation]
- Fat mass (kg) [Time frame: at the 16th to 34-36th week of gestation]
- Fat mass index (kg/m2) [Time frame: at the 16th to 34-36th week of gestation]
- Appendicular lean mass index (kg/m2) [Time frame: at the 16th to 34-36th week of gestation]
- Lean mass index (kg/m2) [Time frame: at the 16th to 34-36th week of gestation]
- Lean mass (kg) [Time frame: at the 16th to 34-36th week of gestation]
- Physical activity and sedentary behaviour (in minutes) [Time frame: at the 16th and 34-36th week of gestation]
Eligibility criteria
Inclusion criteria
- Primigravid women
- Gestational age 16-20 weeks
- No severe malformations on ultrasound
- Regular prenatal care and medical clearance from obstetrician
- Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
Exclusion criteria
- Medical or obstetric complication excluding exercise ( ACOG guideline) Major surgery or trauma in past year
- Cancer diagnosis
- Cervical incompetence
- History of ≥2 spontaneous abortions
- Multiple pregnancy
- Vaginal bleeding, placenta previa, or threatened abortion
- COPD, asthma, or chronic bronchitis
- Renal, musculoskeletal, cardiovascular, or systemic infections limiting exercise
- Polyhydramnios or oligohydramnios
- Not availability to attend to the physical exercise program
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Spain · 1 center
- Navarrabiomed, Hospital Universitario de Navarra (HUN) and Universidad Pública de Navarra — Pamplona
Publications
- Ramirez-Velez R, Aguilar de Plata AC, Escudero MM, Echeverry I, Ortega JG, Salazar B, Rey JJ, Hormiga C, Lopez-Jaramillo P. Influence of regular aerobic exercise on endothelium-dependent vasodilation and cardiorespiratory fitness in pregnant women. J Obstet Gynaecol Res. 2011 Nov;37(11):1601-8. doi: 10.1111/j.1447-0756.2011.01582.x. Epub 2011 Jul 6. PMID 21733037
- Ramirez-Velez R, Lobelo F, Aguilar-de Plata AC, Izquierdo M, Garcia-Hermoso A. Exercise during pregnancy on maternal lipids: a secondary analysis of randomized controlled trial. BMC Pregnancy Childbirth. 2017 Nov 28;17(1):396. doi: 10.1186/s12884-017-1571-6. PMID 29179683
- Pinzon DC, Zamora K, Martinez JH, Florez-Lopez ME, de Plata AC, Mosquera M, Ramirez-Velez R. Type of delivery and gestational age is not affected by pregnant Latin-American women engaging in vigorous exercise: a secondary analysis of data from a controlled randomized trial. Rev Salud Publica (Bogota). 2012 Oct;14(5):731-43. PMID 24652353
Identifiers
NCT: NCT07264231 · PI_2024/148