Clinical trial NCT02420288: Effect of Physical Exercise Program on Fetoplacental Growth
Official title: Effect of Physical Exercise Program on Fetoplacental Growth: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Healthy
Keywords: Pregnancy
Fetoplacental growth
Physical exercise
Pregnant
Placental development
Active pregnancy
Lead sponsor: Universidad Politecnica de Madrid
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to examine the effect of a supervised physical exercise program during pregnancy on fetoplacental growth.


Eligibility criteria: Inclusion Criteria:

* Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
* Being able to communicate in spanish
* Giving birth at Hospital Universitario de Torrejón, Hospital Universitario de Puerta de Hierro or Hospital Universitario Severo Ochoa (Madrid)

Exclusion Criteria:

* Multiparity
* Obstetrician complications
* Being interested in the study after 18 weeks
* Not having availability to attend to the physical exercise program
* Younger than 18 years old
* Older than 45 years old

Primary outcomes:
measure: Placental weight
timeFrame: At delivery
measure: Fetal birth weight
timeFrame: At delivery
measure: Change from baseline in maternal gestational weight
timeFrame: 38-42 weeks of gestation
Secondary outcomes:
measure: Pregestational weight and Body Mass Index (BMI)
timeFrame: Before pregnancy
measure: pH umbilical cord
timeFrame: At delivery
measure: Fetal size outcomes
timeFrame: At delivery
measure: Fetal glycemia level
timeFrame: At delivery
measure: Apgar score
timeFrame: At delivery
measure: Maternal delivery outcomes (composite)
timeFrame: At delivery
measure: Postpartum depression
timeFrame: 0-12 postpartum months
measure: Changes from baseline in prenatal depression
timeFrame: Up to 36 weeks
measure: Changes from baseline in maternal quality of life
timeFrame: Up to 36 weeks
measure: Changes from baseline in urinary incontinence
timeFrame: Up to 36 weeks
measure: Gestational diabetes
timeFrame: 24-28 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Politécnica de Madrid
Study officials:
affiliation: Universidad Politecnica de Madrid
name: Rubén Barakat Carballo, PhD
role: STUDY_DIRECTOR
References:
citation: Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.
citation: Vargas-Terrones M, Barakat R, Santacruz B, Fernandez-Buhigas I, Mottola MF. Physical exercise programme during pregnancy decreases perinatal depression risk: a randomised controlled trial. Br J Sports Med. 2019 Mar;53(6):348-353. doi: 10.1136/bjsports-2017-098926. Epub 2018 Jun 13.
citation: Barakat R, Vargas M, Brik M, Fernandez I, Gil J, Coteron J, Santacruz B. Does Exercise During Pregnancy Affect Placental Weight?: A Randomized Clinical Trial. Eval Health Prof. 2018 Sep;41(3):400-414. doi: 10.1177/0163278717706235. Epub 2017 Apr 25.