Clinical trial NCT00641550: Exercise and Pregnancy: Randomized Clinical Trial
Official title: Effects of Physical Exercise During Pregnancy on the Maternal and Perinatal Outcomes: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preeclampsia
Gestational Diabetes
Keywords: physical exercise
maternal complications
preterm labor
birthweight
Apgar scores
Lead sponsor: Universidade Estadual da Paraiba
Sponsor class: OTHER
Collaborators: name: University of Campinas, Brazil
First posted: 2008-03-24
Enrollment: 188
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The effects of physical exercise on pregnancy remain to be elucidated. A randomized controlled trial will be conducted to study the impact of exercise on maternal and perinatal outcomes. Our hypothesis is that physical exercise reduces preeclampsia incidence and improves birthweight when started early in pregnancy, with no impact on pregnancy duration, Apgar scores and neonatal complications.

Detailed description: The study will include low risk pregnant women randomized to practice physical exercise beginning at 13 weeks, 20 weeks or no exercise group.

The objectives are:

1. To describe and compare biological and obstetrical variables.
2. To study doppler flow velocimetry indexes.
3. To determine the association between physical exercise and maternal complications: preeclampsia, preterm labor, gestational diabetes and weight gain in pregnancy.
4. To determine the association between physical exercise and perinatal outcomes: Apgar scores, birthweight, admission at intensive neonatal care unit, body composition and neonatal complications.

Eligibility criteria: Inclusion Criteria:

* Gestational age \< 13 weeks
* Single pregnancy
* Alive fetus
* No previous practice of physical activity

Exclusion Criteria:

* Smoking
* Chronic maternal diseases
* Placenta praevia
* History of preterm labor
* Bleeding

Primary outcomes:
measure: Maternal outcome: preterm labor, weight gain, preeclampsia, gestational diabetes Perinatal outcome: birthweight, Apgar scores, body composition, admission at neonatal intensive care unit
timeFrame: nine months
Secondary outcomes:
measure: Doppler flow velocimetry indexes: pulsatility, resistance and A/B relation (uterine arteries, fetal middle cerebral artery and umbilical arteries)
timeFrame: 9 months
Other outcomes:
Locations:
city: Campina Grande
country: Brazil
facility: Universidade Estadual da Paraiba
state: Paraiba
city: Campina Grande
country: Brazil
facility: Universidade Estadual da Paraíba
state: Paraíba
Study officials:
affiliation: Instituto Materno Infantil Prof. Fernando Figueira
name: Melania Amorim, PhD
role: STUDY_DIRECTOR
References:
citation: de Oliveria Melo AS, Silva JL, Tavares JS, Barros VO, Leite DF, Amorim MM. Effect of a physical exercise program during pregnancy on uteroplacental and fetal blood flow and fetal growth: a randomized controlled trial. Obstet Gynecol. 2012 Aug;120(2 Pt 1):302-10. doi: 10.1097/AOG.0b013e31825de592.