Clinical trial NCT01395342: Assessment of Physical Exercise Using Stationary Bicycle for Pregnant Women With Risk for Preeclampsia Development
Official title: Assessment of Physical Exercise Using Stationary Bicycle for Pregnant Women With Risk for Preeclampsia Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pre-eclampsia
Hypertension, Pregnancy-Induced
Pregnancy, High-Risk
Keywords: Pregnant women
Pre-eclampsia
Exercise
Hypertension, Pregnancy-Induced
Parturition
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2011-07-15
Enrollment: 116
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Introduction:

Hypertensive disorders during pregnancy are an important issue in global public health. It is current the leading cause of maternal mortality in Brazil.

Objective:

To assess the effect of physical exercise using stationary bicycle through blood pressure and heart rate measurements, incidence of pre-eclampsia and quality of life survey in pregnant women with chronic high blood pressure, previous preeclampsia pregnancies or both factors associated comparing to a group with no intervention. Verify the type of births, maternal and perinatal outcomes in both groups. Methodology: This randomized clinical trial enrolled pregnant women presenting chronic hih blood pressure, previous pre-eclampsia experience or both. Women from 12 to 20 gestational weeks were selected from the prenatal outpatient clinic and randomly allocated to the study or non-interventional group. Women at the study group performed physical exercise using stationary bicycle (horizontal bench model) during 20 minutes, once a week. The heart rate was maintained at 20% above resting heart rate and up to 140 bpm. Blood pressure and heart rate measurements were evaluated before and after exercise. The non-intervention group followed regular prenatal routine with weekly returns for heart rate and blood pressure measurements. Both groups fulfilled the quality of life survey (SF-36 questionnaire) at three times: between 12 and 20 weeks; 28 and 32 weeks and 36 and 41 weeks of gestation. After that data of parturition will be analyzed to compare the incidence of pre-eclampsia, types of birth, maternal and perinatal outcomes.

Detailed description: Significance was assumed as p\<.5%.

Eligibility criteria: Inclusion Criteria:

* pregnant with 12 to 20 weeks gestational
* have chronic blood pressure, previous pre-eclampsia or both
* able to perform a exercise

Exclusion Criteria:

* multiple pregnancy
* Systemic lupus erythematosus
* heart disease
* neurological disease
* renal failure
* persistent vaginal bleeding
* isthmic-cervical insufficiency

Primary outcomes:
measure: Risk to development pre-eclampsia
timeFrame: up to 28 weeks
Secondary outcomes:
measure: Types of birth
timeFrame: up to 28 weeks
measure: Perinatal outcomes
timeFrame: up to 28 weeks
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Hospital da Mulher Professor Doutor José Aristodemo Pinotti - CAISM/UNICAMP
state: São Paulo
Study officials:
affiliation: University of Campinas (Unicamp)
name: João Luiz C Pinto e Silva
role: STUDY_DIRECTOR
References:
citation: Kasawara KT, Burgos CS, do Nascimento SL, Ferreira NO, Surita FG, Pinto E Silva JL. Maternal and Perinatal Outcomes of Exercise in Pregnant Women with Chronic Hypertension and/or Previous Preeclampsia: A Randomized Controlled Trial. ISRN Obstet Gynecol. 2013 Aug 12;2013:857047. doi: 10.1155/2013/857047. eCollection 2013.