Hypertension, Pregnancy-Induced, Pre-eclampsia, Pregnancy, High-Risk
Conditions
Keywords
Pregnant women, Pre-eclampsia, Exercise, Hypertension, Pregnancy-Induced, Parturition
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%.
Interventions
OTHERExercise using stationary bicycle
Before exercise, blood pressure and heart rate are measured in the sitting position. Exercise is realized using stationary bicycle (horizontal bench mode) once at week, during 20 minutes under physiotherapist supervision. The heart rate was maintained at 20% above resting heart rate and up to 140 bpm. After exercise is performed a leg stretching and a low back stretching. The blood pressure and heart rate are measured in the sitting position.
Sponsors
University of Campinas, Brazil
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk to development pre-eclampsia | up to 28 weeks | The comparison between groups will be by the diagnosis of pre-eclampsia. Pre-eclampsia is diagnosed after 20 week of gestation with systolic blood pressure equal to or greater than 140 mmHg, diastolic blood pressure equal to or greater than 90 mmHg and proteinuria greater than or equal 0.3 g/d by 24 hour urine collection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Types of birth | up to 28 weeks | Parturition data will be analyzed. |
| Perinatal outcomes | up to 28 weeks | Number of participants with adverse events. Prematurity by CAPURRO method, APGAR score to measure the health of newborn. |
Countries
Brazil
Outcome results
None listed