Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2017
INTERVENTION: After entry details are recorded on a trial entry form, participants are randomised to either the the aquatic‐aerobic exercise group or the usual antenatal care group. The 1:1 randomization is performed by a researcher not involved with treatment allocation, and are in balanced blocks of six. Group 1: The women randomized to the water aerobics group participate in 45 min water aerobics classes held three times weekly in an indoor pool (28‐30°C) for five months. This procedure is based on recommendations of the American College of Sports Medicine (36), which proposes 3‐5 classes per week, a training zone of 55‐65% of maximum heart rate, classes of 20‐60 min duration, maximum heart rate of 140 bpm, and maintenance of body temperature below 38°C. Aquatic exercise includes four sets of exercise were developed for the study, each set of exercise include exercises that looks at the full work of muscle groups and include breathing and relaxation techniques. All exercises are performed with coordinating breathing and includes the following: 1. Warm‐up out of water (5 to 7 min) 2. Warm‐up in water (5 to 10 min) 3. Moderate aquatic exercise (20 min) 4. Breathing and relaxation exercises (5 min) 5. Playful exercises (5 min) The intervention will stop if any of the followings events appear during the trial: metrorrhagia, placenta previa, premature rupture of membranes, intrauterine growth retardation, severe anemia, or any contraindications to being physically active. Group 2: Women in the control group receive standard antenatal care, and the customary information given by a midwife or general practitioner. They are not discouraged from exercising on their own. Follow‐up is performed by midwives who are responsible for data collection from the clinical history and from the questionnaires in all follow‐up visits at gestation times of 17, 27, and 37 weeks. CONDITION: Epidural analgesia side effect ; Pregnancy and Childbirth ; Epidural analgesia side effect PRIMARY OUTCOME: The incidence of epidural analgesia use during labour is determined through review of the clinical history at one month after birth INCLUSION CRITERIA: 1. Pregnant women who are between 14 and 20 weeks pregnant 2. Aged from 18 to 40 years‐old 3. Pregnancy at low risk of complications (i.e. all women have singleton pregnancies, and none have medical, obstetric, or psychiatric problems) SECONDARY OUTCOME: 1. Morbidity (major complications, poor labor progress, intrapartum maternal fever) is determined through review of the clinical history at one month after birth; 2. Pregnancy weight gain is is determined through review of the clinical history at one month after birth; 3. Induction of labour is determined through review of the clinical history at one month after birth; 4. Method of delivery is determined through review of the clinical history at one month after birth; 5. Episiotomy or perineal tear is determined through review of the clinical history at one month after birth; 6. Total labor pain is measured using a visual analogue scale (VAS) at one month after birth; 7. Postnatal depression is measured using the Edinburgh postnatal depression scale (EPDS) at one month after birth; 8. Health resource utilisation is determined through review of the clinical history at one month after birth; 9. Quality of life is measured using the EuroQol Five Dimension questionnaire (EQ‐5D) at one month after birth; 10. Neonatal medical outcomes (intrapartum fetal distress, birth weight, gestational age, Apgar score, pH umbilical cord blood) is determined through review of the clinical history at one month after birth; 11. Quality and quantity of sleep is measured using the Medical Outcomes Study (MOS) sleep scale at gestation times of 17, 27, and 37 weeks; 12. Physical activity is measured using the International Physical Activity Questionnaire‐Short Form (IPAQ‐SF) at gestation times of 17, 27, and 37 weeks; 13. Perceived exertion during physical activity is measured using the Modified Borg scale (MBS) at gestation times of 17, 27, and 37 weeks
Epistemonikos ID: 94dd694eb49c2e193534cf03fe55923b67e11e63
First added on: Aug 23, 2024