Methods | Randomised controlled trial, set in Hospital de Fuen-labrada, Madrid, Spain | |
Participants | 80 women randomised. Inclusion criteria: healthy pregnant women (age, 23-38 years), had uncomplicated, singleton pregnancies Exclusion criteria: any type of absolute obstetric contraindication to aerobic exercise during pregnancy, which included other contraindications that the authors considered to have a relevant influence on maternal perception of health: significant heart disease, restrictive lung disease, incompetent cervix/cerclage, multiple gestation, risk of premature labour, pre-eclampsia/pregnancy-induced hypertension, thrombophlebitis, recent pulmonary embolism (last 5 years), acquired infectious disease, retarded intrauterine development, serious blood disease, and/or absence of prenatal care |
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Interventions | Intervention group: (40 randomised) moderate physical activity, included a total of 35- to 45-minute weekly sessions 3 days each week from the start of the pregnancy (weeks 6-9) to the end of the 3rd trimester (weeks 38-39), an average of 85 training sessions, exercise intensity was light-to-moderate. Exercise was supervised by a fitness specialist and was in groups of 10-12 women Control group: (40 randomised) routine care. |
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Outcomes | Weight gain, caesarean, birthweight < 4000 gm, birthweight > 4000 gm | |
Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomly assigned by use of a random number table. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding (performance bias and detection bias) All outcomes |
Unclear risk | Not mentioned. It would be difficult to blind women and staff to this type of intervention. It is not clear how lack of blinding would impact on the outcomes measured |
Incomplete outcome data (attrition bias) All outcomes |
Unclear risk | 80 women were randomised and 67 were analysed; 34 in the exercise group, 33 in the control group. Reason of discontinued were similar in both groups |
Selective reporting (reporting bias) | Unclear risk | Assessment from published study report. |
Other bias | Unclear risk | No between-group differences regarding potential confounding variables (such as occupational activities, standing, smoking habits, alcohol intake). Parity was not balanced between groups; the exercise group had a higher percentage of nulliparous women (76.5%) than the control group (36.4%) |