Signe Nilssen Stafne

Regular Exercise During Pregnancy to Prevent Gestational Diabetes A Randomized Controlled Trial

OBJECTIVE: To assess whether exercise during pregnancy can prevent gestational diabetes and improve insulin resistance. METHODS: A total of 855 women in gestational week 18–22 were randomly assigned to receiving a 12-week standard exercise program (intervention group) or standard antenatal care (control group). The exercise program followed standard recommendations and included moderate-intensity to high-intensity activity 3 or more days per week. Primary outcomes were gestational diabetes and insulin resistance estimated by the homeostasis model assessment method. For the power calculation, we assumed a gestational diabetes prevalence of 9% in the control group and a prevalence of 4% in the exercise group (risk difference of 5%). Under these assumptions, a two-sample comparison with a 5% level of significance and power of 0.80 gave a study population of 381 patients in each group. RESULTS: At 32–36 weeks of gestation there were no differences between groups in prevalence of gestational diabetes: 25 of 375 (7%) in the intervention group compared with 18 of 327 (6%) in the control group (P=.52). There were no differences in insulin resistance between groups when adjusting for baseline values. Only 55% of women in the intervention group managed to follow the recommended exercise protocol. No serious adverse events related to physical exercise were seen, and the outcomes of pregnancy were similar in the two groups. CONCLUSION: There was no evidence that offering women a 12-week standard exercise program during the second half of pregnancy prevents gestational diabetes or improves insulin resistance in healthy pregnant women with normal body mass indexes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00476567. LEVEL OF EVIDENCE: I

Does regular exercise including pelvic floor muscle training prevent urinary and anal incontinence during pregnancy? A randomised controlled trial.

Please cite this paper as: Stafne S, Salvesen K, Romundstad P, Torjusen I, Mørkved S. Does regular exercise including pelvic floor muscle training prevent urinary and anal incontinence during pregnancy? A randomised controlled trial. BJOG 2012;119:1270–1280.

Does regular exercise during pregnancy influence lumbopelvic pain? A randomized controlled trial.

Objective. To study lumbopelvic pain in women randomized to a regular exercise program during pregnancy in comparison to women receiving standard antenatal care. Design. A two‐armed, two‐center, randomized controlled trial. Setting. St Olavs Hospital, Trondheim University Hospital and Stavanger University Hospital. Population. A total of 855 pregnant women were randomized to intervention or control groups. Methods. The intervention was a 12 week exercise program, including aerobic and strengthening exercises, conducted between 20 and 36 weeks of pregnancy. One weekly group session was led by physiotherapists, and home exercises were encouraged twice a week. The control group received standard antenatal care. Main outcome measures. Self‐reports of lumbopelvic pain and sick leave due to lumbopelvic pain. The data were analysed according to the “intention‐to‐treat” principle. Results. There were no significant differences between groups of women reporting lumbopelvic pain at 36 weeks (74 vs. 75%, p=0.76). The proportion of women on sick leave due to lumbopelvic pain was lower in the intervention group (22% vs 31%, p=0.01). Conclusions. Exercise during pregnancy does not influence the prevalence of lumbopelvic pain, but women offered a regular exercise course seem to handle the disorder better.

Effects of antenatal diet and physical activity on maternal and fetal outcomes: Individual patient data meta-analysis and health economic evaluation

BACKGROUND Diet- and physical activity-based interventions in pregnancy have the potential to alter maternal and child outcomes. OBJECTIVES To assess whether or not the effects of diet and lifestyle interventions vary in subgroups of women, based on maternal body mass index (BMI), age, parity, Caucasian ethnicity and underlying medical condition(s), by undertaking an individual patient data (IPD) meta-analysis. We also evaluated the association of gestational weight gain (GWG) with adverse pregnancy outcomes and assessed the cost-effectiveness of the interventions. DATA SOURCES MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects and Health Technology Assessment database were searched from October 2013 to March 2015 (to update a previous search). REVIEW METHODS Researchers from the International Weight Management in Pregnancy Collaborative Network shared the primary data. For each intervention type and outcome, we performed a two-step IPD random-effects meta-analysis, for all women (except underweight) combined and for each subgroup of interest, to obtain summary estimates of effects and 95% confidence intervals (CIs), and synthesised the differences in effects between subgroups. In the first stage, we fitted a linear regression adjusted for baseline (for continuous outcomes) or a logistic regression model (for binary outcomes) in each study separately; estimates were combined across studies using random-effects meta-analysis models. We quantified the relationship between weight gain and complications, and undertook a decision-analytic model-based economic evaluation to assess the cost-effectiveness of the interventions. RESULTS Diet and lifestyle interventions reduced GWG by an average of 0.70 kg (95% CI -0.92 to -0.48 kg; 33 studies, 9320 women). The effects on composite maternal outcome [summary odds ratio (OR) 0.90, 95% CI 0.79 to 1.03; 24 studies, 8852 women] and composite fetal/neonatal outcome (summary OR 0.94, 95% CI 0.83 to 1.08; 18 studies, 7981 women) were not significant. The effect did not vary with baseline BMI, age, ethnicity, parity or underlying medical conditions for GWG, and composite maternal and fetal outcomes. Lifestyle interventions reduce Caesarean sections (OR 0.91, 95% CI 0.83 to 0.99), but not other individual maternal outcomes such as gestational diabetes mellitus (OR 0.89, 95% CI 0.72 to 1.10), pre-eclampsia or pregnancy-induced hypertension (OR 0.95, 95% CI 0.78 to 1.16) and preterm birth (OR 0.94, 95% CI 0.78 to 1.13). There was no significant effect on fetal outcomes. The interventions were not cost-effective. GWG, including adherence to the Institute of Medicine-recommended targets, was not associated with a reduction in complications. Predictors of GWG were maternal age (summary estimate -0.10 kg, 95% CI -0.14 to -0.06 kg) and multiparity (summary estimate -0.73 kg, 95% CI -1.24 to -0.23 kg). LIMITATIONS The findings were limited by the lack of standardisation in the components of intervention, residual heterogeneity in effects across studies for most analyses and the unavailability of IPD in some studies. CONCLUSION Diet and lifestyle interventions in pregnancy are clinically effective in reducing GWG irrespective of risk factors, with no effects on composite maternal and fetal outcomes. FUTURE WORK The differential effects of lifestyle interventions on individual pregnancy outcomes need evaluation. STUDY REGISTRATION This study is registered as PROSPERO CRD42013003804. FUNDING The National Institute for Health Research Health Technology Assessment programme.

Dietary interventions in overweight and obese pregnant women: a systematic review of the content, delivery, and outcomes of randomized controlled trials.

CONTEXT Interventions targeting maternal obesity are a healthcare and public health priority. OBJECTIVE The objective of this review was to evaluate the adequacy and effectiveness of the methodological designs implemented in dietary intervention trials for obesity in pregnancy. DATA SOURCES A systematic review of the literature, consistent with PRISMA guidelines, was performed as part of the International Weight Management in Pregnancy collaboration. STUDY SELECTION Thirteen randomized controlled trials, which aimed to modify diet and physical activity in overweight and obese pregnant women, were identified. DATA SYNTHESIS There was significant variability in the content, delivery, and dietary assessment methods of the dietary interventions examined. A number of studies demonstrated improved dietary behavior in response to diet and/or lifestyle interventions. Nine studies reduced gestational weight gain. CONCLUSION This review reveals large methodological variability in dietary interventions to control gestational weight gain and improve clinical outcomes in overweight and obese pregnant women. This lack of consensus limits the ability to develop clinical guidelines and apply the evidence in clinical practice.

Does exercise during pregnancy prevent postnatal depression

Objective. To study whether exercise during pregnancy reduces the risk of postnatal depression. Design. Randomized controlled trial. Setting. Trondheim and Stavanger University Hospitals, Norway. Population and Sample. Eight hundred and fifty‐five pregnant women were randomized to intervention or control groups. Methods. The intervention was a 12week exercise program, including aerobic and strengthening exercises, conducted between week 20 and 36 of pregnancy. One weekly group session was led by physiotherapists, and home exercises were encouraged twice a week. Control women received regular antenatal care. Main Outcome Measures. Edinburgh Postnatal Depression Scale (EPDS) completed three months after birth. Scores of 10 or more and 13 or more suggested probable minor and major depression, respectively. Results. Fourteen of 379 (3.7%) women in the intervention group and 17 of 340 (5.0%) in the control group had an EPDS score of ≥10 (p=0.46), and four of 379 (1.2%) women in the intervention group and eight of 340 (2.4%) in the control group had an EPDS score of ≥13 (p=0.25). Among women who did not exercise prior to pregnancy, two of 100 (2.0%) women in the intervention group and nine of 95 (9.5%) in the control group had an EPDS score of ≥10 (p=0.03). Conclusions. We did not find a lower prevalence of high EPDS scores among women randomized to regular exercise during pregnancy compared with the control group. However, a subgroup of women in the intervention group who did not exercise regularly prior to pregnancy had a reduced risk of postnatal depression.

Physical activity monitor for recording energy expenditure in pregnancy

Objective. To determine whether the energy expenditure recorded with the physical activity monitor SenseWear™ Pro2 Armband differs from that recorded with indirect calorimetry. Design. Cross‐sectional comparison of measures of energy expenditure. Setting. A convenient sample recruited from a randomized controlled trial. Population. Twenty‐nine pregnant women (24–43years old). Methods. Energy expenditure was recorded with SenseWear™ Pro2 Armband and a portable oxygen analyzer for 90minutes while carrying out a variety of activities of different intensities. Main Outcome Measures. Energy expenditure recorded with the physical activity monitor SenseWear™ Pro2 Armband. Results. Comparing energy expenditure during free‐living activities, the mean differences and limits of agreements from Bland–Altman plots was −136±343kJ, giving an underestimation of energy expenditure by 9%. The intraclass correlation coefficient was 0.85 (95% confidence interval 0.71–0.93; p<0.001), giving 85% of the variance explained by differences among individuals. Conclusions. SenseWear™ Pro2 Armband is a valid measure of energy expenditure during pregnancy.

Study protocol: differential effects of diet and physical activity based interventions in pregnancy on maternal and fetal outcomes-individual patient data (IPD) meta-analysis and health economic evaluation

BackgroundPregnant women who gain excess weight are at risk of complications during pregnancy and in the long term. Interventions based on diet and physical activity minimise gestational weight gain with varied effect on clinical outcomes. The effect of interventions on varied groups of women based on body mass index, age, ethnicity, socioeconomic status, parity, and underlying medical conditions is not clear. Our individual patient data (IPD) meta-analysis of randomised trials will assess the differential effect of diet- and physical activity-based interventions on maternal weight gain and pregnancy outcomes in clinically relevant subgroups of women.Methods/designRandomised trials on diet and physical activity in pregnancy will be identified by searching the following databases: MEDLINE, EMBASE, BIOSIS, LILACS, Pascal, Science Citation Index, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects, and Health Technology Assessment Database. Primary researchers of the identified trials are invited to join the International Weight Management in Pregnancy Collaborative Network and share their individual patient data. We will reanalyse each study separately and confirm the findings with the original authors. Then, for each intervention type and outcome, we will perform as appropriate either a one-step or a two-step IPD meta-analysis to obtain summary estimates of effects and 95% confidence intervals, for all women combined and for each subgroup of interest. The primary outcomes are gestational weight gain and composite adverse maternal and fetal outcomes. The difference in effects between subgroups will be estimated and between-study heterogeneity suitably quantified and explored. The potential for publication bias and availability bias in the IPD obtained will be investigated. We will conduct a model-based economic evaluation to assess the cost effectiveness of the interventions to manage weight gain in pregnancy and undertake a value of information analysis to inform future research.Systematic review registrationPROSPERO 2013:CRD42013003804

Does regular exercise in pregnancy influence duration of labor? A secondary analysis of a randomized controlled trial

To study effects of regular physical exercise in pregnancy on duration of the active phase of labor and the proportions of women with prolonged active second stage.

Effect of diet and physical activity based interventions in pregnancy on gestational weight gain and pregnancy outcomes: meta-analysis of individual participant data from randomised trials

Abstract Objective To synthesise the evidence on the overall and differential effects of interventions based on diet and physical activity during pregnancy, primarily on gestational weight gain and maternal and offspring composite outcomes, according to women’s body mass index, age, parity, ethnicity, and pre-existing medical condition; and secondarily on individual complications. Design Systematic review and meta-analysis of individual participant data (IPD). Data sources Major electronic databases from inception to February 2017 without language restrictions. Eligibility criteria for selecting studies Randomised trials on diet and physical activity based interventions in pregnancy. Data synthesis Statistical models accounted for clustering of participants within trials and heterogeneity across trials leading to summary mean differences or odds ratios with 95% confidence intervals for the effects overall, and in subgroups (interactions). Results IPD were obtained from 36 randomised trials (12 526 women). Less weight gain occurred in the intervention group than control group (mean difference −0.70 kg, 95% confidence interval −0.92 to −0.48 kg, I2=14.1%; 33 studies, 9320 women). Although summary effect estimates favoured the intervention, the reductions in maternal (odds ratio 0.90, 95% confidence interval 0.79 to 1.03, I2=26.7%; 24 studies, 8852 women) and offspring (0.94, 0.83 to 1.08, I2=0%; 18 studies, 7981 women) composite outcomes were not statistically significant. No evidence was found of differential intervention effects across subgroups, for either gestational weight gain or composite outcomes. There was strong evidence that interventions reduced the odds of caesarean section (0.91, 0.83 to 0.99, I2=0%; 32 studies, 11 410 women), but not for other individual complications in IPD meta-analysis. When IPD were supplemented with study level data from studies that did not provide IPD, the overall effect was similar, with stronger evidence of benefit for gestational diabetes (0.76, 0.65 to 0.89, I2=36.8%; 59 studies, 16 885 women). Conclusion Diet and physical activity based interventions during pregnancy reduce gestational weight gain and lower the odds of caesarean section. There is no evidence that effects differ across subgroups of women.