Objective To evaluate the effectiveness of an exercise programme for pregnant women who were overweight or obese and at risk for gestational diabetes mellitus (GDM).Design Randomised controlled trial.Setting Hospitals and midwifery practices in the Netherlands.Population Pregnant women who were overweight or obese and at risk for GDM between 2007 and 2011.Methods Normal care was compared with an exercise training programme during pregnancy. The training consisted of aerobic and strength exercises, and was aimed at improving maternal fasting blood glucose, insulin sensitivity, and birthweight. Linear regression analyses were performed to determine the effects.Main outcome measures Maternal outcome measures were fasting blood glucose (mmol/l), fasting insulin (pmol/l) and HbA1c (%), body weight (kg), body mass index (kg/m 2 ), and daily physical activity (minute/week). Offspring outcome measures were birthweight and fetal growth.Results A total of 121 women were randomly allocated to either a control (n = 59) or an intervention (n = 62) group. Intention-totreat analysis showed that the exercise programme did not reduce maternal fasting blood glucose levels nor insulin sensitivity. Also, no effect was found on birthweight.Conclusions The exercise intervention performed over the second and third trimester of pregnancy had no effects on fasting blood glucose, insulin sensitivity, and birthweight, most probably because of low compliance. The high prevalence of women at risk for GDM calls for further research on possible interventions that can prevent GDM, and other types of interventions to engage this target group in physical activity and exercise.
Doppler ultrasound, ultrasound M-mode analysis, fetal electrocardiography, and fetal magnetocardiography are methods by which the fetal heart can be monitored non-invasively. In this paper, they are evaluated and compared. Customarily, it is solely the fetal heart rate, which is monitored using the Doppler ultrasound technique since it is both simple to use and cheap. However, this method inherently produces an averaged heart rate and therefore cannot give the beat-to-beat variability. Fetal electrocardiography has similar advantages, but in addition offers the potential for monitoring beat-to-beat variability and performing electrocardiogram morphological analysis. Its disadvantage is that its reliability is only 60%, although it is the only technique that offers truly long-term ambulatory monitoring. Ultrasound M-mode analysis allows a estimation of atrial and ventricular coordination, as well as an estimation of PR intervals. Bradycardias, supraventricular tachycardias, extra systoles are readily diagnosed using this method although timing will be inaccurate. Fetal magnetocardiograms can be detected reliably and used for accurate beat-to-beat measurements and morphological analysis. Consequently, they can be used for the classification of arrhythmias and the diagnosis of a long QT syndrome and some congenital heart diseases.
ObjectiveTo compare the effectiveness of a hysteroscopic niche resection versus no treatment in women with postmenstrual spotting and a uterine caesarean scar defect.DesignMulticentre randomised controlled trial.SettingEleven hospitals collaborating in a consortium for women's health research in the Netherlands.PopulationWomen reporting postmenstrual spotting after a caesarean section who had a niche with a residual myometrium of ≥3 mm, measured during sonohysterography.MethodsWomen were randomly allocated to hysteroscopic niche resection or expectant management for 6 months.Main outcome measuresThe primary outcome was the number of days of postmenstrual spotting 6 months after randomisation. Secondary outcomes were spotting at the end of menstruation, intermenstrual spotting, dysuria, sonographic niche measurements, surgical parameters, quality of life, women's satisfaction, sexual function, and additional therapy. Outcomes were measured at 3 months and, except for niche measurements, also at 6 months after randomisation.ResultsWe randomised 52 women to hysteroscopic niche resection and 51 women to expectant management. The median number of days of postmenstrual spotting at baseline was 8 days in both groups. At 6 months after randomisation, the median number of days of postmenstrual spotting was 4 days (interquartile range, IQR 2–7 days) in the intervention group and 7 days (IQR 3–10 days) in the control group (P = 0.04); on a scale of 0–10, discomfort as a result of spotting had a median score of 2 (IQR 0–7) in the intervention group, compared with 7 (IQR 0–8) in the control group (P = 0.02).ConclusionsIn women with a niche with a residual myometrium of ≥3 mm, hysteroscopic niche resection reduced postmenstrual spotting and spotting‐related discomfort.Tweetable abstractA hysteroscopic niche resection is an effective treatment to reduce niche‐related spotting.
BackgroundA caesarean section (CS) can cause a defect or disruption of the myometrium at the site of the uterine scar, called a niche. In recent years, an association between a niche and postmenstrual spotting after a CS has been demonstrated. Hysteroscopic resection of these niches is thought to reduce spotting and menstrual pain. However, there are no randomised trials assessing the effectiveness of a hysteroscopic niche resection.Methods/DesignWe planned a multicentre randomised trial comparing hysteroscopic niche resection to no intervention. We study women with postmenstrual spotting after a CS and a niche with a residual myometrium of at least 3 mm during sonohysterography. After informed consent is obtained, eligible women will be randomly allocated to hysteroscopic resection of the niche or expectant management for 6 months.The primary outcome is the number of days with postmenstrual spotting during one menstrual cycle 6 months after randomisation. Secondary outcomes are menstrual characteristics, menstruation related pain and experienced discomfort due to spotting or menstrual pain, quality of life, patient satisfaction, sexual function, urological symptoms, medical consultations, medication use, complications, lost productivity and medical costs. Measurements will be performed at baseline and at 3 and 6 months after randomisation. A cost-effectiveness analysis will be performed from a societal perspective at 6 months after randomisation.DiscussionThis trial will provide insight in the (cost)effectiveness of hysteroscopic resection of a niche versus expectant management in women who have postmenstrual spotting and a niche with sufficient residual myometrium to perform a hysteroscopic niche resection.Trial registrationDutch Trial Register NTR3269. Registered 1 February 2012. ZonMw Grant number 80-82305-97-12030
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