Kjell Å. Salvesen

Prepregnancy cardiovascular risk factors as predictors of pre-eclampsia: population based cohort study

Objective To examine the effect of cardiovascular risk factors before pregnancy on risk of pre-eclampsia. Design Population based prospective study. Setting Linkage between a Norwegian population based study (Nord-Tr�ndelag health study, HUNT-2) and Norways medical birth registry. Participants 3494 women who gave birth after participating in the Nord-Tr�ndelag health study at baseline; of whom 133 (3.8%) delivered after a pre-eclamptic pregnancy. Main outcome measure Odds ratio of developing pre-eclampsia. Results After adjustment for smoking; previous pre-eclampsia; parity; maternal age, education, and socioeconomic position; and duration between baseline measurements and delivery, positive associations were found between prepregnancy serum levels of triglycerides, cholesterol, low density lipoprotein cholesterol, non-high density lipoprotein cholesterol, and blood pressure and risk of pre-eclampsia. The odds ratio of developing pre-eclampsia for women with baseline systolic blood pressures greater than 130 mm Hg (highest fifth) was 7.3 (95% confidence interval 3.1 to 17.2) compared with women with systolic blood pressures less than 111 mm Hg (lowest fifth). Similar results were found for nulliparous and parous women. Women who used oral contraceptives at baseline had half the risk of pre-eclampsia compared with never or former users (0.5, 0.3 to 0.9). Conclusion Women with cardiovascular risk factors may be predisposed to pre-eclampsia.

Risk factors and clinical manifestations of pre‐eclampsia

Objective To study associations between established risk factors for pre‐eclampsia and different clinical manifestations of the disease.

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

Use of recombinant activated factor VII in primary postpartum hemorrhage - The northern European registry 2000-2004

OBJECTIVE: To collect data from nine European countries for cases of obstetric hemorrhage between 2000 and 2004 in which recombinant activated factor VII (rFVIIa) was used. METHODS: The cases were identified through national surveys. Standardized case report forms included sociodemographic details, past medical and obstetric history, and details of the progress and management of labor in which the postpartum hemorrhage occurred. Clinicians were asked to describe subjectively the effect of rFVIIa administration using two mutually exclusive categories: 1) bleeding reduced or 2) bleeding unchanged or worse. RESULTS: A total of 113 forms were returned (88%) with 97 (86%) classified as treatment, and 16 (14%) as “secondary prophylaxis.” Clinicians noted improvements after a single dose for 80% of women in the treatment group, and for 75% in the secondary “prophylaxis” group. However, rFVIIa failed in 15 cases (13.8%). Few serious adverse events were noted related to rFVIIa administration; there were four cases of thromboembolism, one myocardial infarction, and one skin rash. CONCLUSION: Clinical reports and hematologic data suggest improvement for more than 80% of women after rFVIIa administration and few adverse effects. LEVEL OF EVIDENCE: II

Routine ultrasound screening in pregnancy and the children's subsequent handedness.

OBJECTIVE To study a possible association between ultrasound screening in early pregnancy and altered cerebral dominance measured by the prevalence of non-right handedness among children, particularly boys. METHODS Follow-up of 8 to 9 year old children to women who participated in a randomised controlled trial on ultrasound screening during pregnancy in 1985-87. The children were followed up through a questionnaire sent to their mothers. The dominant hand of the child was assessed by eleven questions. The dominant foot by one question. RESULTS No differences were found in non-right handedness between children in the screening and non-screening group. In separate analyses on ultrasound exposure and non-right handedness among boys a significant difference was found (odds ratio 1.33; 95% confidence interval 1.02-1.74). CONCLUSION This study could not rule out a possible association between non-right handedness among boys and ultrasound exposure in early fetal life. The association was, however, confined to analyses comparing exposed and non-exposed boys and no associations were found when the comparisons were performed according to the randomised groups.

RANDOMISED CONTROLLED TRIAL OF PELVIC FLOOR MUSCLE TRAINING DURING PREGNANCY

Abstract Objectives To examine a possible effect on labour of training the muscles of the pelvic floor during pregnancy. Design Randomised controlled trial. Setting Trondheim University Hospital and three outpatient physiotherapy clinics in a primary care setting. Participants 301 healthy nulliparous women randomly allocated to a training group (148) or a control group (153). Intervention A structured training programme with exercises for the pelvic floor muscles between the 20th and 36th week of pregnancy. Main outcome measures Duration of the second stage of labour and number of deliveries lasting longer than 60 minutes of active pushing among women with spontaneous start of labour after 37 weeks of pregnancy with a singleton fetus in cephalic position. Results Women randomised to pelvic floor muscle training had a lower rate of prolonged second stage labour (24%, 95% confidence interval 16% to 33%; 22 out of 105 women were at risk (undelivered) at 60 minutes in the survival analysis) than women allocated to no training (38% (37/109), 28% to 47%). The duration of the second stage was not significantly shorter (40 minutes v 45 minutes, P = 0. 06). Conclusions A structured training programme for the pelvic floor muscles is associated with fewer cases of active pushing in the second stage of labour lasting longer than 60 minutes.

American Institute of Ultrasound in Medicine consensus report on potential bioeffects of diagnostic ultrasound: Executive summary

The continued examination of potential biological effects of ultrasound and their relationship to clinical practice is a key element in evaluating the safety of diagnostic ultrasound. Periodically, the American Institute of Ultrasound in Medicine (AIUM) sponsors conferences bringing experts together to examine the literature on ultrasound bioeffects and to develop conclusions and recommendations related to diagnostic ultrasound. The most recent effort included the examination of effects whose origins were thermal or nonthermal, with separate evaluations for potential effects related to fetal ultrasound. In addition, potential effects due to the introduction of ultrasound contrast agents were summarized. This information can be used to assess risks in comparison to the benefits of diagnostic ultrasound. The conclusions and recommendations are organized into 5 broad categories, with a comprehensive background and evaluation of each topic provided in the corresponding articles in this issue. The following summary is not meant as a substitute for the detailed examination of issues presented in each of the articles but rather as a means to facilitate further study of this consensus report and implementation of its recommendations. The conclusions and recommendations are the result of several rounds of deliberations at the consensus conference, subsequent review by the Bioeffects Committee of the AIUM, and approval by the AIUM Board of Governors.

Induction of Labor or Serial Antenatal Fetal Monitoring in Postterm Pregnancy A Randomized Controlled Trial

OBJECTIVE: To compare induction of labor at gestational age 41 weeks with expectant management in regard to neonatal morbidity. Secondary aims were to assess the effect of these managements on mode of delivery and maternal complications. METHODS: Between September 2002 and July 2004, postterm women with singleton cephalic presentation and no prelabor rupture of membranes were randomly assigned to induction of labor at 289 days or antenatal fetal surveillance every third day until spontaneous labor. Main outcome measures were neonatal morbidity, operative delivery rates, and maternal complications. RESULTS: Five hundred eight women were randomly assigned, 254 in each group. No differences of clinical importance were observed in women in whom labor was induced compared with women who were expectantly managed with regard to the following outcomes: neonates whose 5-minute Apgar score was less than 7 (three neonates in the induction group compared with four in the monitoring group, P=.72); neonates whose umbilical cord pH was less than 7 (three compared with two, P=.69); prevalence of cesarean delivery (28 compared with 33, P=.50); or prevalence of operative vaginal delivery (32 compared with 27, P=.49). In the induction group more women had precipitate labors (33 compared with 12, P<.01; number needed to treat was 13), and the duration of second stage of labor was more often less than 15 minutes (94 compared with 56, P<.01; number needed to treat was 7). CONCLUSION: No differences were found between the induced and monitored groups regarding neonatal morbidity or mode of delivery, and the outcomes were generally good. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00385229 LEVEL OF EVIDENCE: I

Does group training during pregnancy prevent lumbopelvic pain? A randomized clinical trial

Background. Prevention of lumbopelvic pain in pregnancy has been sparsely studied. One aim of this study was to assess if a 12‐week training program during pregnancy can prevent and/or treat lumbopelvic pain. A randomized controlled trial was conducted at Trondheim University Hospital and three outpatient physiotherapy clinics. Three hundred and one healthy nulliparous women were included at 20 weeks of pregnancy and randomly allocated to a training group (148) or a control group (153). Methods. The outcome measures were self‐reported symptoms of lumbopelvic pain (once per week or more), sick leave, and functional status. Pain drawing was used to document the painful area of the body. The intervention included daily pelvic floor muscle training at home, and weekly group training over 12 weeks including aerobic exercises, pelvic floor muscle and additional exercises, and information related to pregnancy. Results. At 36 weeks of gestation women in the training group were significantly less likely to report lumbopelvic pain: 65/148 (44%) versus 86/153 (56%) (p = 0.03). Three months after delivery the difference was 39/148 (26%) in the training group versus 56/153 (37%) in the control group (p = 0.06). There was no difference in sick leave during pregnancy, but women in the training group had significantly (p = 0.01) higher scores on functional status. Conclusions. A 12‐week specially designed training program during pregnancy was effective in preventing lumbopelvic pain in pregnancy.

Pregnancy and delivery in women with chronic inflammatory arthritides with a specific focus on first birth.

OBJECTIVE To examine possible associations between chronic inflammatory arthritides and pregnancy outcomes with separate analyses of first and subsequent births before and after diagnosis. METHODS Linkage of data from a registry of patients with chronic inflammatory arthritides and the Medical Birth Registry of Norway enabled a comparison of pregnancy outcomes in women with chronic inflammatory arthritides and pregnancy outcomes in reference subjects. Outcomes of first birth and subsequent births before and after diagnosis were analyzed separately. Associations between chronic inflammatory arthritides and the womens health during pregnancy and delivery as well as perinatal outcomes were assessed in logistic regression analyses with adjustments for maternal age at delivery and gestational age. RESULTS We analyzed 128 first births and 151 subsequent births after diagnosis and 286 first births and 262 subsequent births before diagnosis in patients and compared them with first and subsequent births in reference subjects. Firstborn children of women diagnosed as having chronic inflammatory arthritides were more often preterm (odds ratio [OR] 1.85 [95% confidence interval (95% CI) 1.09-3.13]) and small for gestational age (OR 1.60 [95% CI 1.00-2.56]). They also had lower mean birth weight (P=0.01) and higher perinatal mortality (OR 3.26 [95% CI 1.04-10.24]). Birth by caesarean section (all classifications) was more frequent in patients than in reference subjects, and elective caesarean section was 2-fold more frequent in patients, both in first birth (OR 2.60 [95% CI 1.43-4.75]) and in subsequent births (OR 2.18 [95% CI 1.33-3.58]). No excess risks of clinical importance were observed prior to diagnosis of chronic inflammatory arthritides. CONCLUSION Excess risks were related to first birth in women diagnosed as having chronic inflammatory arthritides, including a higher rate of perinatal mortality. A higher caesarean section rate was related to all patient deliveries. Mainly, pregnancy outcomes before diagnosis did not differ from those in reference subjects.