Adherence to guidelines and suboptimal practice in term breech delivery with perinatal death- a population-based case-control study in Norway.

BACKGROUND: In a recent population-based study we reported excess risk of neonatal mortality associated with vaginal breech delivery. In this case-control study we examine whether deviations from Norwegian guidelines are more common in breech deliveries resulting in intrapartum or neonatal deaths than in breech deliveries where the offspring survives, and if these deaths are potentially avoidable. MATERIAL AND METHODS: Case-control study completed as a perinatal audit including term breech deliveries of singleton without congenital anomalies in Norway from 1999 to 2015. Deliveries where the child died intrapartum or in the neonatal period were case deliveries. For each case, two control deliveries who survived were identified. All the included deliveries were reviewed by four obstetricians independently assessing if the deaths in the case group might have been avoided and if the management of the deviations from Norwegian guidelines were more common in case than in control deliveries. RESULTS: Thirty-one case and 62 control deliveries were identified by the Medical Birth Registry of Norway. After exclusion of non-eligible deliveries, 22 case and 31 control deliveries were studied. Three case and two control deliveries were unplanned home deliveries, while all in-hospital deliveries were in line with national guidelines. Antenatal care and/or management of in-hospital deliveries was assessed as suboptimal in seven (37%) case and two (7%) control deliveries (p = 0.020). Three case deliveries were completed as planned caesarean delivery and 12 (75%) of the remaining 16 deaths were considered potentially avoidable had planned caesarean delivery been done. In seven of these 16 deliveries, death was associated with cord prolapse or difficult delivery of the head. CONCLUSION: All in-hospital breech deliveries were in line with Norwegian guidelines. Seven of twelve potentially avoidable deaths were associated with birth complications related to breech presentation. However, suboptimal care was more common in case than control deliveries. Further improvement of intrapartum care may be obtained through continuous rigorous training and feedback from repeated perinatal audits.

PCOS--what matters in early pregnancy?--data from a cross-sectional, multicenter study.

OBJECTIVE: To describe patient characteristics according to different diagnostic criteria in early pregnancy, in women with polycystic ovary syndrome (PCOS). DESIGN: Descriptive, cross-sectional study of 257 women with PCOS in the first trimester of pregnancy. SETTING: Data from a multicenter trial at the time of inclusion. POPULATION: 257 PCOS women with singleton pregnancies. METHODS: Investigator-administrated questionnaires were filled out. Clinical examination was performed by the investigators. Fasting blood samples were collected. MAIN OUTCOME MEASURES: Biometric data, androgens, glucose and insulin levels. RESULTS: Women who met the National Institutes of Health (NIH) criteria for PCOS had higher body mass index (BMI), testosterone, dehydroepiandrostenedione, free testosterone index (FTI) and insulin levels compared with those who only met the Rotterdam consensus criteria. Adjusted for age and BMI, only testosterone and FTI were higher in those who met the NIH criteria. BMI was a strong, independent predictor of both systolic and diastolic blood pressure in early PCOS pregnancy, while both FTI and fasting insulin were independent predictors of systolic blood pressure. Twenty-two (9%) of the participants had gestational diabetes mellitus in the first trimester of pregnancy. CONCLUSIONS: In the first trimester, PCOS women diagnosed according to NIH criteria were more metabolically and endocrinologically abnormal compared with those who only met the Rotterdam consensus criteria. BMI and FTI were independent predictive factors for blood pressure. There was a high prevalence of gestational diabetes mellitus in early PCOS pregnancies.

Does caesarean delivery in the first pregnancy increase the risk for adverse outcome in the second? A registry-based cohort study on first and second singleton births in Norway.

OBJECTIVE: To explore if newborns in the second pregnancy following a previous caesarean delivery (CD) have higher risk of perinatal mortality or cerebral palsy than newborns in pregnancies following a previous vaginal delivery (VD). DESIGN: Cohort study with information from the Medical Birth Registry of Norway and the Cerebral Palsy Registry of Norway. SETTING: Births in Norway. PARTICIPANTS: 294 598 women with their first and second singleton delivery during 1996-2015. MAIN OUTCOME MEASURES: Stillbirth, perinatal mortality, neonatal mortality and cerebral palsy. RESULTS: Among 294 598 included women, 42 962 (15%) had a CD in their first pregnancy while 251 636 (85%) had a VD. Compared with the second delivery of mothers with a previous VD, the adjusted OR (adjOR), for stillbirth in the second pregnancy following a previous CD was 1.45, 95% CI 1.22 to 1.73; for perinatal death the adjOR was 1.42 (1.22 to 1.73) and for neonatal death 1.13 (0.86 to 1.49). Among children who survived the neonatal period, the adjOR for cerebral palsy was 1.27 (0.99 to 1.64). Secondary outcomes, including small for gestational age, preterm and very preterm birth, uterine rupture and placental complications (eg, postpartum haemorrhage and pre-eclampsia) were more frequent in the subsequent pregnancy following a previous CD compared with a previous VD, in particular for uterine rupture adjOR 86.7 (48.2 to 156.1). Adjustment for potential confounders attenuated the ORs somewhat, but the excess risk in the second pregnancy persisted for all outcomes. CONCLUSION: A previous CD was in this study associated with increased risk for stillbirth and perinatal death compared with a previous VD. Although less robust, we also found that a previous CD was associated with a slightly increased risk of cerebral palsy among children surviving the neonatal period. The aetiology behind these associations needs further investigation.

Use of metformin to treat pregnant women with polycystic ovary syndrome (PregMet2): a randomised, double-blind, placebo-controlled trial.

BACKGROUND: Women with polycystic ovary syndrome (PCOS) have an increased risk of pregnancy complications. Epi-analysis of two previous randomised controlled trials that compared metformin with placebo during pregnancy in women with PCOS showed a significant reduction in late miscarriages and preterm births in the metformin group. The aim of this third randomised trial (PregMet2) was to test the hypothesis that metformin prevents late miscarriage and preterm birth in women with PCOS. METHODS: PregMet2 was a randomised, placebo-controlled, double-blind, multicentre trial done at 14 hospitals in Norway, Sweden, and Iceland. Singleton pregnant women with PCOS aged 18-45 years were eligible for inclusion. After receiving information about the study at their first antenatal visit or from the internet, women signed up individually to participate in the study. Participants were randomly assigned (1:1) to receive metformin or placebo by computer-generated random numbers. Randomisation was in blocks of ten for each country and centre; the first block had a random size between one and ten to assure masking. Participants were assigned to receive oral metformin 500 mg twice daily or placebo during the first week of treatment, which increased to 1000 mg twice daily or placebo from week 2 until delivery. Placebo tablets and metformin tablets were identical and participants and study personnel were masked to treatment allocation. The primary outcome was the composite incidence of late miscarriage (between week 13 and week 22 and 6 days) and preterm birth (between week 23 and week 36 and 6 days), analysed in the intention-to-treat population. Secondary endpoints included the incidence of gestational diabetes, preeclampsia, pregnancy-induced hypertension, and admission of the neonate to the neonatal intensive care unit. We also did a post-hoc individual participant data analysis of pregnancy outcomes, pooling data from the two previous trials with the present study. The study was registered with ClinicalTrials.gov, number NCT01587378, and EudraCT, number 2011-002203-15. FINDINGS: The study took place between Oct 19, 2012, and Sept 1, 2017. We randomly assigned 487 women to metformin (n=244) or placebo (n=243). In the intention-to-treat analysis, our composite primary outcome of late miscarriage and preterm birth occurred in 12 (5%) of 238 women in the metformin group and 23 (10%) of 240 women in the placebo group (odds ratio [OR] 0·50, 95% CI 0·22-1·08; p=0·08). We found no significant differences for our secondary endpoints, including incidence of gestational diabetes (60 [25%] of 238 women in the metformin group vs 57 [24%] of 240 women in the placebo group; OR 1·09, 95% CI 0·69-1·66; p=0·75). We noted no substantial between-group differences in serious adverse events in either mothers or offspring, and no serious adverse events were considered drug-related by principal investigators. In the post-hoc pooled analysis of individual participant data from the present trial and two previous trials, 18 (5%) of 397 women had late miscarriage or preterm delivery in the metformin group compared with 40 (10%) of 399 women in the placebo group (OR 0·43, 95% CI 0·23-0·79; p=0·004). INTERPRETATION: In pregnant women with PCOS, metformin treatment from the late first trimester until delivery might reduce the risk of late miscarriage and preterm birth, but does not prevent gestational diabetes. FUNDING: Research Council of Norway, Novo Nordisk Foundation, St Olav's University Hospital, and Norwegian University of Science and Technology.

Is vaginal breech delivery associated with higher risk for perinatal death and cerebral palsy compared with vaginal cephalic birth? Registry-based cohort study in Norway.

OBJECTIVE: This paper aims to study if vaginal breech delivery is associated with increased risk for neonatal mortality (NNM) or cerebral palsy (CP) in Norway where vaginal delivery accounts for 1/3 of all breech deliveries. DESIGN: Cohort study using information from the national Medical BirthRegister and Cerebral Palsy Register. SETTING: Births in Norway 1999-2009. PARTICIPANTS: 520 047 term-born singletons without congenital malformations. MAIN OUTCOME MEASURES: NNM, CP and a composite outcome of these and death during birth. RESULTS: Compared with cephalic births, breech births had substantially increased risk for NNM but not for CP. Vaginal delivery was planned for 7917 of 16 700 fetuses in breech, while 5561 actually delivered vaginally. Among these, NNM was 0.9 per 1000 compared with 0.3 per 1000 in vaginal cephalic delivery, and 0.8 per 1000 in those actually born by caesarean delivery (CD) in breech. Compared with planned cephalic delivery, planned vaginal delivery was associated with excess risk for NNM (OR 2.4; 95% CI 1.2 to 4.9), while the OR associated with planned breech CD was 1.6 (95% CI 0.7 to 3.7). These risks were attenuated when NNM was substituted by the composite outcome. Vaginal breech delivery was not associated with excess risk for CP compared with vaginal cephalic delivery. CONCLUSION: Vaginal breech delivery, regardless of whether planned or actual, and actual breech CD were associated with excess risk for NNM compared with vaginal cephalic delivery, but not with CP. The risk for NNM and CP in planned breech CD did not differ significantly from planned vaginal cephalic delivery. However, the absolute risk for these outcomes was low, and taking into consideration potential long-term adverse consequences of CD for the child and later deliveries, we therefore conclude that vaginal breech delivery may be recommended, provided competent obstetric care and strict criteria for selection to vaginal delivery.

A multicenter interventional program to reduce the incidence of anal sphincter tears.

OBJECTIVE: In Norway, we have experienced a gradual increase in the incidence of obstetric anal sphincter injuries from under 1% in the late 1960s to 4.3% in 2004. This study was aimed to assess whether an interventional program causes a decrease in the frequency of anal sphincter tears. METHODS: In all, 40,152 vaginal deliveries between 2003 and 2009 were enrolled in the interventional cohort study from four Norwegian obstetric departments. The focus of the intervention was on manual assistance during the final part of the second stage of labor. Data were analyzed in relation to occurrence of obstetric anal sphincter tears. RESULTS: The proportion of parturients with anal sphincter tears decreased from 4-5% to 1-2% during the study period in all four hospitals (P<.001). The tears associated with both noninstrumental and instrumental deliveries decreased dramatically. The number of patients with grades 3 and 4 anal sphincter ruptures decreased significantly, and the reduction was most pronounced in grade 4 tears (-63.5%) and least in 3c tears (-47.5%) (both P<.001). The number of episiotomies increased in two hospitals but remained unchanged in the other two. The lowest proportion of tears at the end of the intervention (1.2% and 1.3%, respectively) was found in the two hospitals with an unchanged episiotomy rate. CONCLUSION: The multicenter intervention caused a highly significant decrease in obstetric anal sphincter injuries. LEVEL OF EVIDENCE: II.

Metformin versus placebo from first trimester to delivery in polycystic ovary syndrome: a randomized, controlled multicenter study.

CONTEXT: Metformin is widely prescribed to pregnant women with polycystic ovary syndrome (PCOS) in an attempt to reduce pregnancy complications. Metformin is not approved for this indication, and evidence for this practice is lacking. OBJECTIVES: Our objective was to test the hypothesis that metformin, from first trimester to delivery, reduces pregnancy complications in women with PCOS. DESIGN AND SETTING: We conducted a randomized, placebo-controlled, double-blind, multicenter study at 11 secondary care centers. PARTICIPANTS: The participants were 257 women with PCOS, in the first trimester of pregnancy, aged 18-42 yr. INTERVENTION: We randomly assigned 274 singleton pregnancies (in 257 women) to receive metformin or placebo, from first trimester to delivery. MAIN OUTCOME MEASURES: The prevalence of preeclampsia, gestational diabetes mellitus, preterm delivery, and a composite of these three outcomes is reported. RESULTS: Preeclampsia prevalence was 7.4% in the metformin group and 3.7% in the placebo group (3.7%; 95% CI, -1.7-9.2) (P=0.18). Preterm delivery prevalence was 3.7% in the metformin group and 8.2% in the placebo group (-4.4%; 95%, CI, -10.1-1.2) (P=0.12). Gestational diabetes mellitus prevalence was 17.6% in the metformin group and 16.9% in the placebo group (0.8%; 95% CI, -8.6-10.2) (P=0.87). The composite primary endpoint prevalence was 25.9 and 24.4%, respectively (1.5%; 95% CI, -8.9-11.3) (P=0.78). Women in the metformin group gained less weight during pregnancy compared with those in the placebo group. There was no difference in fetal birth weight between the groups. CONCLUSIONS: Metformin treatment from first trimester to delivery did not reduce pregnancy complications in PCOS.