Antenatal risk score for prediction of shoulder dystocia with focus on fetal ultrasound data.

BACKGROUND: Shoulder dystocia is one of the most threatening complications during delivery, and although it is difficult to predict, individual risk should be considered when counseling for mode of delivery. OBJECTIVE: This study aimed to develop and validate a risk score for shoulder dystocia based on fetal ultrasound and maternal data from 15,000 deliveries. STUDY DESIGN: Data were retrospectively obtained of deliveries in 3 tertiary centers between 2014 and 2017 for the derivation cohort and between 2018 and 2020 for the validation cohort. Inclusion criteria were singleton pregnancy, vaginal delivery in cephalic presentation at ≥37+0 weeks' gestation, and fetal biometry data available within 2 weeks of delivery. Independent predictors were determined by multivariate regression analysis in the derivation cohort, and a score was developed on the basis of the effect of the predictors. RESULTS: The derivation cohort consisted of 7396 deliveries with a 0.91% rate of shoulder dystocia, and the validation cohort of 7965 deliveries with a 1.0% rate of shoulder dystocia. Among all women, 13.8% had diabetes mellitus, and 12.1% were obese (body mass index ≥30 kg/m2). Independent risk factors in the derivation cohort were: estimated fetal weight ≥4250 g (odds ratio, 4.27; P=.002), abdominal-head-circumference ≥2.5 cm (odds ratio, 3.96; P<.001), and diabetes mellitus (odds ratio, 2.18; P=.009). On the basis of the strength of effect, a risk score was developed: estimated fetal weight ≥4250 g=2, abdominal-head-circumference ≥2.5 cm=2, and diabetes mellitus=1. The risk score predicted shoulder dystocia with moderate discriminatory ability (area under the receiver-operating characteristic curve, 0.69; P<.001; area under the receiver-operating characteristic curve, 0.71; P<.001) and good calibration (Hosmer-Lemeshow goodness-of-fit; P=.466; P=.167) for the derivation and validation cohorts, respectively. With 1 score point, 16 shoulder dystocia cases occurred in 1764 deliveries, with 0.6% shoulder dystocia incidence and a number needed to treat with cesarean delivery to avoid 1 case of shoulder dystocia of 172 (2 points: 38/1809, 2.1%, 48; 3 points: 18/336, 5.4%, 19; 4 points: 10/96, 10.5%, 10; and 5 points: 5/20, 25%, 4); 40.8% of the shoulder dystocia cases occurred without risk factors. CONCLUSION: The presented risk score for shoulder dystocia may act as a supplemental tool for the clinical decision-making regarding mode of delivery. According to our score model, in pregnancies with a score ≤2, meaning having solely estimated fetal weight ≥4250 g, or abdominal-head-circumference ≥2.5, or diabetes mellitus, cesarean delivery for prevention of shoulder dystocia should not be recommended because of the high number needed to treat to avoid 1 case of shoulder dystocia. Conversely, in patients with a score of ≥4 with or without diabetes mellitus, cesarean delivery may be considered. However, in 40% of the shoulder dystocia cases, no risk factors had been present.

Antenatal risk prediction of shoulder dystocia: influence of diabetes and obesity: a multicenter study.

PURPOSE: To estimate the risk of shoulder dystocia (SD) in pregnancies with/without maternal diabetes or obesity; to identify antenatal maternal and fetal ultrasound-derived risk factors and calculate their contributions. METHODS: A multicenter retrospective analysis of 13,428 deliveries in three tertiary hospitals (2014-2017) with fetal ultrasound data ≤ 14 days prior to delivery (n = 7396). INCLUSION CRITERIA: singleton pregnancies in women ≥ 18 years old; vertex presentation; vaginal delivery at ≥ 37 weeks of gestation. Estimated fetal weight (EFW) and birth weight (BW) were categorized by steps of 250 g. To evaluate risk factors, a model was performed using ultrasound data with SD as the dependent variable. RESULTS: Diabetes was present in 9.3%; BMI ≥ 30 kg/m2 in 10.4% and excessive weight gain in 39.8%. The total SD rate was 0.9%, with diabetes 2.0% and with obesity 1.9%. These increased with BW 4250-4499 g compared to 4000-4249 g in women with diabetes (12.1% vs 1.9%, P = 0.010) and without (6.1% vs 1.6%, P < 0.001) and at the same BW threshold for women with obesity (9.6% vs 0.6%, P = 0.002) or without (6.4% vs 1.8%, P < 0.001). Rates increased similarly for EFW at 4250 g and for AC-HC at 2.5 cm. Independent risk factors for SD were EFW ≥ 4250 g (OR 3.8, 95% CI 1.5-9.4), AC-HC ≥ 2.5 cm (OR 3.1, 95% CI 1.3-7.5) and diabetes (OR 2.2, 95% CI 1.2-4.0). HC/AC ratio, obesity, excessive weight gain and labor induction were not significant. CONCLUSION: Independent of diabetes, which remains a risk factor for SD, a significant increase may be expected if the EFW is ≥ 4250 g and AC-HC is ≥ 2.5 cm.

Resolving the Gestational Diabetes Diagnosis Conundrum: The Need for a Randomized Controlled Trial of Treatment.

The diagnosis of and criteria for gestational diabetes mellitus (GDM) continue to divide the scientific and medical community, both between and within countries. Many argue for universal adoption of the International Association of the Diabetes and Pregnancy Study Groups (IADPSG) criteria and feel that further clinical trials are unjustified and even unethical. However, there are concerns about the large increase in number of women who would be diagnosed with GDM using these criteria and the subsequent impact on health care resources and the individual. This Perspective reviews the origins of the IADPSG consensus and points out some of its less well-known limitations, particularly with respect to identifying women at risk for an adverse pregnancy outcome. It also questions the clinical and cost-effectiveness data often cited to support the IADPSG glycemic thresholds. We present the argument that adoption of diagnostic criteria defining GDM should be based on response to treatment at different diagnostic thresholds of maternal glycemia. This will likely require an international multicenter trial of treatment.

A core outcome set for studies of gestational diabetes mellitus prevention and treatment.

AIMS/HYPOTHESIS: The aim of this systematic review was to develop core outcome sets (COSs) for trials evaluating interventions for the prevention or treatment of gestational diabetes mellitus (GDM). METHODS: We identified previously reported outcomes through a systematic review of the literature. These outcomes were presented to key stakeholders (including patient representatives, researchers and clinicians) for prioritisation using a three-round, e-Delphi study. A priori consensus criteria informed which outcomes were brought forward for discussion at a face-to-face consensus meeting where the COS was finalised. RESULTS: Our review identified 74 GDM prevention and 116 GDM treatment outcomes, which were presented to stakeholders in round 1 of the e-Delphi study. Round 1 was completed by 173 stakeholders, 70% (121/173) of whom went on to complete round 2; 84% (102/121) of round 2 responders completed round 3. Twenty-two GDM prevention outcomes and 30 GDM treatment outcomes were discussed at the consensus meeting. Owing to significant overlap between included prevention and treatment outcomes, consensus meeting stakeholders agreed to develop a single prevention/treatment COS. Fourteen outcomes were included in the final COS. These consisted of six maternal outcomes (GDM diagnosis, adherence to the intervention, hypertensive disorders of pregnancy, requirement and type of pharmacological therapy for hyperglycaemia, gestational weight gain and mode of birth) and eight neonatal outcomes (birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, neonatal hypoglycaemia, neonatal death and stillbirth). CONCLUSIONS/INTERPRETATION: This COS will enable future GDM prevention and treatment trials to measure similar outcomes that matter to stakeholders and facilitate comparison and combination of these studies. TRIAL REGISTRATION: This study was registered prospectively with the Core Outcome Measures in Effectiveness Trials (COMET) database: http://www.comet-initiative.org/studies/details/686/.

A core outcome set for studies evaluating the effectiveness of prepregnancy care for women with pregestational diabetes.

AIMS/HYPOTHESIS: The aim of this study was to develop a core outcome set (COS) for trials and other studies evaluating the effectiveness of prepregnancy care for women with pregestational (pre-existing) diabetes mellitus. METHODS: A systematic literature review was completed to identify all outcomes reported in prior studies in this area. Key stakeholders then prioritised these outcomes using a Delphi study. The list of outcomes included in the final COS were finalised at a face-to-face consensus meeting. RESULTS: In total, 17 outcomes were selected and agreed on for inclusion in the final COS. These outcomes were grouped under three domains: measures of pregnancy preparation (n = 9), neonatal outcomes (n = 6) and maternal outcomes (n = 2). CONCLUSIONS/INTERPRETATION: This study identified a COS essential for studies evaluating prepregnancy care for women with pregestational diabetes. It is advocated that all trials and other non-randomised studies and audits in this area use this COS with the aim of improving transparency and the ability to compare and combine future studies with greater ease.

Serum Fatty Acid Binding Protein 4 (FABP4) Predicts Pre-eclampsia in Women With Type 1 Diabetes.

OBJECTIVE: To examine the association between fatty acid binding protein 4 (FABP4) and pre-eclampsia risk in women with type 1 diabetes. RESEARCH DESIGN AND METHODS: Serum FABP4 was measured in 710 women from the Diabetes and Pre-eclampsia Intervention Trial (DAPIT) in early pregnancy and in the second trimester (median 14 and 26 weeks' gestation, respectively). RESULTS: FABP4 was significantly elevated in early pregnancy (geometric mean 15.8 ng/mL [interquartile range 11.6-21.4] vs. 12.7 ng/mL [interquartile range 9.6-17]; P < 0.001) and the second trimester (18.8 ng/mL [interquartile range 13.6-25.8] vs. 14.6 ng/mL [interquartile range 10.8-19.7]; P < 0.001) in women in whom pre-eclampsia later developed. Elevated second-trimester FABP4 level was independently associated with pre-eclampsia (odds ratio 2.87 [95% CI 1.24-6.68], P = 0.03). The addition of FABP4 to established risk factors significantly improved net reclassification improvement at both time points and integrated discrimination improvement in the second trimester. CONCLUSIONS: Increased second-trimester FABP4 independently predicted pre-eclampsia and significantly improved reclassification and discrimination. FABP4 shows potential as a novel biomarker for pre-eclampsia prediction in women with type 1 diabetes.

Glycemic targets in the second and third trimester of pregnancy for women with type 1 diabetes.

OBJECTIVE: To assess the relationship between second and third trimester glycemic control and adverse outcomes in pregnant women with type 1 diabetes, as uncertainty exists about optimum glycemic targets. RESEARCH DESIGN AND METHODS: Pregnancy outcomes were assessed prospectively in 725 women with type 1 diabetes from the Diabetes and Pre-eclampsia Intervention Trial. HbA1c (A1C) values at 26 and 34 weeks' gestation were categorized into five groups, the lowest, <6.0% (42 mmol/mol), being the reference. Average pre- and postprandial results from an eight-point capillary glucose profile the previous day were categorized into five groups, the lowest (preprandial <5.0 mmol/L and postprandial <6.0 mmol/L) being the reference. RESULTS: An A1C of 6.0-6.4% (42-47 mmol/mol) at 26 weeks' gestation was associated with a significantly increased risk of large for gestational age (LGA) (odds ratio 1.7 [95% CI 1.0-3.0]) and an A1C of 6.5-6.9% (48-52 mmol/mol) with a significantly increased risk of preterm delivery (odds ratio 2.5 [95% CI 1.3-4.8]), pre-eclampsia (4.3 [1.7-10.8]), need for a neonatal glucose infusion (2.9 [1.5-5.6]), and a composite adverse outcome (3.2 [1.3-8.0]). These risks increased progressively with increasing A1C. Results were similar at 34 weeks' gestation. Glucose data showed less consistent trends, although the risk of a composite adverse outcome increased with preprandial glucose levels between 6.0 and 6.9 mmol/L at 34 weeks (3.3 [1.3-8.0]). CONCLUSIONS: LGA increased significantly with an A1C ≥6.0 (42 mmol/mol) at 26 and 34 weeks' gestation and with other adverse outcomes with an A1C ≥6.5% (48 mmol/mol). The data suggest that there is clinical utility in regular measurement of A1C during pregnancy.

The role of angiogenic and antiangiogenic factors in the second trimester in the prediction of preeclampsia in pregnant women with type 1 diabetes.

OBJECTIVE: To assess the association between circulating angiogenic and antiangiogenic factors in the second trimester and risk of preeclampsia in women with type 1 diabetes. RESEARCH DESIGN AND METHODS: Maternal plasma concentrations of placental growth factor (PlGF), soluble fms-like tyrosine kinase 1 (sFlt-1), and soluble endoglin (sEng) were available at 26 weeks of gestation in 540 women with type 1 diabetes enrolled in the Diabetes and Preeclampsia Intervention Trial. RESULTS: Preeclampsia developed in 17% of pregnancies (n = 94). At 26 weeks of gestation, women in whom preeclampsia developed later had significantly lower PlGF (median [interquartile range]: 231 pg/mL [120-423] vs. 365 pg/mL [237-582]; P < 0.001), higher sFlt-1 (1,522 pg/mL [1,108-3,393] vs. 1,193 pg/mL [844-1,630] P < 0.001), and higher sEng (6.2 ng/mL [4.9-7.9] vs. 5.1 ng/mL[(4.3-6.2]; P < 0.001) compared with women who did not have preeclampsia. In addition, the ratio of PlGF to sEng was significantly lower (40 [17-71] vs. 71 [44-114]; P < 0.001) and the ratio of sFlt-1 to PlGF was significantly higher (6.3 [3.4-15.7] vs. 3.1 [1.8-5.8]; P < 0.001) in women who later developed preeclampsia. The addition of the ratio of PlGF to sEng or the ratio of sFlt-1 to PlGF to a logistic model containing established risk factors (area under the curve [AUC], 0.813) significantly improved the predictive value (AUC, 0.850 and 0.846, respectively; P < 0.01) and significantly improved reclassification according to the integrated discrimination improvement index (IDI) (IDI scores 0.086 and 0.065, respectively; P < 0.001). CONCLUSIONS: These data suggest that angiogenic and antiangiogenic factors measured during the second trimester are predictive of preeclampsia in women with type 1 diabetes. The addition of the ratio of PlGF to sEng or the ratio of sFlt-1 to PlGF to established clinical risk factors significantly improves the prediction of preeclampsia in women with type 1 diabetes.

Optimal glycemic control, pre-eclampsia, and gestational hypertension in women with type 1 diabetes in the diabetes and pre-eclampsia intervention trial.

OBJECTIVE: To assess the relationship between glycemic control, pre-eclampsia, and gestational hypertension in women with type 1 diabetes. RESEARCH DESIGN AND METHODS: Pregnancy outcome (pre-eclampsia or gestational hypertension) was assessed prospectively in 749 women from the randomized controlled Diabetes and Pre-eclampsia Intervention Trial (DAPIT). HbA(1c) (A1C) values were available up to 6 months before pregnancy (n = 542), at the first antenatal visit (median 9 weeks) (n = 721), at 26 weeks' gestation (n = 592), and at 34 weeks' gestation (n = 519) and were categorized as optimal (<6.1%: referent), good (6.1-6.9%), moderate (7.0-7.9%), and poor (≥8.0%) glycemic control, respectively. RESULTS: Pre-eclampsia and gestational hypertension developed in 17 and 11% of pregnancies, respectively. Women who developed pre-eclampsia had significantly higher A1C values before and during pregnancy compared with women who did not develop pre-eclampsia (P < 0.05, respectively). In early pregnancy, A1C ≥ 8.0% was associated with a significantly increased risk of pre-eclampsia (odds ratio 3.68 [95% CI 1.17-11.6]) compared with optimal control. At 26 weeks' gestation, A1C values ≥ 6.1% (good: 2.09 [1.03-4.21]; moderate: 3.20 [1.47-7.00]; and poor: 3.81 [1.30-11.1]) and at 34 weeks' gestation A1C values ≥ 7.0% (moderate: 3.27 [1.31-8.20] and poor: 8.01 [2.04-31.5]) significantly increased the risk of pre-eclampsia compared with optimal control. The adjusted odds ratios for pre-eclampsia for each 1% decrement in A1C before pregnancy, at the first antenatal visit, at 26 weeks' gestation, and at 34 weeks' gestation were 0.88 (0.75-1.03), 0.75 (0.64-0.88), 0.57 (0.42-0.78), and 0.47 (0.31-0.70), respectively. Glycemic control was not significantly associated with gestational hypertension. CONCLUSIONS: Women who developed pre-eclampsia had significantly higher A1C values before and during pregnancy. These data suggest that optimal glycemic control both early and throughout pregnancy may reduce the risk of pre-eclampsia in women with type 1 diabetes.

Vitamins C and E for prevention of pre-eclampsia in women with type 1 diabetes (DAPIT): a randomised placebo-controlled trial.

BACKGROUND: Results of several trials of antioxidant use during pregnancy have not shown a reduction in pre-eclampsia, but the effect in women with diabetes is unknown. We aimed to assess whether supplementation with vitamins C and E reduced incidence of pre-eclampsia in women with type 1 diabetes. METHODS: We enrolled women from 25 UK antenatal metabolic clinics in a multicentre randomised placebo-controlled trial. Eligibility criteria were type 1 diabetes preceding pregnancy, presentation between 8 weeks' and 22 weeks' gestation, singleton pregnancy, and age 16 years or older. Women were randomly allocated in a 1:1 ratio to receive 1000 mg vitamin C and 400 IU vitamin E (alpha-tocopherol) or matched placebo daily until delivery. The randomisation sequence was stratified by centre with balanced blocks of eight patients. All trial personnel and participants were masked to treatment allocation. The primary endpoint was pre-eclampsia, which we defined as gestational hypertension with proteinuria. Analysis was by modified intention to treat. This study is registered, ISRCTN27214045. FINDINGS: Between April, 2003, and June, 2008, 762 women were randomly allocated to treatment groups (379 vitamin supplementation, 383 placebo). The primary endpoint was assessed for 375 women allocated to receive vitamins, and 374 allocated to placebo. Rates of pre-eclampsia did not differ between vitamin (15%, n=57) and placebo (19%, 70) groups (risk ratio 0.81, 95% CI 0.59-1.12). No adverse maternal or neonatal outcomes were reported. INTERPRETATION: Supplementation with vitamins C and E did not reduce risk of pre-eclampsia in women with type 1 diabetes. However, the possibility that vitamin supplementation might be beneficial in women with a low antioxidant status at baseline needs further testing. FUNDING: The Wellcome Trust.