Predictive factors of subsequent insulin requirement for glycemic control during pregnancy at diagnosis of gestational diabetes mellitus.

OBJECTIVE: To determine maternal and biological parameters at diagnosis of gestational diabetes mellitus (GDM) as predictors of antenatal insulin therapy (AIT) for glycemic control. METHODS: In this planned secondary analysis of a prospective observational study, we recruited women diagnosed with GDM between July 1, 2014, and October 31, 2015. Maternal and biological parameters were analyzed as predictors of AIT using multivariable logistic regression analyses. Predictive accuracy of a cut-off value for a biological predictor was determined using the area under the receiver operating characteristic curve (AUC) and the Youden index (J). RESULTS: Of 200 women included (mean gestational age 22 ± 6 weeks), 72 (36%) required AIT. No maternal characteristic was associated with AIT. Glycated hemoglobin (HbA1c; adjusted odds ratio [aOR] 3.15, 95% CI 1.03-9.69) and elevated 1-hour oral glucose tolerance test (OGTT; aOR 1.23, 95% CI 1.13-1.46) were predictors of AIT. Analyses suggested inaccurate prediction of AIT, with an optimal cut-off HbA1c value of 5.4% (J=0.14; AUC 0.58, 95% CI 0.48-0.67), and an optimal 1-hour plasma glucose OGTT value of 1.77 mg/dL (J=0.24; AUC 0.62, 95% CI 0.50-0.74). CONCLUSION: HbA1c at diagnosis of GDM and elevated 1-hour OGTT were independent predictors of AIT for glycemic control. Clinicaltrials.gov: NCT02159378.

Predictive factors for successful cervical ripening using a double-balloon catheter after previous cesarean delivery.

OBJECTIVE: To identify predictors of successful cervical ripening using double-balloon catheter (DBC) for labor induction among women with previous cesarean delivery (PCD) and unfavorable cervix at term. METHODS: The present prospective observational study was conducted among women who underwent cervical ripening with DBC at a French tertiary care hospital between January 1, 2014, and December 31, 2017. Inclusion criteria were PCD; singleton term fetus; cephalic presentation; and unfavorable cervix (Bishop score <6). Indications for DBC were gestational diabetes mellitus, intrahepatic cholestasis of pregnancy, pre-eclampsia, prolonged pregnancy, fetal growth restriction, or prenatal suspicion of macrosomia. The primary outcome was Bishop score of at least six after DBC removal. RESULTS: Among the 105 patients included, the initial Bishop score was 2.5 ± 1.5; successful cervical ripening occurred among 74 (70.5%) women; and vaginal delivery occurred among 46 (43.8%). The mean time from DBC insertion to delivery was 19.3 ± 6.7 hours. No adverse events were observed. Predictors of successful cervical ripening were initial Bishop score of at least three (adjusted odds ratio [aOR] 12.74, 95% confidence interval [CI] 2.78-58.47); PCD during labor (aOR 4.38, 95% CI 1.10-17.45); and internal cervical os open (aOR 4.94, 95% CI 1.44-17.01). CONCLUSION: Several factors were found to predict successful cervical ripening using DBC.

Axillary lymph node metastases from unknown primary: A French multicentre study.

PURPOSE: The aim of the study was to investigate the management and prognosis of axillary cancers from unknown primaries (CUPax). METHODS: We included all patients with lesions described as axillary nodal metastases from an unknown primary referred to four French tertiary breast cancer centres between January 1988 and December 2012. The inclusion criteria comprised: no sign of primary breast cancer on clinical examination nor on imaging (mammography, ultrasonography and breast MRI) and no primary tumour identified elsewhere. RESULTS: CUPax represented 1.8% of all metastatic axillary lymphadenopathies in our institutions. The overall survival rate was 71%, and 16.7% of patients had secondary inflammatory breast cancer signalling a posteriori that CUPax originated from the breast. Factors that favourably affected survival according to univariate analysis were: histological type of non specific adenocarcinoma (versus other types, p = 0.02), only one lymph node involved (versus several, p = 0.04), a normal CA153 serum-level (p = 0.02), no distant metastasis at initial assessment (p = 0.02), no secondary distant metastasis (p = 0.005) and radiotherapy to the ipsilateral breast/chest wall/lymph nodes (p = 0.04). On multivariate analysis including these factors, a histological type of non-specific adenocarcinoma (p = 0.03) and distant metastases (p = 0.03) were identified as independent factors affecting survival. CONCLUSION: We believe that these results will shed light on current investigations and treatment of this rare entity.

Efficacy of serum procalcitonin to predict spontaneous preterm birth in women with threatened preterm labour: a prospective observational study.

BACKGROUND: A hypothesis of preterm parturition is that the pathogenesis of spontaneous preterm birth (sPTB) may be associated with an inflammatory process. Based on this theory, we have hypothesized that an inflammatory biomarker, procalcitonin (PCT), may be a good predictive marker of sPTB at the admission for threatened preterm labour (TPL). The present study was aimed to investigate the association between serum PCT and sPTB in women with TPL and to evaluate whether PCT levels may predict sPTB in women with TPL within 7 or 14 days. METHODS: In a prospective observational laboratory-based study, women with singleton pregnancies, TPL between 24 and 36 weeks and intact membranes, were enrolled between January 2014 and June 2016. Participants received routine medical management of TPL (tocolysis with atosiban, antenatal corticosteroids, and biological tests at admission (C-reactive protein, white blood cell count, and PCT measured on electrochemiluminescence immunoassay)). The primary endpoint was sPTB before 37 weeks of gestation. The value of serum PCT levels to predict sPTB within 7 or 14 days were evaluated using receiver-operating curves (ROC) analysis. RESULTS: A total of 124 women were included in our study. PCT levels did not statistically differ between women with sPTB (n = 30, 24.2%) and controls (n = 94) (median in ng/mL [interquartile range]: 0.043 [0.02-0.07] compared to 0.042 [0.02-0.13], respectively; P = 0.56). PCT levels did not also statistically differ between women with sPTB within 7 days (n = 7, 5.6%) or 14 days (n = 12, 9.7%) after testing and controls. Moreover, subgroup analysis revealed no difference among PCT levels at admission between 24 and 28 weeks, between 28 and 32 weeks and over 32 weeks, and controls. On the basis of the receiver-operating characteristic curve, the highest sensitivity and specificity corresponded to a PCT concentration of 0.038 ng/mL, with poor predictive values for sPTB within 7 or 14 days. CONCLUSION: Serum PCT was not relevant to predict sPTB within 7 or 14 days in women admitted with TPL between 24 and 36 weeks, and thus it is not a suitable biological marker to confirm the hypothesis of an inflammatory process associated with preterm parturition. TRIAL REGISTRATION: Clinicaltrials.gov ( NCT01977079 ), Registered 24 October 2013.

Using the Female Sexual Function Index (FSFI) to evaluate sexual function in women with genital mutilation undergoing surgical reconstruction: a pilot prospective study.

OBJECTIVES: Few prospective studies have evaluated sexual function in women with female genital mutilation by cutting (FGM/C) before and after clitoral reconstructive surgery, and none used a validated questionnaire. A validated questionnaire, the Female Sexual Function Index (FSFI) was used for the first time, to assess the impact of reconstructive surgery on sexual function in women with female genital mutilation/cutting (FGM/C) before and after clitoral reconstructive surgery. STUDY DESIGN: Women with FGM/C consulting at the Nantes University Hospital for clitoral reconstruction between 2013 and 2014 were prospectively included. All patients completed a questionnaire at inclusion, describing their social, demographic, and FGM/C characteristics. They were also asked to complete the FSFI as well as a questionnaire about clitoral sensations, symptoms of depression or anxiety, and self-esteem before and 3 and 6 months after the surgery. Paired Wilcoxon and McNemar tests were used to compare data. RESULTS: Of the 12 women included, 9 (75%) had type II mutilations. Results showed a global sexual dysfunction (median FSFI summary score=17) before surgery. Clitoral sensations were absent in 8 women (67%). Six months after surgery, all FSFI dimensions except lubrication had improved significantly (median FSFI summary score=29, P=0.009). Ten women had clitoral sensations, and 11 (92%) were satisfied with their surgery. CONCLUSION: This study shows that 6 months after clitoral reconstructive surgery, women reported a multidimensional positive improvement in their sexual function. The FSFI is a promising tool for routine standardized assessment of the sexual function of women with FGM/C for determining appropriate management and assessing it. Larger studies with validated questionnaires assessing self-esteem, depression, and body image are also needed to develop an integrative approach and to provide evidence-based recommendations about management of these women.