Publications by authors named "Francisca Romero-Narbona"

2 Publications

  • Page 1 of 1

MeDiGes Study. Metformin versus insulin in gestational diabetes: Glycemic control, and obstetrical and perinatal outcomes. Randomized prospective trial.

Am J Obstet Gynecol 2021 Apr 19. Epub 2021 Apr 19.

Department of Endocrinology and Nutrition, Hospital Regional Universitario de Málaga. IBIMA; CIBER de Diabetes y Enfermedades Metabólicas (CIBERDEM).

Background: Gestational diabetes not properly controlled with diet has been commonly treated with insulin. In recent years several studies have published that metformin can lead to, at least, similar obstetrical and perinatal outcomes as insulin. Nevertheless, not all clinical guidelines endorse its use, and clinical practice is heterogeneous.

Objectives: The aim of this study was to test if metformin could achieve the same glycemic control as insulin and similar obstetrical and perinatal results, with a good safety profile, in women with gestational diabetes not properly controlled with lifestyle changes.

Study Design: The MeDiGes study was a multicenter, open-label, parallel arms, randomized clinical trial performed at two hospitals in Málaga (Spain), enrolling women with GDM who needed pharmacological treatment. Women aged 18-45 years, in the second or third trimesters of pregnancy, were randomized to receive metformin or insulin (Detemir and/or Aspart). The main outcomes were: 1. glycemic control (mean glycemia, pre-prandial and postprandial) and hypoglycemic episodes, and 2. obstetrical and perinatal outcomes and complications (hypertensive disorders, type of labor, prematurity, macrosomia, large for gestational age, neonatal care unit admissions, respiratory distress syndrome, hypoglycemia, jaundice). Outcomes were analyzed on an intention-to-treat basis.

Results: Between 2016-October and 2019-June 200 women were randomized, 100 to the insulin-treated group and 100 to the metformin-treated group. Mean fasting and postprandial glycemia did not differ between groups, but postprandial glycemia was significantly better after lunch and/or dinner in the metformin-treated-group. Hypoglycemic episodes were significantly more common in the insulin-treated group (55.9% vs 17.7% on metformin, OR 6.118, 95% CI 3.134-11.944, p 0.000). Women treated with metformin gained less weight from the enrollment to the prepartum visit (36-37 gestational weeks) (1.35±3.21 vs 3.87±3.50 Kg, p 0.000). Labor inductions (MET 45.7% vs INS 62.5%, OR 0.506, 95% CI 0.283-0.903, p 0.029) and cesarean deliveries (MET 27.6% vs INS 52.6%, OR 0.345, 95% CI 0.187-0.625, p 0.001) were significantly lower in the MET-group. Mean birth weight, macrosomia and large for gestational age were not different between treatment groups, as well as babies' complications. The lower cesarean delivery rate for women treated with metformin was not associated with macrosomia, large or small for gestational age, or other complications of pregnancy.

Conclusions: Metformin treatment was associated with a better postprandial glycemic control than insulin for some meals, a lower risk of hypoglycemic episodes, less maternal weight gain, and a low rate of failure as an isolated treatment. Most obstetrical and perinatal outcomes were similar between groups.
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http://dx.doi.org/10.1016/j.ajog.2021.04.229DOI Listing
April 2021

Seroprevalence and epidemiology of hepatitis B and C viruses in pregnant women in Spain. Risk factors for vertical transmission.

PLoS One 2020 21;15(5):e0233528. Epub 2020 May 21.

Hospital Universitario San Cecilio, Granada, Spain.

Background & Aim: Worldwide, measures are being implemented to eradicate hepatitis B (HBV) and C (HCV) viruses, which can be transmitted from the mother during childbirth. This study aims to determine the prevalence of HBV and HCV in pregnant women in Spain, focusing on country of origin, epidemiological factors and risk of vertical transmission (VT).

Methodology: Multicentre open-cohort study performed during 2015. HBV prevalence was determined in 21870 pregnant women and HCV prevalence in 7659 pregnant women. Epidemiological and risk factors for VT were analysed in positive women and differences between HBV and HCV cases were studied.

Results: HBV prevalence was 0.42% (91/21870) and HCV prevalence was 0.26% (20/7659). Of the women with HBV, 65.7% (44/67) were migrants. The HBV transmission route to the mother was unknown in 40.3% of cases (27/67) and VT in 31.3% (21/67). Among risk factors for VT, 67.7% (42/62) of the women had viraemia and 14.5% (9/62) tested HBeAg-positive. All of the neonates born to HBV-positive mothers received immunoprophylaxis, and none contracted infection by VT. In 80% (16/20) of the women with HCV, the transmission route was parenteral, and nine were intravenous drug users. Viraemia was present in 40% (8/20) of the women and 10% (2/20) were HIV-coinfected. No children were infected. Women with HCV were less likely than women with HBV to breastfeed their child (65% vs. 86%).

Conclusions: The prevalences obtained in our study of pregnant women are lower than those previously documented for the general population. Among the women with HBV, the majority were migrants and had a maternal family history of infection, while among those with HCV, the most common factor was intravenous drug use. Despite the risk factors observed for VT, none of the children were infected. Proper immunoprophylaxis is essential to prevent VT in children born to HBV-positive women.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0233528PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7241747PMC
August 2020