%0 Journal Article %J BJOG %D 2017 %T Immediate delivery or expectant management in gestational diabetes at term: the GINEXMAL randomised controlled trial. %A Alberico, S %A Erenbourg, A %A Hod, M %A Yogev, Y %A Hadar, E %A Neri, F %A Ronfani, L %A Maso, G %K Adult %K Delivery, Obstetric %K Diabetes, Gestational %K Female %K Humans %K Infant, Newborn %K Israel %K Italy %K Maternal Mortality %K Perinatal Mortality %K Pregnancy %K Pregnancy Outcome %K Slovenia %K Term Birth %K Watchful Waiting %X

OBJECTIVE: To evaluate maternal and perinatal outcomes after induction of labour versus expectant management in pregnant women with gestational diabetes at term.

DESIGN: Multicentre open-label randomised controlled trial.

SETTING: Eight teaching hospitals in Italy, Slovenia, and Israel.

SAMPLE: Singleton pregnancy, diagnosed with gestational diabetes by the International Association of Diabetes and Pregnancy Study Groups criteria (IADPSGC), between 38 and 39 weeks of gestation, without other maternal or fetal conditions.

METHODS: Patients were randomly assigned to induction of labour or expectant management and intensive follow-up. Data were analysed by 'intention to treat'.

MAIN OUTCOME MEASURES: The primary outcome was incidence of caesarean section. Secondary outcomes were maternal and perinatal mortality and morbidity.

RESULTS: A total of 425 women were randomised to the study groups. The incidence of caesarean section was 12.6% in the induction group versus 11.7% in the expectant group. No difference was found between the two groups (relative risk, RR 1.06; 95% confidence interval, 95% CI 0.64-1.77; P = 0.81). The incidence of non-spontaneous delivery, either by caesarean section or by operative vaginal delivery, was 21.0 and 22.3%, respectively (RR 0.94; 95% CI 0.66-1.36; P = 0.76). Neither maternal nor fetal deaths occurred. The few cases of shoulder dystocia were solved without any significant birth trauma.

CONCLUSIONS: In women with gestational diabetes, without other maternal or fetal conditions, no difference was detected in birth outcomes regardless of the approach used (i.e. active versus expectant management). Although the study was underpowered, the magnitude of the between-group difference was very small and without clinical relevance.

TWEETABLE ABSTRACT: Immediate delivery or expectant management in gestational diabetes at term?

%B BJOG %V 124 %P 669-677 %8 2017 Mar %G eng %N 4 %1 http://www.ncbi.nlm.nih.gov/pubmed/27813240?dopt=Abstract %R 10.1111/1471-0528.14389 %0 Journal Article %J BJOG %D 2011 %T Periodontal infection and preterm birth: successful periodontal therapy reduces the risk of preterm birth. %A Di Mario, S %A Spettoli, D %A Alessandrini, C %A Erenbourg, A %A Ronfani, L %A Basevi, V %K Female %K Humans %K Periodontal Diseases %K Pregnancy %K Pregnancy Complications, Infectious %K Premature Birth %K Randomized Controlled Trials as Topic %K Risk Factors %B BJOG %V 118 %P 635; author reply 635-6 %8 2011 Apr %G eng %N 5 %1 http://www.ncbi.nlm.nih.gov/pubmed/21392234?dopt=Abstract %R 10.1111/j.1471-0528.2011.02913.x %0 Journal Article %J Minerva Ginecol %D 2010 %T Gestational diabetes and fetal growth acceleration: induction of labour versus expectant management. %A Alberico, S %A Businelli, C %A Wiesenfeld, U %A Erenbourg, A %A Maso, G %A Piccoli, M %A Ronfani, L %K Adult %K Body Mass Index %K Cesarean Section %K Diabetes, Gestational %K Elective Surgical Procedures %K Female %K Fetal Development %K Fetal Macrosomia %K Gestational Age %K Humans %K Incidence %K Infant, Newborn %K Italy %K Labor, Induced %K Medical Records %K Obesity %K Pregnancy %K Pregnancy Outcome %K Retrospective Studies %K Risk Factors %K Statistics, Nonparametric %K Watchful Waiting %X

AIM: The aim of the study was to compare elective induction of labour at 38 weeks versus expectant management in A1 and A2 gestational diabetes (GDM) pregnancies with fetal growth acceleration. Primary outcome of the study was C-section (CS) rate, while secondary outcomes were macrosomia incidence and adverse perinatal outcomes.

METHODS: A retrospective cohort study was carried out. Data were collected between 1996 and 2006 and evaluated through patients' records analysis. Differences between the two study groups were investigated using non-parametric tests for continuous variables and χ2 test for categorical ones.

RESULTS: There was no significant difference between induction and expectant management in terms of caesarean section rate. A trend favoring women in the induction group in terms of incidence of macrosomia and neonatal outcomes was identified, but results were not statistically significant.

CONCLUSION: Labour induction at 38 weeks in GDM patients with fetal growth acceleration does not seem to determine an increased incidence of C-section in comparison to expectant management, particularly in case of maternal obesity.

%B Minerva Ginecol %V 62 %P 533-9 %8 2010 Dec %G eng %N 6 %1 http://www.ncbi.nlm.nih.gov/pubmed/21079575?dopt=Abstract