TY - JOUR
T1 - mmediate delivery or expectant management in gestational diabetes at term
T2 - the GINEXMAL randomised controlled trial
AU - the GINEXMAL Group
AU - Alberico, S.
AU - Erenbourg, A.
AU - Hod, M.
AU - Yogev, Y.
AU - Hadar, E.
AU - Neri, F.
AU - Ronfani, L.
AU - Maso, G.
AU - Marcella, Montico
AU - Steblovnik, Lili
AU - Sketelj, Alenka
AU - Tomazic, Marjeta
AU - Frusca, Tiziana
AU - Zatti, Sonia
AU - Lojacono, Andrea
AU - Pagani, Giorgio
AU - Maggino, Tiziano
AU - Mello, Giorgio
AU - Mecacci, Federico
AU - Martini, Elisabetta
AU - Zanini, Alberto
AU - Andreotti, Camilla
AU - Tenore, Alberto
AU - Dallavalle, Cristina
N1 - Publisher Copyright:
© 2016 Royal College of Obstetricians and Gynaecologists
PY - 2017/3/1
Y1 - 2017/3/1
N2 - 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+0and 39+0weeks 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?.
AB - 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+0and 39+0weeks 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?.
UR - http://www.scopus.com/inward/record.url?scp=85013328474&partnerID=8YFLogxK
U2 - 10.1111/1471-0528.14389
DO - 10.1111/1471-0528.14389
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AN - SCOPUS:85013328474
SN - 1470-0328
VL - 124
SP - 669
EP - 677
JO - BJOG: An International Journal of Obstetrics and Gynaecology
JF - BJOG: An International Journal of Obstetrics and Gynaecology
IS - 4
ER -