Immediate delivery or expectant management in gestational diabetes at term: the GINEXMAL randomised controlled trial.
OBJECTIVE
To evaluate maternal and perinatal outcomes after induction of labour versus expectant management in pregnant women with gestational diabetes at term.


METHODS
Multicentre open-label randomised controlled trial.


METHODS
Eight teaching hospitals in Italy, Slovenia, and Israel.


METHODS
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'.


METHODS
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.


CONCLUSIONS
Immediate delivery or expectant management in gestational diabetes at term?
Department of Obstetrics and Gynaecology, Institute for Maternal and Child Health - IRCCS Burlo Garofolo, Trieste, Italy.
S
S
Alberico
Department of Obstetrics and Gynaecology, Institute for Maternal and Child Health - IRCCS Burlo Garofolo, Trieste, Italy.
A
A
Erenbourg
Department of Obstetrics and Gynaecology, The Helen Schneider Hospital for Women at Rabin Medical Center, Petah-Tiqva, Israel.
M
M
Hod
Department of Obstetrics and Gynaecology, The Helen Schneider Hospital for Women at Rabin Medical Center, Petah-Tiqva, Israel.
Y
Y
Yogev
Department of Obstetrics and Gynaecology, The Helen Schneider Hospital for Women at Rabin Medical Center, Petah-Tiqva, Israel.
E
E
Hadar
Department of Obstetrics and Gynaecology, Hospital Angelo Zelarino di Mestre, Mestre-Venezia, Italy.
F
F
Neri
Clinical Epidemiology and Public Health Research Unit, Institute for Maternal and Child Health - IRCCS Burlo Garofolo, Trieste, Italy.
L
L
Ronfani
Department of Obstetrics and Gynaecology, The Helen Schneider Hospital for Women at Rabin Medical Center, Petah-Tiqva, Israel.
G
G
Maso
D000328:Adult; D036861:Delivery, Obstetric / Q000009:adverse effects / Q000379:methods*; D016640:Diabetes, Gestational / Q000628:therapy*; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007557:Israel; D007558:Italy; D008428:Maternal Mortality; D054238:Perinatal Mortality; D011247:Pregnancy; D011256:Pregnancy Outcome / Q000453:epidemiology*; D017524:Slovenia; D047929:Term Birth; D057832:Watchful Waiting / Q000379:methods* / Q000706:statistics & numerical data
Expectant management; gestational diabetes; induction of labour