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"GINEXMAL RCT: Induction of labour versus expectant management in gestational diabetes pregnancies".

Maso G, Alberico S, Wiesenfeld U, Ronfani L, Erenbourg A, Hadar E, Yogev Y, Hod M, GINEXMAL Study Cooperative Research Gro - BMC Pregnancy Childbirth (2011)

Bottom Line: This clinical condition is associated with an increased risk of developing fetal macrosomia and is related to a higher incidence of caesarean section in comparison to the general population.The primary study outcome is the Caesarean section (C-section) rate, whilst secondary measurements are maternal and neonatal outcomes.Analysis of the outcome measures will be carried out by intention to treat.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Obstetrics and Gynaecology, Institute for Maternal and Child Health-IRCCS Burlo Garofolo, Via dell'Istria 65/1, Trieste, Italy. maso@burlo.trieste.it

ABSTRACT

Background: Gestational diabetes (GDM) is one of the most common complications of pregnancies affecting around 7% of women. This clinical condition is associated with an increased risk of developing fetal macrosomia and is related to a higher incidence of caesarean section in comparison to the general population. Strong evidence indicating the best management between induction of labour at term and expectant monitoring are missing.

Methods/design: Pregnant women with singleton pregnancy in vertex presentation previously diagnosed with gestational diabetes will be asked to participate in a multicenter open-label randomized controlled trial between 38+0 and 39+0 gestational weeks. Women will be recruited in the third trimester in the outpatient clinic or in the Day Assessment Unit according to local protocols. Women who opt to take part will be randomized according to induction of labour or expectant management for spontaneous delivery. Patients allocated to the induction group will be admitted to the obstetric ward and offered induction of labour via use of prostaglandins, Foley catheter or oxytocin (depending on clinical conditions). Women assigned to the expectant arm will be sent to their domicile where they will be followed up until delivery, through maternal and fetal wellbeing monitoring twice weekly. The primary study outcome is the Caesarean section (C-section) rate, whilst secondary measurements are maternal and neonatal outcomes. A total sample of 1760 women (880 each arm) will be recruited to identify a relative difference between the two arms equal to 20% in favour of induction, with concerns to C-section rate. Data will be collected until mothers and newborns discharge from the hospital. Analysis of the outcome measures will be carried out by intention to treat.

Discussion: The present trial will provide evidence as to whether or not, in women affected by gestational diabetes, induction of labour between 38+0 and 39+0 weeks is an effective management to ameliorate maternal and neonatal outcomes. The primary objective is to determine whether caesarean section rate could be reduced among women undergoing induction of labour, in comparison to patients allocated to expectant monitoring. The secondary objective consists of the assessment and comparison of maternal and neonatal outcomes in the two study arms. .

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Trial Flow chart.
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Figure 1: Trial Flow chart.

Mentions: Data about obstetric history will be collected through consultation with the patient and evaluation of the patient's previous records and clinical reports. The outcomes will be evaluated during delivery and until maternal and neonatal discharge. Perinatal and maternal deaths will be identified until discharge. Perinatal deaths should include events up to 7 days after birth and most newborns will be discharged earlier. Our assumption is that perinatal death would occur almost exclusively in newborns manifesting complications during admission and consequently this could be accurately estimated by the time of discharge. At enrolment, patients assigned to the induction group will be admitted to the obstetric ward (Figure 1). Induction of labour will be performed by using dinoprostone, 2 mg vaginally, or dinoprostone, 0.5 mg intracervically, in 6-8 hour intervals (up to 5 doses) or dinoprostone, 10 mg vaginal device. Once the patient's Bishop score exceeds 7 or regular contractions are diagnosed, patients will be transferred to the delivery ward for artificial rupture of membranes (ARM) or oxytocin augmentation as indicated. Patients, in which cervical ripening does not occur (Bishop score < 7) after 5 attempts with Prostaglandin E2 (PGE2), will be offered either oxytocin or Foley catheter induction or C-section, according to local protocols.


"GINEXMAL RCT: Induction of labour versus expectant management in gestational diabetes pregnancies".

Maso G, Alberico S, Wiesenfeld U, Ronfani L, Erenbourg A, Hadar E, Yogev Y, Hod M, GINEXMAL Study Cooperative Research Gro - BMC Pregnancy Childbirth (2011)

Trial Flow chart.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3108319&req=5

Figure 1: Trial Flow chart.
Mentions: Data about obstetric history will be collected through consultation with the patient and evaluation of the patient's previous records and clinical reports. The outcomes will be evaluated during delivery and until maternal and neonatal discharge. Perinatal and maternal deaths will be identified until discharge. Perinatal deaths should include events up to 7 days after birth and most newborns will be discharged earlier. Our assumption is that perinatal death would occur almost exclusively in newborns manifesting complications during admission and consequently this could be accurately estimated by the time of discharge. At enrolment, patients assigned to the induction group will be admitted to the obstetric ward (Figure 1). Induction of labour will be performed by using dinoprostone, 2 mg vaginally, or dinoprostone, 0.5 mg intracervically, in 6-8 hour intervals (up to 5 doses) or dinoprostone, 10 mg vaginal device. Once the patient's Bishop score exceeds 7 or regular contractions are diagnosed, patients will be transferred to the delivery ward for artificial rupture of membranes (ARM) or oxytocin augmentation as indicated. Patients, in which cervical ripening does not occur (Bishop score < 7) after 5 attempts with Prostaglandin E2 (PGE2), will be offered either oxytocin or Foley catheter induction or C-section, according to local protocols.

Bottom Line: This clinical condition is associated with an increased risk of developing fetal macrosomia and is related to a higher incidence of caesarean section in comparison to the general population.The primary study outcome is the Caesarean section (C-section) rate, whilst secondary measurements are maternal and neonatal outcomes.Analysis of the outcome measures will be carried out by intention to treat.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Obstetrics and Gynaecology, Institute for Maternal and Child Health-IRCCS Burlo Garofolo, Via dell'Istria 65/1, Trieste, Italy. maso@burlo.trieste.it

ABSTRACT

Background: Gestational diabetes (GDM) is one of the most common complications of pregnancies affecting around 7% of women. This clinical condition is associated with an increased risk of developing fetal macrosomia and is related to a higher incidence of caesarean section in comparison to the general population. Strong evidence indicating the best management between induction of labour at term and expectant monitoring are missing.

Methods/design: Pregnant women with singleton pregnancy in vertex presentation previously diagnosed with gestational diabetes will be asked to participate in a multicenter open-label randomized controlled trial between 38+0 and 39+0 gestational weeks. Women will be recruited in the third trimester in the outpatient clinic or in the Day Assessment Unit according to local protocols. Women who opt to take part will be randomized according to induction of labour or expectant management for spontaneous delivery. Patients allocated to the induction group will be admitted to the obstetric ward and offered induction of labour via use of prostaglandins, Foley catheter or oxytocin (depending on clinical conditions). Women assigned to the expectant arm will be sent to their domicile where they will be followed up until delivery, through maternal and fetal wellbeing monitoring twice weekly. The primary study outcome is the Caesarean section (C-section) rate, whilst secondary measurements are maternal and neonatal outcomes. A total sample of 1760 women (880 each arm) will be recruited to identify a relative difference between the two arms equal to 20% in favour of induction, with concerns to C-section rate. Data will be collected until mothers and newborns discharge from the hospital. Analysis of the outcome measures will be carried out by intention to treat.

Discussion: The present trial will provide evidence as to whether or not, in women affected by gestational diabetes, induction of labour between 38+0 and 39+0 weeks is an effective management to ameliorate maternal and neonatal outcomes. The primary objective is to determine whether caesarean section rate could be reduced among women undergoing induction of labour, in comparison to patients allocated to expectant monitoring. The secondary objective consists of the assessment and comparison of maternal and neonatal outcomes in the two study arms. .

Show MeSH
Related in: MedlinePlus