Secondary outcomes were the time from induction to delivery, need for oxytocin augmentation, mode of delivery, frequency of side effects, and neonatal and maternal outcome.
Next, in an additional analysis, possible explanatory factors (i.e. receiving medicinal pain relief, anxiety during pregnancy, transfer, augmentation, mode of birth and complications with baby) were added to the model in addition to the confounders, one at a time.
No differences were found in use of pharmacological analgesia, need for augmentation or mode of delivery.
No statistically difference between the groups was detected in regard to parity, gestation age, cervical Bishop score, number of foetal blood samples, PDA rate, rate of oxytocin augmentation, and mode of birth.
Here, the focus is on comparing the generalized ZEM/ZEV feedback guidance with the OSG law to explicitly demonstrate the benefits of the sliding mode augmentation.
Results: There was a significant inter-unit variation in the use of intrapartum foetal blood sampling, use of syntocinon for augmentation of labour, mode of delivery, type of perineal damage, postpartum haemorrhage, low Apgar score and admission to SCBU.
Factors from the second birth were chosen for previously recognised association with OASI and included maternal age, hypertension, gestation, induction or augmentation, epidural analgesia, mode of birth, episiotomy, birthweight, infant sex and year of birth.
The latter will be obtained (with informed consent) from the existing computerised obstetric database and include: medical or obstetric complications, induction or augmentation of labour, mode of delivery (vaginal, emergency or planned CS), enrolment to delivery interval, gestational age, birthweight, Apgar scores, perinatal deaths, Neonatal Intensive Care Unit admission and length of stay.
At present, more than half of all surgical procedures are possible to realize in the DS mode, while augmentation of procedure number suitable to DS does not indicate any threat for hospitals, as there are wide spectrum of a difficult operation that will always belong to standard bed facility.
We further carried out sensitivity analyses in which covariates were added incrementally to the model, starting with maternal pre-pregnancy factors, followed by maternal pregnancy factors, and lastly obstetric factors, namely, labour induction and labour augmentation, epidural analgesia, and mode of delivery.
In conclusion, despite the body of work indicating therapeutic potential from several groups using different models, species and modes of augmentation, elafin's promise as a therapeutic agent to attenuate myocardial ischaemia-reperfusion injury and inflammation was not translated in this first phase II clinical trial.
