2.8. Study Procedure
scar dehiscence, artificial rupture
IOL, FAILED INDUCTION, CONTRACTIONS, SPONTANEOUS RUPTURE, COMPLICATION, COMPLICATED PREGNANCIES, COMPLICATIONS
Women with uncomplicated pregnancies with a previous caesarean section were screened from 39 weeks onwards clinically and with sonography for eligibility for TOLAC. The gestation period was calculated as per the last menstrual period (LMP) and was corrected based on the crown-rump length scan of 14–41 mm if the discrepancy in the expected delivery date was ≥7 days from that based on the LMP. After obtaining informed written consent, we randomized the women fulfilling the study criteria and willing for TOLAC to either group on the day of completion of 40 weeks. We reassessed the Bishop score after randomization.We induced women in the induction group (group II) on the same day (40 weeks) or within 24 hours of randomization. If the Bishop scored unfavourable (<6), induction was done by ripening the cervix with a single application of 22 French Foley single balloon catheter inflated to 60 ml just above the internal os, under aseptic precautions. The women were monitored for onset of contractions/leaking/bleeding/any other complication and the foetus by intermittent auscultation and a nonstress test after 12 hours. The Foley catheter was deflated and removed 24 hours later if she did not spontaneously expel it or earlier if she developed a spontaneous rupture of membranes. We noted the Bishop score again and started low-dose oxytocin infusion delivered through a pump starting from 3 mIU/min and incremented by 3 mIU every half-hourly until she achieved good contractions or a maximum of 24 mIU/min. We performed an artificial rupture of membranes once the women started regular contractions or after four hours of the maximum dose of oxytocin. We used an electronic tocodynamometer to monitor the foetal heart and uterine contractions. We monitored the labour progress and symptoms and signs of scar dehiscence. If women failed to achieve active labour (4 cm dilatation with 75-100% effacement), even after 6 hours of maximum dose of oxytocin or 6 hours of good uterine contractions, it was considered as failed induction and terminated by caesarean section. The trial of labour continued if she achieved active labour.Women in the expectant arm of the study remained admitted to the hospital as a standard policy. We monitored the foetus by a nonstress test (NST) every 48 hours and a repeat ultrasound for amniotic fluid index and biophysical profile for foetal surveillance at 40 weeks plus three days. It was repeated at 41 weeks if she had not delivered by then. In case any complications arose between 40 and 41 weeks, pregnancies were terminated either by IOL or by caesarean as per the case. W carried out IOL in them as per the protocol followed in the induction group if not already delivered by 41 weeks. We followed up with the neonates and women till discharge from the hospital. We did not change the inclusion criteria or methodology after trial commencement.