Objectives:
The aim of this study is to investigate the effect of early interrupting of Oxytocin compared to continuing of Oxytocin during the active phase of labor, cesarean risk during labor, maternal and neonatal outcomes; so we can increase the mother and infant safety and reach to hospital aims for Mother-Baby Friendly Hospital which is normal vaginal delivery with minimal intervention.
Design, Setting and conduct:
In a prospective randomized clinical trial, all patients who will randomize by blocks divide into two groups. The first group will receive Oxytocin which continue until delivery and in second group Oxytocin discontinued in initial of active phase.
Participants, inclusion and exclusion criteria:
All pregnant women with gestational age ≥ 34 weeks and vertex presentation and an indication for induction (gestational age less than 42 weeks, rupture of membranes - oligohydramnios, high blood pressure) enrolled in study. Inclusion criteria included singleton pregnancy, vertex presentation, estimated weight <4 kg, gestational age> 34 weeks without any contraindication for NVD. Exclusion criteria included any contraindication for normal vaginal delivery or administration of Oxytocin such as malpresentation, Placenta Previa, previous cesarean section cervix surgery, Twin or multiple pregnancy, uncertain fetal heart rate.
Intervention:
All women will receive 10 units of Oxytocin by infusion. Oxytocin initiated equal to 2mu/min and increased 2mu/min every 15 minutes up to mg 32mu/min or until contractions of uterine reach to 3-5 per 10 minutes. Oxytocin is maintained at a constant level at this time. After the beginning of the active phase (cervical dilatation 4 cm) then patients divided into 2 groups, in the first group Oxytocin continues until delivery and in the other group will discontinue at the beginning of the active phase.
Main outcome:
Patients undergoing vaginal exam to evaluate the progress of labor and fetal heart rate and uterine contractions is controlled every 15 minutes . If in second group within 2 hours cervix dilatation do not progress or numbers of contractions reach to less than 3 contractions per 10 minutes, Oxytocin start again. Also, if there is Non-Reassuring Fetal Heart Rate Patterns in first group, Oxytocin will discontinue. Duration of the active phase, total duration of labor, amount of administrated Oxytocin intake, maternal complications (including uterus hyperstimulation which is 6 or more uterine contractions per 10 minutes), Non-Reassuring Fetal Heart Rate Patterns, abnormal postpartum hemorrhage and type of delivery (caesarean or normal) and its reason, neonatal outcomes including fifth minute Apgar score, and admission to NICU evaluate in both groups. The decision for cesarean delivery will make based on obstetrical indications includes decelerations and lack of progress and is same in both groups.