Methods
PROM, nausea, hyperstimulation, vomiting, pyrexia, foetal distress, allergies
IOL, MATERNAL DISTRESS, CONTRACTIONS, ANTEPARTUM HAEMORRHAGE, INTRAUTERINE GROWTH RESTRICTION, ANTEPARTUM HEMORRHAGE, SECONDARY, FOETAL DISTRESS, ALLERGIES, SCARRING
This randomized controlled clinical trial was conducted in Ain Shams University Maternity Hospital (ASUMH), Cairo, Egypt over the period of one year (January 2021 to January 2022). The study protocol was approved by the ethical committee, faculty of Medicine, Ain Shams University (FMASU MS 733/2020/2021). The study was conducted in accordance with the Declaration of Helsinki and retrospectively registered at We included pregnant women between the ages of 18 and 40 who had term (gestational age: 36 to 42 weeks) PROM during the previous 24 h, had vertex presentation, and were scheduled for IOL at ASUMH. Multiple pregnancies, antepartum haemorrhage, chorioamnionitis/PROM lasting longer than 24 h, abnormal FHR pattern upon admission, intrauterine growth restriction, foetal malpresentation, estimated foetal weight greater than 4 kg, patients already in labour, women with a history of uterine scarring, current or past medical conditions, and known allergies to prostaglandin/oxytocin were among the exclusion criteria. We included the gestational age (36 weeks) in our study as per our hospital’s protocol, we follow active management and delivery for patients 36 weeks and beyond with PROM. As per hospital protocol, patients received parenteral antibiotic Unasyn® 1.5g every 8h till delivery.Eligible patients were randomized using a computer-generated sequence 1:1 either to the Misoprostol group (group A) or to Oxytocin group (group B). Randomization was done using computer generated randomization sheet using MedCalc® version 13. Accordingly, patients were allocated to either: Group A: received 25μg misoprostol oral tablet every 4 h, for maximum 5doses to induce labour; while—according to the ASUMH oxytocin protocol—women in group B underwent IOL by oxytocin infusion as follows: Oxytocin Mix: 3IU oxytocin (3000mIU) + 50ml of normal saline in syringe pump (60mIU/ml), to start at 1ml/hour (1mIU/min) for half-hour, then shift to 2ml/h for half-hour if contractions weren't strong enough with reassuring FHR. When FHR was reassuring but still insufficient contractions, we raised by 2 ml/hour every half-hour until a maximum of 27 ml/h. Follow-up throughout labour included continuous electronic FHR monitoring, a vaginal examination every 4 h to check for cervical changes, maternal vital signs, and uterine contractions. After noting the time until the active phase (cervical dilatation: 6 cm), follow-up monitoring continued till delivery.End point: reaching maximum dose of drugs with failure of IOL in which another decision was taken. Also, at any point there was foetal or maternal distress (e.g., pathological FHR pattern, antepartum hemorrhage, etc.) the study intervention was stopped, and the maternal/fetal condition was managed accordingly.Our primary outcome was the percentage of successful vaginal deliveries within 24 h. The secondary outcomes were the time from the beginning of induction to the active phase (6 cm cervical dilatation), the induction to delivery interval, the maternal side effects of pyrexia, nausea, and vomiting, foetal distress (hyperstimulation), the Apgar score, the birth weight, and the admission to the neonatal intensive care unit (NICU).