Study design and participant selection
fetal abnormalities, macrosomia, hyperstimulation, pain, HIV, hepatitis B or C
CHORIOAMNIONITIS, IOL, GROUP B, CONTRACTIONS, COVID-19 INFECTION, CAVITY, FETAL GROWTH RESTRICTION
This is a randomized controlled, non-blind trial. Participants were randomly assigned to two parallel-groups: Group A: Early amniotomy (EA) and Group B: Late amniotomy (LA). The allocation ratio was 1:1.Women admitted for IOL were considered eligible if they met the following criteria: age ≥ 18 years, a full-term (≥ 37 weeks of gestation), singleton, fetus in cephalic presentation and bishop score of ≥ 6.Exclusion criteria were women with history of uterine surgery that breached the uterine cavity, previous cesarean section, ruptured membranes, spontaneous onset of labor, macrosomia, severe fetal growth restriction defined as estimated fetal weight by ultrasound < 3rd centile, major fetal abnormalities, maternal HIV, hepatitis B or C, COVID-19 infection or other contraindications to vaginal delivery.This trial was carried out in the department of obstetrics and gynecology, University Hospital of Mongi Slim La Marsa, Tunis from February 8After inclusion, each woman was assigned randomly to either early amniotomy (EA) or late amniotomy (LA) group.In Group A (EA): women had amniotomy soon after randomization and oxytocin infusion was started 30 minutes later.In Group B (LA): IOL was initiated with oxytocin infusion, and amniotomy was performed 4 hours later unless deemed necessary earlier (e.g. for non-reassuring fetal heart rate on the cardiotocography (CTG).Oxytocin was administered intravenously using a syringe infusion pump. The initial dose was 2mUI/min, with a 2mUI increase every 30 minutes. The target was 3–4 uterine contractions per 10 minutes. Once the target was reached, the infusion rate was not increased and kept constant. The maximum infusion rate was 42 mUI/min. The oxytocin infusion was stopped or reduced if hyperstimulation or abnormal CTG occurred. CTG abnormalities were evaluated according to the International Federation of Gynecology and Obstetrics (FIGO) guidelines [The same protocol of oxytocin administration was used in both groups.Throughout IOL, constant monitoring of fetal heart rate (FHR) and uterine contractions was conducted using an external paper scale CTG and an external tocodynamometer.Epidural was offered as an option of pain management in the labor ward when the contractions become regular and painful. The monitoring of labor relies on a one-to-one care. To minimize the incidence of chorioamnionitis, cervical examinations were performed every 4 hours in the absence of uterine contractions. However, if the patient experienced the onset of labor, the examinations were conducted hourly, and the midwife documented the findings.