Leong 2017.

Trial name or title	Membrane sweeping versus transcervical Foley catheter for induction of labour in women with previous caesarean delivery
Methods	Randomised controlled trial
Participants	Inclusion criteria Pregnant women with 1 previous caesarean section who are admitted to Sibu Hospital for induction of labour (IOL) will be recruited. The inclusion criteria are age at least 18 years old, gestational age ≥ 37 weeks, singleton pregnancy, reassuring fetal status and modified Bishop score ≤ 6. Exclusion criteria Ruptured membranes, intrauterine death, polyhydramnios, severe fetal anomalies, and multiple pregnancy. Contraindications for IOL, e.g. placenta previa, suspected macrosomia, suspected cephalopelvic disproportion, non‐cephalic presentation, and obstructive pelvic masses.
Interventions	Two groups Group 1: membrane sweeping Membrane sweeping involves the insertion of a digit past the internal cervical os followed by 3 circumferential passes of the digit causing separation of the membranes from the lower uterine segment. When the cervix is closed, a massage of the cervical surface for 15 to 30 seconds will be performed instead. Membrane sweeping will be undertaken twice a day at 8 to 10 hours apart. Group 2: transcervical Foley catheter for induction of labour in women with previous caesarean delivery Transcervical Foley catheter No. 18 F will be inserted under aseptic technique into the endocervical canal surpassed beyond the internal os. The balloon will be inflated with 60 mL of sterile water and the catheter is plastered to patient's thigh with gentle traction. The catheter will be checked for its position and the traction at 6‐hour intervals. If it were expelled spontaneously, it would not be re‐inserted. Otherwise, the catheter will be removed after 24 hours.
Outcomes	Primary outcome measures Achievement of favourable cervix (Bishop score of 8 or more) within 48 hours of induction of labour (time frame: from the time of commencing induction until the time whereby the cervix becomes favourable (Bishop score of 8 or more), assessed up to 48 hours). The number of women who achieve Bishop score of 8 or more within 48 hours of induction of labour Secondary outcome measures Induction outcomes: improvement of modified Bishop score at interval of 24 hours after induction (time frame: from the time of commencing induction until 4 hours after induction). The difference of modified Bishop score between pre‐induction and 24 hours post‐induction. The score is assessed based on the station of the presentation, os dilation, and effacement (or length), position and consistency of the cervix. Score ranges from 0 to 12. A score of 8 or more generally indicates that the cervix is ripe/favourable. Induction outcomes: improvement of modified Bishop score at interval of 48 hours after induction (time frame: from the time of commencing induction till 48 hours after induction). The difference of modified Bishop score between pre‐induction and 48 hours post‐induction. The score is assessed based on the station of the presentation, os dilation, and effacement (or length), position and consistency of the cervix. Score ranges from 0 to 12. A score of 8 or more generally indicates that the cervix is ripe/favourable. Delivery outcomes: mode of delivery (time frame: at time of delivery). Final mode of delivery, i.e. vaginal delivery and caesarean section. Delivery outcomes: duration of oxytocin augmentation (time frame: from the time of administrating oxytocin augmentation until the time of delivery, assessed up to 16 hours). Duration of oxytocin augmentation during intrapartum period. Delivery outcomes: induction to vaginal delivery interval (time frame: from the time of induction of labour until the time of vaginal delivery, assessed up to 72 hours). Duration between the time of induction of labour and vaginal delivery Delivery outcomes: amniotomy to vaginal delivery interval (time frame: from the time of amniotomy till the time of vaginal delivery, assessed up to 16 hours). Duration between the time of amniotomy and vaginal delivery. Maternal outcomes: uterine hyperstimulation (time frame: from the time of induction until the time of delivery, assessed up to 72 hours). The occurrence of uterine hyperstimulation (> 5 contractions per 10 minutes for at least 20 minutes or a contraction lasting at least 2 minutes with/without abnormal fetal heart rate) during labour process. Maternal outcomes: uterine rupture (time frame: from the time of induction until the time of delivery, assessed up to 72 hours). The occurrence of uterine rupture during labour process. Maternal outcomes: postpartum haemorrhage (time frame: from the time of delivery until the time of discharge, assessed up to 48 hours). The occurrence of postpartum haemorrhage (estimated blood loss ≥ 500 mL) after delivery. Maternal outcomes: maternal pyrexia (time frame: from the time of induction until the time of delivery, assessed up to 72 hours). The occurrence of maternal fever (temperature > 38.0 °C once, or 37.5 °C on 2 occasions 2 hours apart) during labour process. Maternal outcomes: duration of hospitalisation (time frame: from the time of induction until the time of discharge home following delivery, assessed up to 120 hours). To measure the duration of hospitalisation required. Neonatal outcomes: 5‐minute Apgar score (time frame: upon the baby is delivered, assessed up to 5 minutes of life). To measure the Apgar score of the newborn at 5 minutes of life, scores range between 0 to 10, score < 7 is considered abnormal. Neonatal outcomes: cord pH (time frame: upon baby is delivered, assessed immediately). To obtain umbilical cord blood of the newborn for pH measurement upon birth, normal levels are 7.25 and above, pH < 7.25 is abnormal and < 7.0 is considered pathological acidosis due to perinatal asphyxia.
Starting date	31 October 2017
Contact information	Yong Soon Leong, Ministry of Health, Malaysia Email: yongsoonleong@moh.gov.my
Notes	Trial completed. Email sent 26/06/2019 requesting trial data. Reply received 26/06/19 from Dr Leong stated: "I regret to inform you that it is not feasible for us, at the moment, to provide you the information and findings about the trial"