Pathiraja 2014.

Trial name or title	Induction of multiparous women at term using different methods: prostaglandin E2 (dinopristone) vaginal gel, intracervical Foley catheter insertion and sweeping of membrane: an open‐label, randomised controlled trial.
Methods	Randomised controlled trial
Participants	Inclusion criteria Multiparous women undergoing induction of labour at the study setting. Gestation more than 40 + 4 weeks Singleton pregnancy with cephalic presentation Unruptured membrane Modified Bishop Score (MBS) less than 8 Exclusion criteria Primiparity Malpresentation and unstable lie. Favourable cervix (MBS of 8 or above) Any contraindication to vaginal birth, with previous uterine surgery (including caesarean section, placenta previa and other placental anomalies) Age less than 18 years Lethal fetal congenital anomaly Known allergy to any of the interventional products
Interventions	Four arms Arm 1 (prostaglandin group): dinoprostone gel 2 mg will be inserted following initial cervical assessment. If the cervix is unfavourable after 6 hours a second dose of prostaglandin (2 mg) will inserted. Fetal well‐being will be monitored by CTG at 3 hours and 5 hours after insertion of prostaglandin. Arm 2 (Foley catheter group): the Foley catheter balloon will inserted through the cervical canal and the catheter bulb dilated with 60 mL of normal saline done. Sufficient cervical dilatation will result in the catheter dropping out. The Foley catheter will be kept for a maximum of 48 hours. Fetal well‐being will be monitored by CTG and daily Doppler assessment. Arm 3 (membrane sweeping group): the sweeping of membrane will done once daily till 41 weeks. Fetal well‐being will be monitored by CTG at 3 hours after membrane sweeping and daily Doppler assessment. Arm 4 (control group): spontaneous onset of labour will be awaited with fetal monitoring done daily by 20 minutes CTG and daily Doppler assessment.
Outcomes	Primary outcomes Time interval between induction of labour to vaginal delivery Rates of failed induction (needing caesarean section or second induction method) Secondary outcomes Requirement for oxytocin augmentation Incidence of uterine hyperstimulation Incidence of intrapartum fetal blood sampling Mode of delivery Blood loss at delivery Incidence of maternal pyrexia (> 37.3°C) Perineal lacerations require suturing Apgar score at 1 minute and 5 minutes Need for admission to a neonatal intensive care unit (NICU).
Starting date	Anticipated start date 15 October 2014
Contact information	Dr. P.D.M. Pathiraja Registrar in Obstetrics and Gynaecology New unit for Obstetrics and Gynaecology Teaching Hospital, Peradeniya 0812388261 0772532828 madushan_pathi@yahoo.com
Notes	Email requesting trial information sent. No reply to date.