Outcome of induction of labour comparing double and single balloon catheters and Prostaglandin E2 Gel; an Open-label Trial.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2024
INTERVENTION: Arm 1 ‐ induction of labour with single balloon catheter , it will be short procedure performed in labor room, 18‐Fr Foley catheter will be inserted per vaginally above the internal os. The catheter bulb will be inflated with 60 ml of normal saline. After inflation, the catheter will be pulled back until the balloon is against the internal cervical os Arm 2‐ induction of labour with double balloon catheter it will be short procedure performed in labor room , two 18 F foleys catheter will be tied to each other and inserted together in cervi Xper vaginally, one bulb will be extra amniotic, above the internal os, inflated with 60ml saline, 2nd the bulb will be placed in the cervix, inflated with 30ml saline Arm 4 ‐ induction of labour with single single Balloon catherter & PGE2 a single bulb Foley catheter 18F will be placed above the internal os per vaginally, it will be inflated with 60 ml of normal saline, after 12 hours PGE2 Gel will be placed in the posterior forni X(2mg ,maximum 2 doses, 6 hours apart). The intervention will be done by final year resident / consultant obstetrician . CONDITION: induction of labour ; ; induction of labour Reproductive Health and Childbirth ‐ Childbirth and postnatal care PRIMARY OUTCOME: rate of cesarean section verified by medical record [ 24‐48 hours after intervention ] SECONDARY OUTCOME: Cervical readiness for labour determined by bishop score before and after expulsion of cathete[ within 24 hour of intervention] failed induction verified by medical documentation [ within 24 hour of intervention] fever via clinical assessment , verified by medical documentation.[ 24‐48 hours after intervention] frequency of hyperstimulation of uterus measured as more than 4 contractions in 10 minutes Lasting more than 40 seconds ; Rate of uterine rupture secondary to hyperstimulation determined by clinical assessment'[ within 24‐48 hours after intervention] indication of cesarean section verified by medical documentation[ within 48 hour of intervention] mode of delivery verified by medical documentation [ within 48 hour of intervention] pain score on insertion of catherter will be noticd using visual analog scale [ at time of insertion of catheter ] postpartum haemorrhage (PPH) via amount of blood loss after delivery , blood loss of more than 500ml after Normal Vaginal Deliveries (NVD) and more than 1000 ml after Casearean Section( Cs ) will be considered as PPH, blood loss will be estimated by weighing surgical guaze packs used , pre and post delivery, 1mg increase in weight equals to 1ml blood loss[ within 24‐48 hour of delivery] the Time duration between insertion and expulsion of catheters verified by medical documentation [ within 24 hours] time from insertion to delivery verified by medical documentation [ within 24‐48 hours after intervention] INCLUSION CRITERIA: single fetus between 37‐42 weeks who need induction of labour for maternal or fetal reasons other than mentioned in exclusion criteria, BMI 20‐35 Kg/m2, cephalic presentation, intact membrane, and reassuring CTG on admission
Epistemonikos ID: d920f2dc31ba996d2b121788feff05e719fde1d8
First added on: Aug 28, 2024