Comparison of efficacy and safety outcomes in mother and neonate following, sending home versus keeping in the hospital after induction of labour with Foley catheter

Not Applicable

Conditions: Pregnancy

Registration Number: SLCTR/2021/023

Lead Sponsor: Dr. Malitha Patabendige

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: Not specified

Inclusion Criteria

•Women with live singleton pregnancies with a cephalic presentation
•Women with >37 weeks +0 days to 42 weeks +0 days gestation, with intact membranes requiring IOL
•Women living within 20km or less (40-minute drive or less) from the hospital, having a telephone, and someone to provide transport to the hospital in an emergency

Exclusion Criteria

•Women with high-risk pregnancies (heart disease, hypertension, hyper-glycaemia on metformin or insulin therapy, fetal growth restriction)
•Less than 18 years of age
•Major congenital anomaly as per routine anomaly scan
•Previous caesarean delivery
•Modified Bishop Score (MBS) > 6
•Evidence of regular uterine contractions
•Known hypersensitivity for any of the products for induction/ latex
•Any contraindications to vaginal birth, i.e. Placenta praevia
•Evidence of any vaginal or cervical infection

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vaginal delivery rate<br><br><br> [At the time of hospital discharge]<br> Perinatal morbidity and mortality parameters (composite measure) <br><br>a.Stillbirth<br>b.Admission to neonatal intensive care unit (NICU- for any period)<br>c.Birth trauma (mechanical causes during childbirth) <br>d.Intrapartum death<br>e.Neonatal mortality<br>f.Neonatal seizures<br>g.Confirmed neonatal infection needing antibiotics<br>h.Hypoxic-ischaemic encephalopathy (HIE)<br>i.Meconium aspiration syndrome (MAS)<br>j.Severe neonatal respiratory morbidity (consists of mechanical ventilation, infantile respiratory distress syndrome (RDS) and pneumothorax)<br> [ At the time of hospital discharge]<br>

Secondary Outcome Measures