Pregnancy
Conditions
Interventions
Study settings:
Six Teaching Hospitals in Sri Lanka- Teaching Hospital, Mahamodara, Galle, North Colombo Teaching Hospital, Teaching Hospital, Anuradhapura, Teaching Hospital, Batticaloa, Castle Stre
Sponsors
Dr. Malitha Patabendige
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vaginal delivery rate [At the time of hospital discharge] Perinatal morbidity and mortality parameters (composite measure) a.Stillbirth b.Admission to neonatal intensive care unit (NICU- for any period) c.Birth trauma (mechanical causes during childbirth) d.Intrapartum death e.Neonatal mortality f.Neonatal seizures g.Confirmed neonatal infection needing antibiotics h.Hypoxic-ischaemic encephalopathy (HIE) i.Meconium aspiration syndrome (MAS) j.Severe neonatal respiratory morbidity (consists of mechanical ventilation, infantile respiratory distress syndrome (RDS) and pneumothorax) [ At the time of hospital discharge] | — |
Secondary
| Measure | Time frame |
|---|---|
| Admission to intensive care unit (ICU)- for any period [At the time of hospital discharge] Maternal infection (temperature = 38 ºC at any time during induction, labour, and delivery/ use of intravenous antibiotics/ clinically suspected/confirmed infection such as chorioamnionitis or postpartum endometritis) [48 hours postpartum] Postpartum haemorrhage > 1000mLs [ 48 hours postpartum] Uterine rupture [48 hours postpartum] Hysterectomy for any complications resulting from birth [ At the time of hospital discharge and six weeks postpartum] Damage to internal organs (bladder, bowel, ureters) [48 hours postpartum] Cardio-respiratory arrest [at the time of hospital discharge upto six weeks postpartum] Stroke [ at the time of hospital discharge and six weeks postpartum] Pulmonary embolism [at the time of hospital discharge and six weeks postpartum] Postnatal depression [48 hours postpartum] Maternal mortality [48 hours postpartum] Mode of delivery (spontaneous vaginal and operative delivery and caesarean delivery with indications [48 hours postpartum] Induction to delivery interval [48 hours postpartum] Length of hospital stay for mother and baby [at the time of hospital discharge] Women’s satisfaction with their respective outpatient or inpatient approach [48 hours postpartum] Acceptability of the Foley catheter as an outpatient method to women [ After six weeks of delivery] Acceptability of the Foley catheter as an outpatient method to partners [ After six weeks of delivery] Healthcare cost for the two methods of induction of labour and their cost-effectiveness [at the time of hospital discharge and six weeks postpartum] | — |
Countries
Sri Lanka
Contacts
Public ContactMalitha Patabendige
Consultant Obstetrician and Gynaecologist
Outcome results
None listed