Pre-induction cervical ripening with Foley catheter, Misoprostol and their combination
Conditions
Interventions
ARM 1 Mechanical method Foley catheter
ARM 2 Pharmacological method Misoprostol
ARM 3 Synchronous Foley catheter with vaginal misoprostol
Sponsors
Ajani Ezekiel Babatunde
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Estimated gestational age of 41weeks to 41weeks +6days Unfavourable cervix (modified Bishop score, mBS of 1.52m Intact foetal membranes A reactive non-stress test Normal amniotic fluid index (AFI)
Exclusion criteria
Exclusion criteria: Medical conditions e.g. pregnancy-induced hypertension, gestational diabetes, asthma, glaucoma Clotting disorders Hypersensitivity to any of the methods Multiple gestations Previous surgeries, e.g. Caesarean section, myomectomy Active genital warts Antepartum Haemorrhage (placenta praevia, abruptio placenta)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Time from placement of cervical ripening agents to time to achieve a favourable BS of =6 within 24 hours of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal- Ripening to active phase interval - Ripening to vaginal delivery interval within 24 hours - Oxytocin requirement - Cumulative misoprostol doses - Mode of delivery: Caesarean section, vaginal delivery or operative vaginal delivery - Foley catheter insertion to expulsion time - Method related adverse events: Fever, shivering, anaphylaxis, intracervical bleeding, balloon rupture, purulent vaginal discharge, chorioamnionitis, failed ripening, tachysystole, hypertonus, uterine hyperstimulation, PPH, and uterine rupture. - Participants’ satisfaction Neonatal - Meconium-stained liquor - Apgar score <7 at 1 and 5minutes - SCBU admission - Perinatal death | — |
Countries
Nigeria
Contacts
Public ContactAdeniji Olanrewaju Adediran
Chief Medical Director Adeoyo Maternity Hospital
Outcome results
None listed