Induction of Labor Affected Fetus / Newborn, Preterm Premature Rupture of Fetal Membranes
Conditions
Brief summary
This study evaluates the addition of transcervical Foley catheter balloon and vaginal prostaglandin E2 induction in premature rupture of membranes. Half of participants will be used combine transcervical Foley catheter balloon and vaginal prostaglandin E2, while the other half will be used alone vaginal prostaglandin E2.
Interventions
DEVICEFoley balloon catheter
18-F Foley catheter which filling with 60 mL of saline solution will be placed into the cervix
Sponsors
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. singleton pregnancy, 2. gestational age ≥34 weeks, 3. rupture of membranes, 4. cephalic presentation, 5. bishop score ≤5, 6. had less than three uterine contractions in every 10 minutes.
Exclusion criteria
1. Patients who had contraindications for vaginal delivery, 2. previous uterine surgery, 3. fetal malpresentation, 4. multifetal pregnancy, 5. more than three contractions in 10 minutes, 6. contraindications to prostaglandins, 7. a category II or III fetal heart rate pattern, 8. anomalous fetus, 9. fetal demise 10. women with immediate delivery indications -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| induction-to- delivery time | an average of one year | the length of time between the beginning of induction and the end of labor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| tachysystole | an average of one year | uterine contractions more than 3 in 10 minutes |
| chorioamnionitis | an average of one year | clinical chorioamnionitis(Maternal fever and Fetal tachycardia \>160/min and Maternal tachycardia \>100/min |
| postpartum hemorrhage | an average of one year | abnormal uterine bleeding after birth |
| neonatal outcome | an average of one year | APGAR scores |
| admission to neonatal intensive care unit | an average of one year | admission to neonatal intensive care unit |
Countries
Turkey (Türkiye)
Contacts
Primary Contactahmet eser
Backup Contactand yavuz
Outcome results
None listed