Combined Transcervical Foley Catheter Balloon and Vaginal Prostaglandin E2 for Induction of Labor at Term: A Randomized Study
This trial has been completed.
|Condition||unfavorable cervix, cervical ripening|
|Treatments||foley catheter, pge2|
|Sponsor||Zeynep Kamil Maternity and Pediatric Research and Training Hospital|
|Start date||August 2016|
|End date||October 2016|
|Trial size||250 participants|
|Trial identifier||NCT02861079, 144|
This study evaluates the addition of transcervical Foley catheter balloon and vaginal prostaglandin E2 in induction of labor at term. 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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
induction-to- delivery time
time frame: the length of time between the beginning of induction and the end of labor
induction-to-active phase of labor time
time frame: the length of time between the beginning of induction and the onset of labor
Female participants from 18 years up to 40 years old.
Inclusion Criteria: 1. singleton pregnancy, 2. gestational age ≥34 weeks, 3. intact membranes, 4. cephalic presentation, 5. bishop score ≤5, 6. had obstetrical indications for induction of labor, 7. 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 -
|Official title||Compare Prostaglandin E2 Against to Combined Transcervical Foley Catheter Balloon and Vaginal Prostaglandin E2 for Induction of Labor at Term: A Randomized Study|
|Description||An unfavorable cervix during induction decreases the success rate of labor induction and vaginal delivery. Therefore it is required to apply cervical ripening methods for unfavorable cervices. Application of transcervical Foley catheter is an effective mechanical method and has the advantages of lower cost and lowest rate of fetal heart rate changes due to tachysystole compared with PGE1 and PGE2. Despite the advantages of mechanical methods, PGE1 and PGE2 are reported to be more effective than mechanical methods to achieve vaginal delivery within 24 hours. Although there are a lot of studies comparing PGE1, PGE2 and transcervical Foley balloon catheter separately and PGE1 combined with transcervical Foley balloon catheter, less is known about combined usage of PGE2 and transcervical Foley balloon catheter.|
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