A Phase 4 interventional study of Misoprostol and Foley catheter in Induction of Labor, Cervical Ripening and Pregnancy, sponsored by Consorci Sanitari de Terrassa. Status unknown at 1 site in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-12.
Sponsored by Consorci Sanitari de Terrassa · Phase 4, Interventional, and Treatment
Demonstrate that with concomitant and synchronous use of supracervical balloon and vaginal misoprostol for induction of labour, vaginal delivery is achieved in less time compared with vaginal misoprostol alone.
Consorci Sanitari de Terrassa is the lead sponsor of 41 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria
Women in this group will receive 25mcg of vaginal misoprostol every 4 hours up to a maximum of 5 doses. Misoprostol will be stopped in case of a favorable cervix or if the patient is in active labor. In case of no progression after 5 doses of misoprostol, intravenous oxytocin will be perfused 4 hours after the last dose of misoprostol according to local protocols
Drug: Misoprostol
Women in this group will receive 25mcg of vaginal misoprostol every 4 hours up to a maximum of 5 doses. At the same time a 16French Foley catheter will be inserted through the internal os with visualization of the cervix by sterile speculum examination. The catheter balloon will be inflated with 30 ml of sterile normal saline solution and then the catheter will be taped with gentle traction to the inner thigh of the patient until spontaneous expulsion. If this does not occur, the catheter will be deflated and removed after 12 hours. Misoprostol will be stopped in case of a favorable cervix or if the patient is in active labor. In case of no progression after 5 doses of misoprostol, intravenous oxytocin will be perfused 4 hours after the last dose of misoprostol.
Drug: Misoprostol · Device: Foley catheter
Administration of 25 mcg of vaginal misoprostol every 4 hours up to 5 doses
Also known as: Misofar
Insertion of a Foley catheter (16French) through the internal os for a maximum of 12 hours
Also known as: Supracervical balloon
Induction to delivery time
Time frame: 1 year
Bishop score at 12 hours from the onset of induction
Time frame: 1 year
Bishop score at 24 hours from the onset of induction
Time frame: 1 year
Number of doses of misoprostol required
Time frame: 1 year
Percentage of pregnant women requiring oxytocin
Time frame: 1 year
Maximum dosage of oxytocin given (mU / min)
Time frame: 1 year
Percentage of pregnant women requiring epidural analgesia
Time frame: 1 year
Percentage of pregnant women with tachysystole and / or hypertonus with absence of fetal heart rate decelerations
Time frame: 1 year
Percentage of pregnant women with tachysystole and / or hypertonus with fetal heart rate decelerations
Time frame: 1 year
Percentage of pregnant women with intrapartum fever
Time frame: 1 year
Percentage of pregnant women with maternal side effects
Time frame: 1 year
Percentage of pregnant women with vaginal delivery within 12 hours from the onset of induction
Time frame: 1 year
Percentage of pregnant women with vaginal delivery within 24 hours from the onset of induction
Time frame: through study completion
Total rate of cesarean section
Time frame: 1 year
Percentage of cesarean sections for failed induction
Time frame: 1 year
Percentage of cesarean sections for nonreassuring fetal status
Time frame: 1 year
Neonatal intensive care unit admission
Time frame: 1 year
Apgar score at 5 minutes
Time frame: 1 year
Umbilical artery ph
Time frame: 1 year
Plan to share: No
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This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Consorci Sanitari de Terrassa