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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002061-29 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal misoprostol alone | Active Comparator | 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 |
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| Vaginal misoprostol + Foley catheter | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | Administration of 25 mcg of vaginal misoprostol every 4 hours up to 5 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Induction to delivery time | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Bishop score at 12 hours from the onset of induction | 1 year | |
| Bishop score at 24 hours from the onset of induction | 1 year | |
| Number of doses of misoprostol required |
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Inclusion criteria:
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Àngels Vives Argilagós, MD | Contact | +34 937310007 | 7098 | MAVives@cst.cat |
| Marino Romero Ramírez, MD | Contact | +34 937310007 | 2319 | marino.rora@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Àngels Vives Argilagós, MD | Consorci Sanitari de Terrassa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consorci Sanitari de Terrassa | Recruiting | Terrassa | Barcelona | 08227 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36996264 | Derived | de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4. |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Foley catheter | Device | Insertion of a Foley catheter (16French) through the internal os for a maximum of 12 hours |
|
|
| 1 year |
| Percentage of pregnant women requiring oxytocin | 1 year |
| Maximum dosage of oxytocin given (mU / min) | 1 year |
| Percentage of pregnant women requiring epidural analgesia | 1 year |
| Percentage of pregnant women with tachysystole and / or hypertonus with absence of fetal heart rate decelerations | 1 year |
| Percentage of pregnant women with tachysystole and / or hypertonus with fetal heart rate decelerations | 1 year |
| Percentage of pregnant women with intrapartum fever | 1 year |
| Percentage of pregnant women with maternal side effects | 1 year |
| Percentage of pregnant women with vaginal delivery within 12 hours from the onset of induction | 1 year |
| Percentage of pregnant women with vaginal delivery within 24 hours from the onset of induction | through study completion |
| Total rate of cesarean section | 1 year |
| Percentage of cesarean sections for failed induction | 1 year |
| Percentage of cesarean sections for nonreassuring fetal status | 1 year |
| Neonatal intensive care unit admission | 1 year |
| Apgar score at 5 minutes | 1 year |
| Umbilical artery ph | 1 year |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |