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Inadequate Patient Recruitment.
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| Name | Class |
|---|---|
| St. Joseph's Healthcare Hamilton | OTHER |
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The purpose of this study is to examine the feasibility of using intracervical balloon catheters for cervical ripening as part of labour induction in healthy, GBS-negative women with prelabour rupture of membranes at term.
This is a randomized controlled trial comparing two methods of induction of labour for pregnant, GBS-negative women presenting with prelabour rupture of membranes at term.
The intervention consists of the insertion of a double-balloon intracervical catheter at the time of induction, followed immediately by oxytocin infusion. The control consists of standard therapy: oxytocin induction. Our primary outcome is feasibility, and our secondary outcomes are length of first and second stages of labour, rate of vaginal delivery, intrapartum fever, chorioamnionitis, NICU admission, suspected or proven neonatal sepsis, or serious neonatal complication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin | Active Comparator | Induction of Labour with Oxytocin Alone |
|
| Intracervical Catheter | Experimental | Insertion of an Intracervical Balloon Catheter plus administration of oxytocin for labour induction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracervical Balloon Catheter | Procedure | Intracervical insertion of an 80cc Double-Balloon Catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Intrapartum Fever | 48 Hours | |
| Duration of Labour | 48 hours | |
| NICU Admission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dustin Costescu, MD, BSc | McMaster University, Department of Obstetrics and Gynaecology | Principal Investigator |
| Amie Cullimore, MD BSc BEd | McMaster University, Department of Obstetrics and Gynaecology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Joseph's Healthcare Hamilton | Hamilton | Ontario | Canada |
| 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. | |
| 23766376 | Derived | Costescu DJ, Cullimore AJ. Lessons learned from a resident-led clinical trial in obstetrics. Clin Trials. 2013 Aug;10(4):612-6. doi: 10.1177/1740774513492045. Epub 2013 Jun 13. |
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| ID | Term |
|---|---|
| D005322 | Fetal Membranes, Premature Rupture |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Oxytocin | Drug | IV Oxytocin infusion, dose dependent on patient response. Start at 2mIU/min, increasing every 30 minutes by 2mIU/min, to max 24mIU/min. |
|
| 0-7 days postpartum |
| Chorioamnionitis | 48 Hours |
| Patient Satisfaction | 0-6 weeks Postpartum |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |