Failed Induction of Labor Clinical Trial
| NCT number | NCT02618096 |
| Other study ID # | SWP_PG_M2 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | October 2015 |
| Est. completion date | October 2018 |
| Verified date | October 2016 |
| Source | Seoul National University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to compare concurrent oxytocin with membrane sweeping versus dinoprostone pessary in labor induction for multiparas at term with an unfavorable cervix.
| Status | Completed |
| Enrollment | 154 |
| Est. completion date | October 2018 |
| Est. primary completion date | October 2018 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - singleton pregnancy - Multiparous women - gestational age >=37.0 weeks - Bishop score <=6 - intact amniotic membrane - absence of labor - live fetus with vertex presentation - no previous uterine surgical procedure Exclusion Criteria: - Multiple pregnancy - Placenta previa |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Department of Obstetrics and Gynecology Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do |
| Lead Sponsor | Collaborator |
|---|---|
| Seoul National University Hospital |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Vaginal delivery within 24 hours | Vaginal delivery within 24 hours is defined as vaginal delivery after 24 hours of initiating intervention (i.e. membrane sweeping or dinoprostone) on the first day of induction. | From the time of initiating intervention (i.e. membrane sweeping or dinoprostone) until the time of vaginal delivery, assessed up to 24 hours | |
| Secondary | Successful labor induction | to achieve the active phase of labor corresponding to a cervical dilatation of >=4cm | From the time of initiating intervention (i.e. membrane sweeping or dinoprostone) until the time of active phase of labor (defined as a cervical dilatation of >=4cm), assessed up to 24 hours | |
| Secondary | Incidence of cesarean delivery | End of labor induction (assessed up to 120 hours) | ||
| Secondary | The interval from start of oxytocin to delivery | From the time of initiating oxytocin infusion until the time of delivery, assessed up to 120 hours |
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