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| Name | Class |
|---|---|
| University of Turku | OTHER |
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Randomized trial comparing double balloon catheter for induction of labor between in- and outpatient groups.Investigators assess feasibility, clinical effectiveness and patient acceptability of outpatient versus inpatient catheter for induction of labor.
The objective of this study is to describe labor outcomes in women with double balloon induction catheter of labor. Participants included are women with uncomplicated singleton pregnancy of ≥37- ≤41+5 weeks of gestation. Patients are randomized to two groups: one hundred are randomized to the inpatient and one hundred to the outpatient group.
The main outcome measure is the pain evaluated by VAS at one, five, nine and 13 hours after the placement of double balloon induction catheter. The total hospital stay and induction to delivery interval time is measured. Also the mode of birth as well as maternal and neonatal morbidity and patient satisfaction are recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outpatient group | Other | After insertion of double balloon induction catheter of labor, women are discharged overnight to home. Intervention is to let patient to go home. |
|
| Inpatient group | Other | After insertion of double balloon induction catheter of labor, women are observed in the prenatal ward. Intervention is to observe women in the ward. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention is to let patient to go home. | Other | Intervention is to let patient to go home. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The pain measured by visual analogy scale(VAS) after double balloon catheter | Visual analogy score assessed by patient. Minimum 1mm to maximum 100 mm. | During the induction of the labor and postpartum period in the hospital. |
| Measure | Description | Time Frame |
|---|---|---|
| The maternal morbidity | number of mothers having any kind of infection | during the induction of the labor and postpartum period in the hospital |
| The total hospital stay in both groups | length in days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirsi M Rinne, PhD | Turku University Hospital | Principal Investigator |
| Päivi ML Polo, PhD | Turku University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Turku University Hospital | Turku | 20520 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11704164 | Background | Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. doi: 10.1016/s0029-7844(01)01579-4. | |
| 18715244 | Background | Prager M, Eneroth-Grimfors E, Edlund M, Marions L. A randomised controlled trial of intravaginal dinoprostone, intravaginal misoprostol and transcervical balloon catheter for labour induction. BJOG. 2008 Oct;115(11):1443-50. doi: 10.1111/j.1471-0528.2008.01843.x. Epub 2008 Aug 19. |
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Letter to patients.
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| ID | Term |
|---|---|
| D011273 | Pregnancy, Prolonged |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Intervention is to observe women in the ward. | Other | Intervention is to observe women in the ward. |
|
| maximum 14 days |
| neonatal morbidity | number of babies having any kind of infection | during the induction of the labor and postpartum period in the hospital |
| 23356673 | Result | Henry A, Madan A, Reid R, Tracy SK, Austin K, Welsh A, Challis D. Outpatient Foley catheter versus inpatient prostaglandin E2 gel for induction of labour: a randomised trial. BMC Pregnancy Childbirth. 2013 Jan 29;13:25. doi: 10.1186/1471-2393-13-25. |
| 32852803 | Derived | Alfirevic Z, Gyte GM, Nogueira Pileggi V, Plachcinski R, Osoti AO, Finucane EM. Home versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007372. doi: 10.1002/14651858.CD007372.pub4. |