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| Name | Class |
|---|---|
| University of Turku | OTHER |
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Randomised trial comparing double balloon catheter for induction of labor between inpatient and outpatient groups. The investigators assess how sleep disturbances and depression of the mother affect to the pain during balloon catheter induction of labour.
Participants included to this randomised study are women with uncomplicated singleton pregnancy with ≥ 37- ≤ 41+5 weeks of gestation. Participants are randomised to two groups: one hundred are randomised 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 investigators assess also the effect of the sleep disturbance and depression of the mother to the pain during balloon catheter induction of the labour.
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 | Active Comparator | After insertion of induction catheter for labor, women of the outpatient group can go home and assess their pain with visual analogy scale at home. The intervention is to go home. Intervention for outpatient group was to go home. |
|
| Inpatient group | Placebo Comparator | After insertion of induction catheter for labor, women of the inpatient group assess their pain with visual analogy scale in the ward. The intervention is to stay at ward. Intervention for inpatient group was to stay at ward. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention for outpatient group was to go home | Other | Intervention for outpatient group was to go home and assess the the pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| The pain measured by VAS | The pain measured by VAS after double balloon catheter insertion. | one to 14 days after induction of the labor |
| Measure | Description | Time Frame |
|---|---|---|
| The affect of the sleep disturbances of the mother to the pain assessed by VAS | The affect of the sleep disturbances to the pain assessed by VAS | one to 14 days after induction of the labor |
| The effect of depression of the mother to the pain assessed by VAS |
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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 |
|---|---|---|---|
| 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. | |
| 11704164 | Result | 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. |
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Letter to patients
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| ID | Term |
|---|---|
| D011273 | Pregnancy, Prolonged |
| D020447 | Parasomnias |
| D003863 | Depression |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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Factorial assignment
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Open Label
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| Intervention for inpatient group was to stay at ward | Other | Intervention for inpatient group was to stay at ward and assess the pain |
|
|
The effect of depression of the mother to the pain assessed by VAS |
| one to 14 days after induction of the labor |
| The total hospital stay in both groups | The total hospital stay in both groups | one to 14 days after induction of the labor |
| The maternal and neonatal morbidity after balloon catheter induction | The maternal and neonatal morbidity after balloon catheter induction | one to 14 days after induction of the labor |
| 18715244 | Result | 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. |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |