Depression Clinical Trial
Official title:
Sleep Disturbances and Depression of the Mother Affect to the Pain During Balloon Catheter Induction of Labour
Verified date | June 2020 |
Source | Turku University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 117 |
Est. completion date | December 30, 2019 |
Est. primary completion date | December 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - uncomplicated pregnancy - singleton pregnancy - pregnancy weeks = 37 - = 41+5 - the patient is living in1/2 hour away from hospital Exclusion Criteria: - patient has a disease that is effecting to the pregnancy e.g. pre-eclampsia, gestational hepatosis - the patient has medical treatment of diabetes - baby is not growing normally - multiple pregnancy - preterm rupture of membranes - earlier caesarean section - the patient is living more than 1/2 hour away from hospital |
Country | Name | City | State |
---|---|---|---|
Finland | Turku University Hospital | Turku |
Lead Sponsor | Collaborator |
---|---|
Turku University Hospital | University of Turku |
Finland,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The pain measured by VAS | The pain measured by VAS after double balloon catheter insertion. | one to 14 days after induction of the labor | |
Secondary | 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 | |
Secondary | The effect of depression of the mother to the pain assessed by VAS | The effect of depression of the mother to the pain assessed by VAS | one to 14 days after induction of the labor | |
Secondary | The total hospital stay in both groups | The total hospital stay in both groups | one to 14 days after induction of the labor | |
Secondary | 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 |
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