An interventional study of Intervention for outpatient group was to go home and Intervention for inpatient group was to stay at ward in Prolonged Pregnancy, Sleep Disturbance and Depression, sponsored by Turku University Hospital. Completed at 1 site in Finland. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-11.
Sponsored by Turku University Hospital · Not applicable, Interventional, and Health services research
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.
Exclusion Criteria:
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.
Other: Intervention for outpatient group was to go home
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.
Other: Intervention for inpatient group was to stay at ward
Intervention for outpatient group was to go home and assess the the pain
Also known as: Intervention was to assess the pain by visual analogy scale.
Intervention for inpatient group was to stay at ward and assess the pain
Also known as: Intervention was to assess the pain by visual analogy scale.
The pain measured by VAS
The pain measured by VAS after double balloon catheter insertion.
Time frame: one to 14 days after induction of the labor
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
Time frame: one to 14 days after induction of the labor
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
Time frame: one to 14 days after induction of the labor
The total hospital stay in both groups
The total hospital stay in both groups
Time frame: 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
Time frame: one to 14 days after induction of the labor
Plan to share: No — Letter to patients
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Turku University Hospital