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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
117
Intervention for outpatient group was to go home and assess the the pain
Intervention for inpatient group was to stay at ward and assess the pain
Turku University Hospital
Turku, Finland
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
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