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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
117
Intervention is to let patient to go home.
Intervention is to observe women in the ward.
Turku University Hospital
Turku, Finland
The pain measured by visual analogy scale(VAS) after double balloon catheter
Visual analogy score assessed by patient. Minimum 1mm to maximum 100 mm.
Time frame: During the induction of the labor and postpartum period in the hospital.
The maternal morbidity
number of mothers having any kind of infection
Time frame: during the induction of the labor and postpartum period in the hospital
The total hospital stay in both groups
length in days
Time frame: maximum 14 days
neonatal morbidity
number of babies having any kind of infection
Time frame: during the induction of the labor and postpartum period in the hospital
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.