Prolonged Pregnancy
Conditions
Keywords
induction of labor, double balloon catheter, mechanical ripening
Brief summary
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.
Detailed description
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.
Interventions
OTHERIntervention is to let patient to go home.
Intervention is to let patient to go home.
OTHERIntervention is to observe women in the ward.
Intervention is to observe women in the ward.
Sponsors
University of Turku
Turku University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* uncomplicated pregnancy * singleton pregnancy * pregnancy weeks between \>37 and \<41+5 * the patient is living in 1/2 hour away from hospital
Exclusion criteria
* patient has any disease or medication * multiple pregnancy * pregnancy week \> 41+5 * preterm rupture of membranes * patient living more than 1/2 hour away from hospital
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The pain measured by visual analogy scale(VAS) after double balloon catheter | During the induction of the labor and postpartum period in the hospital. | Visual analogy score assessed by patient. Minimum 1mm to maximum 100 mm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The maternal morbidity | during the induction of the labor and postpartum period in the hospital | number of mothers having any kind of infection |
| The total hospital stay in both groups | maximum 14 days | length in days |
| neonatal morbidity | during the induction of the labor and postpartum period in the hospital | number of babies having any kind of infection |
Countries
Finland
Outcome results
None listed