Depression, Prolonged Pregnancy, Sleep Disturbance
Conditions
Keywords
induction of labor, double balloon catheter, mechanical ripening
Brief summary
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.
Detailed description
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.
Interventions
OTHERIntervention for outpatient group was to go home
Intervention for outpatient group was to go home and assess the the pain
OTHERIntervention for inpatient group was to stay at ward
Intervention for inpatient group was to stay at ward and assess the pain
Sponsors
University of Turku
Turku University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
Open Label
Intervention model description
Factorial assignment
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The pain measured by VAS | one to 14 days after induction of the labor | The pain measured by VAS after double balloon catheter insertion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The affect of the sleep disturbances of the mother to the pain assessed by VAS | one to 14 days after induction of the labor | The affect of the sleep disturbances 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 | The effect of depression of the mother to the pain assessed by VAS |
| The total hospital stay in both groups | one to 14 days after induction of the labor | The total hospital stay in both groups |
| The maternal and neonatal morbidity after balloon catheter induction | one to 14 days after induction of the labor | The maternal and neonatal morbidity after balloon catheter induction |
Countries
Finland
Outcome results
None listed