Sleep Disturbances and Depression of the Mother Affect to the Pain During Balloon Catheter Induction of Labour
| Registry | NCT03380897 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, factorial, masking: none, health services research |
| Enrollment | 117 (Actual) |
| Sponsor | Turku University Hospital (Other gov); collaborators: University of Turku |
| Conditions | Prolonged Pregnancy, Sleep Disturbance, Depression |
| Interventions | Intervention for outpatient group was to go home, Intervention for inpatient group was to stay at ward (Other) |
| Dates | start 2017-06-07, primary completion 2019-12-30, completion 2019-12-30, first posted 2017-12-21, last updated 2020-06-11 |
| Locations | 1 site in Finland |
Related Papers Related Patents Related Grants Related Experts
All trials for Prolonged Pregnancy All trials for Sleep Disturbance All trials of Intervention for outpatient group was to go home All trials of Intervention for inpatient group was to stay at ward
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Outpatient group | Active comparator | Other: Intervention for outpatient group was to go home | 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. |
| Inpatient group | Placebo comparator | Other: Intervention for inpatient group was to stay at ward | 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. |
Sex: Female, ages: 18 Years to 45 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Turku University Hospital | Turku | Finland |