NCT03380897

Sleep and Depression in Induction of Labour

Sleep Disturbances and Depression of the Mother Affect to the Pain During Balloon Catheter Induction of Labour

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Turku University Hospital · Other Government
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Prolonged Pregnancy
• Sleep Disturbance
• Depression

Interventions

Type	Name	Description
OTHER	Intervention for outpatient group was to go home	Intervention for outpatient group was to go home and assess the the pain
OTHER	Intervention for inpatient group was to stay at ward	Intervention for inpatient group was to stay at ward and assess the pain

Timeline

• Start date: 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 across 1 country: Finland