Sleep and Depression in Induction of Labour

Not Applicable

Completed

• Conditions: Prolonged Pregnancy; Sleep Disturbance; Depression
• Interventions: Other: Intervention for inpatient group was to stay at ward; Other: Intervention for outpatient group was to go home

• Registration Number: NCT03380897
• Lead Sponsor: Turku University Hospital

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.

Study Timeline

• Study First Submitted: 2017-05-30
• Study Start: 2017-06-07
• Study First Submitted QC: 2017-12-19
• Study First Posted: 2017-12-21
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-07
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 117

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Inpatient group	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.
Outpatient group	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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
The total hospital stay in both groups	one to 14 days after induction of the labor	The total hospital stay in both groups

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Finland