Sleep and Depression in Induction of Labour

Turku University Hospital (TYKS)

Status: Completed

Conditions: Prolonged Pregnancy; Depression; Sleep Disturbance

Treatments: Other: Intervention for inpatient group was to stay at ward; Other: Intervention for outpatient group was to go home

Study type: Interventional

Funder types: Other

Identifiers

NCT03380897

T146/2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 117 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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117 participants in 2 patient groups, including a placebo group

Outpatient group

Active Comparator group

Description:

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.

Treatment:

Other: Intervention for outpatient group was to go home

Inpatient group

Placebo Comparator group

Description:

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.

Treatment:

Other: Intervention for inpatient group was to stay at ward