Sleep and Depression in Induction of Labour

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-07

Study Completion Date

2019-12-30

Brief Summary

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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.

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Detailed Description

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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

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Prolonged Pregnancy Sleep Disturbance Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Factorial assignment

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Open Label

Study Groups

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Outpatient group

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.

Group Type ACTIVE_COMPARATOR

Intervention for outpatient group was to go home

Intervention Type OTHER

Intervention for outpatient group was to go home and assess the the pain

Inpatient group

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.

Group Type PLACEBO_COMPARATOR

Intervention for inpatient group was to stay at ward

Intervention Type OTHER

Intervention for inpatient group was to stay at ward and assess the pain

Interventions

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Intervention for outpatient group was to go home

Intervention for outpatient group was to go home and assess the the pain

Intervention Type OTHER

Intervention for inpatient group was to stay at ward

Intervention for inpatient group was to stay at ward and assess the pain

Intervention Type OTHER

Other Intervention Names

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Intervention was to assess the pain by visual analogy scale. Intervention was to assess the pain by visual analogy scale.

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes