Sleep and Depression in Induction of Labour

Study Overview
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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.

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.

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

Conditions
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Prolonged Pregnancy, Sleep Disturbance, Depression

Intervention / Treatment
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* Other: Intervention for outpatient group was to go home
* Other: Intervention for inpatient group was to stay at ward


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Factorial assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Outpatient group<br>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. | Other: Intervention for outpatient group was to go home<br>* Intervention for outpatient group was to go home and assess the the pain<br>* Other names: Intervention was to assess the pain by visual analogy scale.;|
| Placebo Comparator: Inpatient group<br>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. | Other: Intervention for inpatient group was to stay at ward<br>* Intervention for inpatient group was to stay at ward and assess the pain<br>* Other names: Intervention was to assess the pain by visual analogy scale.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pain measured by VAS | The pain measured by VAS after double balloon catheter insertion. | one to 14 days after induction of the labor | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The affect of the sleep disturbances of the mother to the pain assessed by VAS | The affect of the sleep disturbances 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 effect of depression of the mother to the pain assessed by VAS | one to 14 days after induction of the labor | 
| The total hospital stay in both groups | The total hospital stay in both groups | one to 14 days after induction of the labor | 
| The maternal and neonatal morbidity after balloon catheter induction | The maternal and neonatal morbidity after balloon catheter induction | one to 14 days after induction of the labor | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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double balloon catheter, induction of labor, mechanical ripening