Outpatient Versus Inpatient Balloon Catheter Induction of Labor

Study Overview
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Brief Summary
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Randomized trial comparing double balloon catheter for induction of labor between in- and outpatient groups.Investigators assess feasibility, clinical effectiveness and patient acceptability of outpatient versus inpatient catheter for induction of labor.

Detailed Description
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The objective of this study is to describe labor outcomes in women with double balloon induction catheter of labor. Participants included are women with uncomplicated singleton pregnancy of ≥37- ≤41+5 weeks of gestation. Patients are randomized to two groups: one hundred are randomized 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 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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Outpatient Versus Inpatient Double Balloon Catheter for Induction of Labor: a Randomised Trial

Conditions
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Prolonged Pregnancy

Intervention / Treatment
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* Other: Intervention is to let patient to go home.
* Other: Intervention is to observe women in the ward.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: uncomplicated pregnancy singleton pregnancy pregnancy weeks between >37 and <41+5 the patient is living in 1/2 hour away from hospital Exclusion Criteria: patient has any disease or medication multiple pregnancy pregnancy week > 41+5 preterm rupture of membranes patient living more than 1/2 hour away from hospital

Ages Eligible for Study
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Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Outpatient group<br>After insertion of double balloon induction catheter of labor, women are discharged overnight to home. Intervention is to let patient to go home. | Other: Intervention is to let patient to go home.<br>* Intervention is to let patient to go home.<br>|
| Other: Inpatient group<br>After insertion of double balloon induction catheter of labor, women are observed in the prenatal ward. Intervention is to observe women in the ward. | Other: Intervention is to observe women in the ward.<br>* Intervention is to observe women in the ward.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pain measured by visual analogy scale(VAS) after double balloon catheter | Visual analogy score assessed by patient. Minimum 1mm to maximum 100 mm. | During the induction of the labor and postpartum period in the hospital. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The maternal morbidity | number of mothers having any kind of infection | during the induction of the labor and postpartum period in the hospital | 
| The total hospital stay in both groups | length in days | maximum 14 days | 
| neonatal morbidity | number of babies having any kind of infection | during the induction of the labor and postpartum period in the hospital | 

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