Outpatient Versus Inpatient Balloon Catheter Induction of Labor

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

2016-06-01

Study Completion Date

2019-12-30

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.

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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.

Conditions

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Prolonged Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Outpatient group

After insertion of double balloon induction catheter of labor, women are discharged overnight to home. Intervention is to let patient to go home.

Group Type OTHER

Intervention is to let patient to go home.

Intervention Type OTHER

Intervention is to let patient to go home.

Inpatient group

After insertion of double balloon induction catheter of labor, women are observed in the prenatal ward. Intervention is to observe women in the ward.

Group Type OTHER

Intervention is to observe women in the ward.

Intervention Type OTHER

Intervention is to observe women in the ward.

Interventions

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Intervention is to let patient to go home.

Intervention Type OTHER

Intervention is to observe women in the ward.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes