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NCT Number: NCT02793609

Outpatient Versus Inpatient Balloon Catheter Induction of Labor

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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Key information

Conditions

Prolonged Pregnancy Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Pregnancy, Prolonged Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Turku University Hospital

Turku, 20520, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention is to let patient to go home.

Other

Intervention is to let patient to go home.

Intervention is to observe women in the ward.

Other

Intervention is to observe women in the ward.

Primary outcomes

  1. The pain measured by visual analogy scale(VAS) after double balloon catheter

    Time frame: During the induction of the labor and postpartum period in the hospital.

    Visual analogy score assessed by patient. Minimum 1mm to maximum 100 mm.

Secondary outcomes

  1. The maternal morbidity

    Time frame: during the induction of the labor and postpartum period in the hospital

    number of mothers having any kind of infection

  2. The total hospital stay in both groups

    Time frame: maximum 14 days

    length in days

  3. neonatal morbidity

    Time frame: during the induction of the labor and postpartum period in the hospital

    number of babies having any kind of infection

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Collaborators

  • University of Turku

Registry information

Official study title

Outpatient Versus Inpatient Double Balloon Catheter for Induction of Labor: a Randomised Trial

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 8, 2016
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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