CompletedNot Applicable

Outpatient Versus Inpatient Balloon Catheter Induction of Labor

Finland117 participantsStarted 2016-06-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT02793609

SponsorTurku University Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2019-12-30

View on ClinicalTrials.gov More Prolonged Pregnancy trials