Clinical trial NCT02793609: Outpatient Versus Inpatient Balloon Catheter Induction of Labor
Official title: Outpatient Versus Inpatient Double Balloon Catheter for Induction of Labor: a Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prolonged Pregnancy
Keywords: induction of labor
double balloon catheter
mechanical ripening
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: University of Turku
First posted: 2016-06-08
Enrollment: 117
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: The maternal morbidity
timeFrame: during the induction of the labor and postpartum period in the hospital
measure: The total hospital stay in both groups
timeFrame: maximum 14 days
measure: neonatal morbidity
timeFrame: during the induction of the labor and postpartum period in the hospital
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Turku University Hospital
name: Kirsi M Rinne, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Turku University Hospital
name: Päivi ML Polo, PhD
role: STUDY_DIRECTOR
References:
citation: Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. doi: 10.1016/s0029-7844(01)01579-4.
citation: Prager M, Eneroth-Grimfors E, Edlund M, Marions L. A randomised controlled trial of intravaginal dinoprostone, intravaginal misoprostol and transcervical balloon catheter for labour induction. BJOG. 2008 Oct;115(11):1443-50. doi: 10.1111/j.1471-0528.2008.01843.x. Epub 2008 Aug 19.
citation: Henry A, Madan A, Reid R, Tracy SK, Austin K, Welsh A, Challis D. Outpatient Foley catheter versus inpatient prostaglandin E2 gel for induction of labour: a randomised trial. BMC Pregnancy Childbirth. 2013 Jan 29;13:25. doi: 10.1186/1471-2393-13-25.
citation: Alfirevic Z, Gyte GM, Nogueira Pileggi V, Plachcinski R, Osoti AO, Finucane EM. Home versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007372. doi: 10.1002/14651858.CD007372.pub4.