Outpatient Versus Inpatient Balloon Catheter Induction of Labor

Prolonged Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02793609
• Other study ID #: T169/2016
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: December 30, 2019

Study information

• Verified date: June 2020
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy, Prolonged
• Prolonged Pregnancy

Intervention

Other:
• Intervention is to let patient to go home.
Intervention is to let patient to go home.
• Intervention is to observe women in the ward.
Intervention is to observe women in the ward.

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (2)

Lead Sponsor	Collaborator
Turku University Hospital	University of Turku

Country where clinical trial is conducted

Finland, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The maternal morbidity	number of mothers having any kind of infection	during the induction of the labor and postpartum period in the hospital
Secondary	The total hospital stay in both groups	length in days	maximum 14 days
Secondary	neonatal morbidity	number of babies having any kind of infection	during the induction of the labor and postpartum period in the hospital