Sleep and Depression in Induction of Labour

Depression Clinical Trial

Official title:

Sleep Disturbances and Depression of the Mother Affect to the Pain During Balloon Catheter Induction of Labour

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03380897
• Other study ID #: T146/2017
• Status: Completed
• Phase: N/A
• Start date: June 7, 2017
• 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

Randomised trial comparing double balloon catheter for induction of labor between inpatient and outpatient groups. The investigators assess how sleep disturbances and depression of the mother affect to the pain during balloon catheter induction of labour.

Description:

Participants included to this randomised study are women with uncomplicated singleton pregnancy with ≥ 37- ≤ 41+5 weeks of gestation. Participants are randomised to two groups: one hundred are randomised 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 investigators assess also the effect of the sleep disturbance and depression of the mother to the pain during balloon catheter induction of the labour.

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 to 45 Years

Eligibility

Inclusion Criteria:

• uncomplicated pregnancy

• singleton pregnancy

• pregnancy weeks = 37 - = 41+5

• the patient is living in1/2 hour away from hospital

Exclusion Criteria:

• patient has a disease that is effecting to the pregnancy e.g. pre-eclampsia, gestational hepatosis

• the patient has medical treatment of diabetes

• baby is not growing normally

• multiple pregnancy

• preterm rupture of membranes

• earlier caesarean section

• the patient is living more than 1/2 hour away from hospital

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Dyssomnias
• Parasomnias
• Pregnancy, Prolonged
• Prolonged Pregnancy
• Sleep Disturbance

Intervention

Other:
• Intervention for outpatient group was to go home
Intervention for outpatient group was to go home and assess the the pain
• Intervention for inpatient group was to stay at ward
Intervention for inpatient group was to stay at ward and assess the pain

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. — 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 VAS	The pain measured by VAS after double balloon catheter insertion.	one to 14 days after induction of the labor
Secondary	The affect of the sleep disturbances of the mother to the pain assessed by VAS	The affect of the sleep disturbances to the pain assessed by VAS	one to 14 days after induction of the labor
Secondary	The effect of depression of the mother to the pain assessed by VAS	The effect of depression of the mother to the pain assessed by VAS	one to 14 days after induction of the labor
Secondary	The total hospital stay in both groups	The total hospital stay in both groups	one to 14 days after induction of the labor
Secondary	The maternal and neonatal morbidity after balloon catheter induction	The maternal and neonatal morbidity after balloon catheter induction	one to 14 days after induction of the labor