Clinical trial NCT03380897: Sleep and Depression in Induction of Labour
Official title: Sleep Disturbances and Depression of the Mother Affect to the Pain During Balloon Catheter Induction of Labour
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prolonged Pregnancy
Sleep Disturbance
Depression
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: 2017-12-21
Enrollment: 117
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Factorial assignment
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

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