Sleep and Depression in Induction of Labour

NCT03380897 | Completed

• 1 other identifier: T146/2017
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Prolonged Pregnancy; Sleep Disturbance; Depression

Keywords

induction of labor; double balloon catheter; mechanical ripening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The affect of the sleep disturbances of the mother to the pain assessed by VAS

  one to 14 days after induction of the labor

• The effect of depression of the mother to the pain assessed by VAS

  one to 14 days after induction of the labor

• The total hospital stay in both groups

  one to 14 days after induction of the labor

• The maternal and neonatal morbidity after balloon catheter induction

  one to 14 days after induction of the labor

Study Arms (2)

Outpatient group

ACTIVE COMPARATOR

After insertion of induction catheter for labor, women of the outpatient group can go home and assess their pain with visual analogy scale at home. The intervention is to go home. Intervention for outpatient group was to go home.

Other: Intervention for outpatient group was to go home

Inpatient group

PLACEBO COMPARATOR

After insertion of induction catheter for labor, women of the inpatient group assess their pain with visual analogy scale in the ward. The intervention is to stay at ward. Intervention for inpatient group was to stay at ward.

Other: Intervention for inpatient group was to stay at ward

Interventions

Intervention for outpatient group was to go home OTHER

Intervention for outpatient group was to go home and assess the the pain

Also known as: Intervention was to assess the pain by visual analogy scale.

Outpatient group

Intervention for inpatient group was to stay at ward OTHER

Intervention for inpatient group was to stay at ward and assess the pain

Also known as: Intervention was to assess the pain by visual analogy scale.

Inpatient group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• uncomplicated pregnancy
• singleton pregnancy
• pregnancy weeks ≥ 37 - ≤ 41+5
• the patient is living in1/2 hour away from hospital

You may not qualify if:

• 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

Sponsors & Collaborators

• Turku University Hospital: lead
• University of Turku: collaborator

Study Sites (1)

Turku University Hospital

Turku, 20520, Finland

Location

Related 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.

  PMID: 23356673 RESULT

• 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.

  PMID: 11704164 RESULT

• 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.

  PMID: 18715244 RESULT

MeSH Terms

Conditions

Pregnancy, Prolonged; Parasomnias; Depression

Interventions

Methods

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Kirsi M Rinne, PhD

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

• Päivi ML Polo, PhD

  Turku University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Doctor

Model Details: Factorial assignment

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: December 21, 2017
• Study Start: June 7, 2017
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)