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NCT Number: NCT03380897

Sleep and Depression in Induction of Labour

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.

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Key information

Conditions

Prolonged Pregnancy Behavior Behavioral Symptoms Depression Female Urogenital Diseases and Pregnancy Complications Mental Disorders Nervous System Diseases Parasomnias Pregnancy Complications Pregnancy, Prolonged Sleep Disturbance Sleep Wake Disorders Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Turku University Hospital

Turku, 20520, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention for outpatient group was to go home

Other

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

Other names: Intervention was to assess the pain by visual analogy scale.

Intervention for inpatient group was to stay at ward

Other

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

Other names: Intervention was to assess the pain by visual analogy scale.

Primary outcomes

  1. The pain measured by VAS

    Time frame: one to 14 days after induction of the labor

    The pain measured by VAS after double balloon catheter insertion.

Secondary outcomes

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

    Time frame: one to 14 days after induction of the labor

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

  2. The effect of depression of the mother to the pain assessed by VAS

    Time frame: one to 14 days after induction of the labor

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

  3. The total hospital stay in both groups

    Time frame: one to 14 days after induction of the labor

    The total hospital stay in both groups

  4. The maternal and neonatal morbidity after balloon catheter induction

    Time frame: one to 14 days after induction of the labor

    The maternal and neonatal morbidity after balloon catheter induction

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Collaborators

  • University of Turku

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 21, 2017
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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