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Completed

NCT Number: NCT07299708

Effects of Sleep Quality, Anxiety, and Digital Behavior on Labor Progression in Term Primiparous Women: A Prospective Observational Study

This prospective observational study evaluates whether maternal sleep quality, anxiety levels, and nighttime digital behavior are associated with labor progression among term primiparous women. Sleep quality and anxiety are assessed before the onset of labor during routine antenatal visits using validated instruments, including the Pittsburgh Sleep Quality Index (PSQI) and the Beck Anxiety Inventory (BAI). Nighttime digital behavior characteristics, such as screen exposure and smartphone use prior to sleep, are recorded through standardized antenatal interviews.

Labor outcomes, including the duration of the latent, active, and second stages of labor, requirement for oxytocin augmentation, use of analgesia, and mode of delivery, are prospectively documented from hospital admission until birth. By examining behavioral and psychological factors prior to labor onset, the study aims to determine whether poor sleep quality, increased anxiety, or irregular nighttime digital activity are associated with prolonged labor phases or greater need for obstetric interventions.

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Key information

Conditions

Labor Progression Anxiety Disorders Dyssomnias Mental Disorders Nervous System Diseases Pregnancy Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Tepecik Training and Research Hospital

Izmir, 35020, Turkey (Türkiye)

About this study

This prospective observational cohort study investigates the influence of maternal sleep quality, anxiety levels, and nighttime digital device use on labor progression among term primiparous women. Eligible participants were term primiparous women attending routine antenatal follow-up at Izmir Tepecik Training and Research Hospital. All psychosocial assessments were completed prior to the onset of labor. Sleep quality was evaluated using the Pittsburgh Sleep Quality Index (PSQI), and anxiety levels were assessed using the Beck Anxiety Inventory (BAI). Nighttime digital behavior characteristics were documented through structured antenatal interviews and included pre-sleep screen exposure, smartphone use in bed, frequency of nighttime phone checking, and the type of digital content viewed before sleep.

Participants were subsequently followed through spontaneous labor, and labor-related data were collected prospectively. Initial labor characteristics documented at hospital admission included cervical dilation, contraction pattern, and overall clinical presentation. Additional labor outcomes, including the duration of the latent, active, and second stages of labor, use of oxytocin augmentation, requirement for epidural or opioid analgesia, operative vaginal delivery, cesarean delivery, and neonatal outcomes, were recorded systematically according to standardized institutional protocols.

The primary aim of the study is to determine whether poor sleep quality, elevated anxiety levels, or increased nighttime digital device use are associated with prolonged labor or dysfunctional labor patterns. Secondary aims include examining whether interactions between digital behavior variables and psychological factors contribute to variations in maternal labor physiology or to increased obstetric intervention rates.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Pregnant women at ≥ 37 weeks of gestation
  • Completion of PSQI (sleep quality) and BAI (anxiety) assessments during antenatal clinic visit
  • Singleton pregnancy
  • Cephalic presentation
  • Age 18 to 50 years
  • Planning to deliver at the study hospital
  • Able to provide informed consent

Exclusion criteria

  • Multiple pregnancy
  • Non-cephalic presentation
  • Delivery occurring at another hospital or birth center
  • Elective planned cesarean delivery
  • Major fetal anomaly
  • Placenta previa or placenta accreta spectrum
  • Preeclampsia, eclampsia, HELLP syndrome
  • Gestational diabetes requiring insulin
  • Chronic medical disorders affecting labor physiology
  • Use of sedative, hypnotic, or psychotropic medications
  • Inability to complete questionnaires

Treatment and study plan

No Intervention: Observational Cohort

Other

Observational study with no assigned treatment or intervention.

Primary outcomes

  1. Duration of Active Labor

    Time frame: From onset of active labor (≥4 cm) until full cervical dilatation (10 cm), typically within 2 to 12 hours.

    Time in minutes from the onset of active labor (defined as cervical dilatation of ≥4 cm with regular contractions) to full cervical dilatation (10 cm). Data will be obtained prospectively from electronic delivery records.

Secondary outcomes

  1. Duration of Latent Phase of Labor

    Time frame: From onset of regular contractions until onset of active labor (≥4 cm), typically lasting up to 20 hours.

    Time (in minutes) from onset of regular contractions to 4 cm cervical dilation, recorded prospectively from labor charts. Evaluated in relation to sleep quality, anxiety levels, and nighttime digital behavior.

  2. Duration of Second Stage of Labor

    Time frame: From full dilatation (10 cm) until birth, typically lasting up to 3 hours.

    Time in minutes from full cervical dilatation (10 cm) to the delivery of the neonate. Pushing time will be recorded prospectively.

  3. Oxytocin Augmentation Requirement

    Time frame: From admission in active labor (≥4 cm) until delivery, typically within 2 to 12 hours.

    Proportion of participants requiring oxytocin infusion due to inadequate uterine contractions or labor arrest, as documented by obstetric staff.

  4. Mode of Delivery

    Time frame: Assessed at delivery.

    Rates of spontaneous vaginal delivery, operative vaginal delivery, and cesarean delivery, evaluated according to sleep, anxiety, and digital behavior parameters.

  5. Use of Epidural Analgesia

    Time frame: From onset of active labor (≥4 cm) until delivery, typically within 2 to 12 hours.

    Proportion of participants receiving epidural anesthesia for labor pain management, and its association with sleep quality, anxiety scores, and digital device use.

  6. APGAR Score at 1 and 5 Minutes

    Time frame: Assessed at 1 and 5 minutes after birth.

    Apgar scores assessed at 1 and 5 minutes after birth.

  7. Neonatal Intensive Care Unit (NICU) Admission

    Time frame: Assessed within the first 24 hours after birth.

    Number of neonates requiring admission to the neonatal intensive care unit.

  8. Birth Weight

    Time frame: Assessed at birth.

    Neonatal birth weight measured in grams immediately after delivery.

Sponsors and collaborators

Lead sponsor

Tepecik Training and Research Hospital

Other

Registry information

Acronym: SAD-LABOR

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 23, 2025
Registry last updated
Dec 23, 2025

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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