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

NCT07299708 | Completed DMC

• 2 other identifiers: TEPECIK-SAD-LABORTEPECIK-EC-2025-07-10 (06/08/2
• Study Type: observational
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Labor Progression; Pregnancy

Keywords

Sleep Quality; Anxiety; Digital Behavior; Primiparous Women; Childbirth; Oxytocin Augmentation

Outcome Measures

Primary Outcomes (1)

• Duration of Active Labor

  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.

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

Secondary Outcomes (8)

• Duration of Latent Phase of Labor

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

• Duration of Second Stage of Labor

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

• Oxytocin Augmentation Requirement

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

• Mode of Delivery

  Assessed at delivery.

• Use of Epidural Analgesia

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

Study Arms (1)

Primiparous Cohort

Term primiparous women assessed for sleep quality, anxiety, digital behavior, and followed through spontaneous labor.

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

Observational study with no assigned treatment or intervention.

Primiparous Cohort

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Only self-identified women who are biologically female and pregnant are eligible to participate in this study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study population consists of term primiparous pregnant women who attended routine antenatal follow-up at Izmir Tepecik Training and Research Hospital and subsequently experienced spontaneous onset of labor. All participants were healthy, low-risk obstetric patients with singleton, cephalic presentations and no medical or obstetric complications.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tepecik Training and Research Hospital: lead

Study Sites (1)

Tepecik Training and Research Hospital

Izmir, 35020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstetrics and Gynecology Specialist, Principal Investigator

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 23, 2025
• Study Start: August 10, 2025
• Primary Completion: November 25, 2025
• Study Completion: November 30, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)