Labor ProgressionSAD-LABORNCT07299708
Effects of Sleep Quality, Anxiety, and Digital Behavior on Labor Progression in Term Primiparous Women: A Prospective Observational Study
An observational study of Labor Progression and Pregnancy, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Progression, Pregnancy
- How many people
- 127 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Aug 2025to 30 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tepecik Training and Research Hospital
Izmir, 35020
About this 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.
Read the detailed description
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.
- Conditions
- Labor Progression, Pregnancy
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Sleep Quality, Anxiety, Digital Behavior, Primiparous Women, Childbirth, Oxytocin Augmentation
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
Observational study with no assigned treatment or intervention.
| Study group | Role | What they receive |
|---|---|---|
| Primiparous Cohort | Term primiparous women assessed for sleep quality, anxiety, digital behavior, and followed through spontaneous labor. Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: From onset of regular contractions until onset of active labor (≥4 cm), typically lasting up to 20 hours.
Duration of Second Stage of Labor
Time in minutes from full cervical dilatation (10 cm) to the delivery of the neonate. Pushing time will be recorded prospectively.
Measured: From full dilatation (10 cm) until birth, typically lasting up to 3 hours.
Oxytocin Augmentation Requirement
Proportion of participants requiring oxytocin infusion due to inadequate uterine contractions or labor arrest, as documented by obstetric staff.
Measured: From admission in active labor (≥4 cm) until delivery, typically within 2 to 12 hours.
Mode of Delivery
Rates of spontaneous vaginal delivery, operative vaginal delivery, and cesarean delivery, evaluated according to sleep, anxiety, and digital behavior parameters.
Measured: Assessed at delivery.
Use of Epidural Analgesia
Proportion of participants receiving epidural anesthesia for labor pain management, and its association with sleep quality, anxiety scores, and digital device use.
Measured: From onset of active labor (≥4 cm) until delivery, typically within 2 to 12 hours.
APGAR Score at 1 and 5 Minutes
Apgar scores assessed at 1 and 5 minutes after birth.
Measured: Assessed at 1 and 5 minutes after birth.
Neonatal Intensive Care Unit (NICU) Admission
Number of neonates requiring admission to the neonatal intensive care unit.
Measured: Assessed within the first 24 hours after birth.
Birth Weight
Neonatal birth weight measured in grams immediately after delivery.
Measured: Assessed at birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start10 Aug 2025
- Primary completion25 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor ProgressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tepecik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Yıldırım, Tepecik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299708
- Sponsor's protocol ID
- TEPECIK-SAD-LABOR
- Other IDs
- TEPECIK-EC-2025-07-10 (06/08/2
- Acronym
- SAD-LABOR
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The dataset contains sensitive clinical information from pregnant women and cannot be made publicly available due to institutional and national data protection regulations. Summary results will be published in peer-reviewed journals, but no individual-level data will be released.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sleep Quality, Anxiety, and Digital Behavior on Labor Progression in Term Primiparous Women: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07299708
- Acronym / sponsor ID
- SAD-LABOR / TEPECIK-SAD-LABOR
- Conditions
- Labor Progression, Pregnancy
- Keywords
- Sleep Quality, Anxiety, Digital Behavior, Primiparous Women, Childbirth, Oxytocin Augmentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Tepecik Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Aug 2025 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primiparous Cohort | – | Other: No Intervention: Observational CohortTerm primiparous women assessed for sleep quality, anxiety, digital behavior, and followed through spontaneous labor. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- Multiple pregnancy
- Non-cephalic presentation
- Delivery occurring at another hospital or birth center
- Elective planned cesarean delivery
- Major fetal anomaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortObservational study with no assigned treatment or intervention. | Other | Primiparous Cohort |
Primary outcome
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.
8 secondary outcomes
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.
Duration of Second Stage of Labor
Time frame: From full dilatation (10 cm) until birth, typically lasting up to 3 hours.
Oxytocin Augmentation Requirement
Time frame: From admission in active labor (≥4 cm) until delivery, typically within 2 to 12 hours.
Mode of Delivery
Time frame: Assessed at delivery.
Use of Epidural Analgesia
Time frame: From onset of active labor (≥4 cm) until delivery, typically within 2 to 12 hours.
APGAR Score at 1 and 5 Minutes
Time frame: Assessed at 1 and 5 minutes after birth.
Neonatal Intensive Care Unit (NICU) Admission
Time frame: Assessed within the first 24 hours after birth.
Birth Weight
Time frame: Assessed at birth.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The dataset contains sensitive clinical information from pregnant women and cannot be made publicly available due to institutional and national data protection regulations. Summary results will be published in peer-reviewed journals, but no individual-level data will be released.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor Progression and Pregnancy, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.