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CompletedNCT07929376Updated Nov 10, 2026

Effect of Epidural Analgesia Timing on Labor Duration and Obstetric Outcomes

An observational study in Labor Pain and to Reduce Pain, sponsored by Başakşehir Çam & Sakura City Hospital. Completed at 2 sites in Turkey (Türkiye). Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Başakşehir Çam & Sakura City Hospital · Observational

Updated Nov 10, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
188
Ages
18 Years to 50 Years
Sex
Female
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Study summary

This retrospective cohort study evaluated whether the timing of epidural analgesia initiation affects labor outcomes in obstetric patients. Patients were categorized as EARLY (cervical dilation less than 4 cm, n=59) or LATE (4 cm or greater, n=129) at epidural placement. The primary outcome was second stage labor duration in vaginally delivering patients (n=177). Secondary outcomes included first stage duration, epidural-to-delivery interval, total fentanyl consumption, cesarean section rate, and neonatal outcomes. EARLY epidural initiation was associated with significantly longer second stage duration (37 vs 25 min, p=0.003), higher fentanyl consumption (56 vs 36 mcg, p\<0.001), and higher cesarean section rate (13.6% vs 2.3%, p=0.005). Neonatal outcomes were comparable between groups.

Read the detailed description

Epidural analgesia is the most effective method for labor pain management. The optimal timing of initiation has historically been debated, with concerns that early placement may prolong labor or increase operative delivery rates. This single-center retrospective cohort study was conducted at BasaksehirCamSakuraSehirH, Istanbul, following standardization of the institutional epidural protocol (June 2025 - July 2026). A total of 196 patients were screened; 8 were excluded due to inaccessible epidural records, leaving 188 patients for analysis (EARLY n=59, LATE n=129). The epidural solution consisted of bupivacaine 1 mg/mL and fentanyl 1 mcg/mL in 100 mL normal saline. The primary outcome (second stage duration) was analyzed in vaginally delivering patients only (n=177). Multiple linear regression confirmed that early epidural timing was an independent predictor of longer second stage duration (beta=+9.5 min, p=0.034) and higher opioid consumption (beta=+9.6 mcg, p=0.001) after adjusting for nulliparity and epidural duration. Logistic regression demonstrated that early timing was associated with a 6.3-fold increased odds of cesarean delivery (OR 6.28, 95% CI 1.56-25.18, p=0.010). The study was approved by the Acibadem University Non-Interventional Research Ethics Committee (ATADEK 2026/14, September 24, 2026).

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Conditions studied

  • Labor Pain and to Reduce Pain

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Keywords

  • epidural analgesia
  • labor analgesia
  • timing of epidural
  • second stage labor
  • obstetric analgesia
  • opioid consumption
  • cesarean section
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In context

Labor Pain

423 studies on the registry are indexed under Labor Pain; 74 are open to participants now.

This study's enrollment of 188 is above the median of 132 across 62 observational studies indexed under Labor Pain.

Browse Labor Pain studies →

Lead sponsor

Başakşehir Çam & Sakura City Hospital is the lead sponsor of 109 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Obstetric patients who requested and received epidural labor analgesia at Acibadem Maslak Hospital between June 1, 2025 and July 1, 2026, following standardization of the hospital epidural protocol.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Term pregnancy (37 weeks gestational age or greater)
  2. Singleton pregnancy
  3. Cephalic presentation
  4. Received epidural labor analgesia during the study period
  5. Complete epidural analgesia record available

Exclusion criteria

Exclusion Criteria:

  1. Inaccessible or incomplete epidural records (n=8 excluded)
  2. Multiple gestation
  3. Preterm labor (less than 37 weeks gestational age)
  4. Pre-existing to neuraxial anesthesia
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
188 participants (actual)
Patient registry
No

Groups and cohorts

  • EARLY Group

    Patients who received epidural analgesia at cervical dilation less than 4 cm. n=59.

    Procedure: Epidural labor analgesia

  • LATE Group

    Patients who received epidural analgesia at cervical dilation 4 cm or greater. n=129.

    Procedure: Epidural labor analgesia

Interventions

  • ProcedureEpidural labor analgesia

    Bupivacaine 1 mg/mL + fentanyl 1 mcg/mL in 100 mL normal saline. Timing of initiation (early vs late) constitutes the exposure.

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What researchers measure

Primary outcomes

  1. Second Stage Labor Duration

    Duration of the second stage of labor from full cervical dilation to delivery, measured in minutes. Analyzed in vaginally delivering patients only (n=177).

    Time frame: Perioperative/Periprocedural

Secondary outcomes

  1. First Stage Labor Duration

    Duration from epidural placement to full cervical dilation, in minutes.

    Time frame: Perioperative/Periprocedural

  2. Epidural-to-Delivery Interval

    Time from epidural catheter placement to delivery, in minutes.

    Time frame: Perioperative/Periprocedural

  3. Total Opioid Consumption

    Cumulative fentanyl dose (micrograms) administered via epidural from placement to delivery.

    Time frame: Perioperative/Periprocedural

  4. Cesarean Section Rate

    Proportion of patients delivering by cesarean section in each group.

    Time frame: Perioperative/Periprocedural

  5. APGAR Score at 1 Minute

    Neonatal APGAR score at 1 minute after delivery.

    Time frame: Perioperative/Periprocedural

  6. APGAR Score at 5 Minutes

    Neonatal APGAR score at 5 minutes after delivery.

    Time frame: Perioperative/Periprocedural

  7. Neonatal Birth Weight

    Birth weight in grams.

    Time frame: Perioperative/Periprocedural

  8. NICU Admission Rate

    Proportion of neonates requiring NICU admission.

    Time frame: Day 1

  9. Need for Neonatal Resuscitation

    Proportion of neonates requiring any resuscitation at birth

    Time frame: Perioperative/Periprocedural

  10. Maternal Intrapartum Hypotension

    Proportion with systolic BP less than 90 mmHg or greater than 20% decrease from baseline after epidural.

    Time frame: Perioperative/Periprocedural

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Study locations

2 sites
  • Acibadem Maslak hospital
    Istanbul, Sariyer, Turkey (Türkiye)
  • Basaksehir Çam Ve Sakura City Hospital
    Istanbul, Turkey (Türkiye)
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References and documents

Individual participant data

Plan to share: No — Individual patient data will not be shared due to institutional privacy regulations and retrospective design.

No publications or documents are linked to this record.

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Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07929376
Collaborators
Acibadem Maslak Hospital
Responsible party
Ozal Adiyeke (SpecialistMD, Principal Investigator, Başakşehir Çam & Sakura City Hospital) — Principal investigator
First posted
Nov 10, 2026
Start date
Jun 1, 2025
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026
Last update
Nov 10, 2026

Study contacts

Ozal Adiyeke, MD, Specialist
study director · Acibadem Maslak Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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