CompletedNCT07929376ClinicalTrials.gov record

Effect of Epidural Analgesia Timing on Labor Duration and Obstetric Outcomes

Labor Pain and to Reduce Pain

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THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Observational
Phase: Not applicable / not listed
Age range: 18 years - 50 years
Sex eligible: Female
Healthy volunteers: Accepted
Participants: 188 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 full 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).

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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:

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

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.

Understand screening

Treatment, groups and participation

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Assignment: Not reported
Masking: Not reported

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

Epidural labor analgesia PROCEDURE

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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