Labor AnalgesiaDPEA-OXYNCT07873814
Effect of Dural Puncture Epidural Analgesia on Oxytocin in Early vs Late Labor
An observational study of Labor Analgesia and Labor Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Oxytocin is a key hormone that regulates uterine contractions during labor. Dural Puncture Epidural Analgesia (DPEA) is a modern technique for labor pain relief that provides faster onset and more reliable analgesia than standard epidural.While it is known that neuraxial analgesia can suppress oxytocin levels, it is… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Labor Analgesia, Labor Pain, Oxytocin
- What is being tested?
- Dural Puncture Epidural Analgesia (DPEA)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2026to 1 Aug 2027
- Phase
- Observational
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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women aged 18-40 years admitted to the Labor Ward of Ankara Bilkent City Hospital with spontaneous labor who request Dural Puncture Epidural Analgesia (DPEA). Participants will be classified according to cervical dilation at the time of DPEA request as Early Labor Group (≤5 cm) or Late Labor Group (≥6 cm). Eligible participants will have a singleton, vertex pregnancy at 37-41 weeks of gestation and ASA physical status II.
Who may be able to join
- Gestational age 37-41 weeks, singleton pregnancy, vertex presentation
- Spontaneous onset of labor (not induced)
- Request for neuraxial labor analgesia (DPEA)
- Cervical dilation ≤5 cm (Early Group) or ≥ 6 cm (Late Group) at the time of DPEA
- Age 18-40 years, ASA physical status II
- Able to communicate in Turkish; written informed consent
Who cannot join
- CRITICAL EXCLUSION (methodological requirement):
- Any administration of exogenous oxytocin (induction or augmentation) prior to T-0 blood sampling
- Use of misoprostol, dinoprostone, or other labor-stimulating agents
- STANDARD EXCLUSION:
- Opioid use within the preceding 12 hours
- Membrane rupture >2 hours before enrollment
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- Uterine hyperstimulation
- History of lumbar spine surgery, coagulopathy (platelet count <80,000/mm³)
- Known allergy to local anesthetics or opioids
- Preeclampsia, gestational hypertension, or insulin-dependent gestational diabetes
- Suspected placenta previa/abruption, non-reassuring fetal status
- Polyhydramnios or oligohydramnios
- Technical failure of DPEA (>2 attempts, failed dural puncture confirmation)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Ankara
Esra UYAR TÜRKYILMAZ, MD, Assoc. Prof., +90505 384 04 29, esrauyarturkyilmaz@yahoo.com
Hilal KÜÇÜK, MD, +90 531 978 33 83, drhilalkucuk@gmail.com
About this study
Official title: Comparison of Maternal Plasma Oxytocin Response to Dural Puncture Epidural Analgesia in Early (≤5cm) vs Late (≥6cm) Cervical Dilation Stages of Spontaneous Labor: A Prospective Comparative Study
Oxytocin is a key hormone that regulates uterine contractions during labor. Dural Puncture Epidural Analgesia (DPEA) is a modern technique for labor pain relief that provides faster onset and more reliable analgesia than standard epidural.While it is known that neuraxial analgesia can suppress oxytocin levels, it is unclear whether this effect depends on the stage of labor at which analgesia is administered. This prospective comparative study will enroll 120 pregnant women in spontaneous labor who request DPEA, divided into two groups: Early group (cervical dilation≤5 cm, n=60) and Late group (cervical dilation≥6 cm , n=60). Both groups receive identical DPEA (a total volume of 15 mL containing 0.1% bupivacaine and 100 µg fentanyl is administered through the epidural catheter, following dural puncture with a 26G spinal needle without intrathecal drug injection). The primary outcome is the percentage change in plasma oxytocin from baseline (T-0, before analgesia) to T-Eff (30 minutes after onset of effective analgesia defined as VAS<2). Patients who received any exogenous oxytocin (induction or augmentation) before T-0 are excluded to ensure that the measured oxytocin represents endogenous production. The study will contribute to understanding how the timing of neuraxial analgesia relative to labor progression affects the endogenous oxytocin system, with potential implications for optimal clinical timing of labor analgesia administration.
Read the detailed description
Background:
Oxytocin is a neuropeptide produced in the hypothalamus and released from the posterior pituitary in a pulsatile manner during labor. Through the Ferguson reflex, oxytocin release increases substantially as labor progresses, with peak release around delivery. The effect of neuraxial analgesia on oxytocin dynamics has been controversial. Previous studies have reported both suppression and no significant change in oxytocin levels following epidural analgesia. DPEA, a technique that involves controlled dural puncture to enhance epidural local anesthetic spread without intrathecal drug administration, provides an opportunity to investigate whether the oxytocin response to neuraxial analgesia varies according to the stage of labor.
Design:
This is a prospective, comparative, observational cohort study. Patients are not randomized. Participants are classified into two groups according to cervical dilation at the time of DPEA request: Early Labor Group (≤5 cm) and Late Labor Group (≥6 cm). All participants receive standardized DPEA. Laboratory personnel performing oxytocin assays are blinded to group assignment.
DPEA protocol: After sterile preparation and local infiltration with 1% lidocaine, the epidural space is identified at L3-L4 or L4-L5 using a 17G Tuohy needle and loss-of-resistance technique. A 26G spinal needle is passed through the Tuohy needle to perform dural puncture, and cerebrospinal fluid return is confirmed. No intrathecal drug is administered. The spinal needle is withdrawn and the epidural catheter is advanced 5 cm into the epidural space. Following negative aspiration and an appropriate test dose, a total volume of 15 mL containing 0.1% bupivacaine and 100 µg fentanyl is administered through the epidural catheter. Maintenance analgesia is provided with patient-controlled epidural analgesia (PCEA). Blood sampling: A baseline blood sample (T-0) is obtained immediately before DPEA. The time at which the patient first reports a VAS pain score <2 is recorded as T-VAS; no blood sample is obtained at this time. The second blood sample (T-Eff) is obtained 30 minutes after T-VAS. Plasma samples are stored at -80°C until batch analysis for oxytocin concentration. The primary outcome is the percentage change in maternal plasma oxytocin concentration from T-0 to T-Eff, calculated as: [(T-Eff - T-0) / T-0] × 100. Patients who receive exogenous oxytocin before the T-0 blood sample are excluded from the study.
- Conditions
- Labor Analgesia, Labor Pain, Oxytocin
- Being tested
- Dural Puncture Epidural Analgesia (DPEA)
- Keywords
- dural puncture epidural, neuraxial analgesia, oxytocin, cervical dilatation, labor analgesia
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dural Puncture Epidural Analgesia (DPEA)Procedure or surgery
Standard clinical DPEA procedure: Combined spinal-epidural kit used to locate epidural space at L3-L4 or L4-L5 with 17G Tuohy needle (loss of resistance). A 26G spinal needle is passed through the Tuohy needle to perform dural puncture; CSF return is confirmed. NO intrathecal drug is administered. The spinal needle is withdrawn, the epidural catheter is advanced 5 cm into the epidural space. After negative aspiration and test dose, 15 mL of 0.1% bupivacaine is administered through the epidural catheter. Maintenance analgesia is provided via patient-controlled epidural analgesia (PCEA).
Dural Puncture Epidural Analgesia (DPEA)Procedure or surgery
Standard clinical DPEA procedure: Combined spinal-epidural kit used to locate epidural space at L3-L4 or L4-L5 with 17G Tuohy needle (loss of resistance). A 26G spinal needle is passed through the Tuohy needle to perform dural puncture; CSF return is confirmed. NO intrathecal drug is administered. The spinal needle is withdrawn, the epidural catheter is advanced 5 cm into the epidural space. After negative aspiration and test dose, 15 mL of 0.1% bupivacaine is administered through the epidural catheter. Maintenance analgesia is provided via patient-controlled epidural analgesia (PCEA).
| Study group | Role | What they receive |
|---|---|---|
| Early Labor Group | Pregnant women in spontaneous labor who request Dural Puncture Epidural Analgesia (DPEA) when cervical dilation is 5 cm or less. All receive standardized DPEA with a total volume of 15 mL containing 0.1% bupivacaine and 100 µg fentanyl via epidural catheter after dural puncture (26G) without intrathecal drug injection. Plasma oxytocin measured at T-0 (before DPEA) and T-Eff (30 min after VAS<2). Receives: Procedure: Dural Puncture Epidural Analgesia (DPEA) | |
| Late Labor Group | Pregnant women in spontaneous labor who request Dural Puncture Epidural Analgesia (DPEA) when cervical dilation is 6 cm or greater. DPEA protocol identical to Early Group. Plasma oxytocin measured at same timepoints (T-0 and T-Eff). Receives: Procedure: Dural Puncture Epidural Analgesia (DPEA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in maternal plasma oxytocin concentration from baseline to T-Eff
Calculated as: [(T-Eff plasma oxytocin - T-0 plasma oxytocin) / T-0 plasma oxytocin] × 100. Positive values indicate an increase in oxytocin; negative values indicate suppression. Plasma oxytocin concentration will be measured in pg/mL using an enzyme-linked immunosorbent assay (ELISA).
Measured: From T-0 (immediately before DPEA) to T-Eff (30 minutes after onset of effective analgesia defined as VAS<2); total duration approximately 35-45 minutes depending on time to VAS<2. (VAS: Visual analogue scale 0-10 poits. 10 means worst pain)
Secondary outcomes (9)
Time to effective analgesia (VAS<2). (VAS: Visual analogue scale 0-10 poits. 10 means worst pain)
Duration in minutes from DPEA injection to the first time point when patient reports VAS pain score <2. (VAS: Visual analogue scale 0-10 poits. 10 means worst pain)
Measured: Within 30 minutes of DPEA administration
Cervical dilation progression rate
Rate of cervical dilation in cm/hour from DPEA administration to delivery.
Measured: From DPEA to delivery (variable, typically 1-6 hours)
Bromage motor block score
Degree of motor block assessed by Bromage scale (0=no block, 3=complete block).
Measured: At delivery
Need for post-T-Eff oxytocin augmentation
Binary outcome: whether exogenous oxytocin was initiated after T-Eff for labor augmentation (yes/no), start time, and initial dose
Measured: From T-Eff to delivery
Mode of delivery
Vaginal, instrumental, or cesarean delivery; if cesarean, indication is recorded.
Measured: At delivery
First and second stage durations
Duration of first stage (from DPEA to full dilation) and second stage (full dilation to delivery) in minutes.
Measured: At delivery
Neonatal Apgar scores (0-10 points. 10 is the best score)
Apgar scores at 1 and 5 minutes of life.
Measured: At 1 and 5 minutes after delivery
Umbilical cord blood pH
pH value from umbilical cord arterial blood.
Measured: Immediately after delivery
Hemodynamic parameters
Systolic blood pressure (SBP) and heart rate (HR) at baseline, 5, 10, 15, 20, and 30 minutes after DPEA
Measured: 0-30 minutes after DPEA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Labor AnalgesiaStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Uyar Türkyılmaz, Ankara City Hospital Bilkent
- Investigators
- Esra UYAR TÜRKYILMAZ, MD, Assoc. Prof., Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873814
- Sponsor's protocol ID
- BSH-DPEA-OXY-2024-01
- Other IDs
- TABED 1-26-3010
- Acronym
- DPEA-OXY
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan to share individual participant data (IPD) outside the research team. Aggregate results will be published in peer-reviewed journals and presented at scientific conferences. Any further data sharing requests may be considered on a case-by-case basis with appropriate institutional and ethical approval.
Publications
Stocche RM, Klamt JG, Antunes-Rodrigues J, Garcia LV, Moreira AC. Effects of intrathecal sufentanil on plasma oxytocin and cortisol concentrations in women during the first stage of labor. Reg Anesth Pain Med. 2001 Nov-Dec;26(6):545-50. doi: 10.1053/rapm.2001.27851.
PubMed 11707794Goodfellow CF, Hull MG, Swaab DF, Dogterom J, Buijs RM. Oxytocin deficiency at delivery with epidural analgesia. Br J Obstet Gynaecol. 1983 Mar;90(3):214-9. doi: 10.1111/j.1471-0528.1983.tb08611.x.
PubMed 6830729Tabak BA, Leng G, Szeto A, Parker KJ, Verbalis JG, Ziegler TE, Lee MR, Neumann ID, Mendez AJ. Advances in human oxytocin measurement: challenges and proposed solutions. Mol Psychiatry. 2023 Jan;28(1):127-140. doi: 10.1038/s41380-022-01719-z. Epub 2022 Aug 23.
PubMed 35999276Uvnas-Moberg K, Ekstrom-Bergstrom A, Berg M, Buckley S, Pajalic Z, Hadjigeorgiou E, Kotlowska A, Lengler L, Kielbratowska B, Leon-Larios F, Magistretti CM, Downe S, Lindstrom B, Dencker A. Maternal plasma levels of oxytocin during physiological childbirth - a systematic review with implications for uterine contractions and central actions of oxytocin. BMC Pregnancy Childbirth. 2019 Aug 9;19(1):285. doi: 10.1186/s12884-019-2365-9.
PubMed 31399062Tsen LC, Thue B, Datta S, Segal S. Is combined spinal-epidural analgesia associated with more rapid cervical dilation in nulliparous patients when compared with conventional epidural analgesia? Anesthesiology. 1999 Oct;91(4):920-5. doi: 10.1097/00000542-199910000-00010.
PubMed 10519493Rahm VA, Hallgren A, Hogberg H, Hurtig I, Odlind V. Plasma oxytocin levels in women during labor with or without epidural analgesia: a prospective study. Acta Obstet Gynecol Scand. 2002 Nov;81(11):1033-9. doi: 10.1034/j.1600-0412.2002.811107.x.
PubMed 12421171Chau A, Bibbo C, Huang CC, Elterman KG, Cappiello EC, Robinson JN, Tsen LC. Dural Puncture Epidural Technique Improves Labor Analgesia Quality With Fewer Side Effects Compared With Epidural and Combined Spinal Epidural Techniques: A Randomized Clinical Trial. Anesth Analg. 2017 Feb;124(2):560-569. doi: 10.1213/ANE.0000000000001798.
PubMed 28067707Cappiello E, O'Rourke N, Segal S, Tsen LC. A randomized trial of dural puncture epidural technique compared with the standard epidural technique for labor analgesia. Anesth Analg. 2008 Nov;107(5):1646-51. doi: 10.1213/ane.0b013e318184ec14.
PubMed 18931227