Skip to content

The effect of dural epidural puncture technique in comparison with combined epidural-spinal and epidural techniques in painless delivery and the consequences of labor, mother and newborn

Evaluation of the effect of dural epidural puncture technique in comparison with combined epidural-spinal and epidural techniques in painless delivery and the consequences of labor, mother and newborn

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20211112053042N4
Enrollment
90
Registered
2022-09-29
Start date
2022-10-06
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Painless delivery. Encounter for full-term uncomplicated delivery

Interventions

Intervention 1: The first intervention group: Dural epidural puncture group: With the needle-through-needle technique, a Whitacre 25 gage spinal needle is used to confirm dural puncture in the axis of

Sponsors

Karaj University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Pregnant women with ASA Class I, II Gestation age 38-42weeks Singleton Vertex presentation Entering the active phase of labor with dilatation less than 5 cm A candidate for painless delivery Pregnant women with consent to participate in the project

Exclusion criteria

Exclusion criteria: Pregnant women with lack of consent to participate in the project History of back surgery Diseases related to pregnancy such as gestational hypertension, preeclampsia, gestational diabetes Contraindications for performing neuraxial analgesia techniques Known fetal anomaly A condition with an increased risk of cesarean section, such as a history of previous cesarean section, a history of uterine rupture Diseases of the central nervous system Allergy to the drugs used in the study Coagulation disorders, decreased platelet count Local or systemic infection The presence of blood or cerebrospinal fluid in the epidural catheter during the procedure History of drug abuse People who are unable to maintain the position when the needle is inserted History of spine surgery Presence of wound and infection at the needle entry site

Design outcomes

Primary

MeasureTime frame
Pain. Timepoint: Before the start of the procedure, 5, 10, 15, 30, 45, 60, 90, 120, 180, 240 minutes after the procedure, cervical dilatation 6 cm, cervical dilatation 10 cm, immediately after the exit of the fetus. Method of measurement: Visual Analogue Scale.

Secondary

MeasureTime frame
Analgesia onset time. Timepoint: When with the first bolus injection, the pain score is <= 3 based on VAS. Method of measurement: Ask the patient.;Movement block. Timepoint: every 15 minutes. Method of measurement: Based on scoring Bromage criteria.;Sensory block. Timepoint: every 15 minutes. Method of measurement: Sensory block at S2 and T10 levels.;Systolic blood pressure. Timepoint: Before the procedure, 5, 10, 15, 30, 45, 60, 75, 105, 135, 165 minutes later. Method of measurement: Measurement with pressure gauge.;Diastolic blood pressure. Timepoint: Before the procedure, 5, 10, 15, 30, 45, 60, 75, 105, 135, 165 minutes later. Method of measurement: Measurement with pressure gauge.;Heart rate. Timepoint: Before the procedure, 5, 10, 15, 30, 45, 60, 75, 105, 135, 165 minutes later. Method of measurement: Measurement with non-invasive devices.;Oxygen saturation. Timepoint: Before the procedure, 5, 10, 15, 30, 45, 60, 75, 105, 135, 165 minutes later. Method of measurement: Pulse Oximetry.;Apgar score. Timepoint: At 1 and 5 minutes after birth. Method of measurement: Neonatal specialist examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Hossein Delshad MD.

Karaj University of Medical Sciences

m.delshad@abzums.ac.ir+98 26 3350 2347

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026