Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
NCT07401147

Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management During Labor.

Led by Ricardo A Gutierrez Ramirez, MD, MSc, FACOG · Updated on 2026-02-13

132

Participants Needed

2

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a randomized, double-blind, crossover clinical trial to evaluate the efficacy of transcutaneous electrical nerve stimulation (TENS) as a non-pharmacological therapeutic intervention for reducing pain in women during the active phase of labor. Nulliparous women with term pregnancies will be randomly assigned to sequences involving TENS intervention and placebo (device off) periods, separated by a washout. The primary outcome is labor pain intensity measured by the Visual Analog Scale (VAS). Secondary outcomes include duration of the active labor phase, maternal and neonatal safety profile, and childbirth experience satisfaction. The study will be conducted at the Hospital Escuela Universitario from feb 2026 to Ago 2026.

CONDITIONS

Official Title

Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management During Labor.

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent.
  • Women aged 18-45 years.
  • Nulliparous (first pregnancy).
  • Term singleton pregnancy (37-42 weeks).
  • Cephalic (head-down) fetal presentation.
  • Spontaneous or induced labor under adequate control.
  • Cervical dilation of at least 5 cm at enrollment.
  • Normal amniotic fluid volume and reassuring fetal monitoring.
  • Uncomplicated pregnancy.
Not Eligible

You will not qualify if you...

  • Multiple pregnancy.
  • Non-cephalic fetal presentation.
  • Severe obstetric complications (e.g., preeclampsia, placental abruption).
  • Maternal chronic or acute diseases that interfere with safety.
  • History of neurological or psychiatric disorders that contraindicate TENS.
  • Abnormal fetal monitoring or amniotic fluid.
  • Pre-pregnancy body mass index over 30 kg/m².
  • Fetal demise.
  • Illiteracy.

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Hospital Escuela

Tegucigalpa, Francisco Morazán Department, Honduras, 11101

Actively Recruiting

2

Instituto Hondureño de Seguridad Social

Tegucigalpa, Francisco Morazán Department, Honduras, 11101

Actively Recruiting

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Research Team

R

Ricardo A. Gutierrez Ramirez, MD, MSc

CONTACT

S

Sara J. Sevilla Ardon, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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