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

RecruitingNAAges 18 Years - 45 YearsFemaleRicardo A Gutierrez Ramirez, MD, MSc, FACOG
NCT07401147 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Signed informed consent. * Women aged 18-45 years. * Nulliparous. * Term singleton pregnancy (37-42 weeks). * Cephalic presentation. * Spontaneous onset of labor or induced/conducted labor under adequate control. * Cervical dilation of at least 5 cm at enrollment. * Normal amniotic fluid volume and reassuring fetal monitoring. * Uncomplicated pregnancy. Exclusion Criteria: * Multiple pregnancy. * Non-cephalic presentation. * Severe obstetric complications (e.g., preeclampsia, placental abruption). * Maternal chronic or acute diseases interfering with safety. * History of neurological/psychiatric disorders contraindicating TENS. * Abnormal fetal monitoring or amniotic fluid. * Pre-pregnancy BMI \>30 kg/m². * Fetal demise. * Illiteracy.
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What it tests

  • Transcutaneous Electrical Nerve Stimulation (TENS); TENSCARE Perfect Mama+ TENS unit
  • Sham Comparator
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Where

2 sites
Hospital Escuela
Tegucigalpa, Honduras
Instituto Hondureño de Seguridad Social
Tegucigalpa, Honduras
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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