NCT07401147 Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management During Labor.
| NCT ID | NCT07401147 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ricardo A Gutierrez Ramirez, MD, MSc, FACOG |
| Condition | Labor Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 132 participants |
| Start Date | 2026-02-15 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 132 participants in total. It began in 2026-02-15 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07401147 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Labor Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07401147 currently recruiting?
Yes, NCT07401147 is actively recruiting participants. Contact the research team at ricardo.gutierrez@unah.edu.hn for enrollment information.
Where is the NCT07401147 trial being conducted?
This trial is being conducted at Tegucigalpa, Honduras, Tegucigalpa, Honduras.
Who is sponsoring the NCT07401147 clinical trial?
NCT07401147 is sponsored by Ricardo A Gutierrez Ramirez, MD, MSc, FACOG. The trial plans to enroll 132 participants.