Acupuncture's effect on cervical ripening in pregnant women
Clinical Trial with Two Branches to Study the Effect of Semi-permanent Acupuncture At Specific Acupuncture Points on Reducing the Number of Inductions During Labor in Women At Low or Moderate Risk
This study is testing if acupuncture can help pregnant women get their bodies ready for labor without needing extra medical treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | N/A to 40 Years |
| Sex | Female |
| Sponsor | Consorci Sanitari de l'Alt Penedès i Garraf Academic / other |
| Locations | 1 site (Vilafranca Del Penedès, Barcelona) |
| Trial ID | NCT06357962 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the feasibility of using acupuncture to reduce the need for cervical ripening treatments in pregnant women at low or intermediate risk. Participants will be randomly assigned to receive either semi-permanent acupuncture or a sham treatment. The study will assess the effectiveness of acupuncture in facilitating cervical ripening while minimizing discomfort and risks associated with traditional methods. The results will help determine the necessary sample size for a larger clinical trial.
Who should consider this trial
Good fit: Ideal candidates are pregnant women at low or intermediate risk who are expected to deliver at the study center.
Not a fit: Patients with high-risk pregnancies or those with a history of cesarean delivery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and less invasive option for cervical ripening in pregnant women.
How similar studies have performed: While acupuncture has been explored in various contexts, this specific approach to cervical ripening is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Anticipated delivery at the study center. * Ability to collaborate in necessary evaluations. * Legal capacity to provide informed consent. * Signature of the informed consent for inclusion in the study, by oneself. Exclusion Criteria: * Pregnancy with high or very high risk as described by the Pregnancy and Childbirth Monitoring Protocols of the Department of Health of Catalonia * History of cesarean delivery. * Language barrier preventing collaboration in study procedures. * Cognitive or affective pathology limiting the ability to collaborate with study procedures. * Participation in another clinical trial involving an experimental intervention during the period of this trial and/or establishing a visit frequency incompatible with this trial.
Where this trial is running
Vilafranca Del Penedès, Barcelona
- Consorci Sanitari Alt Penedes i Garraf — Vilafranca Del Penedès, Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Gloria Villena — Csapg
- Study coordinator: Gloria Villena
- Email: gvillena@csapg.cat
- Phone: +34 938 18 04 40
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.