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NCT06357962 | NOT YET RECRUITING | Pregnancy Complications

Semi-permanent Acupuncture Effect on Cervical Ripening
Sponsor:

Health Consortium of Alt Penedès and Garraf

Brief Summary:

Cervical ripening is a medical treatment that can cause physical or emotional discomfort in pregnant women and is not without risks. This is a pilot study to assess feasibility and calculate the number of participants necessary for a complete clinical trial. The aim is to evaluate whether acupuncture can reduce the need for treatment (cervical ripening) in pregnant women at low or intermediate risk. Participants will be divided into two groups: one group will receive acupuncture, and the other will receive a simulated treatment of acupuncture.

Condition or disease

Pregnancy Complications

Intervention/treatment

Semi-permanent acupuncture

Sham of semi-permanent acupuncture

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : DOUBLE
Primary Purpose : SUPPORTIVE_CARE
Official Title : 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
Actual Study Start Date : 2024-09
Estimated Primary Completion Date : 2025-09
Estimated Study Completion Date : 2025-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: to 40 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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.
Semi-permanent Acupuncture Effect on Cervical Ripening

Location Details

NCT06357962

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Spain, Barcelona

High Penedes and Garraf Health Consortium

Vilafranca del Penedès, Barcelona, Spain, 08720