Semi-permanent Acupuncture Effect on Cervical Ripening

Last updated: February 10, 2025
Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy Complications

Treatment

Semi-permanent acupuncture

Sham of semi-permanent acupuncture

Clinical Study ID

NCT06357962
CSAPG-40
  • Ages < 40
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Pregnancy with high or very high risk as described by the Pregnancy and ChildbirthMonitoring 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 studyprocedures.

  • Participation in another clinical trial involving an experimental interventionduring the period of this trial and/or establishing a visit frequency incompatiblewith this trial.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Semi-permanent acupuncture
Phase:
Study Start date:
May 22, 2024
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • Consorci Sanitari Alt Penedes i Garraf

    Vilafranca Del Penedès, Barcelona 08720
    Spain

    Active - Recruiting

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