Semi-permanent Acupuncture Effect on Cervical Ripening

Pregnancy Complications Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06357962
• Other study ID #: CSAPG-40
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: October 2025

Study information

• Verified date: April 2024
• Source: Consorci Sanitari de l'Alt Penedès i Garraf
• Contact: Gloria Villena
• Phone: +34 938 18 04 40
• Email: gvillena[@]csapg.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy Complications

Intervention

Other:
• Semi-permanent acupuncture
These are sessions that last approximately one hour. The selection of points will be based on the energy diagnosis made during the first visit. In some cases, a point may be changed depending on progress. During the session, an interrogation will be conducted to assess symptoms and signs of the condition, and to evaluate if there have been any adverse reactions to the previous session. At the end of the visit, semi-permanent acupuncture will be applied to the selected points.
• Sham of semi-permanent acupuncture
A simulated semi-permanent acupuncture session will be conducted, consisting of specific placebo materials without needles and without stimulation for a few minutes. These points will not correspond to any acupuncture point and will be located on the hands, feet, and back. Stickers without pins will be applied, but never in critical points related to contraction stimulation or cervical ripening.

Locations

Country	Name	City	State
Spain	Consorci Sanitari Alt Penedes i Garraf	Vilafranca Del Penedès	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari de l'Alt Penedès i Garraf

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacological induction	Percentage of pregnant women who have undergone pharmacological induction to initiate labor.	Birth date
Secondary	Change on score of Bishop scale	Change from the initial obstetric assessment (weeks 36 to 38 of gestation) to the day of admission for delivery in the total score of the Bishop scale	Birth date
Secondary	Onset of spontaneous labor	Time in days until the onset of spontaneous labor from the first follow-up visit.	Birth date
Secondary	Duration of induction period Duration of the induction period Duration of the induction period Duration of the induction period	Time in hours from the administration of medication for induction to the onset of labor.	Birth date
Secondary	Duration of labor period	Time in hours of labor period	Birth date
Secondary	Satisfaction of pregnants	Degree of satisfaction with the care provided, measured by conducting the Birth Satisfaction Scale Revised survey	Birth date