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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06357962
Other study ID # CSAPG-40
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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