Semi-permanent Acupuncture Effect on Cervical Ripening

Consorci Sanitari de l'Alt Penedès i Garraf

Status: Terminated

Conditions: Pregnancy Complications

Treatments: Other: Semi-permanent acupuncture; Other: Sham of semi-permanent acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06357962

CSAPG-40

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: Female

Ages: Under 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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8 participants in 2 patient groups

Acupuncture

Experimental group

Description:

This group will receive sessions the study intervention (semi-permanent acupuncture)

Treatment:

Other: Semi-permanent acupuncture

Control

Sham Comparator group

Description:

This group will receive a sham treatment of semi-permanent acupuncture

Treatment:

Other: Sham of semi-permanent acupuncture