Semi-permanent Acupuncture Effect on Cervical Ripening

Consorci Sanitari de l'Alt Penedès i Garraf8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Pregnancy Complications

Interventions

Semi-permanent acupunctureOTHER

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 acupunctureOTHER

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.

Eligibility

Sex: FEMALEMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

Consorci Sanitari Alt Penedes i Garraf

Vilafranca del Penedès, Barcelona, Spain

Outcomes

Primary Outcomes

Pharmacological induction

Percentage of pregnant women who have undergone pharmacological induction to initiate labor.

Time frame: Birth date

Secondary Outcomes

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

Time frame: Birth date

Onset of spontaneous labor

Time in days until the onset of spontaneous labor from the first follow-up visit.

Time frame: Birth date

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.

Time frame: Birth date

Duration of labor period

Time in hours of labor period

Time frame: Birth date

Satisfaction of pregnants

Degree of satisfaction with the care provided, measured by conducting the Birth Satisfaction Scale Revised survey

Time frame: Birth date

Data from ClinicalTrials.gov

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