Semi-permanent Acupuncture Effect on Cervical Ripening

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-22

Study Completion Date

2025-04-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Pregnancy Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Acupuncture

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

Group Type EXPERIMENTAL

Semi-permanent acupuncture

Intervention Type OTHER

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.

Control

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

Group Type SHAM_COMPARATOR

Sham of semi-permanent acupuncture

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No