Semi-permanent Acupuncture Effect on Cervical Ripening

NCT06357962 | Terminated

• 1 other identifier: CSAPG-40
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy Complications

Keywords

Cervical Ripening; Acupuncture Therapy

Outcome Measures

Primary Outcomes (1)

• Pharmacological induction

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

  Birth date

Secondary Outcomes (5)

• Change on score of Bishop scale

  Birth date

• Onset of spontaneous labor

  Birth date

• Duration of induction period Duration of the induction period Duration of the induction period Duration of the induction period

  Birth date

• Duration of labor period

  Birth date

• Satisfaction of pregnants

  Birth date

Study Arms (2)

Acupuncture

EXPERIMENTAL

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

Other: Semi-permanent acupuncture

Control

SHAM COMPARATOR

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

Other: Sham of semi-permanent acupuncture

Interventions

Semi-permanent acupuncture 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.

Acupuncture

Sham of semi-permanent acupuncture 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.

Control

Eligibility Criteria

• Age: Up to 40 Years
• Gender Eligibility Details: The participants will be pregnant women
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Anticipated delivery at the study center.
• Ability to collaborate in necessary evaluations.
• Legal capacity to provide informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Consorci Sanitari de l'Alt Penedès i Garraf: lead

Study Sites (1)

Consorci Sanitari Alt Penedes i Garraf

Vilafranca del Penedès, Barcelona, 08720, Spain

Location

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Gloria Villena

  CSAPG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 10, 2024
• Study Start: May 22, 2024
• Primary Completion: March 16, 2025
• Study Completion: April 19, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After publication of main results of the study.
• Access Criteria: IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.

Locations

ES (1)