Semi-permanent Acupuncture Effect on Cervical Ripening

Clinical Trial With Two Branches to Study the Effect of Semi-permanent Acupuncture at Specific Acupuncture Points on Reducing the Number of Inductions During Labor in Women at Low or Moderate Risk

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 Overview

• Status: Not yet recruiting
• Conditions: Pregnancy Complications
• Intervention / Treatment: Other: Semi-permanent acupuncture; Other: Sham of semi-permanent acupuncture

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Noemí Casaponsa; Phone Number: 43197 +34 938960025; Email: recerca@csapg.cat
• Study Contact Backup: Name: Gloria Villena; Phone Number: 47809 +34 938 18 04 40; Email: gvillena@csapg.cat

Study Locations

• Spain
  • Barcelona
    • Vilafranca Del Penedès, Barcelona, Spain, 08720
      • Consorci Sanitari Alt Penedes i Garraf
      • Contact: Noemí Casaponsa; Phone Number: 43197 +34 938960025; Email: recerca@csapg.cat
      • Contact: Gloria Villena; Phone Number: 43197 +34 938180440; Email: gvillena@csapg.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture; This group will receive sessions the study intervention (semi-permanent acupuncture)	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 Comparator: Control; This group will receive a sham treatment of semi-permanent acupuncture	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacological induction	Percentage of pregnant women who have undergone pharmacological induction to initiate labor.	Birth date

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Onset of spontaneous labor	Time in days until the onset of spontaneous labor from the first follow-up visit.	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.	Birth date
Duration of labor period	Time in hours of labor period	Birth date
Satisfaction of pregnants	Degree of satisfaction with the care provided, measured by conducting the Birth Satisfaction Scale Revised survey	Birth date

Collaborators and Investigators

• Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
• Investigators: Principal Investigator: Gloria Villena, CSAPG

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Acupuncture Therapy; Cervical Ripening
• Additional Relevant MeSH Terms: Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications
• Other Study ID Numbers: CSAPG-40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
• IPD Sharing Time Frame: After publication of main results of the study.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No