Semi-permanent Acupuncture Effect on Cervical Ripening

Not Applicable

Recruiting

• Conditions: Pregnancy Complications
• Interventions: Other: Semi-permanent acupuncture; Other: Sham of semi-permanent acupuncture

• Registration Number: NCT06357962
• Lead Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-05
• Study First Submitted QC: 2024-04-05
• Study First Posted: 2024-04-10
• Study Start: 2024-05-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Primary Completion: 2025-09
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture	Semi-permanent acupuncture	This group will receive sessions the study intervention (semi-permanent acupuncture)
Control	Sham of semi-permanent acupuncture	This group will receive a sham treatment of semi-permanent acupuncture

Primary Outcome Measures

Name	Time	Method
Pharmacological induction	Birth date	Percentage of pregnant women who have undergone pharmacological induction to initiate labor.

Secondary Outcome Measures

Name	Time	Method
Change on score of Bishop scale	Birth date	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
Duration of labor period	Birth date	Time in hours of labor period
Onset of spontaneous labor	Birth date	Time in days until the onset of spontaneous labor from the first follow-up visit.
Satisfaction of pregnants	Birth date	Degree of satisfaction with the care provided, measured by conducting the Birth Satisfaction Scale Revised survey
Duration of induction period Duration of the induction period Duration of the induction period Duration of the induction period	Birth date	Time in hours from the administration of medication for induction to the onset of labor.

Trial Locations

Locations (1)

Consorci Sanitari Alt Penedes i Garraf; 🇪🇸 Vilafranca Del Penedès, Barcelona, Spain