Pregnancy ComplicationsNCT06357962
Semi-permanent Acupuncture Effect on Cervical Ripening
A study testing Semi-permanent acupuncture in people with Pregnancy Complications, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 40 years, women only
- Conditions the study is for
- Pregnancy Complications
- What is being tested?
- Semi-permanent acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteSpain
- Study dates
- 22 May 2024to 19 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Consorci Sanitari Alt Penedes i Garraf
Vilafranca del Penedès, Barcelona, 08720
About this study
Official title: 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.
- Conditions
- Pregnancy Complications
- Being tested
- Semi-permanent acupuncture, Sham of semi-permanent acupuncture
- Keywords
- Cervical Ripening, Acupuncture Therapy
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | This group will receive sessions the study intervention (semi-permanent acupuncture) Receives: Other: Semi-permanent acupuncture |
| Control | Sham comparator | This group will receive a sham treatment of semi-permanent acupuncture Receives: Other: Sham of semi-permanent acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacological induction
Percentage of pregnant women who have undergone pharmacological induction to initiate labor.
Measured: Birth date
Secondary outcomes (5)
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
Measured: Birth date
Onset of spontaneous labor
Time in days until the onset of spontaneous labor from the first follow-up visit.
Measured: 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.
Measured: Birth date
Duration of labor period
Time in hours of labor period
Measured: Birth date
Satisfaction of pregnants
Degree of satisfaction with the care provided, measured by conducting the Birth Satisfaction Scale Revised survey
Measured: Birth date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start22 May 2024
- Primary completion16 Mar 2025
- Study completion19 Apr 2025
Why it stopped: Lack of resources to continue the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i Garraf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gloria Villena, Principal investigator, CSAPG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357962
- Sponsor's protocol ID
- CSAPG-40
- Status last verified
- Nov 2025
- First submitted
- 5 Apr 2024
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06357962
- Acronym / sponsor ID
- CSAPG-40
- Conditions
- Pregnancy Complications
- Keywords
- Cervical Ripening, Acupuncture Therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of resources to continue the study
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i GarrafUniversity, hospital or other
- Study start
- 22 May 2024 (actual)
- Primary completion
- 16 Mar 2025 (actual)
- Study completion
- 19 Apr 2025 (actual)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Other: Semi-permanent acupunctureThis group will receive sessions the study intervention (semi-permanent acupuncture) |
| Control | Sham comparator | Other: Sham of semi-permanent acupunctureThis group will receive a sham treatment of semi-permanent acupuncture |
Who may qualify
- Ages
- Up to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-permanent acupunctureThese 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. | Other | Acupuncture |
| Sham of semi-permanent acupunctureA 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. | Other | Control |
Primary outcome
Pharmacological induction
Time frame: Birth date
Percentage of pregnant women who have undergone pharmacological induction to initiate labor.
5 secondary outcomes
Change on score of Bishop scale
Time frame: Birth date
Onset of spontaneous labor
Time frame: Birth date
Duration of induction period Duration of the induction period Duration of the induction period Duration of the induction period
Time frame: Birth date
Duration of labor period
Time frame: Birth date
Satisfaction of pregnants
Time frame: Birth date
Results and safety
The study was stopped early (reason given: Lack of resources to continue the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gloria Villena principal investigator
CSAPG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semi-permanent acupuncture in people with Pregnancy Complications, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of resources to continue the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacological induction (time frame: Birth date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.