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Lack of resources to continue the study
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | This group will receive sessions the study intervention (semi-permanent acupuncture) |
|
| Control | Sham Comparator | This group will receive a sham treatment of semi-permanent acupuncture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacological induction | Percentage of pregnant women who have undergone pharmacological induction to initiate labor. | Birth date |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
The participants will be pregnant women
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| Name | Affiliation | Role |
|---|---|---|
| Gloria Villena | CSAPG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consorci Sanitari Alt Penedes i Garraf | Vilafranca del Penedès | Barcelona | 08720 | Spain |
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).
After publication of main results of the study.
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.
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| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| 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. |
|
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 |