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Clitoris Potential Analgesic Function Research by Pregnant Women : Feasibility Study (FAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04257318
Recruitment Status : Recruiting
First Posted : February 6, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Brief Summary:
Assessment of the acceptability by pregnant women on the research of the potential analgesic function of the clitoris.

Condition or disease Intervention/treatment Phase
Pregnancy Related Other: Vibrating Relaxation Tool Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Clitoris Potential Analgesic Function Research by Pregnant Women : Feasibility Study
Actual Study Start Date : August 11, 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Arm Intervention/treatment
Experimental: Vibrating Relaxation Tool
Use of a Vibrating Relaxation Tool in case of pain during pregn
Other: Vibrating Relaxation Tool
Use of a Vibrating Relaxation Tool in case of pain during pregnancy




Primary Outcome Measures :
  1. Acceptability [ Time Frame: through study completion, an average of 15 months ]
    Among patients who had the information visit, proportion of those who were included and applied the procedure at least twice



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant woman, whatever the term, primiparous or multiparous
  • Age ≥ 18 years old
  • Patient having read and understood the information letter and signed the consent form
  • Patient affiliated to Social Security

Exclusion Criteria:

  • Inability to understand French or information,
  • Person deprived of their liberty by an administrative or judicial decision
  • Person placed under the protection of justice
  • Person under guardianship or curatorship

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04257318


Contacts
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Contact: Manon BESTAUX 02 32 88 ext 82 44 Manon.Bestaux@chu-rouen.fr

Locations
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France
Rouen University Hospital Recruiting
Rouen, France
Contact: Manon BESTAUX    02 32 88 ext 82 44    Manon.Bestaux@chu-rouen.fr   
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: Eric VERSPYCK, Pr Rouen University Hospital
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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT04257318    
Other Study ID Numbers: 2018/0415/HP
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No