Prospective, Monocentric, Interventional Study on Spontaneous Vaginal Clearance of Mycoplasma Genitalium

NCT04841408 | Completed

• 1 other identifier: CHUBX 2021/06
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

It is a prospective, monocentric, interventional study on spontaneous vaginal clearance of Mycoplasma genitalium. The main objective is to evaluate the spontaneous vaginal clearance of M. genitalium in patients coming to perform a voluntary termination of pregnancy at the University Hospital of Bordeaux at 9 weeks after a vaginal sample positive for M. genitalium

Conditions

Mycoplasma Genitalium Infection

Keywords

Mycoplasma genitalium; abortion; clearance; IST

Outcome Measures

Primary Outcomes (1)

• clearance at week 3

  The clearance will be defined by a negative PCR test for M. genitalium in the vaginal sample taken at week 3.

  Week 3

Secondary Outcomes (5)

• clearance at week 9

  Week 9

• Prevalence of N. gonorrhoeae infections

  Week 3, Week 9

• Prevalence of C. trachomatis infections

  Week 3, Week 9

• Prevalence of M. genitalium infections

  Week 3, Week 9

• patient's sex life

  Week 3, Week 9

Study Arms (1)

Vaginal self-sampling

EXPERIMENTAL

Vaginal self-sampling performed by the patient at the follow-up visit at 3 weeks and remote follow-up at 9 weeks.

Other: Vaginal self-sampling

Interventions

Vaginal self-sampling OTHER

Vaginal self-sampling performed by the patient at the follow-up visit at 3 weeks and remote follow-up at 9 weeks.

Vaginal self-sampling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient selected during the first consultation, pre-abortion, and having a vaginal swab positive to M. genitalium.
• Patient hospitalized for an abortion at the University Hospital of Bordeaux.
• An affiliated patient or beneficiary of a social security system.
• Signing free and informed consent.

You may not qualify if:

• Patient with vaginal co-infection with C. trachomatis.
• Patient with symptoms of high genital infection.
• Patient under legal protection.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU Bordeaux

Bordeaux, France

Location

Related Publications (1)

• Berdoyes M, Bebear C, Roy CL, Balcon C, Hocke C, Baita D, Peuchant O. Spontaneous Clearance of Vaginal Mycoplasma genitalium in Women Undergoing Pregnancy Termination: A Prospective Cohort Study. BJOG. 2026 Jan 7. doi: 10.1111/1471-0528.70151. Online ahead of print.

  PMID: 41502158 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Vaginal self-sampling performed by the patient at the follow-up visit at 3 weeks and remote follow-up at 9 weeks

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 12, 2021
• Study Start: April 5, 2021
• Primary Completion: January 31, 2023
• Study Completion: February 21, 2023
• Last Updated: April 28, 2023

Record last verified: 2023-04

Locations

FR (1)