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Combined Use of Vaginal Clindamycin cream and Oral Metronidazole versus Oral Metronidazole in Treatment of Bacterial Vagionosis: A Randomized Controlled Clinical Trial

Combined Use of Vaginal Clindamycin cream and Oral Metronidazole versus Oral Metronidazole in Treatment of Bacterial Vagionosis: A Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
PACTR
Registry ID
PACTR202510895720817
Enrollment
130
Registered
2025-10-31
Start date
2024-01-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Vagionosis Pregnancy and Childbirth Urological and Genital Diseases Fertility-female

Interventions

Clindamycine and Metronidazole Group
Metronidazole Group

Sponsors

Faculty of Medicine. Ain Shams University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: - Women aged = 18 years with a clinical diagnosis and laboratory diagnosis as (cervical smear & high vaginal swab) of bacterial vaginosis. - Diagnosed with Bacterial vaginosis the Amsel scoring system which requires 3 criteria of 4 criteria for diagnosis: - The presence of homogeneous, thin, greyish white vaginal discharge. - Vaginal pH over 4.5. - Positive whiff-amine test (the presence of a fishy odor following addition of KOH to the vaginal sample). - More than 20% clue cells/high power field on a wet mount of vaginal secretions. - This examinations were done at Ain shams Maternity laboratory hospitals

Exclusion criteria

Exclusion criteria: Other types of infections based on history and clinical examination as candida vaginitis (itching with cottage cheese whitish discharge, Trichomonas vaginalis (with yellowish green offensive discharge) and any sexually transmitted disease (STDs) as gonorrhea(watery creamy greenish discharge, pain on micturation)syphilis(appearance of shung-kur ulcer, painless sore), chlamydia(abnormal discharge from vagina, burning sensation on peeing, abnormal discharge from penis) or genital herpes (tingling, burning, itching around genitals on both parteners). - Pregnant and lactating females - Any contraindication or hypersensitivity to metronidazole use - Use of other antibiotics or systemic antifungal agents within the previous 2 weeks or planned use within 2 weeks - Use of topical vaginal antibiotics, antifungals or acidifying products recently or planned within 2 weeks - Atrophic vaginitis - Using IUD as contraceptive method because IUD is a risk factor for infection.

Design outcomes

Primary

MeasureTime frame
Efficacy of both medications (reliving symptoms of Bacterial Vaginosis as discharge & odour) and microbiological detection in the laboratory.

Secondary

MeasureTime frame
Side effects as local vulvovaginal irritation, diarrhea etc as In case of persistent infection the medication dose will be changed investigation the case of resistance

Countries

Egypt

Contacts

Public ContactLaila Aly Farid

Professor of Obstetrics and Gynecology. Faculty of Medicine. Ain Shams University

laila.farid67@med.asu.edu.eg+201283262382

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026