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Completed

NCT Number: NCT01722708

Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies

Abnormal vaginal flora is a risk factor for preterm labor. Therefore, in high risk pregnancies for preterm labor the diagnosis and treatment of abnormal flora is indicated. Clindamycin and metronidazole given orally are both acceptable treatments in these cases. The purpose of this study is to compare the effectiveness of Clindamycin Vs metronidazole for the treatment of abnormal vaginal flora in high risk pregnancies. For this purpose, pregnant women who are considered high risk for preterm labor and were diagnosed with abnormal vaginal flora will be randomly treated either with clindamycin or metronidazole. Eradication of the abnormal flora and adverse effects will be monitored and compared

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Key information

Conditions

Abnormal Vaginal Flora Bacterial Infections Bacterial Infections and Mycoses Clindamycin Vs Metronidazole Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female High Risk Pregnancies for Preterm Labor Infections Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Departement of obstetric and gynecology, Poriya Medical Center, Tiberias, Israel

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women at increased risk for preterm labor (preterm cervical effacement, preterm uterine contractions, twins pregnancy, vaginal bleeding, past preterm delivery)
  • Age above 18 years

Exclusion criteria

  • Known allergy to the tested antibiotics
  • Antibacterial treatment in the week before the vaginal culture was taken
  • preterm premature rupture of membranes

Treatment and study plan

Clindamycin

Drug

Oral clindamycin 300 Milligrams*2/Day for a week

Metronidazole

Drug

Oral metronidazole 500 Milligrams*2/Day for a week

Primary outcomes

  1. To compare the efficacy between oral Clindamycin Vs Metronidazole in the eradication of abnormal vaginal flora

    Time frame: Primary outcome will be assessed by taking a vaginal culture sample a week after one-week antibacterial treatment

Secondary outcomes

  1. The prevalence of adverse effects

    Time frame: During the antibacterial treatment which is 1 week of therapy

  2. The prevalence of late abortions and preterm deliveries

    Time frame: From date of randomization until the date of delivery or abortion, assessed up to 28 weeks

  3. Assessing the correlation between Nugent score , physical examination and Ph indicators

    Time frame: The outcome is assessed after the diagnosis of abnormal vaginal flora is made at 14-26 weeks of gestation

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Important dates

Study start
2012
Primary completion
2025
Study completion
2025
First posted
Nov 7, 2012
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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