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

Last updated: June 19, 2024
Sponsor: HaEmek Medical Center, Israel
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Clindamycin

Metronidazole

Clinical Study ID

NCT01722708
0012-12-EMC
  • Ages 18-50
  • Female
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pregnant women at increased risk for preterm labor (preterm cervical effacement,preterm uterine contractions, twins pregnancy, vaginal bleeding, past pretermdelivery)

  • Age above 18 years

Exclusion

Exclusion Criteria:

  • Known allergy to the tested antibiotics

  • Antibacterial treatment in the week before the vaginal culture was taken

  • preterm premature rupture of membranes

Study Design

Total Participants: 750
Treatment Group(s): 2
Primary Treatment: Clindamycin
Phase:
Study Start date:
November 01, 2012
Estimated Completion Date:
August 01, 2025

Connect with a study center

  • Departement of obstetric and gynecology, HaEmek medical center

    Afula,
    Israel

    Active - Recruiting

  • Departement of obstetric and gynecology, Poriya Medical Center

    Tiberias,
    Israel

    Active - Recruiting

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