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

Abnormal Vaginal Flora research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Abnormal Vaginal Flora

Clindamycin Vs Metronidazole

High Risk Pregnancies for Preterm Labor

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:ClindamycinOral clindamycin 300 Milligrams*2/Day for a week

Drug:MetronidazoleOral metronidazole 500 Milligrams*2/Day for a week

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

clindamycin

metronidazole

Study Status

Recruiting

Start Date: April 2012

Completed Date: March 2020

Phase: N/A

Type: Interventional

Design:

Primary Outcome: To compare the efficacy between oral Clindamycin Vs Metronidazole in the eradication of abnormal vaginal flora

Secondary Outcome: The prevalence of adverse effects

Study sponsors, principal investigator, and references

Principal Investigator: Zohar Nachum, MD

Lead Sponsor: HaEmek Medical Center, Israel

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01722708

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