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

Study Overview
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Brief Summary
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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

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

Conditions
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Abnormal Vaginal Flora, Clindamycin Vs Metronidazole, High Risk Pregnancies for Preterm Labor

Intervention / Treatment
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* Drug: Clindamycin
* Drug: Metronidazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: clindamycin<br> | Drug: Clindamycin<br>* Oral clindamycin 300 Milligrams*2/Day for a week<br>|
| Experimental: metronidazole<br> | Drug: Metronidazole<br>* Oral metronidazole 500 Milligrams*2/Day for a week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy between oral Clindamycin Vs Metronidazole in the eradication of abnormal vaginal flora |  | Primary outcome will be assessed by taking a vaginal culture sample a week after one-week antibacterial treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of adverse effects |  | During the antibacterial treatment which is 1 week of therapy | 
| The prevalence of late abortions and preterm deliveries |  | From date of randomization until the date of delivery or abortion, assessed up to 28 weeks | 
| Assessing the correlation between Nugent score , physical examination and Ph indicators |  | The outcome is assessed after the diagnosis of abnormal vaginal flora is made at 14-26 weeks of gestation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abnormal vaginal flora, clindamycin Vs metronidazole, High risk pregnancies for preterm labor, Preterm labor, Late abortion, bacterial vaginosis