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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-01

Study Completion Date

2025-12-30

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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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clindamycin

Group Type EXPERIMENTAL

Clindamycin

Intervention Type DRUG

Oral clindamycin 300 Milligrams\*2/Day for a week

metronidazole

Group Type EXPERIMENTAL

Metronidazole

Intervention Type DRUG

Oral metronidazole 500 Milligrams\*2/Day for a week

Interventions

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Clindamycin

Oral clindamycin 300 Milligrams\*2/Day for a week

Intervention Type DRUG

Metronidazole

Oral metronidazole 500 Milligrams\*2/Day for a week

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes