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

HaEmek Medical Center, Israel

Status: Enrolling

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

Treatments: Drug: Metronidazole; Drug: Clindamycin

Study type: Interventional

Funder types: Other

Identifiers

NCT01722708

0012-12-EMC

Details and patient eligibility

About

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

Enrollment: 750 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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750 participants in 2 patient groups

clindamycin

Experimental group

Treatment:

Drug: Clindamycin

metronidazole

Experimental group

Treatment:

Drug: Metronidazole