Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies
Information source: HaEmek Medical Center, Israel
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Abnormal Vaginal Flora; Clindamycin Vs Metronidazole; High Risk Pregnancies for Preterm Labor
Intervention: Clindamycin (Drug); Metronidazole (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: HaEmek Medical Center, Israel Official(s) and/or principal investigator(s): Zohar Nachum, MD, Principal Investigator, Affiliation: Departement of obstetric and gynecology, HaEmek medical center, Afula, Israel
Overall contact: Zohar Nachum, MD, Phone: 972-46495483
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
Clinical Details
Official title: Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: To compare the efficacy between oral Clindamycin Vs Metronidazole in the eradication of abnormal vaginal flora
Secondary outcome: The prevalence of adverse effectsThe prevalence of late abortions and preterm deliveries Assessing the correlation between Nugent score , physical examination and Ph indicators
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Zohar Nachum, MD, Phone: 972-46495483
Departement of obstetric and gynecology, HaEmek medical center, Afula, Israel; Recruiting
Additional Information
Starting date: April 2012
Last updated: May 10, 2015
|