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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 effects

The 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

Page last updated: August 23, 2015

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