Comparing Clindamycin and Metronidazole for Treating Abnormal Vaginal Flora in High Risk Pregnancies
Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies
This study tests whether Clindamycin or Metronidazole is better at treating abnormal vaginal flora in pregnant women who are at high risk for preterm labor.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 750 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | HaEmek Medical Center, Israel Academic / other |
| Locations | 2 sites (Afula and 1 other locations) |
| Trial ID | NCT01722708 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of two antibiotics, Clindamycin and Metronidazole, in treating abnormal vaginal flora in pregnant women who are at high risk for preterm labor. Pregnant participants diagnosed with abnormal vaginal flora will be randomly assigned to receive either Clindamycin or Metronidazole. The study will monitor the eradication of abnormal flora and any adverse effects associated with the treatments. This approach seeks to determine which antibiotic is more effective in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women over 18 years old who are at increased risk for preterm labor due to factors like cervical effacement or past preterm deliveries.
Not a fit: Patients who have known allergies to the tested antibiotics or have received antibacterial treatment within the week prior to the study will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for high-risk pregnant women, potentially reducing the incidence of preterm labor.
How similar studies have performed: Other studies have explored the use of antibiotics for treating abnormal vaginal flora, but this specific comparison of Clindamycin and Metronidazole in high-risk pregnancies is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Afula and 1 other locations
- Departement of obstetric and gynecology, HaEmek medical center — Afula, Israel (Recruiting)
- Departement of obstetric and gynecology, Poriya Medical Center — Tiberias, Israel (Recruiting)
Study contacts
- Principal investigator: Zohar Nachum, MD — Departement of obstetric and gynecology, HaEmek medical center, Afula, Israel
- Study coordinator: Zohar Nachum, MD
- Phone: 972-46495483
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.