Abnormal Vaginal Flora, Clindamycin Vs Metronidazole, High Risk Pregnancies for Preterm Labor
Conditions
Keywords
Abnormal vaginal flora, clindamycin Vs metronidazole, High risk pregnancies for preterm labor, Preterm labor, Late abortion, bacterial vaginosis
Brief 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
Interventions
DRUGClindamycin
Oral clindamycin 300 Milligrams\*2/Day for a week
DRUGMetronidazole
Oral metronidazole 500 Milligrams\*2/Day for a week
Sponsors
HaEmek Medical Center, Israel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy between oral Clindamycin Vs Metronidazole in the eradication of abnormal vaginal flora | Primary outcome will be assessed by taking a vaginal culture sample a week after one-week antibacterial treatment |
Secondary
| Measure | Time frame |
|---|---|
| The prevalence of adverse effects | During the antibacterial treatment which is 1 week of therapy |
| The prevalence of late abortions and preterm deliveries | From date of randomization until the date of delivery or abortion, assessed up to 28 weeks |
| Assessing the correlation between Nugent score , physical examination and Ph indicators | The outcome is assessed after the diagnosis of abnormal vaginal flora is made at 14-26 weeks of gestation |
Countries
Israel
Outcome results
None listed