Clinical trial NCT01722708: Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies
Official title: Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Abnormal Vaginal Flora
Clindamycin Vs Metronidazole
High Risk Pregnancies for Preterm Labor
Keywords: Abnormal vaginal flora
clindamycin Vs metronidazole
High risk pregnancies for preterm labor
Preterm labor
Late abortion
bacterial vaginosis
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2012-11-07
Enrollment: 750
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: To compare the efficacy between oral Clindamycin Vs Metronidazole in the eradication of abnormal vaginal flora
timeFrame: Primary outcome will be assessed by taking a vaginal culture sample a week after one-week antibacterial treatment
Secondary outcomes:
measure: The prevalence of adverse effects
timeFrame: During the antibacterial treatment which is 1 week of therapy
measure: The prevalence of late abortions and preterm deliveries
timeFrame: From date of randomization until the date of delivery or abortion, assessed up to 28 weeks
measure: Assessing the correlation between Nugent score , physical examination and Ph indicators
timeFrame: The outcome is assessed after the diagnosis of abnormal vaginal flora is made at 14-26 weeks of gestation
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Departement of obstetric and gynecology, HaEmek medical center
city: Tiberias
country: Israel
facility: Departement of obstetric and gynecology, Poriya Medical Center
Study officials:
affiliation: Departement of obstetric and gynecology, HaEmek medical center, Afula, Israel
name: Zohar Nachum, MD
role: PRINCIPAL_INVESTIGATOR
References: