Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies
Primary Purpose
Abnormal Vaginal Flora, Clindamycin Vs Metronidazole, High Risk Pregnancies for Preterm Labor
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Clindamycin
Metronidazole
Sponsored by
About this trial
This is an interventional treatment trial for Abnormal Vaginal Flora focused on measuring Abnormal vaginal flora, clindamycin Vs metronidazole, High risk pregnancies for preterm labor, Preterm labor, Late abortion, bacterial vaginosis
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
Sites / Locations
- Departement of obstetric and gynecology, HaEmek medical center
- Departement of obstetric and gynecology, Poriya Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
clindamycin
metronidazole
Arm Description
Outcomes
Primary Outcome Measures
To compare the efficacy between oral Clindamycin Vs Metronidazole in the eradication of abnormal vaginal flora
Secondary Outcome Measures
The prevalence of adverse effects
The prevalence of late abortions and preterm deliveries
Assessing the correlation between Nugent score , physical examination and Ph indicators
Full Information
NCT ID
NCT01722708
First Posted
October 28, 2012
Last Updated
August 2, 2022
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT01722708
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 2012 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
169 (Actual)
8. Arms, Groups, and Interventions
Arm Title
clindamycin
Arm Type
Experimental
Arm Title
metronidazole
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Clindamycin
Intervention Description
Oral clindamycin 300 Milligrams*2/Day for a week
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Intervention Description
Oral metronidazole 500 Milligrams*2/Day for a week
Primary Outcome Measure Information:
Title
To compare the efficacy between oral Clindamycin Vs Metronidazole in the eradication of abnormal vaginal flora
Time Frame
Primary outcome will be assessed by taking a vaginal culture sample a week after one-week antibacterial treatment
Secondary Outcome Measure Information:
Title
The prevalence of adverse effects
Time Frame
During the antibacterial treatment which is 1 week of therapy
Title
The prevalence of late abortions and preterm deliveries
Time Frame
From date of randomization until the date of delivery or abortion, assessed up to 28 weeks
Title
Assessing the correlation between Nugent score , physical examination and Ph indicators
Time Frame
The outcome is assessed after the diagnosis of abnormal vaginal flora is made at 14-26 weeks of gestation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zohar Nachum, MD
Organizational Affiliation
Departement of obstetric and gynecology, HaEmek medical center, Afula, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departement of obstetric and gynecology, HaEmek medical center
City
Afula
Country
Israel
Facility Name
Departement of obstetric and gynecology, Poriya Medical Center
City
Tiberias
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies
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