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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
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

First Posted
October 28, 2012
Last Updated
August 2, 2022
Sponsor
HaEmek Medical Center, Israel
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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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