Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies

August 2, 2022 updated by: HaEmek Medical Center, Israel
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

169

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel
        • Departement of obstetric and gynecology, HaEmek medical center
      • Tiberias, Israel
        • Departement of obstetric and gynecology, Poriya Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: clindamycin
Drug: Clindamycin
Oral clindamycin 300 Milligrams*2/Day for a week
Experimental: metronidazole
Drug: Metronidazole
Oral metronidazole 500 Milligrams*2/Day for a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Primary outcome will be assessed by taking a vaginal culture sample a week after one-week antibacterial treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
The prevalence of adverse effects
Time Frame: During the antibacterial treatment which is 1 week of therapy
During the antibacterial treatment which is 1 week of therapy
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
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
Time Frame: The outcome is assessed after the diagnosis of abnormal vaginal flora is made at 14-26 weeks of gestation
The outcome is assessed after the diagnosis of abnormal vaginal flora is made at 14-26 weeks of gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Investigators

  • Principal Investigator: Zohar Nachum, MD, Departement of obstetric and gynecology, HaEmek medical center, Afula, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2012

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

October 28, 2012

First Submitted That Met QC Criteria

November 6, 2012

First Posted (Estimate)

November 7, 2012

Study Record Updates

Last Update Posted (Actual)

August 4, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0012-12-EMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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