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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01722708
Recruitment Status : Completed
First Posted : November 7, 2012
Last Update Posted : August 4, 2022
Sponsor:
Information provided by (Responsible Party):
HaEmek Medical Center, Israel

Tracking Information
First Submitted Date  ICMJE October 28, 2012
First Posted Date  ICMJE November 7, 2012
Last Update Posted Date August 4, 2022
Actual Study Start Date  ICMJE April 2012
Actual Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2012)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2012)
  • The prevalence of adverse effects [ Time Frame: 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies
Official Title  ICMJE Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Abnormal Vaginal Flora
  • Clindamycin Vs Metronidazole
  • High Risk Pregnancies for Preterm Labor
Intervention  ICMJE
  • Drug: Clindamycin
    Oral clindamycin 300 Milligrams*2/Day for a week
  • Drug: Metronidazole
    Oral metronidazole 500 Milligrams*2/Day for a week
Study Arms  ICMJE
  • Experimental: clindamycin
    Intervention: Drug: Clindamycin
  • Experimental: metronidazole
    Intervention: Drug: Metronidazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 2, 2022)
169
Original Estimated Enrollment  ICMJE
 (submitted: November 6, 2012)
230
Actual Study Completion Date  ICMJE August 1, 2022
Actual Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01722708
Other Study ID Numbers  ICMJE 0012-12-EMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party HaEmek Medical Center, Israel
Original Responsible Party Same as current
Current Study Sponsor  ICMJE HaEmek Medical Center, Israel
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zohar Nachum, MD Departement of obstetric and gynecology, HaEmek medical center, Afula, Israel
PRS Account HaEmek Medical Center, Israel
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP