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

This study is currently recruiting participants.
Verified April 2017 by HaEmek Medical Center, Israel
Sponsor:
ClinicalTrials.gov Identifier:
NCT01722708
First Posted: November 7, 2012
Last Update Posted: April 4, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
HaEmek Medical Center, Israel
  Purpose
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

Condition Intervention
Abnormal Vaginal Flora Clindamycin Vs Metronidazole High Risk Pregnancies for Preterm Labor Drug: Clindamycin Drug: Metronidazole

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Estimated Enrollment: 230
Study Start Date: April 2012
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01722708


Contacts
Contact: Zohar Nachum, MD 972-46495483

Locations
Israel
Departement of obstetric and gynecology, HaEmek medical center Recruiting
Afula, Israel
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Zohar Nachum, MD Departement of obstetric and gynecology, HaEmek medical center, Afula, Israel
  More Information

Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01722708     History of Changes
Other Study ID Numbers: 0012-12-EMC
First Submitted: October 28, 2012
First Posted: November 7, 2012
Last Update Posted: April 4, 2017
Last Verified: April 2017

Keywords provided by HaEmek Medical Center, Israel:
Abnormal vaginal flora
clindamycin Vs metronidazole
High risk pregnancies for preterm labor
Preterm labor
Late abortion
bacterial vaginosis

Additional relevant MeSH terms:
Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications
Clindamycin palmitate
Clindamycin phosphate
Metronidazole
Clindamycin
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action