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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by HaEmek Medical Center, Israel
Sponsor:
Information provided by (Responsible Party):
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01722708
First received: October 28, 2012
Last updated: May 23, 2013
Last verified: May 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The prevalence of adverse effects [ Time Frame: During the antibacterial treatment which is 1 week of therapy ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 230
Study Start Date: April 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (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

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01722708     History of Changes
Other Study ID Numbers: 0012-12-EMC
Study First Received: October 28, 2012
Last Updated: May 23, 2013
Health Authority: Israel: department of obstetric and gynecology, HaEmek Medical Center

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:
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Clindamycin
Clindamycin-2-phosphate
Metronidazole
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on July 24, 2014