Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies
This study is currently recruiting participants.
Verified November 2012 by HaEmek Medical Center, Israel
Sponsor:
HaEmek Medical Center, Israel
Information provided by (Responsible Party):
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01722708
First received: October 28, 2012
Last updated: November 6, 2012
Last verified: November 2012
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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:
Drug Information available for:
Metronidazole
Metronidazole benzoate
Clindamycin hydrochloride
Clindamycin phosphate
Clindamycin palmitate hydrochloride
Clindamycin palmitate
Metronidazole hydrochloride
U.S. FDA Resources
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 2014 |
| Estimated Primary Completion Date: | March 2013 (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
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: | November 6, 2012 |
| 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 May 16, 2013