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

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ClinicalTrials.gov Identifier: NCT01722708

Recruitment Status : Recruiting

First Posted : November 7, 2012

Last Update Posted : May 30, 2018

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

HaEmek Medical Center, Israel

Study Description

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

Condition or disease	Intervention/treatment	Phase
Abnormal Vaginal Flora Clindamycin Vs Metronidazole High Risk Pregnancies for Preterm Labor	Drug: Clindamycin Drug: Metronidazole	Not Applicable

Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	230 participants
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
Actual Study Start Date :	April 2012
Estimated Primary Completion Date :	March 2020
Estimated Study Completion Date :	March 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Metronidazole Metronidazole benzoate Clindamycin Clindamycin hydrochloride Clindamycin phosphate Clindamycin palmitate hydrochloride Clindamycin palmitate Metronidazole hydrochloride

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

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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 Posted:	November 7, 2012 Key Record Dates
Last Update Posted:	May 30, 2018
Last Verified:	May 2018

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 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

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