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 :
Completed
First Posted : November 7, 2012
Last Update Posted : August 4, 2022
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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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 169 participants |
Allocation: | Randomized |
Intervention Model: | Parallel 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 |
Actual Primary Completion Date : | August 1, 2022 |
Actual Study Completion Date : | August 1, 2022 |

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 |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

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
Israel | |
Departement of obstetric and gynecology, HaEmek medical center | |
Afula, Israel | |
Departement of obstetric and gynecology, Poriya Medical Center | |
Tiberias, Israel |
Principal Investigator: | Zohar Nachum, MD | Departement of obstetric and gynecology, HaEmek medical center, Afula, Israel |
Responsible Party: | HaEmek Medical Center, Israel |
ClinicalTrials.gov Identifier: | NCT01722708 |
Other Study ID Numbers: |
0012-12-EMC |
First Posted: | November 7, 2012 Key Record Dates |
Last Update Posted: | August 4, 2022 |
Last Verified: | August 2022 |
Abnormal vaginal flora clindamycin Vs metronidazole High risk pregnancies for preterm labor |
Preterm labor Late abortion bacterial vaginosis |
Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Metronidazole Clindamycin Clindamycin palmitate Clindamycin phosphate |
Anti-Infective Agents Anti-Bacterial Agents Antiprotozoal Agents Antiparasitic Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |