Abnormal Vaginal FloraNCT01722708
Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies
A study testing Clindamycin and Metronidazole in people with Abnormal Vaginal Flora and Clindamycin Vs Metronidazole, run by HaEmek Medical Center, Israel at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abnormal Vaginal Flora, Clindamycin Vs Metronidazole, High Risk Pregnancies for Preterm Labor
- What is being tested?
- Clindamycin and Metronidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 2 sitesIsrael
- Study dates
- 1 Nov 2012to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Known allergy to the tested antibiotics
- Antibacterial treatment in the week before the vaginal culture was taken
- preterm premature rupture of membranes
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Departement of obstetric and gynecology, HaEmek medical center
Afula
Departement of obstetric and gynecology, Poriya Medical Center
Tiberias, Israel
About this study
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
- Conditions
- Abnormal Vaginal Flora, Clindamycin Vs Metronidazole, High Risk Pregnancies for Preterm Labor
- Being tested
- Clindamycin, Metronidazole
- Keywords
- Abnormal vaginal flora, clindamycin Vs metronidazole, High risk pregnancies for preterm labor, Preterm labor, Late abortion, bacterial vaginosis
- Medical subject headings
- Obstetric Labor, Premature, Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClindamycinDrug
Oral clindamycin 300 Milligrams*2/Day for a week
MetronidazoleDrug
Oral metronidazole 500 Milligrams*2/Day for a week
| Study group | Role | What they receive |
|---|---|---|
| clindamycin | Experimental | Not described Receives: Drug: Clindamycin |
| metronidazole | Experimental | Not described Receives: Drug: Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficacy between oral Clindamycin Vs Metronidazole in the eradication of abnormal vaginal flora
Measured: Primary outcome will be assessed by taking a vaginal culture sample a week after one-week antibacterial treatment
Secondary outcomes (3)
The prevalence of adverse effects
Measured: During the antibacterial treatment which is 1 week of therapy
The prevalence of late abortions and preterm deliveries
Measured: 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
Measured: The outcome is assessed after the diagnosis of abnormal vaginal flora is made at 14-26 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study start1 Nov 2012
- Primary completion2 Jul 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Vaginal FloraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zohar Nachum, MD, Principal investigator, Departement of obstetric and gynecology, HaEmek medical center, Afula, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722708
- Sponsor's protocol ID
- 0012-12-EMC
- Status last verified
- Jan 2026
- First submitted
- 28 Oct 2012
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies
- ClinicalTrials.gov ID
- NCT01722708
- Acronym / sponsor ID
- 0012-12-EMC
- Conditions
- Abnormal Vaginal Flora, Clindamycin Vs Metronidazole, High Risk Pregnancies for Preterm Labor
- Keywords
- Abnormal vaginal flora, clindamycin Vs metronidazole, High risk pregnancies for preterm labor, Preterm labor, Late abortion, bacterial vaginosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 1 Nov 2012 (actual)
- Primary completion
- 2 Jul 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 7 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clindamycin | Experimental | Drug: Clindamycin |
| metronidazole | Experimental | Drug: Metronidazole |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Known allergy to the tested antibiotics
- Antibacterial treatment in the week before the vaginal culture was taken
- preterm premature rupture of membranes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClindamycinOral clindamycin 300 Milligrams*2/Day for a week | Drug | clindamycin |
| MetronidazoleOral metronidazole 500 Milligrams*2/Day for a week | Drug | metronidazole |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zohar Nachum, MD principal investigator
Departement of obstetric and gynecology, HaEmek medical center, Afula, Israel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clindamycin and Metronidazole in people with Abnormal Vaginal Flora and Clindamycin Vs Metronidazole, run by HaEmek Medical Center, Israel at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.