Vaginosis, BacterialPhase 2NCT00153517
Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy
A Phase 2 study testing oral versus vaginal metronidazole in people with Vaginosis, Bacterial and Premature Birth, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
The goal of this study is to examine acceptability and efficacy of 2 kinds of BV treatment among women at low risk for preterm delivery. The objectives are: 1. To examine the side effects and patient acceptability of oral versus intravaginal metronidazole. 2. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Vaginosis, Bacterial, Premature Birth, Birth Weight
- What is being tested?
- oral versus vaginal metronidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1999to Sep 2004
- Phase
- Phase 2
- 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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Tested positive for bacerial vaginosis (Nugent score >7)
- African American, Hispanic, Asian/Pacific Islander, Native American, and white women
Who cannot join
- >20 weeks gestaion
- history of preterm delivery
- had a multiple gestation pregnancy
- had major medical complications (e.g., chronic hypertension or pre-existing diabetes)
- antibiotic use within 7 days of screening visit for enrollment in the study,
- allergy to metronidazole
- history of alcohol dependency in past year women under age 16
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy (Randomized Trial of BV Treatment in Pregnancy)
The goal of this study is to examine acceptability and efficacy of 2 kinds of BV treatment among women at low risk for preterm delivery. The objectives are:
- To examine the side effects and patient acceptability of oral versus intravaginal metronidazole.
- To compare the efficacy of oral and intravaginal metronidazole for the treatment of BV
- To study the efficacy of oral and intravaginal metronidazole for the prevention of hospital admission during the 3rd trimester, chorioamnionitis, preterm delivery, and maternal infectious morbidity.
Read the detailed description
This is a randomized, placebo-controlled intervention trial. Women diagnosed as BV+ by Gram stain at 12-16 weeks gestation are randomly assigned to the following treatment groups: oral metronidazole (250 mg TID x 7 days) with intravaginal placebo; intravaginal metronidazole (5g 0.75% gel BID x 5 days) with oral placebo. African American, Hispanic, Asian/Pacific Islander, Native American, and white women are eligible. Women with a prior preterm delivery, multiple gestation, chronic hypertension or pre-existing diabetes, antibiotic use before enrollment in the study, allergy to metronidazole, history of alcohol abuse in past year, and women under age 18 are excluded.
- Conditions
- Vaginosis, Bacterial, Premature Birth, Birth Weight, Chorioamnionitis
- Being tested
- oral versus vaginal metronidazole
- Keywords
- Bacterial Vaginosis, Metronidazole
- Medical subject headings
- Vaginosis, Bacterial, Premature Birth, Birth Weight, Chorioamnionitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral versus vaginal metronidazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| Oral Treatment | Active comparator | oral (250mg three times daily for 7 days) metronidazole Receives: Drug: oral versus vaginal metronidazole |
| Vaginal Treatment | Active comparator | intravaginal (5 g of 0.75% gel twice daily for 5 days) metronidazole Receives: Drug: oral versus vaginal metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological, Clinical, and Therapeutic Cure Rates at Follow-Up among Women Treated with Oral vs. Intravaginal Metronidazole
Cure rates were assessed by Gram Stain Score (0-3, 4-6, 7-10); Abnormal clincial signs (0, 1-2, 3-4); Therapeutic cure (Gram Stain 0-3 and no symptoms) treatment
Measured: 4 weeks after treatment
Secondary outcomes (2)
preterm delivery
rate of delivery before 37 completed weeks gestation in intervention groups
Measured: at delivery
low birth weight
birth weight less than 2500 grams
Measured: at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startOct 1999
- Primary completionSep 2004
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vaginosis, BacterialStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- study participants were randomized to treatment with oral metronidazole (Centers for Disease Control and Prevention \[CDC\] recommended regimen: 250mg three times daily for 7 days) plus intravaginal placebo or intravaginal metronidazole (5 g of 0.75% gel twice daily for 5 days) plus oral placebo. The oral and vaginal placebos were indistinguishable from active therapy. Randomization to study group used random number tables, with a 1:1 ratio between study groups.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Cynthia Ferre, Centers for Disease Control and Prevention
- Investigators
- Jane E Hitti, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153517
- Sponsor's protocol ID
- CDC-NCCDPHP-2752
- Other IDs
- U36CCU300430-2239, U36CCU300430-1179
- Status last verified
- May 2024
- First submitted
- 8 Sep 2005
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mitchell C, Balkus J, Agnew K, Lawler R, Hitti J. Changes in the vaginal microenvironment with metronidazole treatment for bacterial vaginosis in early pregnancy. J Womens Health (Larchmt). 2009 Nov;18(11):1817-24. doi: 10.1089/jwh.2009.1378.
PubMed 19951217Mitchell CM, Hitti JE, Agnew KJ, Fredricks DN. Comparison of oral and vaginal metronidazole for treatment of bacterial vaginosis in pregnancy: impact on fastidious bacteria. BMC Infect Dis. 2009 Jun 10;9:89. doi: 10.1186/1471-2334-9-89.
PubMed 19515236
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy (Randomized Trial of BV Treatment in Pregnancy)
- ClinicalTrials.gov ID
- NCT00153517
- Acronym / sponsor ID
- CDC-NCCDPHP-2752
- Conditions
- Vaginosis, Bacterial, Premature Birth, Birth Weight, Chorioamnionitis
- Keywords
- Bacterial Vaginosis, Metronidazole
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Oct 1999
- Primary completion
- Sep 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 12 Sep 2005 (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.
The goal of this study is to examine acceptability and efficacy of 2 kinds of BV treatment among women at low risk for preterm delivery. The objectives are:
- To examine the side effects and patient acceptability of oral versus intravaginal metronidazole.
- To compare the efficacy of oral and intravaginal metronidazole for the treatment of BV
- To study the efficacy of oral and intravaginal metronidazole for the prevention of hospital admission during the 3rd trimester, chorioamnionitis, preterm delivery, and maternal infectious morbidity.
Detailed description
This is a randomized, placebo-controlled intervention trial. Women diagnosed as BV+ by Gram stain at 12-16 weeks gestation are randomly assigned to the following treatment groups: oral metronidazole (250 mg TID x 7 days) with intravaginal placebo; intravaginal metronidazole (5g 0.75% gel BID x 5 days) with oral placebo. African American, Hispanic, Asian/Pacific Islander, Native American, and white women are eligible. Women with a prior preterm delivery, multiple gestation, chronic hypertension or pre-existing diabetes, antibiotic use before enrollment in the study, allergy to metronidazole, history of alcohol abuse in past year, and women under age 18 are excluded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- study participants were randomized to treatment with oral metronidazole (Centers for Disease Control and Prevention [CDC] recommended regimen: 250mg three times daily for 7 days) plus intravaginal placebo or intravaginal metronidazole (5 g of 0.75% gel twice daily for 5 days) plus oral placebo. The oral and vaginal placebos were indistinguishable from active therapy. Randomization to study group used random number tables, with a 1:1 ratio between study groups.
| Arm | Type | Receives |
|---|---|---|
| Oral Treatment | Active comparator | Drug: oral versus vaginal metronidazoleoral (250mg three times daily for 7 days) metronidazole |
| Vaginal Treatment | Active comparator | Drug: oral versus vaginal metronidazoleintravaginal (5 g of 0.75% gel twice daily for 5 days) metronidazole |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Tested positive for bacerial vaginosis (Nugent score >7)
- African American, Hispanic, Asian/Pacific Islander, Native American, and white women
Key exclusion criteria (7 listed)
- >20 weeks gestaion
- history of preterm delivery
- had a multiple gestation pregnancy
- had major medical complications (e.g., chronic hypertension or pre-existing diabetes)
- antibiotic use within 7 days of screening visit for enrollment in the study,
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 |
|---|---|---|
| oral versus vaginal metronidazole | Drug | Oral Treatment, Vaginal Treatment |
Primary outcome
Microbiological, Clinical, and Therapeutic Cure Rates at Follow-Up among Women Treated with Oral vs. Intravaginal Metronidazole
Time frame: 4 weeks after treatment
Cure rates were assessed by Gram Stain Score (0-3, 4-6, 7-10); Abnormal clincial signs (0, 1-2, 3-4); Therapeutic cure (Gram Stain 0-3 and no symptoms) treatment
2 secondary outcomes
preterm delivery
Time frame: at delivery
low birth weight
Time frame: at delivery
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 29 May 2024.
- Background: PubMed 19951217Mitchell C, Balkus J, Agnew K, Lawler R, Hitti J. Changes in the vaginal microenvironment with metronidazole treatment for bacterial vaginosis in early pregnancy. J Womens Health (Larchmt). 2009 Nov;18(11):1817-24. doi: 10.1089/jwh.2009.1378.
- Background: PubMed 19515236Mitchell CM, Hitti JE, Agnew KJ, Fredricks DN. Comparison of oral and vaginal metronidazole for treatment of bacterial vaginosis in pregnancy: impact on fastidious bacteria. BMC Infect Dis. 2009 Jun 10;9:89. doi: 10.1186/1471-2334-9-89.
- Individual participant dataSharing planned: No
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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.
Jane E Hitti, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oral versus vaginal metronidazole in people with Vaginosis, Bacterial and Premature Birth, run by Centers for Disease Control and Prevention at 1 site in United States.
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 7 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 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Microbiological, Clinical, and Therapeutic Cure Rates at Follow-Up among Women Treated with Oral vs. Intravaginal Metronidazole (time frame: 4 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00153517, which also lists 2 linked publications.
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 29 May 2024.