Longitudinal Study of Vaginal Flora
2017年6月30日 更新者:Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Bacterial vaginosis is a syndrome manifested by adverse alterations in vaginal microbial flora.
It is present in 10 to 25% of women in the general population, and is the most common vaginal infection.
It has been associated with a number of adverse sequelae in reproductive health including acquisition of HIV, pelvic inflammatory disease, cervical dysplasia, and complications of gynecological procedures.
During pregnancy it has been associated with an increased risk of preterm birth an postpartum maternal infection.
However, the vaginal microbial flora remains poorly understood.
Information on variation in microbial flora and its association with BV from a longitudinal study is unavailable.
This prospective observational study aims to advance our knowledge of the natural history and abnormal alteration in vaginal microbial flora, and to identify risk factors that are associated with these changes.
A total of 5500 healthy, non-pregnant women of reproductive age will be enrolled and followed up in Birmingham, Alabama, for one year (baseline visit plus once every three months afterwards, totaling 5 visits).
Detailed information on sociodemographic status, medical history, hygiene practice, sexual behavior and psychosocial stress will be collected through in-person interviews.
Routine gynecological and dental examinations will be carried out during the study visits.
Samples of vaginal secretion and blood will be collected.
Laboratory tests to quantify vaginal microbial flora and to identify infection of bacterial vaginosis as well as common sexually transmitted diseases will be conducted.
This project is expected to complete in 5 years.
調査の概要
状態
完了
条件
詳細な説明
Bacterial vaginosis is a syndrome manifested by adverse alterations in vaginal microbial flora.
It is present in 10 to 25% of women in the general population, and is the most common vaginal infection.
It has been associated with a number of adverse sequelae in reproductive health including acquisition of HIV, pelvic inflammatory disease, cervical dysplasia, and complications of gynecological procedures.
During pregnancy it has been associated with an increased risk of preterm birth and postpartum maternal infection.
However, the vaginal microbial flora remains poorly understood.
Information on variation in microbial flora and its association with BV from a longitudinal study is unavailable.
This prospective observational study aims to advance our knowledge of the natural history and abnormal alteration in vaginal microbial flora, and to identify risk factors that are associated with these changes.
A total of 5500 healthy, non-pregnant women of reproductive age will be enrolled and followed up in Birmingham, Alabama, for one year (baseline visit plus once every three months afterwards, totaling 5 visits).
Detailed information on sociodemographic status, medical history, hygiene practice, sexual behavior and psychosocial stress will be collected through in-person interviews.
Routine gynecological and dental examinations will be carried out during the study visits.
Samples of vaginal secretion and blood will be collected.
Laboratory tests to quantify vaginal microbial flora and to identify infection of bacterial vaginosis as well as common sexually transmitted diseases will be conducted.
This project is expected to complete in 5 years.
研究の種類
観察的
入学 (予想される)
5500
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Alabama
-
Birmingham、Alabama、アメリカ
- University of Alabama
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
15年~44年 (子、大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
- ELIGIBILITY CRITERIA:
- Females, age 15-44.
- Since bacterial vaginosis is primarily a condition of reproductive-age women, this study will be restricted to women regarded by demographers as reproductive age.
- Non-pregnant women whose last menstrual period is later than expected will undergo a urine pregnancy test. Women who become pregnant while on study will complete their next regularly scheduled study visit, following which their participation will terminate.
EXCLUSION CRITERIA:
Immunocompromised status
Receiving or expected to receive in the next 12 months cytotoxic or immunosuppressive drugs.
Receiving or expected to receive in the next 12 months one or more 30-day courses of corticosteroids.
Congenital or acquired immune deficiency; known HIV positivity.
- Primary or secondary affective disorder, psychosis, emotional or intellectual limitations that preclude informed consent.
- Non-fluency in English.
- Post-menopausal (natural or surgical).
- Status post hysterectomy or expected to undergo hysterectomy in the next 12 months.
- Status post pelvic radiotherapy, or expected to undergo pelvic radiotherapy in the next 12 months.
- Receiving or expected to receive chronic (daily for at least 30 days) antibiotics in the next 12 months.
- Planning to move out of the area in the next 12 months.
- Participating or expected to participate during the next 12 months in a clinical trial in which antibiotics or topical microbicides will be administered in a blinded manner.
- Women who unexpectedly develop one of these conditions during their participation will continue to be followed, unless a specific contraindication arises.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Goldenberg RL, Klebanoff MA, Nugent R, Krohn MA, Hillier S, Andrews WW. Bacterial colonization of the vagina during pregnancy in four ethnic groups. Vaginal Infections and Prematurity Study Group. Am J Obstet Gynecol. 1996 May;174(5):1618-21. doi: 10.1016/s0002-9378(96)70617-8.
- Fanchin R, Harmas A, Benaoudia F, Lundkvist U, Olivennes F, Frydman R. Microbial flora of the cervix assessed at the time of embryo transfer adversely affects in vitro fertilization outcome. Fertil Steril. 1998 Nov;70(5):866-70. doi: 10.1016/s0015-0282(98)00277-5.
- Amsel R, Totten PA, Spiegel CA, Chen KC, Eschenbach D, Holmes KK. Nonspecific vaginitis. Diagnostic criteria and microbial and epidemiologic associations. Am J Med. 1983 Jan;74(1):14-22. doi: 10.1016/0002-9343(83)91112-9.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
1999年4月14日
研究の完了
2010年11月18日
試験登録日
最初に提出
2006年6月19日
QC基準を満たした最初の提出物
2006年6月19日
最初の投稿 (見積もり)
2006年6月21日
学習記録の更新
投稿された最後の更新 (実際)
2017年7月2日
QC基準を満たした最後の更新が送信されました
2017年6月30日
最終確認日
2010年11月18日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。