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Bacterial Vaginosis clinical trials

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NCT ID: NCT00313131 Completed - Bacterial Vaginosis Clinical Trials

Study of the Management of Vaginal Discharge in West African Using Single Dose Treatments

Start date: January 2004
Phase: Phase 3
Study type: Interventional

This randomised controlled trial aimed to verify whether directly observed single dose treatment (with tinidazole+fluconazole) would be as effective as the longer standard treatments (metronidazole for 7 days, plus vaginal clotrimazole for 3 days) in the syndromic management of women presenting with vaginal discharge in primary health care centers of Ghana, Togo, Guinea and Mali. It was designed as an effectiveness trial, i.e. it was done under conditions typical of routine work in these health centers

NCT ID: NCT00303082 Terminated - Sepsis Clinical Trials

Probiotics for the Prevention of Premature Birth and Neonatal Related Morbidity

Start date: January 2006
Phase: Phase 3
Study type: Interventional

The trial intends to evaluate the efficacy of specially designed probiotics to prevent premature birth and related neonatal morbidity associated to intra-uterine infection. The tested probiotics are efficacious to decrease the prevalence of bacterial vaginosis. The study hypothesis is that the early administration of those probiotics to pregnant women with bacterial vaginosis can prevent premature birth through antibiotic activity and modulation of the immune response to infection.

NCT ID: NCT00229216 Completed - Bacterial Vaginosis Clinical Trials

Treatment of Bacterial Vaginosis With Oral Tinidazole

Start date: January 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to confirm the safety and efficacy of oral tinidazole for the treatment of bacterial vaginosis.

NCT ID: NCT00217308 Withdrawn - Premature Birth Clinical Trials

Effect of Probiotic Lactobacilli on Vaginal Flora of Pregnant Women at High Risk for Preterm Delivery

Start date: February 2005
Phase: Phase 1
Study type: Interventional

Purpose of the study is to determine the effect of probiotic lactobacilli on the vaginal flora and cytokine profile during pregnancy, and the incidence of preterm labour in women at high risk for preterm birth.

NCT ID: NCT00207480 Suspended - Bacterial Vaginosis Clinical Trials

Brief, Behavioral Intervention to Reduce Douching Among Adolescent and Young Women

Start date: October 2004
Phase: Phase 1
Study type: Interventional

This study will implement and test a brief, tailored individual-level intervention to be used in two New Orleans adolescent clinics with female patients aged 16-24 who douche.

NCT ID: NCT00140764 Completed - Bacterial Vaginosis Clinical Trials

Intravaginal Treatment of Disturbances of Vaginal Flora Among HIV Infected and Uninfected Women in Malawi

Start date: January 2003
Phase: Phase 3
Study type: Interventional

The purpose of this intervention is to find out whether intravaginal treatment with a gel containing an antibiotic (metronidazole), compared to a similar placebo gel (without antibiotic), can reduce the frequency of bacterial vaginosis, a common vaginal infection among African women who are HIV uninfected or HIV infected. The study will also determine the effect of these vaginal gels on genitourinary symptoms.

NCT ID: NCT00124878 Active, not recruiting - HIV Infections Clinical Trials

Trial of Male Circumcision: HIV, Sexually Transmitted Disease (STD) and Behavioral Effects in Men, Women and the Community

Start date: August 2003
Phase: Phase 3
Study type: Interventional

This randomized controlled trial conducted in Rakai District, Uganda, has enrolled 997 HIV positive men and 500 men who declined to learn HIV results (regardless of HIV status). The hypotheses are that male circumcision will be acceptable to and safe in both groups and will reduce the rates of STD acquisition in both groups and of HIV acquisition in HIV-negative men. Enrollment was ended on Dec 12, 2006, following an interim Data Monitoring and Safety Board (DSMB) review of a closed report. At that time the DSMB determined that futility with respect to the female HIV outcome. There was an non-significantly higher rate of HIV acquisition in women partners of HIV+ men in couples who had resumed sex prior to certified post-surgical wound healing. The data indicated significant reductions (~50%) in GUD symptoms among circumcised HIV+ men. The DSMB recommended: 1) that men and women should continue to be followed in complete two year follow up on all, 2) that circumcision for remaining HIV+ intervention arm men and for control arm men who had completed their 2 year follow should continue, contingent on a) revision of the study protocol to add additional post-surgical visits to assess wound healing, b) protocol revision to further strengthen education for both male and female partners on the need to postpone sex until certified wound healing, and c) approval of the revised protocol by the IRBs in both the US and Uganda. 3) An additional follow up visit for women be instituted at 18 months after enrollment. Protocol revision and IRB approvals have been finalized in June, 2007. The study has also enrolled and is following 3,700 women sexual partners of men enrolled in this study and in a complementary National Institutes of Health (NIH) funded study (U1 AI51171 which is separately registered). The hypotheses are that male circumcision will be acceptable to and safe in women partners, and will reduce the women's acquisition of HIV and STDs such as herpes simplex virus-2 (HSV-2) and human papillomavirus (HPV).

NCT ID: NCT00070746 Completed - Pregnancy Clinical Trials

Perinatal Infections in Pakistan

Start date: June 2003
Phase: N/A
Study type: Observational

There are large differences in health outcomes related to pregnancy and birth between developed and developing countries. This study will investigate how infections, medical history, health care behavior and psychosocial issues are associated with pregnancy outcomes in Pakistan.