Pregnancy Clinical Trial
Official title:
Impact on Prematurity of a First-trimester Screening for Bacterial Vaginosis in Pregnancy Through Weekly Vaginal pH Determination. An Interventional, Community Study.
| Verified date | April 2013 |
| Source | Hospital Clinic of Barcelona |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Spain: Ethics Committee |
| Study type | Interventional |
Interventional study to assess the effect of early detection and treatment of bacterial vaginosis in pregnancy on preterm delivery rate.
| Status | Completed |
| Enrollment | 1049 |
| Est. completion date | December 2010 |
| Est. primary completion date | December 2010 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Pregnant women Exclusion Criteria: - Diabetes mellitus (pre-gestational) - Hypertension (pre-gestational) - Malformations on ultrasonography at 12 weeks |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Clinic | Barcelona | Catalonia |
| Lead Sponsor | Collaborator |
|---|---|
| Montse Palacio |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Preterm delivery rate | 12 months | Yes |
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