Treatment of Bacterial Vaginosis in Early Pregnancy in Skaraborg and the Effect on Spontaneous Preterm Delivery

NCT ID: NCT02348463

Last Updated: 2015-01-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 540 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2014-06-30

Brief Summary

Bacterial vaginosis (BV) is a known risk factor for preterm delivery. This study was conducted in an attempt to investigate if treatment of bacterial vaginosis in early pregnancy could reduce the risk for preterm delivery.

Women were screened for bacterial vaginosis during the first visits at the maternal health care unit with a vaginal sample that were taken by the midwife or by herself. After the vaginal samples was air dried it was sent to the gynaecological department and was investigated using Hay/Ison classification. Eligible women were those who had lived in Skaraborg and delivered at Skaraborg hospital.

Detailed Description

The study has started 2007 and will continue until 2014. Pregnant women that will come to the maternal health care units in gestational week 8-11 will be offered to be screened for bacterial vaginosis. A vaginal sample will be taken by the midwife or by the women herself. The vaginal sample is air-dried and sent to the gynecological. There it is investigated using Hay/Ison classification for the diagnosis of bacterial vaginosis.

Women with bacterial vaginosis will be offered treatment with topical clindamycin treatment for 7 days if the women has passed the 12th gestational week. A control sample for the test of cure will be done after 10 week. If not cured of BV she will be offered a new treatment.

All women will be followed until delivery.

Conditions

Bacterial Vaginosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

treatment of bacterial vaginosis

women with bacterial vaginosis will be offered treatment with clindamycin-2-phosphate

Clindamycin-2-phosphate

Intervention Type: DRUG

how many women will deliver before the 37th week of gestation

Interventions

Clindamycin-2-phosphate

how many women will deliver before the 37th week of gestation

Intervention Type: DRUG

Other Intervention Names

Dalacin vaginal cream

Eligibility Criteria

Inclusion Criteria

• pregnant women screened for bacterial vaginosis in early pregnancy

Exclusion Criteria

• women not delivered at Skaraborg hospital.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 52 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Skaraborg Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Per-Goran Larsson

Professor Consultat

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

BV and pregnancy

Identifier Type: -

Identifier Source: org_study_id