Treatment of Bacterial Vaginosis in Early Pregnancy in Skaraborg and the Effect on Spontaneous Preterm Delivery
- Conditions
- Bacterial Vaginosis
- Interventions
- Drug: Clindamycin-2-phosphate
- Registration Number
- NCT02348463
- Lead Sponsor
- Skaraborg Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 540
- pregnant women screened for bacterial vaginosis in early pregnancy
- women not delivered at Skaraborg hospital.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description treatment of bacterial vaginosis Clindamycin-2-phosphate women with bacterial vaginosis will be offered treatment with clindamycin-2-phosphate
- Primary Outcome Measures
Name Time Method preterm delivery before 37th week of gestation
- Secondary Outcome Measures
Name Time Method cure of bacterial vaginosis after 10 weeks