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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02348463
Enrollment
540
Registered
2015-01-28
Start date
2007-01-31
Completion date
2014-06-30
Last updated
2015-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Vaginosis

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.

Interventions

DRUGClindamycin-2-phosphate

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

Sponsors

Skaraborg Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 52 Years
Healthy volunteers
No

Inclusion criteria

* pregnant women screened for bacterial vaginosis in early pregnancy

Exclusion criteria

* women not delivered at Skaraborg hospital.

Design outcomes

Primary

MeasureTime frame
preterm deliverybefore 37th week of gestation

Secondary

MeasureTime frame
cure of bacterial vaginosisafter 10 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026