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

Bacterial Vaginosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02348463
• Other study ID #: BV and pregnancy
• Status: Completed
• Phase: N/A
• First received: November 28, 2014
• Last updated: January 27, 2015
• Start date: January 2007
• Est. completion date: June 2014

Study information

• Verified date: January 2015
• Source: Skaraborg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish National Council on Medical Ethics
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 52 Years

Eligibility

Inclusion Criteria:

• pregnant women screened for bacterial vaginosis in early pregnancy

Exclusion Criteria:

• women not delivered at Skaraborg hospital.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Premature Birth
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• Clindamycin-2-phosphate
how many women will deliver before the 37th week of gestation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Skaraborg Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	preterm delivery		before 37th week of gestation	Yes
Secondary	cure of bacterial vaginosis		after 10 weeks	Yes