NCT02348463

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
540

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 28, 2015

Completed
Last Updated

January 28, 2015

Status Verified

January 1, 2015

Enrollment Period

6.9 years

First QC Date

November 28, 2014

Last Update Submit

January 27, 2015

Conditions

Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

  • preterm delivery

    before 37th week of gestation

Secondary Outcomes (1)

  • cure of bacterial vaginosis

    after 10 weeks

Study Arms (1)

treatment of bacterial vaginosis

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

Drug: Clindamycin-2-phosphate

Interventions

Clindamycin-2-phosphateDRUG

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

Also known as: Dalacin vaginal cream
treatment of bacterial vaginosis

Eligibility Criteria

Age18 Years - 52 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant women with bacterial vaginosis in early pregnancy

You may qualify if:

  • pregnant women screened for bacterial vaginosis in early pregnancy

You may not qualify if:

  • women not delivered at Skaraborg hospital.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

clindamycin phosphate

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Consultat

Study Record Dates

First Submitted

November 28, 2014

First Posted

January 28, 2015

Study Start

January 1, 2007

Primary Completion

December 1, 2013

Study Completion

June 1, 2014

Last Updated

January 28, 2015

Record last verified: 2015-01