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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02348463
Recruitment Status : Completed
First Posted : January 28, 2015
Last Update Posted : January 28, 2015
Information provided by (Responsible Party):
Per-Goran Larsson, 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.

Condition or disease Intervention/treatment
Bacterial Vaginosis Drug: Clindamycin-2-phosphate

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.

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Study Type : Observational
Actual Enrollment : 540 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment of Bacterial Vaginosis in Early Pregnancy in Skaraborg County in Sweden and the Effect on Spontaneous Preterm Delivery
Study Start Date : January 2007
Actual Primary Completion Date : December 2013
Actual Study Completion Date : June 2014

Group/Cohort Intervention/treatment
treatment of bacterial vaginosis
women with bacterial vaginosis will be offered treatment with clindamycin-2-phosphate
Drug: Clindamycin-2-phosphate
how many women will deliver before the 37th week of gestation
Other Name: Dalacin vaginal cream

Primary Outcome Measures :
  1. preterm delivery [ Time Frame: before 37th week of gestation ]

Secondary Outcome Measures :
  1. cure of bacterial vaginosis [ Time Frame: after 10 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 52 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pregnant women with bacterial vaginosis in early pregnancy

Inclusion Criteria:

  • pregnant women screened for bacterial vaginosis in early pregnancy

Exclusion Criteria:

  • women not delivered at Skaraborg hospital.

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Responsible Party: Per-Goran Larsson, Professor Consultat, Skaraborg Hospital Identifier: NCT02348463     History of Changes
Other Study ID Numbers: BV and pregnancy
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: January 28, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Clindamycin palmitate
Clindamycin phosphate
Vaginosis, Bacterial
Vaginal Diseases
Premature Birth
Genital Diseases, Female
Bacterial Infections
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action