Treatment of Bacterial Vaginosis in Early Pregnancy in Skaraborg and the Effect on Spontaneous Preterm Delivery
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|ClinicalTrials.gov Identifier: NCT02348463|
Recruitment Status : Completed
First Posted : January 28, 2015
Last Update Posted : January 28, 2015
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|
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.
|Study Type :||Observational|
|Actual Enrollment :||540 participants|
|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|
treatment of bacterial vaginosis
women with bacterial vaginosis will be offered treatment with clindamycin-2-phosphate
how many women will deliver before the 37th week of gestation
Other Name: Dalacin vaginal cream
- preterm delivery [ Time Frame: before 37th week of gestation ]
- cure of bacterial vaginosis [ Time Frame: after 10 weeks ]