Group B Streptococcus (GBS) Infection and in Preterm Labor Women Conceived Through IVF

Preterm Labor Clinical Trial

Official title:

Prevalence of Group B Streptococcus Infection in Pregnant Women Conceived Through IVF Diagnosed With Preterm Labor.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03122704
• Other study ID #: NCKH/CGRH_09_2015
• Status: Withdrawn
• Phase: N/A
• First received: October 21, 2015
• Last updated: April 17, 2017
• Start date: October 2015
• Est. completion date: September 2016

Study information

• Verified date: April 2017
• Source: Vietnam National University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a cross - sectional study to determine the prevalence of GBS infection and associated factors in preterm labor women conceived through ART.

221 subjects will be involved.

Description:

Pregnant women at 20 0/7 to 36 6/7 weeks of gestation, conceived through ART, with signs and symptoms of preterm labor will be recruited.

Anal - vaginal fluid samples will be taken by 2 cotton swabs from each participant for culture. Digital examination will be performed after that. Only participants fulfilling all the study's eligible criteria will be interviewed face-to-face with a questionnaire.

The samples will be sent immediately to My Duc hospital laboratory or will be stored in Stuart-Amies medium in < 4 hours. All culture results are interpreted based on Clinical and Laboratory Standards Institute (CLSI) in 2012.

Statistical analysis was performed by Statistical Package for the Social Sciences (SPSS) v.20 and chi-square test. A p-value of < 0.05 was considered as statistically significant.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

• Inclusion Criteria:

To be eligible for enrolment into this trial, subject must fulfil all of the following criteria, unless specified otherwise

• Being conceived through IVF

• Moderate uterine contractions (2 contractions per 10 minutes, duration < 30 seconds)

• 20 0/7 to 36 6/7 weeks of gestation

• Intact membrane

• Cervical dilation = 3 cm

• Willing to participate into the study

• Exclusion Criteria:

To be eligible for enrolment in this study each subject must not meet any of the following criteria:

• Having had intercourse during 24 hours before

• Being suspected of amniotic leakage

• Rupture of membrane identified by direct observation through speculum examination of amniotic fluid flow from cervix

• Vaginal bleeding

• Being suspected of placenta abruption, placenta previa

• Having been treated with antibiotics within 1 week before

• Vaginal douche within 48 hours before

• Having used vaginal medicines during 48 hours before

• Having vaginal ultrasound shortly before

• Urine culture positive with GBS

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Labor

Intervention

Procedure:
• GBS screening
Vaginal and anal swabs of patients will be screened for GBS screening

Locations

Country	Name	City	State
Vietnam	My Duc Hospital	Ho Chi Minh City	Tan Binh District

Sponsors (1)

Lead Sponsor	Collaborator
Manh Tuong Ho

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of women with GBS infection	Number of women with GBS infection divided by total number of women under screening	7 days after swab taken