Screening and Treating Asymptomatic Bacteriuria Every Trimester and Preterm Birth (Pretermbirth)

University of Zimbabwe

Status: Completed

Conditions: Asymptomatic Bacteriuria in Pregnancy; Preterm Birth

Treatments: Combination Product: Griess,

Study type: Interventional

Funder types: Other

Identifiers

NCT03274960

127/16/JREC

Details and patient eligibility

About

This study is evaluating whether screening of a pregnant woman for asymptomatic bacteriuria in each trimester for early detection and treatment of bacteriuria will reduce the incidence of preterm birth in Harare.

Full description

Asymptomatic bacteriuria is common in pregnancy. If the disease is not detected early in pregnancy and treated it often progresses to an acute symptomatic disease, pyelonephritis which is associated with adverse pregnancy outcomes including preterm birth.

It is recommended that every woman be screened for asymptomatic bacteriuria by urine culture test at initial antenatal care visit so that the disease is if identified is treated early to prevent preventable complications of the disease in pregnancy. Culture test is expensive and therefore unavailable at several primary care settings especially in low resource settings where majority of pregnant women register and visit for antenatal care. In Zimbabwe antenatal care at primary care clinics is not including screening for asymptomatic bacteriuria. Majority who present with symptoms are empirically treated.

In this study the Griess nitrite test, an effective inexpensive screening test for asymptomatic bacteriuria is used. the test detects nitrite in urine which is associated with presence of nitrate reducing uropathogens, commonly the gram negative bacteria. All the positive samples will then be further tested by culture for bacteria identification, quantification and antibiotic sensitivity. A Randomized controlled trial research design is being used. participants are randomly allocated to intervention group or control group. Urine samples will be collected and tested 3 times for each recruited participant in the intervention arm. treatment will be initiated for positive result according to sensitivity test. Control group will only be subjected to routine existing antenatal care.

Participants will be recruited before 22 weeks gestation and followed on for second contact by 28 weeks and third contact by 36 weeks. Follow up will be stopped on delivery for noting gestation at delivery, whether preterm or term.

Enrollment: 480 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant women registering at study site.
• Woman is able to identify her date of last menstrual period.
• Gestation of pregnancy is between 6 and 22 weeks.
• Woman is asymptomatic for bacteriuria
• Woman voluntarily signs the consent form

Exclusion criteria

• Pregnant woman ill and unwell
• Pregnant woman unwilling to sign consent form
• Woman who had antibiotic treatment 2 weeks before recruitment
• Woman on long term antibiotic treatment
• Woman who fails to identify date of last menstrual period
• Woman symptomatic for urinary tract infection

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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480 participants in 2 patient groups

Griess, Culture and antibiotic

Experimental group

Description:

Griess reagents, sulfanilamide and NED added in urine sample for 20 minutes, urine culture using blood agar for 24 hours and treatment with antibiotic every trimester for up to 7 days.

Treatment:

Combination Product: Griess,

No Griess, culture, treatment

No Intervention group

Description:

No Griess reagents added in urine sample, no culture test with blood agar and no treatment with antibiotic for every positive results every trimester