NCT03274960

Screening and Treating Asymptomatic Bacteriuria Every Trimester and Preterm Birth

The Effect of Screening and Treatment of Asymptomatic Bacteriuria Every Trimester During Pregnancy on Incidence of Preterm Birth in Harare, Zimbabwe

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 480 (actual)
• Sponsor: University of Zimbabwe · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Preterm Birth
• Asymptomatic Bacteriuria in Pregnancy

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Griess,	Experimental: Griess, Culture and antibiotic 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.

Timeline

• Start date: 2017-02-23
• Primary completion: 2020-01-30
• Completion: 2020-12-30
• First posted: 2017-09-07
• Last updated: 2023-05-11

Locations

1 site across 1 country: Zimbabwe