An interventional study of Griess, in Preterm Birth and Asymptomatic Bacteriuria in Pregnancy, sponsored by University of Zimbabwe. Completed at 1 site in Zimbabwe. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-11.
Sponsored by University of Zimbabwe · Not applicable, Interventional, and Prevention
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.
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.
Exclusion Criteria:
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.
Combination Product: Griess,
No Griess reagents added in urine sample, no culture test with blood agar and no treatment with antibiotic for every positive results every trimester
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.
Also known as: Culture, Treatment
Preterm birth
Preterm birth will be delivery of a baby before 37 complete weeks of gestation from the first date of last menstrual period. It will be sub-categorized as extremely preterm (\<28 weeks), very preterm (28 to \<32 weeks) and moderate to late preterm (32 to \<37 weeks).
Time frame: Preterm birth will be calculated as gestation at birth of baby using date of birth and the first date of last menstrual period.
symptomatic bacteriuria
Noted from history of urinary tract symptoms which include pain on micturition, fever, blood in urine, increased urine frequency, foul smelling urine and cloudy urine.
Time frame: The symptoms will be noted at interviews at follow up after every 6 to 8 weeks from previous contact.
Isolated uropathogen
All isolated bacterial species from urine sample identified from culture test. These are bacteria identified to be responsible for asymptomatic bacteriuria.
Time frame: These will be available at recruitment by 22 weeks, between 22 and 28 weeks at second screening and at 28 to 36 weeks at the third screening.
Antibiotic sensitivity
from urine culture results identified antibiotics sensitive for treatment of isolated bacteria will be noted.
Time frame: These will be available at recruitment by 22 weeks, between 22 and 28 weeks at second screening and at 28 to 36 weeks at the third screening
Gestation at birth
Gestation is the calculated total number of weeks from first date of last menstrual period to the date of delivery.
Time frame: Gestation will be calculated at delivery of baby.
Plan to share: Yes — plan to share individual participant information will include sharing culture test results on antibiotic sensitivity for those with positive urine culture results. the in formation shared is intended to assist with effective decision making on selection of the best antibiotic to use to treat asymptomatic bacteriuria.
Supporting information: Study protocol, Csr
No publications or documents are linked to this record.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University of Zimbabwe