Screening and Treating Asymptomatic Bacteriuria Every Trimester and Preterm Birth

NCT ID: NCT03274960

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-23
• Study Completion Date: 2020-12-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Griess,

Intervention Type: COMBINATION_PRODUCT

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.

No Griess, culture, treatment

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Culture; Treatment

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Zimbabwe

OTHER

Sponsor Role: lead

Responsible Party

Judith Rukweza, DPhil Student

Mrs

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muchabaiwa F Gidiri, MD

Role: STUDY_DIRECTOR

Senior Lecturer, Chairperson Obstetrics and Gynecology Department, University of Zimbabwe

Pasipanodya Nziramasamga, PHD

Role: STUDY_DIRECTOR

Senior Lecturer, Medical Microbiology Department, University of Zimbabwe

Babil Stray- Pedersen, Professor

Role: STUDY_DIRECTOR

Doctor, Medisin Department, Oslo University

Clara Haruzivishe, PHD

Role: STUDY_CHAIR

Senior lecturer, Department of Nursing Science, University of Zimbabwe

Locations

University of Zimbabwe

Harare, Metropolitan, Zimbabwe

Countries

Zimbabwe

Other Identifiers

127/16/JREC

Identifier Type: -

Identifier Source: org_study_id