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

May 9, 2023 updated by: Judith Rukweza, DPhil Student, University of Zimbabwe

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

480

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zimbabwe
    • Metropolitan
      • Harare, Metropolitan, Zimbabwe, +263
        • University of Zimbabwe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • Treatment
  • Culture
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preterm birth
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.
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).
Preterm birth will be calculated as gestation at birth of baby using date of birth and the first date of last menstrual period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
symptomatic bacteriuria
Time Frame: The symptoms will be noted at interviews at follow up after every 6 to 8 weeks from previous contact.
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.
The symptoms will be noted at interviews at follow up after every 6 to 8 weeks from previous contact.
Isolated uropathogen
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.
All isolated bacterial species from urine sample identified from culture test. These are bacteria identified to be responsible for asymptomatic bacteriuria.
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
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
from urine culture results identified antibiotics sensitive for treatment of isolated bacteria will be noted.
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
Time Frame: Gestation will be calculated at delivery of baby.
Gestation is the calculated total number of weeks from first date of last menstrual period to the date of delivery.
Gestation will be calculated at delivery of baby.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zimbabwe

Investigators

  • Study Director: Muchabaiwa F Gidiri, MD, Senior Lecturer, Chairperson Obstetrics and Gynecology Department, University of Zimbabwe
  • Study Director: Pasipanodya Nziramasamga, PHD, Senior Lecturer, Medical Microbiology Department, University of Zimbabwe
  • Study Director: Babil Stray- Pedersen, Professor, Doctor, Medisin Department, Oslo University
  • Study Chair: Clara Haruzivishe, PHD, Senior lecturer, Department of Nursing Science, University of Zimbabwe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2017

Primary Completion (Actual)

January 30, 2020

Study Completion (Actual)

December 30, 2020

Study Registration Dates

First Submitted

August 25, 2017

First Submitted That Met QC Criteria

September 4, 2017

First Posted (Actual)

September 7, 2017

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 127/16/JREC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

for the period of study for the protocol As soon as culture results are out

IPD Sharing Access Criteria

Soft copy Hard copy

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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