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

Primary Purpose

Preterm Birth, Asymptomatic Bacteriuria in Pregnancy

Status
Completed
Phase
Not Applicable
Locations
Zimbabwe
Study Type
Interventional
Intervention
Griess,
Sponsored by
University of Zimbabwe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth focused on measuring asymptomati bacteriuria, Griess nitrite test, preterm birth

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • University of Zimbabwe

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Griess, Culture and antibiotic

No Griess, culture, treatment

Arm 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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
Isolated uropathogen
All isolated bacterial species from urine sample identified from culture test. These are bacteria identified to be responsible for asymptomatic bacteriuria.
Antibiotic sensitivity
from urine culture results identified antibiotics sensitive for treatment of isolated bacteria will be noted.
Gestation at birth
Gestation is the calculated total number of weeks from first date of last menstrual period to the date of delivery.

Full Information

First Posted
August 25, 2017
Last Updated
May 9, 2023
Sponsor
University of Zimbabwe
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1. Study Identification

Unique Protocol Identification Number
NCT03274960
Brief Title
Screening and Treating Asymptomatic Bacteriuria Every Trimester and Preterm Birth
Acronym
Pretermbirth
Official Title
The Effect of Screening and Treatment of Asymptomatic Bacteriuria Every Trimester During Pregnancy on Incidence of Preterm Birth in Harare, Zimbabwe
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 23, 2017 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zimbabwe

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth, Asymptomatic Bacteriuria in Pregnancy
Keywords
asymptomati bacteriuria, Griess nitrite test, preterm birth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The control group shall be receiving the usual current antenatal services which do not include any screening at all for asymptomatic bacteriuria. Control group participants will however be treated as routinely being done when a woman presents with symptoms of a UTI. Control group will therefore continue to get the routine antenatal care service as currently being done at the clinics. Participants in the intervention group will each be screened for asymptomatic bacteriuria once in each trimester using the Griess test. A culture test will be done which will confirm diagnosis of bacteriuria. participants in intervention group who will present with symptoms and who will test positive for bacteriuria with the Griess and culture test will be treated with antibiotics as per usual treatment protocol. A comparison about number of preterm births for intervention group and control group will be done to reveal the effect of the study intervention.
Masking
InvestigatorOutcomes Assessor
Masking Description
The investigator will not be aware of study group at analysis stage of results. The assessors of outcome will be blinded to study arm as they analyse data to reduce risk of bias.
Allocation
Randomized
Enrollment
480 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Griess, Culture and antibiotic
Arm Type
Experimental
Arm 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.
Arm Title
No Griess, culture, treatment
Arm Type
No Intervention
Arm 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
Intervention Type
Combination Product
Intervention Name(s)
Griess,
Other Intervention Name(s)
Culture, Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Preterm birth
Description
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.
Secondary Outcome Measure Information:
Title
symptomatic bacteriuria
Description
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.
Title
Isolated uropathogen
Description
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.
Title
Antibiotic sensitivity
Description
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
Title
Gestation at birth
Description
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.

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muchabaiwa F Gidiri, MD
Organizational Affiliation
Senior Lecturer, Chairperson Obstetrics and Gynecology Department, University of Zimbabwe
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pasipanodya Nziramasamga, PHD
Organizational Affiliation
Senior Lecturer, Medical Microbiology Department, University of Zimbabwe
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Babil Stray- Pedersen, Professor
Organizational Affiliation
Doctor, Medisin Department, Oslo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Clara Haruzivishe, PHD
Organizational Affiliation
Senior lecturer, Department of Nursing Science, University of Zimbabwe
Official's Role
Study Chair
Facility Information:
Facility Name
University of Zimbabwe
City
Harare
State/Province
Metropolitan
ZIP/Postal Code
+263
Country
Zimbabwe

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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Screening and Treating Asymptomatic Bacteriuria Every Trimester and Preterm Birth

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