Preterm BirthPretermbirthNCT03274960
Screening and Treating Asymptomatic Bacteriuria Every Trimester and Preterm Birth
A study testing Griess, in people with Preterm Birth and Asymptomatic Bacteriuria in Pregnancy, run by University of Zimbabwe at 1 site in Zimbabwe.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Asymptomatic Bacteriuria in Pregnancy
- What is being tested?
- Griess,
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteZimbabwe
- Study dates
- 23 Feb 2017to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Griess,
- Keywords
- asymptomati bacteriuria, Griess nitrite test, preterm birth
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Griess,Combination product
Also called Culture, 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.
| Study group | Role | What they receive |
|---|---|---|
| Griess, Culture and antibiotic | Experimental | 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. Receives: Combination Product: Griess, |
| No Griess, culture, treatment | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Preterm birth will be calculated as gestation at birth of baby using date of birth and the first date of last menstrual period.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Gestation will be calculated at delivery of baby.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start23 Feb 2017
- Primary completion30 Jan 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zimbabwe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judith Rukweza, DPhil Student, University of Zimbabwe
- Investigators
- Muchabaiwa F Gidiri, MD, Study director, Senior Lecturer, Chairperson Obstetrics and Gynecology Department, University of ZimbabwePasipanodya Nziramasamga, PHD, Study director, Senior Lecturer, Medical Microbiology Department, University of ZimbabweBabil Stray- Pedersen, Professor, Study director, Doctor, Medisin Department, Oslo UniversityClara Haruzivishe, PHD, Study chair, Senior lecturer, Department of Nursing Science, University of Zimbabwe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274960
- Sponsor's protocol ID
- 127/16/JREC
- Acronym
- Pretermbirth
- Status last verified
- May 2023
- First submitted
- 25 Aug 2017
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Screening and Treatment of Asymptomatic Bacteriuria Every Trimester During Pregnancy on Incidence of Preterm Birth in Harare, Zimbabwe
- ClinicalTrials.gov ID
- NCT03274960
- Acronym / sponsor ID
- Pretermbirth / 127/16/JREC
- Keywords
- asymptomati bacteriuria, Griess nitrite test, preterm birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- University of ZimbabweUniversity, hospital or other
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 7 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Griess, Culture and antibiotic | Experimental | Combination Product: Griess,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 intervention | –No Griess reagents added in urine sample, no culture test with blood agar and no treatment with antibiotic for every positive results every trimester |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Griess,Also: Culture, TreatmentExperimental: 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, Culture and antibiotic |
Primary outcome
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).
4 secondary outcomes
symptomatic bacteriuria
Time frame: 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.
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
Gestation at birth
Time frame: Gestation will be calculated at delivery of baby.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muchabaiwa F Gidiri, MD study director
Senior Lecturer, Chairperson Obstetrics and Gynecology Department, University of Zimbabwe
Pasipanodya Nziramasamga, PHD study director
Senior Lecturer, Medical Microbiology Department, University of Zimbabwe
Babil Stray- Pedersen, Professor study director
Doctor, Medisin Department, Oslo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Griess, in people with Preterm Birth and Asymptomatic Bacteriuria in Pregnancy, run by University of Zimbabwe at 1 site in Zimbabwe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.