Clinical trial NCT03274960: Screening and Treating Asymptomatic Bacteriuria Every Trimester and Preterm Birth
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
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Asymptomatic Bacteriuria in Pregnancy
Keywords: asymptomati bacteriuria, Griess nitrite test, preterm birth
Lead sponsor: University of Zimbabwe
Sponsor class: OTHER
First posted: 2017-09-07
Enrollment: 480
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Preterm birth
timeFrame: 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:
measure: symptomatic bacteriuria
timeFrame: The symptoms will be noted at interviews at follow up after every 6 to 8 weeks from previous contact.
measure: Isolated uropathogen
timeFrame: 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.
measure: Antibiotic sensitivity
timeFrame: 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
measure: Gestation at birth
timeFrame: Gestation will be calculated at delivery of baby.
Other outcomes:
Locations:
city: Harare
country: Zimbabwe
facility: University of Zimbabwe
state: Metropolitan
Study officials:
affiliation: Senior Lecturer, Chairperson Obstetrics and Gynecology Department, University of Zimbabwe
name: Muchabaiwa F Gidiri, MD
role: STUDY_DIRECTOR
affiliation: Senior Lecturer, Medical Microbiology Department, University of Zimbabwe
name: Pasipanodya Nziramasamga, PHD
role: STUDY_DIRECTOR
affiliation: Doctor, Medisin Department, Oslo University
name: Babil Stray- Pedersen, Professor
role: STUDY_DIRECTOR
affiliation: Senior lecturer, Department of Nursing Science, University of Zimbabwe
name: Clara Haruzivishe, PHD
role: STUDY_CHAIR
References: