Screening and Treating Asymptomatic Bacteriuria Every Trimester and Preterm Birth

NCT03274960 | Completed DMC

• 1 other identifier: 127/16/JREC
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth; Asymptomatic Bacteriuria in Pregnancy

Keywords

asymptomati bacteriuria, Griess nitrite test, preterm birth

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  The symptoms will be noted at interviews at follow up after every 6 to 8 weeks from previous contact.

• Isolated uropathogen

  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

  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 will be calculated at delivery of baby.

Study Arms (2)

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.

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

Interventions

Griess, 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.

Also known as: Culture, Treatment

Griess, Culture and antibiotic

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zimbabwe: lead

Study Sites (1)

University of Zimbabwe

Harare, Metropolitan, +263, Zimbabwe

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Griess reagent; Culture Techniques; Therapeutics

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

In Vitro Techniques; Investigative Techniques

Study Officials

• 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 DIRECTOR

• Clara Haruzivishe, PHD

  Senior lecturer, Department of Nursing Science, University of Zimbabwe

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mrs

Model Details: 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.

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: September 7, 2017
• Study Start: February 23, 2017
• Primary Completion: January 30, 2020
• Study Completion: December 30, 2020
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: for the period of study for the protocol As soon as culture results are out
• Access Criteria: Soft copy Hard copy

Locations

ZI (1)