Screening and Treating Asymptomatic Bacteriuria Every Trimester and Preterm Birth

• Register: ClinicalTrials.gov
• Last refreshed on: 22 May 2023
• Main ID: NCT03274960
• Date of registration: 25/08/2017
• Prospective Registration: No
• Primary sponsor: University of Zimbabwe
• Public title: Screening and Treating Asymptomatic Bacteriuria Every Trimester and Preterm Birth Pretermbirth
• Scientific title: The Effect of Screening and Treatment of Asymptomatic Bacteriuria Every Trimester During Pregnancy on Incidence of Preterm Birth in Harare, Zimbabwe
• Date of first enrolment: February 23, 2017
• Target sample size: 480
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03274960
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Zimbabwe

Contacts

• Name: Babil Stray- Pedersen, Professor
• Affiliation: Doctor, Medisin Department, Oslo University

• Name: Clara Haruzivishe, PHD
• Affiliation: Senior lecturer, Department of Nursing Science, University of Zimbabwe

• Name: Muchabaiwa F Gidiri, MD
• Affiliation: Senior Lecturer, Chairperson Obstetrics and Gynecology Department, University of Zimbabwe

• Name: Pasipanodya Nziramasamga, PHD
• Affiliation: Senior Lecturer, Medical Microbiology Department, University of Zimbabwe

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Preterm Birth

Asymptomatic Bacteriuria in Pregnancy

Intervention(s)

Combination Product: Griess,

Primary Outcome(s)

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.]

Secondary Outcome(s)

symptomatic bacteriuria [Time Frame: The symptoms will be noted at interviews at follow up after every 6 to 8 weeks from previous contact.]

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]

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.]

Gestation at birth [Time Frame: Gestation will be calculated at delivery of baby.]

Secondary ID(s)

127/16/JREC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors