NCT01507974

Brief Summary

Urinary tract infection is the most common bacterial infection during pregnancy. Asymptomatic bacteriuria is the most common infection, in up to 8% of the population. Symptomatic infection may cause cystitis or cause pyelonephritis. Among pregnant women with recurrent bacteriuria, preventive antibiotic treatment has been found to be efficacious in reducing the bacteriuria rate and the complications. the changes of the urinary tract which appear during pregnancy usually resolve up to 3 months post-partum. The purpose of this study is to examine the efficacy of preventive antibiotic treatment during the puerperium.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 11, 2012

Completed
5 days until next milestone

Study Start

First participant enrolled

January 16, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

2.5 years

First QC Date

January 4, 2012

Last Update Submit

May 17, 2020

Conditions

Pregnancy Complications

Keywords

preventiveantibiotic treatmenturinary tract infectionpregnancypuerperium

Outcome Measures

Primary Outcomes (1)

  • Urinary tract complications

    6 weeks

Study Arms (2)

control arm

NO INTERVENTION

The women in this arm will not receive preventive antibiotic treatment after delivery

preventive antibiotic treatment

ACTIVE COMPARATOR

The women in this arm will receive preventive antibiotic treatment after the delivery to 6 weeks

Drug: Preventive antibiotic treatment- NITROFURANTOINDrug: Preventive antibiotic treatment- CEPHALEXINDrug: PREVENTIVE TREATMENT- AMOXICILLINDrug: PREVENTIVE TREATMENT- AMOXICILLIN AND CLAVULANATE POTASSIUMDrug: PREVENTIVE TREATMENT- CEFUROXIMEDrug: PREVENTIVE TREATMENT SULFAMETHOXAZOLE AND TRIMETHOPRIM

Interventions

Preventive antibiotic treatment- NITROFURANTOINDRUG

P.O NITROFURANTOIN 100 mg per day for 6 weeks

preventive antibiotic treatment
Preventive antibiotic treatment- CEPHALEXINDRUG

P.O CEPHALEXIN 500 MG PER DAY FOR 6 WEEKS

preventive antibiotic treatment
PREVENTIVE TREATMENT- AMOXICILLINDRUG

P.O AMOXICILLIN 250 MG PER DAY FOR 6 WEEKS

preventive antibiotic treatment
PREVENTIVE TREATMENT- AMOXICILLIN AND CLAVULANATE POTASSIUMDRUG

P.O AMOXICILLIN AND CLAVULANATE POTASSIUM, 875 MG PER DAY FOR 6 WEEKS

preventive antibiotic treatment
PREVENTIVE TREATMENT- CEFUROXIMEDRUG

P.O CEFUROXIME 250 MG PER DAY FOR 6 WEEKS

preventive antibiotic treatment
PREVENTIVE TREATMENT SULFAMETHOXAZOLE AND TRIMETHOPRIMDRUG

P.O SULFAMETHOXAZOLE AND TRIMETHOPRIM 1 TAB PER DAY FOR 6 WEEKS

preventive antibiotic treatment

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women with two or more episodes of bacteriuria or one episode of pyelonephritis during pregnancy.

You may not qualify if:

  • Women with malformations of the urinary tract
  • women with risk factors to urinary tract infections, for example DIABETES MELLITUS, REFLUX.
  • Women with urinary tract infection caused by resistant bacteria (to conventional treatment)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep of OG/GYN, Emek Medical Center

Afula, Israel

Location

MeSH Terms

Conditions

Pregnancy ComplicationsUrinary Tract Infections

Interventions

Clavulanic AcidTrimethoprim

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesInfectionsUrologic DiseasesFemale Urogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clavulanic Acidsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPyrimidinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2012

First Posted

January 11, 2012

Study Start

January 16, 2012

Primary Completion

July 1, 2014

Study Completion

January 1, 2015

Last Updated

May 19, 2020

Record last verified: 2020-05

Locations

IL(1)