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Pregnancy Complications | Examination of the Efficacy of Preventive Antibiotic Treatment During the Puerperium Among Pregnant Women With Recurrent Urinary Tract Infections

Pregnancy Complications research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - Pregnant women with two or more episodes of bacteriuria or one episode of pyelonephritis during pregnancy, whom are treated with preventive antibiotic treatment Exclusion Criteria: - 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)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pregnancy Complications

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Preventive antibiotic treatment- NITROFURANTOINP.O NITROFURANTOIN 100 mg per day for 6 weeks

Drug:Preventive antibiotic treatment- CEPHALEXINP.O CEPHALEXIN 500 MG PER DAY FOR 6 WEEKS

Drug:PREVENTIVE TREATMENT- AMOXICILLINP.O AMOXICILLIN 250 MG PER DAY FOR 6 WEEKS

Drug:PREVENTIVE TREATMENT- AMOXICILLIN AND CLAVULANATE POTASSIUMP.O AMOXICILLIN AND CLAVULANATE POTASSIUM, 875 MG PER DAY FOR 6 WEEKS

Drug:PREVENTIVE TREATMENT- CEFUROXIMEP.O CEFUROXIME 250 MG PER DAY FOR 6 WEEKS

Drug:PREVENTIVE TREATMENT SULFAMETHOXAZOLE AND TRIMETHOPRIMP.O SULFAMETHOXAZOLE AND TRIMETHOPRIM 1 TAB PER DAY FOR 6 WEEKS

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

control armThe women in this arm will stop the preventive antibiotic treatment after the delivery

preventive antibiotic treatmentThe women in this arm will continue the preventive antibiotic treatment after the delivery to 6 weeks

FOLLOW UP ARMthis arm will include women who do not want to participate in the study, and those women will stop the preventive treatment after delivery, and THE INVESTIGATORS will contact those women to collect information regarding their health status post partum

Study Status

Recruiting

Start Date: January 2012

Completed Date: May 2017

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Urinary tract complications

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: HaEmek Medical Center, Israel

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01507974

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