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

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ClinicalTrials.gov Identifier: NCT01507974

Recruitment Status : Completed

First Posted : January 11, 2012

Last Update Posted : September 20, 2019

Sponsor:

Information provided by (Responsible Party):

HaEmek Medical Center, Israel

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pregnancy Complications	Drug: Preventive antibiotic treatment- NITROFURANTOIN Drug: Preventive antibiotic treatment- CEPHALEXIN Drug: PREVENTIVE TREATMENT- AMOXICILLIN Drug: PREVENTIVE TREATMENT- AMOXICILLIN AND CLAVULANATE POTASSIUM Drug: PREVENTIVE TREATMENT- CEFUROXIME Drug: PREVENTIVE TREATMENT SULFAMETHOXAZOLE AND TRIMETHOPRIM	Not Applicable

Detailed Description:

During pregnancy functional modifications in the urinary tract influence the function of the urinary tract system. Those changes raise the risk of urinary tract infections. The most common bacterial infections during pregnancy are urinary tract infections. Actually, asymptomatic bacteriuria is the most common infection in up to 8% of the population. Symptomatic infection may cause cystitis or include the renal calyces and parenchyma and cause pyelonephritis. There are few common protocols for bacteriuria treatment. The recurrence rate after treatment is 30%. Preventive treatment with nitrofurantoin has been demonstrated to be effective, although there is a small risk to acute respiratory distress which resolved with cessation of the treatment. Renal infection is the most common serious infection during pregnancy. Complication of renal infection can lead to ARDS or urosepsis. Renal infection usually develops during the second trimester and has been related to prim parity and young women.

About 20% of women will deteriorate to renal insufficiency. 30-40% of cases will be followed with recurrent bacteriuria later on, for this reason, a preventive treatment is recommended until delivery. In previous studies the preventive treatment reduced the bacteriuria rate from 38% to 8%.

After delivery, the morphological changes including edema, bladder hyperemia and a raise in the urinary volume, pass away up to 3 months post partum. There is only slight information regarding the rate of bacteriuria during puerperium, most of the information relates to the early puerperium period. In addition, the consequences of such infection are unknown.

The aim of this study is to estimate the efficacy of preventive antibiotic treatment during the puerperium.

Objectives

To estimate the rate of bacteriuria and other urinary tract infections during the puerperium among women with preventive treatment during pregnancy
To evaluate the efficacy of preventive treatment during the puerperium Hypothesis: The pregnancy modifications which cause more urinary tract infections during pregnancy, exist also during the puerperium, and can cause complications Study design Prospective, randomized, open label Study population: Pregnant women with two or more episodes of bacteriuria or one episode of pyelonephritis, whom are treated with prophylactic antibiotic Study period From 6 weeks after delivery The study size has been determined according to a reduction in the bacteriuria rate following preventive treatment from 38% to 8%. Basing on that fact, each group has to include 37 women, to get a 80% power with α=0.05.

Study protocol: women will be randomized at recruitment. Demographic and obstetrical data will be collected. The women in the treatment group will continue the prophylactic treatment after the delivery, for 6 weeks. If the woman breastfeeds, the treatment will be fitted to the situation. Urine culture will be collected the morning following the delivery , 3 and 6 weeks post delivery. The women will be invited to the high risk unit for follow up after 3 and 6 weeks. Details regarding bacteriuria, urinary tract infections, pyelonephritis and admissions for related complications will be collected.

The study was approved by the local Helsinki committee. Time table Duration: one year

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	227 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	The Efficacy of Preventive Antibiotic Treatment During the Puerperium Among Pregnant Women With Recurrent Urinary Tract Infections
Actual Study Start Date :	January 16, 2012
Actual Primary Completion Date :	July 1, 2014
Actual Study Completion Date :	January 1, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Postpartum Care Urinary Tract Infections

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
No Intervention: control arm The women in this arm will stop the preventive antibiotic treatment after the delivery
Active Comparator: preventive antibiotic treatment The women in this arm will continue the preventive antibiotic treatment after the delivery to 6 weeks	Drug: Preventive antibiotic treatment- NITROFURANTOIN P.O NITROFURANTOIN 100 mg per day for 6 weeks Drug: Preventive antibiotic treatment- CEPHALEXIN P.O CEPHALEXIN 500 MG PER DAY FOR 6 WEEKS Drug: PREVENTIVE TREATMENT- AMOXICILLIN P.O AMOXICILLIN 250 MG PER DAY FOR 6 WEEKS Drug: PREVENTIVE TREATMENT- AMOXICILLIN AND CLAVULANATE POTASSIUM P.O AMOXICILLIN AND CLAVULANATE POTASSIUM, 875 MG PER DAY FOR 6 WEEKS Drug: PREVENTIVE TREATMENT- CEFUROXIME P.O CEFUROXIME 250 MG PER DAY FOR 6 WEEKS Drug: PREVENTIVE TREATMENT SULFAMETHOXAZOLE AND TRIMETHOPRIM P.O SULFAMETHOXAZOLE AND TRIMETHOPRIM 1 TAB PER DAY FOR 6 WEEKS
No Intervention: FOLLOW UP ARM this 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

Outcome Measures

Primary Outcome Measures :

Urinary tract complications [ Time Frame: 6 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	16 Years to 50 Years (Child, Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

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)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01507974

Locations

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Israel
Dep of OG/GYN, Emek Medical Center
Afula, Israel

Sponsors and Collaborators

HaEmek Medical Center, Israel

More Information

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Responsible Party:	HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:	NCT01507974 History of Changes
Other Study ID Numbers:	0068-11-EMC
First Posted:	January 11, 2012 Key Record Dates
Last Update Posted:	September 20, 2019
Last Verified:	September 2019

Keywords provided by HaEmek Medical Center, Israel:


preventive antibiotic treatment urinary tract infection pregnancy puerperium

Additional relevant MeSH terms:

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Infection Urinary Tract Infections Pregnancy Complications Urologic Diseases Anti-Bacterial Agents Amoxicillin Clavulanic Acid Clavulanic Acids Cefuroxime Cefuroxime axetil Cephalexin Nitrofurantoin Amoxicillin-Potassium Clavulanate Combination Trimethoprim, Sulfamethoxazole Drug Combination Antibiotics, Antitubercular	Trimethoprim Sulfamethoxazole Anti-Infective Agents Antitubercular Agents Anti-Infective Agents, Urinary Renal Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Cytochrome P-450 CYP2C8 Inhibitors Cytochrome P-450 Enzyme Inhibitors

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