Examination of the Efficacy of Preventive Antibiotic Treatment During the Puerperium Among Pregnant Women With Recurrent Urinary Tract Infections
Primary Purpose
Pregnancy Complications
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Preventive antibiotic treatment- NITROFURANTOIN
Preventive antibiotic treatment- CEPHALEXIN
PREVENTIVE TREATMENT- AMOXICILLIN
PREVENTIVE TREATMENT- AMOXICILLIN AND CLAVULANATE POTASSIUM
PREVENTIVE TREATMENT- CEFUROXIME
PREVENTIVE TREATMENT SULFAMETHOXAZOLE AND TRIMETHOPRIM
Sponsored by
About this trial
This is an interventional treatment trial for Pregnancy Complications focused on measuring preventive, antibiotic treatment, urinary tract infection, pregnancy, puerperium
Eligibility 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)
Sites / Locations
- Dep of OG/GYN, Emek Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
control arm
preventive antibiotic treatment
Arm Description
The women in this arm will not receive preventive antibiotic treatment after delivery
The women in this arm will receive preventive antibiotic treatment after the delivery to 6 weeks
Outcomes
Primary Outcome Measures
Urinary tract complications
Secondary Outcome Measures
Full Information
NCT ID
NCT01507974
First Posted
January 4, 2012
Last Updated
May 17, 2020
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT01507974
Brief Title
Examination of the Efficacy of Preventive Antibiotic Treatment During the Puerperium Among Pregnant Women With Recurrent Urinary Tract Infections
Official Title
The Efficacy of Preventive Antibiotic Treatment During the Puerperium Among Pregnant Women With Recurrent Urinary Tract Infections
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 16, 2012 (Actual)
Primary Completion Date
July 1, 2014 (Actual)
Study Completion Date
January 1, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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 that had recurrent UTIs or pyelonephritis 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.
Study period From after delivery to 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 receive a prophylactic treatment after delivery for 6 weeks. If the woman breastfeeds, the treatment will be fitted to the situation. Urine culture will be collected in the morning following recruitment, 3 and 6 weeks post delivery. Details regarding bacteriuria, urinary tract infections, pyelonephritis and admissions for related complications will be collected.
The study was approved by the local Helsinki committee.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Complications
Keywords
preventive, antibiotic treatment, urinary tract infection, pregnancy, puerperium
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control arm
Arm Type
No Intervention
Arm Description
The women in this arm will not receive preventive antibiotic treatment after delivery
Arm Title
preventive antibiotic treatment
Arm Type
Active Comparator
Arm Description
The women in this arm will receive preventive antibiotic treatment after the delivery to 6 weeks
Intervention Type
Drug
Intervention Name(s)
Preventive antibiotic treatment- NITROFURANTOIN
Intervention Description
P.O NITROFURANTOIN 100 mg per day for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Preventive antibiotic treatment- CEPHALEXIN
Intervention Description
P.O CEPHALEXIN 500 MG PER DAY FOR 6 WEEKS
Intervention Type
Drug
Intervention Name(s)
PREVENTIVE TREATMENT- AMOXICILLIN
Intervention Description
P.O AMOXICILLIN 250 MG PER DAY FOR 6 WEEKS
Intervention Type
Drug
Intervention Name(s)
PREVENTIVE TREATMENT- AMOXICILLIN AND CLAVULANATE POTASSIUM
Intervention Description
P.O AMOXICILLIN AND CLAVULANATE POTASSIUM, 875 MG PER DAY FOR 6 WEEKS
Intervention Type
Drug
Intervention Name(s)
PREVENTIVE TREATMENT- CEFUROXIME
Intervention Description
P.O CEFUROXIME 250 MG PER DAY FOR 6 WEEKS
Intervention Type
Drug
Intervention Name(s)
PREVENTIVE TREATMENT SULFAMETHOXAZOLE AND TRIMETHOPRIM
Intervention Description
P.O SULFAMETHOXAZOLE AND TRIMETHOPRIM 1 TAB PER DAY FOR 6 WEEKS
Primary Outcome Measure Information:
Title
Urinary tract complications
Time Frame
6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Dep of OG/GYN, Emek Medical Center
City
Afula
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Examination of the Efficacy of Preventive Antibiotic Treatment During the Puerperium Among Pregnant Women With Recurrent Urinary Tract Infections
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