Examination of the Efficacy of Preventive Antibiotic Treatment During the Puerperium Among Pregnant Women With Recurrent Urinary Tract Infections
Condition: Pregnancy Complications
MeSH terms: Infections; Urinary Tract Infections; Pregnancy Complications
Study type: Interventional

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

        1. To estimate the rate of bacteriuria and other urinary tract infections during the
           puerperium among women that had recurrent UTIs or pyelonephritis during pregnancy

        2. 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.
    

Intervention name(s): 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
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): P.O NITROFURANTOIN 100 mg per day for 6 weeks; P.O CEPHALEXIN 500 MG PER DAY FOR 6 WEEKS; P.O AMOXICILLIN 250 MG PER DAY FOR 6 WEEKS; P.O AMOXICILLIN AND CLAVULANATE POTASSIUM, 875 MG PER DAY FOR 6 WEEKS; P.O CEFUROXIME 250 MG PER DAY FOR 6 WEEKS; P.O SULFAMETHOXAZOLE AND TRIMETHOPRIM 1 TAB PER DAY FOR 6 WEEKS
Intervention MeSH terms: Anti-Bacterial Agents; Amoxicillin; Clavulanic Acid; Cephalexin; Cefuroxime; Nitrofurantoin; Trimethoprim, Sulfamethoxazole Drug Combination; Antibiotics, Antitubercular; Trimethoprim; Sulfamethoxazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: preventive; antibiotic treatment; urinary tract infection; pregnancy; puerperium