Pregnancy ComplicationsNCT01507974
Examination of the Efficacy of Preventive Antibiotic Treatment During the Puerperium Among Pregnant Women With Recurrent Urinary Tract Infections
A study testing Preventive antibiotic treatment- NITROFURANTOIN, Preventive antibiotic treatment- CEPHALEXIN and PREVENTIVE TREATMENT- AMOXICILLIN in people with Pregnancy Complications, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy Complications
- What is being tested?
- Preventive antibiotic treatment- NITROFURANTOIN, Preventive antibiotic treatment- CEPHALEXIN and PREVENTIVE TREATMENT- AMOXICILLIN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteIsrael
- Study dates
- 16 Jan 2012to 1 Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women with two or more episodes of bacteriuria or one episode of pyelonephritis during pregnancy.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Preventive Antibiotic Treatment During the Puerperium Among Pregnant Women With Recurrent Urinary Tract Infections
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.
Read the 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.
- Conditions
- Pregnancy Complications
- Being tested
- Preventive antibiotic treatment- NITROFURANTOIN, Preventive antibiotic treatment- CEPHALEXIN, PREVENTIVE TREATMENT- AMOXICILLIN, PREVENTIVE TREATMENT- AMOXICILLIN AND CLAVULANATE POTASSIUM, PREVENTIVE TREATMENT- CEFUROXIME
- Keywords
- preventive, antibiotic treatment, urinary tract infection, pregnancy, puerperium
- Medical subject headings
- Pregnancy Complications, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventive antibiotic treatment- NITROFURANTOINDrug
P.O NITROFURANTOIN 100 mg per day for 6 weeks
Preventive antibiotic treatment- CEPHALEXINDrug
P.O CEPHALEXIN 500 MG PER DAY FOR 6 WEEKS
PREVENTIVE TREATMENT- AMOXICILLINDrug
P.O AMOXICILLIN 250 MG PER DAY FOR 6 WEEKS
PREVENTIVE TREATMENT- AMOXICILLIN AND CLAVULANATE POTASSIUMDrug
P.O AMOXICILLIN AND CLAVULANATE POTASSIUM, 875 MG PER DAY FOR 6 WEEKS
PREVENTIVE TREATMENT- CEFUROXIMEDrug
P.O CEFUROXIME 250 MG PER DAY FOR 6 WEEKS
PREVENTIVE TREATMENT SULFAMETHOXAZOLE AND TRIMETHOPRIMDrug
P.O SULFAMETHOXAZOLE AND TRIMETHOPRIM 1 TAB PER DAY FOR 6 WEEKS
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary tract complications
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study start16 Jan 2012
- Primary completion1 Jul 2014
- Study completion1 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507974
- Sponsor's protocol ID
- 0068-11-EMC
- Status last verified
- May 2020
- First submitted
- 4 Jan 2012
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Preventive Antibiotic Treatment During the Puerperium Among Pregnant Women With Recurrent Urinary Tract Infections
- ClinicalTrials.gov ID
- NCT01507974
- Acronym / sponsor ID
- 0068-11-EMC
- Conditions
- Pregnancy Complications
- Keywords
- preventive, antibiotic treatment, urinary tract infection, pregnancy, puerperium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 16 Jan 2012 (actual)
- Primary completion
- 1 Jul 2014 (actual)
- Study completion
- 1 Jan 2015 (actual)
- First posted
- 11 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control arm | No intervention | –The women in this arm will not receive preventive antibiotic treatment after delivery |
| preventive antibiotic treatment | Active comparator | 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 TRIMETHOPRIMThe women in this arm will receive preventive antibiotic treatment after the delivery to 6 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women with two or more episodes of bacteriuria or one episode of pyelonephritis during pregnancy.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preventive antibiotic treatment- NITROFURANTOINP.O NITROFURANTOIN 100 mg per day for 6 weeks | Drug | preventive antibiotic treatment |
| Preventive antibiotic treatment- CEPHALEXINP.O CEPHALEXIN 500 MG PER DAY FOR 6 WEEKS | Drug | preventive antibiotic treatment |
| PREVENTIVE TREATMENT- AMOXICILLINP.O AMOXICILLIN 250 MG PER DAY FOR 6 WEEKS | Drug | preventive antibiotic treatment |
| PREVENTIVE TREATMENT- AMOXICILLIN AND CLAVULANATE POTASSIUMP.O AMOXICILLIN AND CLAVULANATE POTASSIUM, 875 MG PER DAY FOR 6 WEEKS | Drug | preventive antibiotic treatment |
| PREVENTIVE TREATMENT- CEFUROXIMEP.O CEFUROXIME 250 MG PER DAY FOR 6 WEEKS | Drug | preventive antibiotic treatment |
| PREVENTIVE TREATMENT SULFAMETHOXAZOLE AND TRIMETHOPRIMP.O SULFAMETHOXAZOLE AND TRIMETHOPRIM 1 TAB PER DAY FOR 6 WEEKS | Drug | preventive antibiotic treatment |
Primary outcome
Urinary tract complications
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
Related trials for Pregnancy Complications
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preventive antibiotic treatment- NITROFURANTOIN, Preventive antibiotic treatment- CEPHALEXIN and PREVENTIVE TREATMENT- AMOXICILLIN in people with Pregnancy Complications, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary tract complications (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.