- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01633294
Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term
November 24, 2016 updated by: Filipa Faria Vaz Passos, Hospital de Santa Maria, Portugal
Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term - a Randomized Controlled Trial
The aims of this study are to determine whether antibiotics administered routinely in women presenting with premature rupture of membranes later than the 37+0 weeks of gestation can alter the rate of maternal and neonatal infection and to compare these rates between prompt (< 12 hour) and delayed (≥ 12 hour) induction in the group of patients not submitted to antibiotic prophylaxis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
161
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lisboa, Portugal, 1649-035
- Hospital Santa Maria
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- term (≥ 37+0 weeks) singleton pregnancy
- a vertex presentation
- ruptured membranes for less than 12 hours
- negative Group B Streptococcus (GBS) culture performed between 35 and 37 weeks
Exclusion Criteria:
- active labor
- absence of GBS culture or indication for GBS antibiotic prophylaxis (such as maternal GBS colonization between 35 and 37 weeks, GBS bacteriuria, prior infant with GBS sepsis)
- contraindication to expectant management (such as fetal distress, meconium staining of the amniotic fluid or chorioamnionitis) or to vaginal delivery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control group
|
|
ACTIVE_COMPARATOR: Antibiotic group
women submitted to antibiotic prophylaxis
|
ampicillin 1 g every six hours and gentamicin 240 mg every day intravenously
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
neonatal infection rate
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
|
neonatal infection rate includes early onset sepsis, meningitis and pneumonia
|
participants will be followed for the duration of hospital stay, an expected average of 3 days
|
maternal infection rate
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
|
maternal infection rate includes chorioamnionitis or puerperal endometritis
|
participants will be followed for the duration of hospital stay, an expected average of 3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
comparison of the infection rates between prompt and delayed induction
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
|
rate of maternal and neonatal infection between prompt (<12h) and delayed induction (≥12h) in the group of patients not submitted to antibiotic prophylaxis
|
participants will be followed for the duration of hospital stay, an expected average of 3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Filipa Faria Vaz Passos, Dr, Santa Maria Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (ACTUAL)
January 1, 2011
Study Completion (ACTUAL)
January 1, 2012
Study Registration Dates
First Submitted
June 23, 2012
First Submitted That Met QC Criteria
June 30, 2012
First Posted (ESTIMATE)
July 4, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
November 28, 2016
Last Update Submitted That Met QC Criteria
November 24, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Central Nervous System Diseases
- Nervous System Diseases
- Infections
- Systemic Inflammatory Response Syndrome
- Inflammation
- Uterine Diseases
- Wounds and Injuries
- Adnexal Diseases
- Infant, Newborn, Diseases
- Sepsis
- Fetal Diseases
- Pregnancy Complications
- Obstetric Labor Complications
- Placenta Diseases
- Pelvic Inflammatory Disease
- Chorioamnionitis
- Rupture
- Meningitis
- Fetal Membranes, Premature Rupture
- Endometritis
- Neonatal Sepsis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Protein Synthesis Inhibitors
- Ampicillin
- Gentamicins
Other Study ID Numbers
- 335/08 - 28/07/08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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