Necessity of Antibiotics for Prevention of Delivery-associated Infections After Spontaneous Vaginal Delivery at Term
Last updated on April 2022Recruitment
- Recruitment Status
- Terminated
- Estimated Enrollment
- 1600
Inclusion Criteria
- Term pregnancy
- Normal labor
- Term pregnancy
- Normal labor
Exclusion Criteria
- Premature rupture of membranes
- Previous history antibiotic using within 2 weeks
- Patients have underlying disease eg. diabetes mellitus, hypertension, HIV infection
- ...
- Premature rupture of membranes
- Previous history antibiotic using within 2 weeks
- Patients have underlying disease eg. diabetes mellitus, hypertension, HIV infection
- Penicillin allergy
- Patients cannot take oral medication
Summary
- Conditions
- Perineal Wound Infection
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 50 years
- Gender
- Only females
Description
When the pregnant women is admitted due to first stage of labor , the investigator will inform the patients. If the patients give consent, the patient's data will be collect in case record form. the patients will be swab at posterior fornix and around anus to collect specimen and send to microbiolog...
When the pregnant women is admitted due to first stage of labor , the investigator will inform the patients. If the patients give consent, the patient's data will be collect in case record form. the patients will be swab at posterior fornix and around anus to collect specimen and send to microbiology lab before per vaginal examination. After the patients finish in labor, perineal wound will be swab to collect specimen and send to microbiology lab. Then the patients are randomized in two group, the first one will receive amoxicillin and the second one will receive placebo. During admission the patients will be exam by investigator every day. After the patients are discharge, the follow up will be appoint on 6 weeks later. The infant will be swab at rectum to collect specimen and send to microbiology lab when the patient's discharge day. Every specimen will be culture for bacteria and perform antimicrobial susceptibility test for amoxicillin.
Inclusion Criteria
- Term pregnancy
- Normal labor
- Term pregnancy
- Normal labor
Exclusion Criteria
- Premature rupture of membranes
- Previous history antibiotic using within 2 weeks
- Patients have underlying disease eg. diabetes mellitus, hypertension, HIV infection
- ...
- Premature rupture of membranes
- Previous history antibiotic using within 2 weeks
- Patients have underlying disease eg. diabetes mellitus, hypertension, HIV infection
- Penicillin allergy
- Patients cannot take oral medication
Tracking Information
- NCT #
- NCT02131818
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Vitaya Titapant, MD Department of Obstetrics & Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
- Vitaya Titapant, MD Department of Obstetrics & Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
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