Necessity of Antibiotics for Prevention of Delivery-associated Infections After Spontaneous Vaginal Delivery at Term
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Mahidol University
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Incidence of perineal wound infection
Study Overview
Brief Summary
The purpose of this study is to determine amoxicillin is effective in the prevention of wound infection in normal labor.
Detailed 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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Term pregnancy
- •Normal labor
Exclusion Criteria
- •Penicillin allergy
- •Previous history antibiotic using within 2 weeks
- •Patients cannot take oral medication
- •Patients have underlying disease eg. diabetes mellitus, hypertension, HIV infection
- •Premature rupture of membranes
Arms & Interventions
Amoxicillin
The patient will be received amoxicillin 500 mg 2 capsules orally bid pc for 5 days
Intervention: Amoxicillin (Drug)
Placebo
The patient will be received placebo 2 capsules orally bid pc for 5 days
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Incidence of perineal wound infection
Time Frame: within 6 weeks after normal labor
Follow up perineal wound every day during admission and follow up 6 weeks after discharge
Secondary Outcomes
No secondary outcomes reported