Necessity of Antibiotics for Prevention of Delivery-associated Infections After Spontaneous Vaginal Delivery at Term

Study Overview
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Brief Summary
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The purpose of this study is to determine amoxicillin is effective in the prevention of wound infection in normal labor.

Detailed Description
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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.

Official Title
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Necessity of Antibiotics for Prevention of Delivery-associated Infections After Spontaneous Vaginal Delivery at Term

Conditions
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Perineal Wound Infection

Intervention / Treatment
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* Drug: Amoxicillin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amoxicillin<br>The patient will be received amoxicillin 500 mg 2 capsules orally bid pc for 5 days | Drug: Amoxicillin<br>* The patient will be received amoxicillin 500 mg 2 capsules orally bid pc for 5 days<br>* Other names: Drug B;|
| Placebo Comparator: Placebo<br>The patient will be received placebo 2 capsules orally bid pc for 5 days | Drug: Placebo<br>* The patient will be received placebo 2 capsules orally bid pc for 5 days<br>* Other names: Drug B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of perineal wound infection | Follow up perineal wound every day during admission and follow up 6 weeks after discharge | within 6 weeks after normal labor | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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amoxicillin, postpartum infections, puerperal infection