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

Mahidol University

Status and phase

Terminated

Phase 4

Conditions

Perineal Wound Infection

Treatments

Drug: Placebo

Drug: Amoxicillin

Study type

Interventional

Funder types

Other

Identifiers

NCT02131818

SI-OBG-CEU-01-2014

Details and patient eligibility

About

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

Full 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.

Enrollment

5 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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