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

Phase 4

Terminated

• Conditions: Perineal Wound Infection
• Interventions: Drug: Placebo; Drug: Amoxicillin

• Registration Number: NCT02131818
• Lead Sponsor: Mahidol University

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 Timeline

• Study First Submitted: 2014-04-28
• Study Start: 2014-05
• Study First Submitted QC: 2014-05-04
• Study First Posted: 2014-05-06
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	The patient will be received placebo 2 capsules orally bid pc for 5 days
Amoxicillin	Amoxicillin	The patient will be received amoxicillin 500 mg 2 capsules orally bid pc for 5 days

Primary Outcome Measures

Name	Time	Method
Incidence of perineal wound infection	within 6 weeks after normal labor	Follow up perineal wound every day during admission and follow up 6 weeks after discharge

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hoapital Mahidol University; 🇹🇭 Bangkok, Thailand