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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02131818

Enrollment

Registered

2014-05-06

Start date

2014-05-31

Completion date

2015-11-30

Last updated

2015-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perineal Wound Infection

Keywords

amoxicillin, postpartum infections, puerperal infection

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.

Interventions

DRUGAmoxicillin

The patient will be received amoxicillin 500 mg 2 capsules orally bid pc for 5 days

DRUGPlacebo

The patient will be received placebo 2 capsules orally bid pc for 5 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026