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

Perineal Wound Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02131818
• Other study ID #: SI-OBG-CEU-01-2014
• Status: Terminated
• Phase: Phase 4
• First received: April 28, 2014
• Last updated: December 1, 2015
• Start date: May 2014
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Perineal Wound Infection
• Wound Infection

Intervention

Drug:
• Amoxicillin
The patient will be received amoxicillin 500 mg 2 capsules orally bid pc for 5 days
• Placebo
The patient will be received placebo 2 capsules orally bid pc for 5 days

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hoapital Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes