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

Primary Purpose

Perineal Wound Infection

Status

Terminated

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

Amoxicillin

Placebo

About this trial

This is an interventional prevention trial for Perineal Wound Infection focused on measuring amoxicillin, postpartum infections, puerperal infection

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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

Sites / Locations

Faculty of Medicine Siriraj Hoapital Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Amoxicillin

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence of perineal wound infection

Follow up perineal wound every day during admission and follow up 6 weeks after discharge

Secondary Outcome Measures

Full Information

NCT ID

NCT02131818

First Posted

April 28, 2014

Last Updated

December 1, 2015

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT02131818

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Terminated

Why Stopped

The enrollment process is too difficult to complete

Study Start Date

May 2014 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mahidol University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Perineal Wound Infection

Keywords

amoxicillin, postpartum infections, puerperal infection

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Amoxicillin

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Amoxicillin

Other Intervention Name(s)

Drug A, Drug B

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Drug A, Drug B

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of perineal wound infection

Description

Follow up perineal wound every day during admission and follow up 6 weeks after discharge

Time Frame

within 6 weeks after normal labor

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vitaya Titapant, MD

Organizational Affiliation

Department of Obstetrics & Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Medicine Siriraj Hoapital Mahidol University

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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