MedDataX Logo

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

NCT ID: NCT02131818

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Perineal Wound Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Amoxicillin

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

Group Type EXPERIMENTAL

Amoxicillin

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Amoxicillin

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Drug A Drug B Drug A Drug B

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Vitaya Titapant, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Medicine Siriraj Hoapital Mahidol University

Bangkok, , Thailand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Thailand

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SI-OBG-CEU-01-2014

Identifier Type: -

Identifier Source: org_study_id