Necessity of Antibiotics for Prevention of Delivery-assoc... | NCT02131818

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

NCT02131818

Sponsor

Mahidol University

Status

Terminated

Last Update Posted

Dec 3, 2015Estimated

Enrollment

5Actual

Phase

Phase 4

Conditions

Perineal Wound Infection

Interventions

Amoxicillin
Placebo

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The enrollment process is too difficult to complete

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Nov 2015Actual

Completion Date

Nov 2015Actual

First Submitted Date

Apr 28, 2014

First Submission Date that Met QC Criteria

May 4, 2014

First Posted Date

May 6, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2015

Last Update Posted Date

Dec 3, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Amoxicillin	Experimental	The patient will be received amoxicillin 500 mg 2 capsules orally bid pc for 5 days	Drug: Amoxicillin
Placebo	Placebo Comparator	The patient will be received placebo 2 capsules orally bid pc for 5 days	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Amoxicillin	Drug	The patient will be received amoxicillin 500 mg 2 capsules orally bid pc for 5 days	Amoxicillin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vitaya Titapant, MD	Department of Obstetrics & Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine Siriraj Hoapital Mahidol University		Bangkok		10700	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D011645	Puerperal Infection

Ancestor Terms

ID	Term
D011251	Pregnancy Complications, Infectious
D007239	Infections
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000658	Amoxicillin

Ancestor Terms

ID	Term
D000667	Ampicillin
D010400	Penicillin G
D010406	Penicillins
D047090	beta-Lactams
D007769

Browse Leaves

Not provided

Browse Branches

Not provided