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

NCT02131818 | Terminated Phase 4

• 1 other identifier: SI-OBG-CEU-01-2014
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Perineal Wound Infection

Keywords

amoxicillin; postpartum infections; puerperal infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Amoxicillin DRUG

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

Also known as: Drug A, Drug B

Amoxicillin

Placebo DRUG

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

Also known as: Drug A, Drug B

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Term pregnancy
• Normal labor

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hoapital Mahidol University

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Puerperal Infection

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Pregnancy Complications, Infectious; Infections; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Vitaya Titapant, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: May 6, 2014
• Study Start: May 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

TH (1)