Recruitment

Recruitment Status
Terminated
Estimated Enrollment
1600

Inclusion Criterias

Normal labor
Term pregnancy
Normal labor
Term pregnancy

Exclusion Criterias

Patients cannot take oral medication
Premature rupture of membranes
Penicillin allergy
...
Patients cannot take oral medication
Premature rupture of membranes
Penicillin allergy
Patients have underlying disease eg. diabetes mellitus, hypertension, HIV infection
Previous history antibiotic using within 2 weeks

Summary

Conditions
Perineal Wound Infection
Type
Interventional
Phase
Phase 4
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 50 years
Gender
Only females

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 microbiolog...

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.

Inclusion Criterias

Normal labor
Term pregnancy
Normal labor
Term pregnancy

Exclusion Criterias

Patients cannot take oral medication
Premature rupture of membranes
Penicillin allergy
...
Patients cannot take oral medication
Premature rupture of membranes
Penicillin allergy
Patients have underlying disease eg. diabetes mellitus, hypertension, HIV infection
Previous history antibiotic using within 2 weeks

Locations

Bangkok, 10700
Bangkok, 10700

Tracking Information

NCT #
NCT02131818
Collaborators
Not Provided
Investigators
  • Principal Investigator: Vitaya Titapant, MD Department of Obstetrics & Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
  • Vitaya Titapant, MD Department of Obstetrics & Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand