Surgical Site Infection After Episiotomy Repair Related to Routine Use of Antibiotic Prophylaxis in Low-Risk Population

NCT06154720 | Completed

• 1 other identifier: Surgical Site Infection
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Bacterial infections occurring during labor, childbirth, and the puerperium may be associated with considerable maternal and perinatal morbidity and mortality. Antibiotic prophylaxis might reduce wound infection incidence after an episiotomy, particularly in situations associated with a higher risk of postpartum perineal infection, such as midline episiotomy, extension of the incision, or in settings where the baseline risk of infection after vaginal birth is high. However, available evidence is unclear concerning the role of prophylactic antibiotics in preventing infections after an episiotomy.

Conditions

Surgical Site Infection

Keywords

Episiotomy Repair

Outcome Measures

Primary Outcomes (1)

• wound infection at site of episiotomy

  Follow up through a visit or telephone call a weekly until 6 weeks

  6 weeks

Secondary Outcomes (3)

• high temperature

  6 weeks

• Urinary tract infection

  6 weeks

• Intrauterine infection

  6 weeks

Study Arms (2)

Study Group

women who received co-amoxiclav 625gm (Megamox® film-coated tablet formed of clavulanic acid 125 mg + amoxicillin 500 mg) tab twice daily for 3 days after delivery

Drug: Antibiotics

Control Group

women who did not receive antibiotics.

Interventions

Antibiotics DRUG

After the woman had a repaired episiotomy following uncomplicated vaginal birth at 37 weeks or greater with no indication for ongoing antibiotics in the postpartum period. The patients were randomized to receive a co-amoxiclav 625mg (study group) tabs twice daily for 3 days after delivery or no antibiotic arm (control group).

Also known as: Augmentin 625 mg, Co-amoxicalv 625 mg

Study Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The target populations of this study were all patients who underwent episiotomy repair following uncomplicated vaginal birth at 37 weeks or greater with no indication for ongoing antibiotics in the postpartum period.

You may qualify if:

• Patients who underwent elective episiotomy.
• Gestational age 37 weeks or more

You may not qualify if:

• Patients with pro-longed rupture of membranes (PROM \>24hrs).
• pro- longed prelabour rupture of membranes (PPROM).
• Chorioamnionitis.
• Prolonged second stage of labour (\>2hrs).
• Third- or fourth-degree vaginal tears.
• Instrumental delivery like forceps or vacuum.
• Retained placenta and manual removal of placenta and post partum haemorrhage.
• Anaemic patients.
• On steroid or immunocompromised status.
• Diabetic patients

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams Maternity hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Anti-Bacterial Agents; Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Marwan El-Kady, MD

  Ain Shams Maternity Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 4, 2023
• Study Start: September 10, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 29, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)