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

NCT ID: NCT06154720

Last Updated: 2023-12-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-10
• Study Completion Date: 2023-06-29

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.

Detailed Description

Maternal mortality is unacceptably high worldwide, with an estimated 300,000 women dying in 2017, of which around 200,000 deaths were in sub-Saharan Africa. Maternal infection, leading to sepsis, is a leading contributor to these deaths. Yet data for the incidence and cause of maternal infection are scarce.

Several pre-existing maternal conditions may increase the risk of developing bacterial infections among women expected to have uncomplicated vaginal births. These include conditions such as malnutrition, anemia, bacterial vaginosis, and group B streptococcus infections. In addition, complications during labor and childbirth (e.g. prolonged rupture of membranes, prolonged labor, lacerations of the genital tract and retained products of conception) or provider interventions (e.g. frequent vaginal examinations, operative vaginal birth (forceps, vacuum), and episiotomy) might increase the risk of infection in the puerperium.

Episiotomy is an intended incision taken on the perineum during the second stage of labor considered for indications in which failure to perform it will result in significant perineal rupture.

Spontaneous vaginal delivery (SVD) is one which occurs when a pregnant woman goes into labor without the use of drugs or other techniques to induce labor and she delivers her baby through the vagina (birth canal) without forceps, vacuum extraction, or a cesarean section. Out of the about four million deliveries occurring in the United States each year, most of them are spontaneous vaginal deliveries.

Socioeconomic status (SES) is one of the most important factors associated with medical outcomes. When SES is low, medical care is inadequate and this has been attributed to adverse outcomes. In pregnant women, low SES can increase the risk of adverse pregnancy outcomes.

Antibiotic prophylaxis is recommended to avoid infectious complications of infection-prone obstetrical procedures, such as caesarean section, manual removal of the placenta, and repair of third- or fourth-degree perineal tears. Episiotomies are anatomically similar to a second-degree perineal laceration, involving the vaginal mucosa, connective tissue, and underlying muscles, and might not warrant the routine use of prophylactic antibiotics. However, the use of prophylactic antibiotics for episiotomies seems to vary widely. While in high-income countries there is, to our knowledge, no report on the use of prophylactic antibiotics for episiotomies, and clinical recommendations do not mention their use in the absence of infection, it seems to be very common practice in some low-income countries, where the majority of women have episiotomies and receive prophylactic antibiotics.

Conditions

Surgical Site Infection

Keywords

Episiotomy Repair

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Antibiotics

Intervention Type: 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).

Control Group

women who did not receive antibiotics.

No interventions assigned to this group

Interventions

Antibiotics

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).

Intervention Type: DRUG

Other Intervention Names

Augmentin 625 mg; Co-amoxicalv 625 mg

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Marwan Elkady

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marwan El-Kady, MD

Role: STUDY_DIRECTOR

Ain Shams Maternity Hospital

Locations

Ain Shams Maternity hospital

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Surgical Site Infection

Identifier Type: -

Identifier Source: org_study_id