Clinical trial NCT06154720: Surgical Site Infection After Episiotomy Repair Related to Routine Use of Antibiotic Prophylaxis in Low-Risk Population
Official title: Surgical Site Infection Following Episiotomy Repair in Relation to Routine Use of Postpartum Antibiotic Prophylaxis in Low Risk Population: A Randomized Controlled Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Site Infection
Keywords: Episiotomy Repair
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: wound infection at site of episiotomy
timeFrame: 6 weeks
Secondary outcomes:
measure: high temperature
timeFrame: 6 weeks
measure: Urinary tract infection
timeFrame: 6 weeks
measure: Intrauterine infection
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity hospital
Study officials:
affiliation: Ain Shams Maternity Hospital
name: Marwan El-Kady, MD
role: STUDY_DIRECTOR
References: