Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06154720 |
| Other study ID # |
Surgical Site Infection |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 10, 2022 |
| Est. completion date |
June 29, 2023 |
Study information
| Verified date |
December 2023 |
| Source |
Ain Shams University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
