Surgical Site InfectionNCT06154720
Surgical Site Infection After Episiotomy Repair Related to Routine Use of Antibiotic Prophylaxis in Low-Risk Population
An observational study of Surgical Site Infection, run by Ain Shams University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Antibiotics
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2022to 29 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Patients who underwent elective episiotomy.
- Gestational age 37 weeks or more
Who cannot join
- 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.
Show all 10Show fewer
- Retained placenta and manual removal of placenta and post partum haemorrhage.
- Anaemic patients.
- On steroid or immunocompromised status.
- Diabetic patients
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Antibiotics
- Keywords
- Episiotomy Repair
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticsDrug
Also called Augmentin 625 mg, Co-amoxicalv 625 mg
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Antibiotics | |
| Control Group | women who did not receive antibiotics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound infection at site of episiotomy
Follow up through a visit or telephone call a weekly until 6 weeks
Measured: 6 weeks
Secondary outcomes (3)
high temperature
body temperature of 38 degrees Celsius or higher occurring on any two occasions in the first 10 days postpartum, exclusive of the first 24 hours.
Measured: 6 weeks
Urinary tract infection
through pus cells in urine analysis
Measured: 6 weeks
Intrauterine infection
through offensive vaginal discharge and uterine tenderness
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start10 Sep 2022
- Primary completion1 Jun 2023
- Study completion29 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwan Elkady, Ain Shams University
- Investigators
- Marwan El-Kady, MD, Study director, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154720
- Sponsor's protocol ID
- Surgical Site Infection
- Status last verified
- Dec 2023
- First submitted
- 24 Nov 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06154720
- Acronym / sponsor ID
- Surgical Site Infection
- Conditions
- Surgical Site Infection
- Keywords
- Episiotomy Repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Sep 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 4 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Drug: Antibioticswomen 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 |
| Control Group | – | –women who did not receive antibiotics. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Patients who underwent elective episiotomy.
- Gestational age 37 weeks or more
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntibioticsAlso: Augmentin 625 mg, Co-amoxicalv 625 mgAfter 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). | Drug | Study Group |
Primary outcome
wound infection at site of episiotomy
Time frame: 6 weeks
Follow up through a visit or telephone call a weekly until 6 weeks
3 secondary outcomes
high temperature
Time frame: 6 weeks
Urinary tract infection
Time frame: 6 weeks
Intrauterine infection
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwan El-Kady, MD study director
Ain Shams Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Site Infection, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound infection at site of episiotomy (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.