Vaginal Laceration During DeliveryPhase 4ASPIReNCT04573504
Antibiotics for Severe Perineal Laceration to Prevent Infection Following Repair
A Phase 4 study testing Augmentin/Flagyl or Augmentin/Clindamycin in people with Vaginal Laceration During Delivery, run by Northwestern University at 1 site in United States.
Trial summary
Many women experience severe anal sphincter lacerations during childbirth, which put them at risk for infection, improper healing, and accidental bowel leakage. This study aims to determine if oral antibiotics following vaginal delivery in women with severe tears can prevent wound infection and breakdown, and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Laceration During Delivery
- What is being tested?
- Augmentin/Flagyl or Augmentin/Clindamycin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 274 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2020to 31 Dec 2024
- Phase
- Phase 4
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old and older
- 3rd or 4th degree laceration upon delivering vaginally at Prentice Women's Hospital
- English-speaking
- Administered Ancef during wound repair
- First Delivery
- Single child being born
- Term Delivery (i.e. at least 37 weeks gestation)
Who cannot join
- Under 18 years old
- Non-English speaking
- Delivery of more than one fetus (i.e. twins or other multiples)
- Patient is taking systemic steroids
- Allergy to Amoxicillin AND Clindamycin
- Infant with severe jaundice who is receiving breastmilk
- Women who have medical contraindications to the use of metronidazole, clindamycin, and amoxicillin clavulanate.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Prentice Women's Hospital
Chicago, Illinois, 60611
Andrea Villegas, 312-503-1447, andrea.villeags@nm.org
Christina Lewicky-Gaupp, M.D
About this study
Many women experience severe anal sphincter lacerations during childbirth, which put them at risk for infection, improper healing, and accidental bowel leakage. This study aims to determine if oral antibiotics following vaginal delivery in women with severe tears can prevent wound infection and breakdown, and ultimately, accidental bowel leakage. Women who suffer a severe vaginal laceration will be randomized to receive 5-days of oral antibiotics or placebo pills after getting a standard one-time dose of IV antibiotics at the time of repair. All women will have immediate, intensive follow-up with an Urogynecologist at our well-established PEAPOD peripartum clinic at 1 week, 2 weeks, and 3 months postpartum to monitor wound healing and infection. At these visits, we also will assess women's perception of their well-being, perineal pain, and bowel symptoms. All participants will be invited to remain in the study for long-term follow-up. Our goal is to establish whether a five-day course of oral antibiotics should be a standard part of clinical care for severe postpartum lacerations.
Read the detailed description
Approximately 3,000,000 women have vaginal deliveries each year in the United States.
Five percent, (i.e., 150,000) of these women will experience an obstetrical anal sphincter injury (OASIS). OASIS is associated with chronic pain and sexual dysfunction. Moreover, 25% of women with OASIS will suffer from chronic accidental bowel leakage. In other words, one new woman every 14 minutes experiences an injury that leads to uncontrollable leakage of stool and gas. This woman is not only a new mother, but she may also be a teacher, a construction worker, a nurse, a doctor, or an executive who will have to deal with this devastating and embarrassing condition for the rest of her life. At age 45, women suffer from accidental bowel leakage at a rate that is eight times higher than that of men of the same age (1).
It is likely that accidental bowel leakage is related not only to the structural disruptions that occur with OASIS, but also from complications, such as infection and poor wound healing. Women who suffer OASIS are at high risk for infection and poor healing; this is not surprising given that these lacerations are repaired and then continue to heal in a contaminated field (near stool). Poor healing and infection in the setting of OASIS make accidental bowel leakage, chronic pain, and sexual dysfunction even more likely (2-6). Unfortunately, even those infections that are recognized early and treated can still cause accidental bowel leakage decades after childbirth (7-9).
Despite the many women affected by OASIS and its debilitating ramifications through the arc of a woman's life, there is a lack of evidence-based best practice to guide treatment and follow-up when it does occur. Even though infection and poor healing compromise outcomes, there are limited data regarding best practice to prevent of these complications. The use of antibiotics at the time of OASIS repair has become common based on our division's previous studies (15-18). However, no studies have been done to determine whether oral antibiotics immediately postpartum can further decrease the incidence of short and long-term complications. The Royal College of Obstetricians and Gynecologists recommends the use of antibiotics after OASIS repair (10), however, the basis of this recommendation is founded only on expert opinion. On the other hand, the American College of Obstetricians and Gynecologists provides no recommendation with regard to whether antibiotics should be used in the postpartum time. At our institution, almost all women who sustain OASIS during vaginal delivery receive a single dose of IV antibiotics based on our previously published work at Prentice, however, that while many physicians chose to administer oral antibiotics based on expert opinions, it is unknown whether these provide any specific benefit - again as many physicians chose to administer antibiotics regardless of the evidence to date. Standard care postpartum both nationally and internationally is highly varied and likely based on physician training and preference (11).
Therefore, there is a great need for a trial to determine whether the use of supplemental antibiotics for 5 days postpartum will decrease rates of perineal wound infection and breakdown and improve maternal health outcomes. Such a trial will guide best practice, enhance the care of women, and potentially reduce the debilitating consequences of OASIS.
- Conditions
- Vaginal Laceration During Delivery
- Being tested
- Augmentin/Flagyl or Augmentin/Clindamycin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmentin/Flagyl or Augmentin/ClindamycinDrug
Women who suffer a severe vaginal laceration at Prentice Women's Hospital will be randomized to receive 5-days of oral antibiotics or placebo pills after getting a standard one-time dose of IV antibiotics at the time of repair.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic Group | Experimental | The antibiotic regimen chosen is based on the Royal College of Obstetricians and Gynecologists' recommendations (Augmentin and Flagyl or Clindamycin and Flagyl if they are allergic to Penicillin). The dosage for the antibiotics are the following: Flagyl 500mg po BID (twice a day) X 5 days, Clindamycin 400 mg po TID (three times a day) X 5 days, Augmentin 875mg po BID X 5 days. Receives: Drug: Augmentin/Flagyl or Augmentin/Clindamycin |
| Placebo Group | Placebo comparator | Women randomized not to receive antibiotics will be given placebo tablets postpartum, so they will all have an identical experience to the women in the experimental (antibiotic) group. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
This study has one endpoint which will be the 3-month postpartum visit and where all study participants will have completed their study questionnaires.
The primary outcome measure will be at the 3 month postpartum visit where all study participants have complete all study procedures and surveys. We anticipate it will take two years for all participants to have met the time frame of completing their 3 month post-partum visit.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start23 Sep 2020
- Primary completion23 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal Laceration During DeliveryStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oluwateniola Brown, Northwestern University
- Investigators
- Oluwateniola Brown, M.D, Principal investigator, Northwestern Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573504
- Sponsor's protocol ID
- STU00212963
- Acronym
- ASPIRe
- Status last verified
- Mar 2024
- First submitted
- 28 Sep 2020
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotics for Severe Perineal Laceration to Prevent Infection Following Repair
- ClinicalTrials.gov ID
- NCT04573504
- Acronym / sponsor ID
- ASPIRe / STU00212963
- Conditions
- Vaginal Laceration During Delivery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 23 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Oct 2020 (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.
Many women experience severe anal sphincter lacerations during childbirth, which put them at risk for infection, improper healing, and accidental bowel leakage. This study aims to determine if oral antibiotics following vaginal delivery in women with severe tears can prevent wound infection and breakdown, and ultimately, accidental bowel leakage. Women who suffer a severe vaginal laceration will be randomized to receive 5-days of oral antibiotics or placebo pills after getting a standard one-time dose of IV antibiotics at the time of repair. All women will have immediate, intensive follow-up with an Urogynecologist at our well-established PEAPOD peripartum clinic at 1 week, 2 weeks, and 3 months postpartum to monitor wound healing and infection. At these visits, we also will assess women's perception of their well-being, perineal pain, and bowel symptoms. All participants will be invited to remain in the study for long-term follow-up. Our goal is to establish whether a five-day course of oral antibiotics should be a standard part of clinical care for severe postpartum lacerations.
Detailed description
Approximately 3,000,000 women have vaginal deliveries each year in the United States.
Five percent, (i.e., 150,000) of these women will experience an obstetrical anal sphincter injury (OASIS). OASIS is associated with chronic pain and sexual dysfunction. Moreover, 25% of women with OASIS will suffer from chronic accidental bowel leakage. In other words, one new woman every 14 minutes experiences an injury that leads to uncontrollable leakage of stool and gas. This woman is not only a new mother, but she may also be a teacher, a construction worker, a nurse, a doctor, or an executive who will have to deal with this devastating and embarrassing condition for the rest of her life. At age 45, women suffer from accidental bowel leakage at a rate that is eight times higher than that of men of the same age (1).
It is likely that accidental bowel leakage is related not only to the structural disruptions that occur with OASIS, but also from complications, such as infection and poor wound healing. Women who suffer OASIS are at high risk for infection and poor healing; this is not surprising given that these lacerations are repaired and then continue to heal in a contaminated field (near stool). Poor healing and infection in the setting of OASIS make accidental bowel leakage, chronic pain, and sexual dysfunction even more likely (2-6). Unfortunately, even those infections that are recognized early and treated can still cause accidental bowel leakage decades after childbirth (7-9).
Despite the many women affected by OASIS and its debilitating ramifications through the arc of a woman's life, there is a lack of evidence-based best practice to guide treatment and follow-up when it does occur. Even though infection and poor healing compromise outcomes, there are limited data regarding best practice to prevent of these complications. The use of antibiotics at the time of OASIS repair has become common based on our division's previous studies (15-18). However, no studies have been done to determine whether oral antibiotics immediately postpartum can further decrease the incidence of short and long-term complications. The Royal College of Obstetricians and Gynecologists recommends the use of antibiotics after OASIS repair (10), however, the basis of this recommendation is founded only on expert opinion. On the other hand, the American College of Obstetricians and Gynecologists provides no recommendation with regard to whether antibiotics should be used in the postpartum time. At our institution, almost all women who sustain OASIS during vaginal delivery receive a single dose of IV antibiotics based on our previously published work at Prentice, however, that while many physicians chose to administer oral antibiotics based on expert opinions, it is unknown whether these provide any specific benefit - again as many physicians chose to administer antibiotics regardless of the evidence to date. Standard care postpartum both nationally and internationally is highly varied and likely based on physician training and preference (11).
Therefore, there is a great need for a trial to determine whether the use of supplemental antibiotics for 5 days postpartum will decrease rates of perineal wound infection and breakdown and improve maternal health outcomes. Such a trial will guide best practice, enhance the care of women, and potentially reduce the debilitating consequences of OASIS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic Group | Experimental | Drug: Augmentin/Flagyl or Augmentin/ClindamycinThe antibiotic regimen chosen is based on the Royal College of Obstetricians and Gynecologists' recommendations (Augmentin and Flagyl or Clindamycin and Flagyl if they are allergic to Penicillin). The dosage for the antibiotics are the following: Flagyl 500mg po BID (twice a day) X 5 days, Clindamycin 400 mg po TID (three times a day) X 5 days, Augmentin 875mg po BID X 5 days. |
| Placebo Group | Placebo comparator | Drug: PlaceboWomen randomized not to receive antibiotics will be given placebo tablets postpartum, so they will all have an identical experience to the women in the experimental (antibiotic) group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years old and older
- 3rd or 4th degree laceration upon delivering vaginally at Prentice Women's Hospital
- English-speaking
- Administered Ancef during wound repair
- First Delivery
Key exclusion criteria (7 listed)
- Under 18 years old
- Non-English speaking
- Delivery of more than one fetus (i.e. twins or other multiples)
- Patient is taking systemic steroids
- Allergy to Amoxicillin AND Clindamycin
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 |
|---|---|---|
| Augmentin/Flagyl or Augmentin/ClindamycinWomen who suffer a severe vaginal laceration at Prentice Women's Hospital will be randomized to receive 5-days of oral antibiotics or placebo pills after getting a standard one-time dose of IV antibiotics at the time of repair. | Drug | Antibiotic Group |
| PlaceboPlacebo | Drug | Placebo Group |
Primary outcome
This study has one endpoint which will be the 3-month postpartum visit and where all study participants will have completed their study questionnaires.
Time frame: 2 years
The primary outcome measure will be at the 3 month postpartum visit where all study participants have complete all study procedures and surveys. We anticipate it will take two years for all participants to have met the time frame of completing their 3 month post-partum visit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Vaginal Laceration During Delivery
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Prospective Study Comparing Two Classification Systems for Second-degree Vaginal Tears During Spontaneous Childbirth to Assess Their Ability to Predict Postpartum Complications.
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Study on Fewer Tears (SOFT) - The Effect of Local Anesthesia on the Incidence of Perineal Tears in the First Vaginal Birth
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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.
Oluwateniola Brown, M.D principal investigator
Northwestern Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Augmentin/Flagyl or Augmentin/Clindamycin in people with Vaginal Laceration During Delivery, run by Northwestern University at 1 site in United States.
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 2 Apr 2024. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Villegas, M.A. (312-503-1447, andrea.villegas@nm.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
This study has one endpoint which will be the 3-month postpartum visit and where all study participants will have completed their study questionnaires. (time frame: 2 years). 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 2 Apr 2024.