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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Andrea Villegas, M.A. contact

312-503-1447

andrea.villegas@nm.org

Amelia Joblin, M.S. contact

312-695-7748

amelia.joblin@nm.org

United States1 site, 1 recruiting
  • Prentice Women's Hospital

    Chicago, Illinois, 60611

    Andrea Villegas, 312-503-1447, andrea.villeags@nm.org

    Christina Lewicky-Gaupp, M.D

    Recruiting

Other trials in United States

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.

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 groups in NCT04573504
Study groupRoleWhat they receive
Antibiotic GroupExperimentalThe 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 GroupPlacebo comparatorWomen 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.

  1. 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.

  1. First posted5 Oct 2020
  2. Study start23 Sep 2020
  3. Primary completion23 Sep 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

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)
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

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.

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