Surgical Site InfectionPhase 1PACTNCT03187106
Prophylactic Antibiotics After Cesarean
A Phase 1 study testing Cephalexin and Metronidazole in people with Surgical Site Infection, run by The University of Texas Medical Branch, Galveston at 2 sites in United States.
Trial summary
The purpose of this study is to determine if the addition of a 48-hour course of post-operative antibiotics to the recommended course of pre-operative antibiotics improves surgical site infection rate in patients who are obese and undergo Cesarean section after laboring. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Cephalexin and Metronidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 321 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2017to 21 Jul 2023
- Phase
- Phase 1
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women >18 and <50 years
- BMI >30kg/m2
- Decision by clinical team to perform Cesarean section
- Rupture of membranes (ROM) < 24 hours after onset of labor or during the course of labor (ROM defined by spontaneous or artificial rupture of the amniotic sac)
Who cannot join
- Subject unwilling or unable to provide consent
- No prenatal care or a non-UTMB subject who is unlikely to be followed up after delivery
- Fetal demise or major congenital anomaly
- Immunosuppressed subjects: i.e., taking systemic immunosuppressants or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4<200, or other
- Diagnosis or suspicion of chorioamnionitis prior to randomization
- Other planned post-operative antibiotic administration
Show all 9Show fewer
- High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, bowel or adnexal surgery)
- Known allergy or contraindication to cephalosporins or metronidazole
- Incarcerated individuals
Trial locations and contacts
2 sites in 1 country.
United States2 sites
St. David's North Austin Medical Center
Austin, Texas, 78758
University of Texas Medical Branch John Sealy Hospital
Galveston, Texas, 77555
About this study
The purpose of this study is to determine if the addition of a 48-hour course of post-operative antibiotics to the recommended course of pre-operative antibiotics improves surgical site infection rate in patients who are obese and undergo Cesarean section after laboring.
Read the detailed description
The investigators propose the conduction of a prospective, randomized, double-blinded clinical trial to evaluate an alternative prophylactic regimen for the prevention of surgical site infection in women who are obese and have been laboring prior to their Cesarean section. This study is to be conducted by the Department of Obstetrics \& Gynecology at John Sealy Hospital at the University of Texas Medical Branch in Galveston, Texas. The intervention being studied will be the administration of cephalexin and metronidazole post-operatively for 48 hours. The primary outcome measure will be surgical site infection (including superficial or deep incisional surgical site infection, endometritis, and other related infections, such as septic pelvic thrombophlebitis and abdominal or pelvic abscess) in the post-operative period.
In order to most effectively and accurately analyze our primary and secondary research outcomes, the investigators will standardize our surgical operation techniques in all ways feasible. These recommendations will be in concordance with American College of Obstetrics and Gynecology recommendations, as those generally accepted in the medical literature. All patients will undergo surgery in the same small group of HEPA-filtered and positive air-pressure operating rooms. Appropriate limitations on number of surgeons and assistants scrubbed for surgery, as well as general OR traffic, will be enforced. Patients will undergo hair clipping of the incision site when appropriate. Chlorhexidine skin decontamination will be the standard surgical site preparation. An adhesive drape will be used. Prior to skin incision, cefazolin and azithromycin will be administered.
All patients to be considered for recruitment to this study will be undergoing delivery at John Sealy Hospital at the University of Texas Medical Branch in Galveston, Texas. Patients with an elevated BMI >or =30 kg/m2 who undergo cesarean section after laboring will be considered for randomization either prior to delivery or in the first 7 hours after delivery, to accommodate the need for the first dose of study medication or placebo 8 hours after surgery. Only patients who agree to inclusion after informed consent will be randomized per protocol.
- Conditions
- Surgical Site Infection
- Being tested
- Cephalexin, Placebo, Metronidazole
- 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.
CephalexinDrug
Other name(s): Keflex (cephalexin) Cephalexin at 500 mg per oral every 8 hours for a total of 6 doses
PlaceboDrug
Placebo representing standard of care
MetronidazoleDrug
Other name(s): Flagyl (metronidazole) Metronidazole at 500 mg per oral every 8 hours for a total of 6 doses
| Study group | Role | What they receive |
|---|---|---|
| Cephalexin and metronidazole | Experimental | 500 mg cephalexin per oral every 8 hours for a total of 6 doses; 500 mg metronidazole per oral every 8 hours for a total of 6 doses Receives: Drug: Cephalexin; Drug: Metronidazole |
| Placebo / standard of care | Placebo comparator | Placebo pills per oral every 8 hours for a total of 6 doses Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
Including superficial or deep incisional surgical site infection, endometritis, and other related infections, such as septic pelvic thrombophlebitis and abdominal or pelvic abscess
Measured: 6 weeks postpartum
Secondary outcomes (6)
Maternal mortality
Maternal death
Measured: 6 weeks (42 days) postpartum
Febrile morbidity
If the patient develops a measured temperate greater than or equal to 100.4 degrees Fahrenheit (or 38.0 degrees Celsius), she will have a postpartum fever.
Measured: 6 weeks (42 days) postpartum
Postpartum antibiotic use
We will assess via chart review and direct patient inquiry whether or not antibiotics were taken by the patient for any purpose during the six weeks (42 days) immediately following delivery.
Measured: 6 weeks (42 days) postpartum
Wound hematoma or seroma
Wound hematoma or seroma, as diagnosed by a medical provider, according to CDC guidelines for diagnosis of wound hematoma or seroma
Measured: 6 weeks (42 days) postpartum
Use of resources
We will note whether the patient required hospital re-admission, emergency department visits, or need for imaging or other invasive procedures
Measured: 6 weeks (42 days) postpartum
Other adverse events
Such as allergic reaction to study medications
Measured: 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start1 Aug 2017
- Primary completion21 Jul 2023
- Study completion21 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio F Saad, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187106
- Sponsor's protocol ID
- 17-0035
- Acronym
- PACT
- Status last verified
- Aug 2023
- First submitted
- 12 Jun 2017
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saad AF, Goldman B, Spencer N, Kuhlmann M, McDonnold M, Saade GR. Prophylactic Oral Cephalexin and Metronidazole Compared With Placebo After Cesarean Delivery to Reduce Infection Complications in Women With Obesity: A Randomized Controlled Trial. Obstet Gynecol. 2025 May 22;146(1):113-120. doi: 10.1097/AOG.0000000000005936.
PubMed 40403315
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Antibiotics After Cesarean
- ClinicalTrials.gov ID
- NCT03187106
- Acronym / sponsor ID
- PACT / 17-0035
- Conditions
- Surgical Site Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 14 Jun 2017 (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.
The purpose of this study is to determine if the addition of a 48-hour course of post-operative antibiotics to the recommended course of pre-operative antibiotics improves surgical site infection rate in patients who are obese and undergo Cesarean section after laboring.
Detailed description
The investigators propose the conduction of a prospective, randomized, double-blinded clinical trial to evaluate an alternative prophylactic regimen for the prevention of surgical site infection in women who are obese and have been laboring prior to their Cesarean section. This study is to be conducted by the Department of Obstetrics \& Gynecology at John Sealy Hospital at the University of Texas Medical Branch in Galveston, Texas. The intervention being studied will be the administration of cephalexin and metronidazole post-operatively for 48 hours. The primary outcome measure will be surgical site infection (including superficial or deep incisional surgical site infection, endometritis, and other related infections, such as septic pelvic thrombophlebitis and abdominal or pelvic abscess) in the post-operative period.
In order to most effectively and accurately analyze our primary and secondary research outcomes, the investigators will standardize our surgical operation techniques in all ways feasible. These recommendations will be in concordance with American College of Obstetrics and Gynecology recommendations, as those generally accepted in the medical literature. All patients will undergo surgery in the same small group of HEPA-filtered and positive air-pressure operating rooms. Appropriate limitations on number of surgeons and assistants scrubbed for surgery, as well as general OR traffic, will be enforced. Patients will undergo hair clipping of the incision site when appropriate. Chlorhexidine skin decontamination will be the standard surgical site preparation. An adhesive drape will be used. Prior to skin incision, cefazolin and azithromycin will be administered.
All patients to be considered for recruitment to this study will be undergoing delivery at John Sealy Hospital at the University of Texas Medical Branch in Galveston, Texas. Patients with an elevated BMI >or =30 kg/m2 who undergo cesarean section after laboring will be considered for randomization either prior to delivery or in the first 7 hours after delivery, to accommodate the need for the first dose of study medication or placebo 8 hours after surgery. Only patients who agree to inclusion after informed consent will be randomized per protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cephalexin and metronidazole | Experimental | Drug: Cephalexin, Drug: Metronidazole500 mg cephalexin per oral every 8 hours for a total of 6 doses; 500 mg metronidazole per oral every 8 hours for a total of 6 doses |
| Placebo / standard of care | Placebo comparator | Drug: PlaceboPlacebo pills per oral every 8 hours for a total of 6 doses |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women >18 and <50 years
- BMI >30kg/m2
- Decision by clinical team to perform Cesarean section
- Rupture of membranes (ROM) < 24 hours after onset of labor or during the course of labor (ROM defined by spontaneous or artificial rupture of the amniotic sac)
Key exclusion criteria (9 listed)
- Subject unwilling or unable to provide consent
- No prenatal care or a non-UTMB subject who is unlikely to be followed up after delivery
- Fetal demise or major congenital anomaly
- Immunosuppressed subjects: i.e., taking systemic immunosuppressants or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4<200, or other
- Diagnosis or suspicion of chorioamnionitis prior to randomization
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 |
|---|---|---|
| CephalexinOther name(s): Keflex (cephalexin) Cephalexin at 500 mg per oral every 8 hours for a total of 6 doses | Drug | Cephalexin and metronidazole |
| PlaceboPlacebo representing standard of care | Drug | Placebo / standard of care |
| MetronidazoleOther name(s): Flagyl (metronidazole) Metronidazole at 500 mg per oral every 8 hours for a total of 6 doses | Drug | Cephalexin and metronidazole |
Primary outcome
Surgical site infection
Time frame: 6 weeks postpartum
Including superficial or deep incisional surgical site infection, endometritis, and other related infections, such as septic pelvic thrombophlebitis and abdominal or pelvic abscess
6 secondary outcomes
Maternal mortality
Time frame: 6 weeks (42 days) postpartum
Febrile morbidity
Time frame: 6 weeks (42 days) postpartum
Postpartum antibiotic use
Time frame: 6 weeks (42 days) postpartum
Wound hematoma or seroma
Time frame: 6 weeks (42 days) postpartum
Use of resources
Time frame: 6 weeks (42 days) postpartum
Other adverse events
Time frame: 6 weeks postpartum
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 16 Aug 2023.
- Derived from this study: PubMed 40403315Saad AF, Goldman B, Spencer N, Kuhlmann M, McDonnold M, Saade GR. Prophylactic Oral Cephalexin and Metronidazole Compared With Placebo After Cesarean Delivery to Reduce Infection Complications in Women With Obesity: A Randomized Controlled Trial. Obstet Gynecol. 2025 May 22;146(1):113-120. doi: 10.1097/AOG.0000000000005936.
- 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.
Antonio F Saad, MD principal investigator
University of Texas
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cephalexin and Metronidazole in people with Surgical Site Infection, run by The University of Texas Medical Branch, Galveston at 2 sites 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 4 inclusion and 9 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 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Surgical site infection (time frame: 6 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03187106, which also lists 1 linked publication.
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 16 Aug 2023.