NCT03187106

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2017

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2023

Completed
Last Updated

August 16, 2023

Status Verified

August 1, 2023

Enrollment Period

6 years

First QC Date

June 12, 2017

Last Update Submit

August 15, 2023

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

  • 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

    6 weeks postpartum

Secondary Outcomes (6)

  • Maternal mortality

    6 weeks (42 days) postpartum

  • Febrile morbidity

    6 weeks (42 days) postpartum

  • Postpartum antibiotic use

    6 weeks (42 days) postpartum

  • Wound hematoma or seroma

    6 weeks (42 days) postpartum

  • Use of resources

    6 weeks (42 days) postpartum

  • +1 more secondary outcomes

Study Arms (2)

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

Drug: CephalexinDrug: Metronidazole

Placebo / standard of care

PLACEBO COMPARATOR

Placebo pills per oral every 8 hours for a total of 6 doses

Drug: Placebo

Interventions

CephalexinDRUG

Other name(s): Keflex (cephalexin) Cephalexin at 500 mg per oral every 8 hours for a total of 6 doses

Cephalexin and metronidazole
PlaceboDRUG

Placebo representing standard of care

Placebo / standard of care
MetronidazoleDRUG

Other name(s): Flagyl (metronidazole) Metronidazole at 500 mg per oral every 8 hours for a total of 6 doses

Cephalexin and metronidazole

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. David's North Austin Medical Center

Austin, Texas, 78758, United States

Location

University of Texas Medical Branch John Sealy Hospital

Galveston, Texas, 77555, United States

Location

Related Publications (1)

  • 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.

    PMID: 40403315DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

CephalexinMetronidazole

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNitroimidazolesNitro CompoundsImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Antonio F Saad, MD

    University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2017

First Posted

June 14, 2017

Study Start

August 1, 2017

Primary Completion

July 21, 2023

Study Completion

July 21, 2023

Last Updated

August 16, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)