Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-24 @ 1:20 PM
NCT ID:
NCT01587495
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older at the time of enrollment.
* Postpartum period \< 42 days at the time of enrollment.
* Sufficient venous access to permit administration of study medication.
* 2 clinical signs of postpartum endometritis:
* Oral body temperature of \> 101oF at any time, or a temperature of 100.4 on two occasions 6 hours apart.
* Maternal tachycardia that parallels the temperature.
* Uterine tenderness
* Purulent vaginal discharge
* Findings of advanced endometritis: dynamic ileus, pelvic peritonitis, pelvic abscess, bowel obstruction, necrosis of the lower uterine segment.
Exclusion Criteria:
* History of previous hypersensitivity reactions to beta lactams.
* Receiving valproic acid or divalproex sodium.
* Creatinine clearance \< 30 mL/min as calculated by the Cockroft-Gault equation.
* Subject with a medical condition that, in the opinion of the investigator, would interfere with the pharmacokinetic evaluation of the medication, place the subject at an unacceptable risk of injury, or render the subject unable to meet the requirements of the protocol.
* Previous participation in the study.
* Exposure to ertapenem in the week prior to the study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01587495
Study Brief:
Protocol Section:
NCT01587495