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Terminated NCT05603624

Effect of Sterile Versus Clean Gloves Intrapartum and Postpartum Infections at Term

Conditions: Chorioamnionitis, Intrauterine Infection, Postpartum Endometritis, Puerperal Infection

Sex: Female
Ages: 18 Years – 50 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 166
Sponsor: Eastern Virginia Medical School

Location: United States

Summary

This prospective randomized controlled study examines whether the type of glove used (sterile vs clean) for cervical examination to assess progression in labor impacts the rates of intrapartum and/or postpartum infection in patients during labor or induction of labor at term.

Eligibility Criteria

Inclusion Criteria:Between 18 and 50 years oldTerm pregnancy (37w0d to 41w6d gestational age)Amniotic membranes were intact on admissionPatient presenting in spontaneous labor or were to undergo induction of laborPatient attempting for a vaginal delivery initially, even if the final delivery method was by cesarean sectionExclusion Criteria:Preterm pregnancy (before 37w0d gestational age)Postdate pregnancy (after 41w6d gestational age)Ruptured membranes or premature rupture of membranes on admissionPatient being evaluated for preterm laborPatient has diagnosis of chorioamnionitis or any intrauterine infectionPatient has an extrauterine infection that would compromise the diagnosis of intrauterine infection (e.g., COVID, upper respiratory infections, urinary tract infections, cellulitis, appendicitis, etc.)Patient experiencing an immunocompromised state (e.g., human immunodeficiency virus, congenital syndromes, transplant recipient, or immunosuppressant use)Patient with uncertainty of their gestational age and/or no prenatal carePatient with an intrauterine fetal demisePatient requesting a termination of the pregnancy

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05603624). StuddyBuddy aggregates publicly available trial information.