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

NCT05603624 | Terminated DMC

• 1 other identifier: 21-09-FB-0206
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chorioamnionitis; Intrauterine Infection; Postpartum Endometritis; Puerperal Infection

Keywords

Sterile glove; Clean glove; Glove type; Intraamniotic infection; Cervical examination; Sterile vaginal examination; Intrapartum infection; Postpartum infection

Outcome Measures

Primary Outcomes (1)

• Chorioamnionitis or intraamniotic or intrauterine infection

  As defined by ACOG committee opinion 712

  Through study completion, usually withing 72 hours after admission to labor and delivery

Secondary Outcomes (1)

• Postpartum endometritis

  Through study completion, usually withing 72 hours after admission to labor and delivery

Study Arms (2)

Sterile glove

ACTIVE COMPARATOR

Sterile glove is usually the standard of care

Procedure: Cervical examination to assess labor

Clean glove

EXPERIMENTAL

Clean glove is usually not used or in the event of an emergency or lack of access to sterile gloves in the United States.

Procedure: Cervical examination to assess labor

Interventions

Cervical examination to assess labor PROCEDURE

Patients were randomized to receive cervical examinations to assess progression in labor with either sterile or clean gloves.

Clean glove; Sterile glove

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between 18 and 50 years old
• Term pregnancy (37w0d to 41w6d gestational age)
• Amniotic membranes were intact on admission
• Patient presenting in spontaneous labor or were to undergo induction of labor
• Patient attempting for a vaginal delivery initially, even if the final delivery method was by cesarean section

You may not qualify if:

• Preterm pregnancy (before 37w0d gestational age)
• Postdate pregnancy (after 41w6d gestational age)
• Ruptured membranes or premature rupture of membranes on admission
• Patient being evaluated for preterm labor
• Patient has diagnosis of chorioamnionitis or any intrauterine infection
• Patient 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 care
• Patient with an intrauterine fetal demise
• Patient requesting a termination of the pregnancy

Sponsors & Collaborators

• Eastern Virginia Medical School: lead

Study Sites (1)

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Related Publications (9)

• Lamont RF, Sobel JD, Akins RA, Hassan SS, Chaiworapongsa T, Kusanovic JP, Romero R. The vaginal microbiome: new information about genital tract flora using molecular based techniques. BJOG. 2011 Apr;118(5):533-49. doi: 10.1111/j.1471-0528.2010.02840.x. Epub 2011 Jan 20.

  PMID: 21251190 RESULT

• Larsen B, Monif GR. Understanding the bacterial flora of the female genital tract. Clin Infect Dis. 2001 Feb 15;32(4):e69-77. doi: 10.1086/318710. Epub 2001 Feb 9.

  PMID: 11181139 RESULT

• Perez-Munoz ME, Arrieta MC, Ramer-Tait AE, Walter J. A critical assessment of the "sterile womb" and "in utero colonization" hypotheses: implications for research on the pioneer infant microbiome. Microbiome. 2017 Apr 28;5(1):48. doi: 10.1186/s40168-017-0268-4.

  PMID: 28454555 RESULT

• Committee Opinion No. 712: Intrapartum Management of Intraamniotic Infection. Obstet Gynecol. 2017 Aug;130(2):e95-e101. doi: 10.1097/AOG.0000000000002236.

  PMID: 28742677 RESULT

• Rouse DJ, Landon M, Leveno KJ, Leindecker S, Varner MW, Caritis SN, O'Sullivan MJ, Wapner RJ, Meis PJ, Miodovnik M, Sorokin Y, Moawad AH, Mabie W, Conway D, Gabbe SG, Spong CY; National Institute of Child Health And Human Development, Maternal-Fetal Medicine Units Network. The Maternal-Fetal Medicine Units cesarean registry: chorioamnionitis at term and its duration-relationship to outcomes. Am J Obstet Gynecol. 2004 Jul;191(1):211-6. doi: 10.1016/j.ajog.2004.03.003.

  PMID: 15295368 RESULT

• Sweeney EL, Dando SJ, Kallapur SG, Knox CL. The Human Ureaplasma Species as Causative Agents of Chorioamnionitis. Clin Microbiol Rev. 2016 Dec 14;30(1):349-379. doi: 10.1128/CMR.00091-16. Print 2017 Jan.

  PMID: 27974410 RESULT

• Cahill AG, Duffy CR, Odibo AO, Roehl KA, Zhao Q, Macones GA. Number of cervical examinations and risk of intrapartum maternal fever. Obstet Gynecol. 2012 Jun;119(6):1096-101. doi: 10.1097/AOG.0b013e318256ce3f.

  PMID: 22617572 RESULT

• Gluck O, Mizrachi Y, Ganer Herman H, Bar J, Kovo M, Weiner E. The correlation between the number of vaginal examinations during active labor and febrile morbidity, a retrospective cohort study. BMC Pregnancy Childbirth. 2020 Apr 25;20(1):246. doi: 10.1186/s12884-020-02925-9.

  PMID: 32334543 RESULT

• Morshedi B, Strohm S, James H, Springer C, Gould L, Thurman A, Slat S. Effect of sterile vs clean gloves for cervical checks in labor on maternal infection at term: a randomized trial. Am J Obstet Gynecol MFM. 2023 Jun;5(6):100931. doi: 10.1016/j.ajogmf.2023.100931. Epub 2023 Mar 24.

  PMID: 36965695 DERIVED

MeSH Terms

Conditions

Chorioamnionitis; Puerperal Infection

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Membranes, Premature Rupture; Obstetric Labor Complications; Placenta Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pregnancy Complications, Infectious; Infections; Puerperal Disorders

Study Officials

• Stacy Slat, MD

  Eastern Virginia Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The two types of gloves used were labeled as "Glove 1" and "Glove 2" for data collection and analysis. The providers performing examinations and the patients knew the type of glove being used at the time of the study but data collection was deidentified and retrospective analysis was blinded to the investigating team until the study concluded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible and consented participants were randomized to receive all cervical examinations with sterile powder-free polyvinyl chloride exam gloves (current routine practice, control group) or clean powder-free nitrile exam gloves (nonsterile, experimental group). Neither the clinical providers performing the exam nor the participants were blinded to the glove type used, however, the researchers did not know which glove type was used while completing the retrospective data collection and analysis. All other obstetrical care provided to the participants was per ACOG guidelines and the only changes made to their care was the type of glove used for this study.

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 2, 2022
• Study Start: September 2, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After analysis and upon request; for undetermined amount of time.
• Access Criteria: If contacted, can share deidentified participant data.

Locations

US (1)