ChorioamnionitisNCT01852188
Intrapartum Study of Sterile and Clean Gloves
A study testing Type of glove used for intrapartum vaginal exams in people with Chorioamnionitis, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the use of sterile or clean gloves during labor exams affects the rate of chorioamnionitis. Chorioamnionitis is an infection of the membranes around the baby. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chorioamnionitis
- What is being tested?
- Type of glove used for intrapartum vaginal exams
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 507 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to 2 Nov 2014
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Spontaneous or induced labor
- Rupture of membranes < 12 hours
- Nulliparous or multiparous
- Gestational age greater than or equal to 34 weeks
- Age greater than or equal to 18
Who cannot join
- Contraindications to labor
- Multiple gestations
- Rupture of Membranes greater than 12 hours
- Gestational age less than 34 weeks
- Non-English speaking patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: A Comparison of Sterile and Non-sterile Gloves for the Incidence of Chorioamnionitis During Labor: a Randomized Controlled Trial
The purpose of this study is to determine whether the use of sterile or clean gloves during labor exams affects the rate of chorioamnionitis. Chorioamnionitis is an infection of the membranes around the baby.
Read the detailed description
The importance of this study is that intrapartum vaginal exams (while patients are laboring) are performed routinely in modern obstetrical practice, and there is no randomized trial available assessing the relationship between the type of glove used and the rate of chorioamnionitis.
- Conditions
- Chorioamnionitis
- Being tested
- Type of glove used for intrapartum vaginal exams
- Keywords
- Intrapartum, Glove, Chorioamnionitis
- Medical subject headings
- Chorioamnionitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type of glove used for intrapartum vaginal examsOther
Patients will be randomized to either sterile or clean gloves during intrapartum vaginal exams.
| Study group | Role | What they receive |
|---|---|---|
| Nonsterile | Other | Patients will be randomized to either sterile or clean gloves during intrapartum vaginal exams. Receives: Other: Type of glove used for intrapartum vaginal exams |
| Sterile | Other | Patients will be randomized to either sterile or clean gloves during intrapartum vaginal exams. Receives: Other: Type of glove used for intrapartum vaginal exams |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical chorioamnionitis
Clinical chorioamnionitis with at least two of the four criteria met-maternal fever of 38 degrees Celsius or greater, maternal tachycardia (pulse >100), fetal tachycardia (fetal heart rate >160), and/or fundal tenderness
Measured: participants will be followed during their intrapartum hospital stay, an expected average of 48-72hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study startMay 2011
- Primary completion2 Nov 2014
- Study completion2 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChorioamnionitisStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 507 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Houston, MD, Principal investigator, Medical University of South CarolinaDonna Johnson, Study chair, Medical University of South Carolina, Obstetrics-Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852188
- Sponsor's protocol ID
- HR 20638
- Status last verified
- May 2018
- First submitted
- 18 Apr 2012
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Sterile and Non-sterile Gloves for the Incidence of Chorioamnionitis During Labor: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01852188
- Acronym / sponsor ID
- HR 20638
- Conditions
- Chorioamnionitis
- Keywords
- Intrapartum, Glove, Chorioamnionitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 507 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- May 2011 (actual)
- Primary completion
- 2 Nov 2014 (actual)
- Study completion
- 2 Nov 2014 (actual)
- First posted
- 13 May 2013 (estimated)
- 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 whether the use of sterile or clean gloves during labor exams affects the rate of chorioamnionitis. Chorioamnionitis is an infection of the membranes around the baby.
Detailed description
The importance of this study is that intrapartum vaginal exams (while patients are laboring) are performed routinely in modern obstetrical practice, and there is no randomized trial available assessing the relationship between the type of glove used and the rate of chorioamnionitis.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nonsterile | Other | Other: Type of glove used for intrapartum vaginal examsPatients will be randomized to either sterile or clean gloves during intrapartum vaginal exams. |
| Sterile | Other | Other: Type of glove used for intrapartum vaginal examsPatients will be randomized to either sterile or clean gloves during intrapartum vaginal exams. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Spontaneous or induced labor
- Rupture of membranes < 12 hours
- Nulliparous or multiparous
- Gestational age greater than or equal to 34 weeks
- Age greater than or equal to 18
Key exclusion criteria (5 listed)
- Contraindications to labor
- Multiple gestations
- Rupture of Membranes greater than 12 hours
- Gestational age less than 34 weeks
- Non-English speaking patients
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 |
|---|---|---|
| Type of glove used for intrapartum vaginal examsPatients will be randomized to either sterile or clean gloves during intrapartum vaginal exams. | Other | Nonsterile, Sterile |
Primary outcome
Clinical chorioamnionitis
Time frame: participants will be followed during their intrapartum hospital stay, an expected average of 48-72hrs
Clinical chorioamnionitis with at least two of the four criteria met-maternal fever of 38 degrees Celsius or greater, maternal tachycardia (pulse >100), fetal tachycardia (fetal heart rate >160), and/or fundal tenderness
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 18 May 2018.
Related trials for Chorioamnionitis
Recruiting
Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers
Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion
Recruiting
Comparing Infectious Morbidity Among Women With Meconium-stained Amniotic Fluid at Term, Between Those Treated With Prophylactic Antibiotics Zinacef vs. Placebo
Meconium-stained Amniotic Fluid, Chorioamnionitis
Active, not recruitingObservational study
IL-6 and Lactates in Cord Blood and Neonatal Outcomes
Fetal Infection, Fetal Inflammatory Response Syndrome
Enrolling by invitation
Planned Early Induction of Labor vs Expectant Management for PROM
Premature Rupture of Membranes (PROM)
Active, not recruitingObservational study
Association Between Neuraxial Labor Analgesia and Maternal and Neonatal Infectious Outcomes
Intrapartum Maternal Fever, Clinical Chorioamnionitis
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.
Laura Houston, MD principal investigator
Medical University of South Carolina
Donna Johnson study chair
Medical University of South Carolina, Obstetrics-Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Type of glove used for intrapartum vaginal exams in people with Chorioamnionitis, run by Medical University of South Carolina at 1 site 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 5 inclusion and 5 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 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Clinical chorioamnionitis (time frame: participants will be followed during their intrapartum hospital stay, an expected average of 48-72hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2018; AzTrials last refreshed its copy on 6 Nov 2026.