Vaginal Cleansing With Chlorhexidine Gluconate in Women With Preterm Pre-labor Rupture of Membranes
Primary Purpose
Preterm Premature Rupture of Membrane
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vaginal cleansing with chlorhexidine gluconate solution
Sponsored by
About this trial
This is an interventional treatment trial for Preterm Premature Rupture of Membrane
Eligibility Criteria
Inclusion Criteria:
- Pregnant patients at our institution with PPROM diagnosed between 20 - 33 weeks
Exclusion Criteria:
- active preterm labor or imminent delivery expected at the time of PPROM diagnosis
- maternal sepsis or chorioamnionitis
- any contraindications to expectant management (fetal distress, placental abruption with maternal hemodynamic instability or fetal distress cord prolapse)
- preeclampsia
- intrauterine growth restriction (IUGR)
- no antibiotics or steroids given within 7 days prior to the time of enrollment
- multiple gestation
- placenta previa
- fetal part visualized at initial exam
- visual cervical dilation at initial exam
Sites / Locations
- Albany Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Vaginal cleansing
No vaginal cleansing
Arm Description
This group includes patients diagnosed with PPROM that are randomized to undergo vaginal cleansing with chlorhexidine gluconate within 24 hours of PPROM diagnosis.
This group includes patients diagnosed with PPROM that are randomized to not undergo vaginal cleansing.
Outcomes
Primary Outcome Measures
Pregnancy latency
The time measured in days from the diagnosis of pre labor premature rupture of membranes (PPROM) to delivery.
Secondary Outcome Measures
Serum inflammatory markers
Inflammatory markers from maternal serum including IL6, TNF-a, IL10
Amniotic fluid inflammatory markers
Inflammatory markers from amniotic fluid including IL6, TNF-a, IL10
White blood cell count, cells per liter
Maternal CBC measured serially antepartum and postpartum
Number of participants with clinical chorioamnionitis
as defined by treating clinical, requiring treatment with antibiotics and/or delivery
Rate of placental abnormalities on pathology evaluation
Histopathology per pathology lab
Rate of histologic chorioamnionitis
based on placental pathology
Rate of maternal sepsis
as defined by treating clinical, culture proven or presumed
rate of composite neonatal morbidity
culture proven sepsis, respiratory distress, necrotizing enterocolitis, intracranial hemorrhage
rate of neonatal death
demise of neonate
fetal demise
demise of fetus in-utero
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04516226
Brief Title
Vaginal Cleansing With Chlorhexidine Gluconate in Women With Preterm Pre-labor Rupture of Membranes
Official Title
Vaginal Cleansing With Chlorhexidine Gluconate in Women With Preterm Pre-labor Rupture of Membranes in Order to Prolong Pregnancy Latency and Reduce Intraamniotic Inflammation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albany Medical College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomized controlled trial studying the use of vaginal cleansing with chlorhexidine gluconate for pregnant women with PPROM (preterm pre labor rupture of membranes). The primary outcome will be pregnancy latency. Secondary outcomes will include various maternal and neonatal outcomes, and inflammatory markers from maternal blood, amniotic fluid, fetal cord blood and placental analysis.
Detailed Description
A randomized controlled trial, including pregnant women > 18 years old with early onset PPROM occurring between the time of peri-viability through the early third trimester (20 weeks 0 days - 33 weeks 0 days) at Albany Medical Center.
Women will be consented by a physician member of the research team on labor and delivery after clinical diagnosis of PPROM. Participation will be completely voluntary and not impact routine prenatal care for PPROM, which may include but not be limited to hospital admission, standard latency antibiotics, NICU consultation, fetal growth ultrasounds, fetal monitoring, and delivery will be based on physician assessment and not impacted by this study. Participation in the study will involve prospective data collection on maternal, fetal, and neonatal characteristics, randomization into a control and treatment group, collection of maternal serum, fetal cord blood and vaginal fluid. Subjects will be randomized into control and treatment groups via block randomization. Exclusions will include any contraindications to expectant management for PPROM noted at the time on admission, such as preterm labor, chorioamnionitis, maternal sepsis and fetal distress.
The time commitment for each subject will include the time from diagnosis of PPROM until their delivery. Although outcome measures will be collected from each neonate, no further participation from subjects will be required after time of their delivery.
Treatment Group: Women diagnosed with PPROM (20 - 33 weeks) randomized to the treatment group will undergo vaginal cleansing with chlorhexidine gluconate within 24 hours of their diagnosis. This specific procedure will only be done once.
The vaginal cleansing procedure will be performed by a single investigator, Dr. Cagino, to ensure consistency. The patient will be examined in dorsal lithotomy position with a standard speculum. A sterile 2x2 gauze placed on ringed forceps will be soaked in sterile 2% chlorhexidine gluconate in
aqueous solution (all available on labor and delivery). Only the rough volume of 2% chlorhexidine gluconate required to soak the small sterile gauze will be used. This soaked gauze will be used to carefully wipe the vaginal mucosa of the vaginal vault. No pooling of chlorhexidine will be left in the vaginal vault. The chlorhexidine solution will not be applied to the cervix or cervical os. The chlorhexidine solution will not be applied directly to the fetus in any way. If a fetal part is visualized at time of exam, the patient will be excluded from the study.
Otherwise, standard care for PPROM among women in this group will not change. This group will be expectantly managed until the time of delivery, which will be based on physician assessment. Delivery decisions for women with preterm labor or infection will be based on physician assessment only and will not be influenced by their involvement in this study.
Control Group: Women diagnosed with PPROM (20 - 33 weeks) randomized to the control group will undergo standard care for PPROM. This group will be expectantly managed until the time of delivery, which will be based on physician assessment. Data will be collected from both the patient and neonate (please see the collection sheet for further information).
Inclusions:
Pregnant patients at Albany Medical Center with PPROM diagnosed between 20 - 33 weeks
Age > 18 years old
Exclusions:
Active preterm labor or imminent delivery expected at time of PPROM diagnosis
Maternal sepsis or chorioamnionitis diagnosed at time of PPROM diagnosis
Any contraindications to expectant management at time of PPROM diagnosis (fetal distress, placental abruption with maternal hemodynamic instability or fetal distress, cord prolapse)
Preeclampsia
Intrauterine growth restriction (IUGR)
No antibiotics or steroids given within 7 days prior to time of enrollment/randomization in study (not including steroids or treatment given during admission)
Multiple gestation
Placenta previa
Fetal part visualized at initial exam
Visual cervical dilation at initial exam
Primary Outcome: Latency (days from PPROM to delivery)
Secondary Outcomes:
Serum IL6, IL10, TNF-a - admission, day 7, delivery
Vaginal fluid IL6, IL10, TNF-a - admission, day 7, delivery
Serial antepartum CBC - admission, day 7, delivery
Postpartum CBC
Clinical chorioamnionitis (as defined by treating clinician discretion and requiring treatment with antibiotics and/or delivery)
Placenta pathology (per pathology lab)
Histologic chorioamnionitis (based on placental pathology)
Maternal sepsis (as defined by treating clinician discretion)
Culture proven
Presumed sepsis
Composite neonatal morbidity
Neonatal death
Fetal demise
A power analysis was performed based on the mean latency of 18 days (SD 10 days) in patients who remained pregnant at least 7 days following PPROM at AMC. In order to detect a prolongation in latency by at least 10 days in the treatment group, an effect size of 1, with a power 0.8 and alpha 0.05, 17 subjects in each study group are needed. A study duration of 1.5 to 2 years to complete enrollment, data collection and analysis is anticipated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Premature Rupture of Membrane
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vaginal cleansing
Arm Type
Experimental
Arm Description
This group includes patients diagnosed with PPROM that are randomized to undergo vaginal cleansing with chlorhexidine gluconate within 24 hours of PPROM diagnosis.
Arm Title
No vaginal cleansing
Arm Type
No Intervention
Arm Description
This group includes patients diagnosed with PPROM that are randomized to not undergo vaginal cleansing.
Intervention Type
Other
Intervention Name(s)
Vaginal cleansing with chlorhexidine gluconate solution
Intervention Description
Cleansing of the vaginal walls with chlorhexidine gluconate solution for women diagnosed with PPROM
Primary Outcome Measure Information:
Title
Pregnancy latency
Description
The time measured in days from the diagnosis of pre labor premature rupture of membranes (PPROM) to delivery.
Time Frame
Delivery
Secondary Outcome Measure Information:
Title
Serum inflammatory markers
Description
Inflammatory markers from maternal serum including IL6, TNF-a, IL10
Time Frame
Within 24 hours of admission, 7 days after admission, day of delivery
Title
Amniotic fluid inflammatory markers
Description
Inflammatory markers from amniotic fluid including IL6, TNF-a, IL10
Time Frame
Within 24 hours of admission, 7 days after admission, day of delivery
Title
White blood cell count, cells per liter
Description
Maternal CBC measured serially antepartum and postpartum
Time Frame
Within 24 hours of admission, 7 days after admission, day of delivery
Title
Number of participants with clinical chorioamnionitis
Description
as defined by treating clinical, requiring treatment with antibiotics and/or delivery
Time Frame
Through study completion, an average of 1 year
Title
Rate of placental abnormalities on pathology evaluation
Description
Histopathology per pathology lab
Time Frame
studied postpartum, up to 1 week
Title
Rate of histologic chorioamnionitis
Description
based on placental pathology
Time Frame
studied postpartum, up to 1 week
Title
Rate of maternal sepsis
Description
as defined by treating clinical, culture proven or presumed
Time Frame
through study completion, up to 1 year
Title
rate of composite neonatal morbidity
Description
culture proven sepsis, respiratory distress, necrotizing enterocolitis, intracranial hemorrhage
Time Frame
through study completion, up to 1 year
Title
rate of neonatal death
Description
demise of neonate
Time Frame
through study completion, up to 1 year
Title
fetal demise
Description
demise of fetus in-utero
Time Frame
through study completion, up to 1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant patients at our institution with PPROM diagnosed between 20 - 33 weeks
Exclusion Criteria:
active preterm labor or imminent delivery expected at the time of PPROM diagnosis
maternal sepsis or chorioamnionitis
any contraindications to expectant management (fetal distress, placental abruption with maternal hemodynamic instability or fetal distress cord prolapse)
preeclampsia
intrauterine growth restriction (IUGR)
no antibiotics or steroids given within 7 days prior to the time of enrollment
multiple gestation
placenta previa
fetal part visualized at initial exam
visual cervical dilation at initial exam
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Albany Research Coordinator
Phone
518-262-4942
Email
Obgynresearch@amc.edu
Facility Information:
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albany research coordinator
Phone
518-262-4942
12. IPD Sharing Statement
Plan to Share IPD
No
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Vaginal Cleansing With Chlorhexidine Gluconate in Women With Preterm Pre-labor Rupture of Membranes
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