CLINICAL TRIAL

Vaginal cleansing with chlorhexidine gluconate solution for Rupture

Recruiting · 18 - 65 · Female · Albany, NY

This study is evaluating whether a vaginal cleansing with chlorhexidine gluconate may help reduce the risk of preterm birth in pregnant women with preterm premature rupture of membranes.

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About the trial for Rupture

Eligible Conditions
Premature Birth · Fetal Membranes, Premature Rupture · Preterm Premature Rupture of Membranes (PPROM) · Rupture

Treatment Groups

This trial involves 2 different treatments. Vaginal Cleansing With Chlorhexidine Gluconate Solution is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Vaginal cleansing with chlorhexidine gluconate solution
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for female patients between 18 and 65 years old. There is one eligibility criterion to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Pregnant patients at our institution with PPROM diagnosed between 20 - 33 weeks
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: through study completion, up to 1 year
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, up to 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: through study completion, up to 1 year.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Vaginal cleansing with chlorhexidine gluconate solution will improve 1 primary outcome and 10 secondary outcomes in patients with Rupture. Measurement will happen over the course of studied postpartum, up to 1 week.

Rate of histologic chorioamnionitis
STUDIED POSTPARTUM, UP TO 1 WEEK
based on placental pathology
STUDIED POSTPARTUM, UP TO 1 WEEK
Pregnancy latency
DELIVERY
The time measured in days from the diagnosis of pre labor premature rupture of membranes (PPROM) to delivery.
DELIVERY
Rate of placental abnormalities on pathology evaluation
STUDIED POSTPARTUM, UP TO 1 WEEK
Histopathology per pathology lab
STUDIED POSTPARTUM, UP TO 1 WEEK
Serum inflammatory markers
WITHIN 24 HOURS OF ADMISSION, 7 DAYS AFTER ADMISSION, DAY OF DELIVERY
Inflammatory markers from maternal serum including IL6, TNF-a, IL10
WITHIN 24 HOURS OF ADMISSION, 7 DAYS AFTER ADMISSION, DAY OF DELIVERY
White blood cell count, cells per liter
WITHIN 24 HOURS OF ADMISSION, 7 DAYS AFTER ADMISSION, DAY OF DELIVERY
Maternal CBC measured serially antepartum and postpartum
WITHIN 24 HOURS OF ADMISSION, 7 DAYS AFTER ADMISSION, DAY OF DELIVERY
Amniotic fluid inflammatory markers
WITHIN 24 HOURS OF ADMISSION, 7 DAYS AFTER ADMISSION, DAY OF DELIVERY
Inflammatory markers from amniotic fluid including IL6, TNF-a, IL10
WITHIN 24 HOURS OF ADMISSION, 7 DAYS AFTER ADMISSION, DAY OF DELIVERY
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get rupture a year in the United States?

Nearly 2 million (19%) people experienced a ruptured anterior cruciate ligament in the USA in 2006. Recent findings shows that ruptured ACL repairs increase between 70% to 80% in the next year. The mean time between injury and surgery for patients who receive nonoperative treatment is about 28 months. Recent findings shows that ruptured ACL repairs increase between 70% to 80% in the next year. Nonoperative treatment carries a high non-union rate and results in lower patient function. Patients with an intact ACL and symptomatic knee tend to have less knee function.

Anonymous Patient Answer

What are the signs of rupture?

Signs of rupture usually occur without prior rupture: these can be physical or psychological. Physical signs can include a palpable 'loud' or 'penetrating' sound in the affected muscle, or tenderness associated with movement. Psychological signs of rupture can include sadness, or the belief that the affected individual is weak, helpless or undesirable. If there is no physical or psychological sign, then the diagnosis of a ruptured tendon can be strengthened by MRI imaging, but the diagnosis can not be confirmed in all cases. It is important to consider the diagnosis of a ruptured tendon in any case where there have been no recent episodes of acute pain or tenderness.

Anonymous Patient Answer

What are common treatments for rupture?

There are no randomized trials that evaluate the effectiveness of specific treatments for ruptured appendicitis. Evidence favors antibiotics for uncomplicated rupture, especially if negative cultures for appendicitis are proven negative.

Anonymous Patient Answer

What causes rupture?

This retrospective study of ruptured abdominal aortic aneurysm ruptures suggests underlying pathophysiological mechanisms that lead to rupture, that are different from those of unruptured AAA, but warrant further study.

Anonymous Patient Answer

Can rupture be cured?

If a patient is diagnosed with acute ruptured appendicitis before surgery, the patient's survival rate may not be compromised by having appendectomy performed before surgical repair is a curative procedure. The benefit of this approach to the patient depends on the severity of the perforation.

Anonymous Patient Answer

What is rupture?

Rupture is a ruptured blood vessel. It may result in shock, internal bleeding, loss of blood into the surrounding tissues or into the subarachnoid or intracranial spaces, or both. Rupture is caused by the loss of blood pressure resulting in decreased blood flow and insufficient blood to keep tissues oxygenated. Patients may complain of extreme pain with or without neurological signs/symptoms. Seizures may also occur. Severe brain injuries can occur. Many patients will start to experience symptoms within a few hours of the rupture. Rupture is more likely to occur when a person is older.

Anonymous Patient Answer

What are the common side effects of vaginal cleansing with chlorhexidine gluconate solution?

Vaginal cleansing twice weekly with chlorhexidine gluconate solution is associated neither with irritation, inflammation or even discomfort in the vagina during the cleansing period nor with abnormal vaginal discharge during the following months. No common side effects were observed.

Anonymous Patient Answer

What is vaginal cleansing with chlorhexidine gluconate solution?

Vaginal cleansing with chlorhexidine gluconate solution may have an anti-infective effect in the treatment of lower genital tract infection, especially in the prevention and reduction of STI incidence.

Anonymous Patient Answer

Does rupture run in families?

We identified 16 families with one or more children with familial ruptured aneurysms. Although one-third of the ruptured aneurysms were diagnosed with multiple aneurysms, the remaining two-thirds were diagnosed with solitary aneurysms. Results from a recent paper suggest that ruptured aneurysms in the context of aneurysmal disease may have a genetic component.

Anonymous Patient Answer

Is vaginal cleansing with chlorhexidine gluconate solution typically used in combination with any other treatments?

Vaginal cleansing with a CHG solution was associated with increased treatment effectiveness when added to treatment regimens that included vaginal cleansing by any of the disinfectant solutions tested.

Anonymous Patient Answer

How does vaginal cleansing with chlorhexidine gluconate solution work?

Vaginal cleansing of the vagina as part of the preoperative workup can be safely performed using a local anesthetic with chlorhexidine. Although patients may experience some soreness during cleansing, they do not have the symptoms of postoperative pain or discomfort as the use of anesthetic alone during the cleansing has proven effective in controlling these discomfort. Because such a procedure is a part of routine preoperative workup, patients can be safely preprocedurally educated on this simple and effective method of cleansing and they are able to cope with this simple procedure better than they would without this knowledge.

Anonymous Patient Answer

Have there been any new discoveries for treating rupture?

Most of the evidence for treatments currently in use is anecdotal and of low accuracy in predicting the outcome of a treatment. In some respects the latest findings offer a glimpse into the past, while still being of limited utility in the treatment of actual patients. There are many questions that remain unanswered in the field of rupture: whether surgery can be avoided in some cases of tear; how to reduce the pain caused by the trauma before an urgent repair; who should be the first to be treated for an injury; whether non-surgical approaches deserve a special status; where should surgical treatment and non-surgical treatment be coordinated; what is the best way to treat a patient for whom surgery is not an option; can we make any advances with imaging (i.

Anonymous Patient Answer
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