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Endometritis clinical trials

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NCT ID: NCT03442218 Completed - Endometritis Clinical Trials

Use of Antiseptic Solution for Vaginal Wash Before Cesarean Section

Start date: June 1, 2017
Phase: N/A
Study type: Interventional

To evaluate the rate of infections after cesarean sections in patients with premature rupture of membranes after vaginal wash either with an antiseptic solution (clorhexidine solution) vs. saline solution (placebo).

NCT ID: NCT03248297 Completed - Clinical trials for Postpartum Endometritis

Antibiotic Prophlaxis for High-risk Laboring Women in Low Income Countries

Start date: January 12, 2018
Phase: Phase 4
Study type: Interventional

This study, performed over a course of 3 years in 5 collaborating hospitals in Cameroon, Africa, will randomize 750 women in labor with prolonged rupture of membranes ≥ 8 hours or prolonged labor ≥ 18 hours to identical oral regimens of 1 gram of azithromycin, 1 gram of azithromycin+2 grams of amoxicillin or placebo. Women will be followed to ascertain maternal infectious outcomes and perinatal outcomes.

NCT ID: NCT03169621 Terminated - Clinical trials for Chronic Endometritis

Diagnosis of Chronic Endometritis in Endometrial Fluid Using Molecular Techniques to Improve the Outcomes of Assisted Reproductive Treatments

ChEndometritis
Start date: April 27, 2017
Phase:
Study type: Observational

Chronic endometritis (CE) is a persistent inflammation of the endometrial lining caused by the infection of the uterine cavity mainly by bacterial pathogens. It is known that CE can produce implantation failure, recurrent abortion and preterm labor. The study hypothesis is that patients who have repeated implantation failures (RIF) despite transferring good quality and normal embryos, diagnosed by preimplantation Genetic Diagnosis (PGD), into a receptive endometrium, diagnosed by Endometrial Receptivity Analysis (ERA), may present asymptomatic CE, being the altered endometrium the main cause of these implantation failures. The current diagnosis of CE is the microbiological culture of endometrial biopsy samples. Alternatively, examination of the uterine cavity by hysteroscopy is effective at 93.4%. However, both methods have limitations, such as the time needed to obtain the diagnosis, the economic cost of the tests, the possibility of detecting microorganisms in culture etc. For these reasons, the developing of a simple, fast, cheap and minimally invasive diagnostic tool for CE patients subjected to IVF treatments is expected. It would be very useful in order to establish a specific treatment and improve pregnancy rates in infertile patients. For this reason, the bacterial DNA present in the endometrial fluid samples will be obtained and the identification of the causative pathogens of CE will be done by sequencing (NGS) and/or quantitative PCR with specific oligonucleotides for the most common bacteria causing CE. The validation of this new method will be performed by comparison with the microbiological diagnosis of those same patients.

NCT ID: NCT03093194 Not yet recruiting - Clinical trials for A Known Allergy to Chlorohexidine Alcohol or Shellfis

Vaginal Antimicrobacterial Preparation Before Cesarean Secation for Endometritis Prevention

Start date: April 10, 2017
Phase: N/A
Study type: Interventional

The investigators designed a randomized controlled trial to evaluate whether perioperative Vaginal preparation is superior to no Vaginal preparation in decreasing post CS endometritis. Since CS is performed in about 30% of all births and infection complicates 6-11% of all CS reducing the rate of this post CS complication can have a major impact not only on the hospital occupancy and costs but also on the new mother experience and ability to face the challenge that awaits for her with her newborn. In this study patients will be randomly assigned into two groups. The experiment group will not undergo any vaginal preparation. The control will undergo perioperative vaginal preparation with antiseptic soap followed by chlorohexidine-alcohol Both groups will be checked for cervical dilation with sterile gloves before surgery. Primary outcome - signs of endometritis (e.g. erythema around surgical scar, discharge or pain). Patients will be followed daily until discharge. A blood count will be drewn before discharge to rule out signs of infection. Patients will be contacted 6 weeks after surgery by telephone to inquire about any signs of infection, Emergency Room visits or ambulatory visits to the doctor due to endometritis. The participants will be asked if they had positive skin culture or other wound complications such as cellulitis, seroma or scar separation. The investigators estimated that 1040 patients will have to enroll into the study, 520 in each group in order to have 80% power to detect 50% difference in the endometritis rates between the two groups with a two tailed α level of 0.05. The data analysis was conducted according to the per-protocol principle.

NCT ID: NCT02744807 Completed - Clinical trials for Intrauterine Adhesions

Role of Chronic Endometritis in Postoperative Recurrence of Severe Intrauterine Adhesions

Start date: May 2015
Phase: N/A
Study type: Observational

This study is to evaluate the prevalence of chronic endometritis (CE) in women with severe intrauterine adhesions and compare recurrence of adhesion in women with and without CE.

NCT ID: NCT02693483 Recruiting - Clinical trials for Infection; Cesarean Section

Preoperative Vaginal Cleansing With Povidone Iodine and the Risk of Post Cesarean Endometritis

Start date: April 2015
Phase: Phase 4
Study type: Interventional

Preoperative vaginal cleansing with povidone iodine and the risk of post cesarean endometritis.

NCT ID: NCT02680275 Completed - Clinical trials for Chronic Endometritis

Efficacy of Dead Sea Peloid Gel in Chronic Endometritis

Start date: July 2011
Phase: N/A
Study type: Interventional

This study evaluates the effect of Dead Sea Peloid Gel in the treatment of Chronic Endometritis in women with reproductive disorders. Half of participants will receive Dead Sea Peloid Gel and antibiotics, while the other half will receive Placebo Gel and antibiotics. Patients with reproductive disorders who visited Research Medical Center of Family Health Problems and Human Reproduction were recruited.

NCT ID: NCT02648698 Completed - Clinical trials for Chronic Endometritis

RCT(Randomized Clinical Trial ) of Antibiotic Therapy in Chronic Endometritis

Start date: January 10, 2016
Phase: N/A
Study type: Interventional

120 cases with a diagnosis of chronic endometritis, confirmed by the presence of plasma cells in endometrial biopsy sample identified by immunohistochemical staining using CD138 antibody, have been recruited. The subjects have been randomly divided into two groups, the experimental group have been given antibiotic (Levofloxacin and Tinidazole for 14 days) treatment, the control group did not receive any antibiotic. Initially it was planned for women in the control group to take placebo,but the organization was difficult, so it was changed prior to the start of the study to an open label study. A repeat endometrial biopsy sample have been obtained 2-4 weeks after completion of the antibiotic therapy to assess the response to treatment. The conversion rate will be compared between the two groups

NCT ID: NCT02646930 Completed - Clinical trials for in Vitro Fertilization

Chronic Endometritis and IVF

CEIVF
Start date: March 3, 2016
Phase: N/A
Study type: Interventional

Background: Embryo quality is known to be a very important determinant to predict the implantation and pregnancy rate in IVF patients, however, the role of uterine integrity or endometrial receptivity cannot be overlooked. Chronic endometritis (CE) is an inflammation of the endometrium diagnosed by the presence of plasma cells in the endometrial stroma. There is not only no census on the definition of CE, the current literature on the impact of CE on reproductive outcome is controversial and consists only of retrospective studies with small sample sizes. Although there is a presumption that CE is related to poor IVF outcome, this belief has not been proven. Design: Prospective cohort study Setting: Infertility clinics of 2 academic medical centers Patients: Patients between the ages of ≥ 21 and ≤ 35 years old undergoing their first IVF cycle will be invited to participate. Main Outcome Measures: The primary outcome will be ongoing pregnancy after 12 weeks estimated gestational age (EGA) with previously documented fetal cardiac motion. Secondary outcomes will include pregnancy loss rate as defined by chemical pregnancy, blighted ovum or loss of fetal cardiac motion before 12 weeks EGA. Materials and Methods: The cycle prior to IVF, patients will undergo an in-office endometrial biopsy on cycle days 19-24. Samples will be stained for CD138 and the number of plasma cells will be quantified. The number of plasma cells in a sample that yields the best sensitivity and specificity for pregnancy will be determined by a Receiver-Operator-Curve. This number will then be used as a dichotomous variable to assign categories of "positive for CE" and "negative for CE." Pregnancy and miscarriage rates will then be determined in the positive and negative CE sample with Chi Square Analysis. A secondary sub analysis will be performed to determine pregnancy and miscarriage rates in patients who declined to participate in the study. Expected Results: The investigators hypothesize that higher rates of CE will be found in women failing to conceive with IVF and with subsequent first-trimester miscarriage.

NCT ID: NCT02402907 Completed - Clinical trials for Surgical Site Infections

STRIPES Study: Study To Reduce Infection Post cEsarean Section

Start date: April 2015
Phase: N/A
Study type: Interventional

The objective of this study is to determine if the use of chlorhexidine gluconate cloths prior to cesarean section reduce the rate of infectious morbidity (i.e. surgical site infections, endometritis). The study will be offered to women who present for a scheduled primary or repeat cesarean section at Mount Sinai Medical Center. The eligible women will be randomized to use of a 2% chlorhexidine gluconate (CHG) cloth or placebo cloth (a fragrance free cleansing cloth) the night before and the morning of their scheduled procedure. Participants will be blinded to the arm in which they have been assigned. This study intends to show that the use of 2% CHG cloths prior to cesarean section will reduce the rate of surgical site infections.