RECRUITING

Vaginal Cleansing With Chlorhexidine Gluconate in Women With Preterm Pre-labor Rupture of Membranes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2020-08-01
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04516226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant patients at our institution with PPROM diagnosed between 20 - 33 weeks
  1. * active preterm labor or imminent delivery expected at the time of PPROM diagnosis
  2. * maternal sepsis or chorioamnionitis
  3. * any contraindications to expectant management (fetal distress, placental abruption with maternal hemodynamic instability or fetal distress cord prolapse)
  4. * preeclampsia
  5. * intrauterine growth restriction (IUGR)
  6. * no antibiotics or steroids given within 7 days prior to the time of enrollment
  7. * multiple gestation
  8. * placenta previa
  9. * fetal part visualized at initial exam
  10. * visual cervical dilation at initial exam

Contacts and Locations

Study Contact

Albany Research Coordinator
CONTACT
518-262-4942
Obgynresearch@amc.edu

Study Locations (Sites)

Albany Medical Center
Albany, New York, 12208
United States

Collaborators and Investigators

Sponsor: Albany Medical College

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-01
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2020-08-01
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Preterm Premature Rupture of Membrane