Diagnosis and management of clinical chorioamnionitis.
Alan T N Tita, William W Andrews
https://pubmed.ncbi.nlm.nih.gov/20569811Actively Recruiting
Led by Larry Hinkson · Updated on 2024-02-16
356
Participants Needed
1
Research Sites
52 weeks
Total Duration
This research aims to find out if using ultrasound during labor can reduce infections compared to the usual internal vaginal examinations. It focuses on pregnant women in labor, studying whether non-invasive ultrasound monitoring can lead to fewer cases of clinical chorioamnionitis, a type of infection. Secondary goals include looking at overall birth outcomes and how satisfied mothers are with their care. Participants are randomly assigned to one of two groups. One group is monitored during labor using ultrasound measurements such as Angle of Progression, Head Perineum Distance, Midline Angle, and Cervix Dilatation every 3 to 4 hours until delivery. The other group receives the traditional care of internal vaginal examinations at similar intervals. This comparison helps assess whether ultrasound alone can safely guide labor progress. During the study, researchers track signs of infection like fever, rapid heart rates, uterine tenderness, and amniotic fluid odor from admission until delivery. They also collect information on delivery type, newborn health, and maternal satisfaction. Assessments include measuring maternal age, weight, height, pregnancy weeks, previous pregnancies, and neonatal weight shortly after birth. The study follows participants through labor and up to six weeks after delivery, including monitoring antibiotic use and blood loss.
CONDITIONS
Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From admission until delivery
Participants are monitored during labor using either non-invasive ultrasound parameters or traditional internal vaginal examinations to assess labor progress from admission until delivery.
Assessments every 3 to 4 hours during labor
Duration - Up to 6 weeks postpartum
Participants and their newborns are observed after delivery to assess maternal and neonatal outcomes, including neonatal admission and maternal recovery.
Visits up to 6 weeks after delivery
Total: 1 location
1
Charité University Hospital
Berlin, Germany
Actively Recruiting
L
Larry Hinkson, FRCOG
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Alan T N Tita, William W Andrews
https://pubmed.ncbi.nlm.nih.gov/20569811T Ghi, T Eggebø, C Lees...
https://pubmed.ncbi.nlm.nih.gov/29974596