Using ultrasound during labor to reduce infections
Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations
This study is testing if using ultrasound to check on labor can help reduce infections compared to traditional methods that involve more invasive exams.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 356 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin) |
| Trial ID | NCT06261710 on ClinicalTrials.gov |
What this trial studies
This trial investigates whether using ultrasound to monitor labor can lead to fewer infections compared to traditional invasive examinations. It is a prospective, randomized study that employs established non-invasive ultrasound parameters to assess labor progress. The primary focus is on the incidence of clinical chorioamnionitis, while secondary outcomes include maternal satisfaction and overall birth outcomes. The study aims to validate the effectiveness of ultrasound as a reliable method for monitoring labor without the need for invasive procedures.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 and older with a singleton fetus in the cephalic position experiencing spontaneous labor.
Not a fit: Patients in emergency situations requiring urgent delivery or those with non-cephalic positions will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of intrapartum infections and improve maternal and neonatal outcomes.
How similar studies have performed: While the use of ultrasound in labor monitoring has been established, this specific approach to reducing chorioamnionitis through non-invasive methods is novel and has not been comprehensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women of at least 18 years of age with a singleton in the cephalic position * Spontaneous onset of labor; births after induction of labor with otherwise suitable inclusion and exclusion criteria are also permitted. Exclusion Criteria: * Emergency situations such as maternal or fetal bleeding * Indication for urgent delivery by caesarean section * Pathological cardiotocogram * non-cephalic positions * under 18 years of age * women giving birth who are unable to give consent
Where this trial is running
Berlin
- Charité University Hospital — Berlin, Germany (Recruiting)
Study contacts
- Principal investigator: Larry Hinkson, FRCOG — Charité University Hospital Department of Obstetrics
- Study coordinator: Larry Hinkson, FRCOG
- Email: Larry.Hinkson@charite.de
- Phone: 030450664710
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.