Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations
- Conditions
- Labor Complication
- Interventions
- Other: Sonography in labour
- Registration Number
- NCT06261710
- Lead Sponsor
- Larry Hinkson
- Brief Summary
This is a prospective, randomized trial to determine whether the use of sonographic parameters during labor results in less intrapartum infection compared to traditional invasive examination. Other secondary outcomes include maternal satisfaction and overall birth outcomes.
- Detailed Description
It is a prospective, randomized trial to determine whether the use of sonographic parameters during childbirth results in less intrapartum infection compared to traditional invasive examination. Intrapartum non-invasive ultrasound has been established and validated as a method of assessing labor progress. Guidelines from international societies recommend the use of ultrasound to monitor labor and support decision-making during delivery. Despite its reproducibility and reliability, there is no comprehensive work to date demonstrating the potential benefit in reducing clinical chorioamnionitis compared to traditional invasive vaginal examination. With this in mind, the investigators set out to analyze the clinical benefit of using ultrasound alone using established non-invasive, intrapartum, translabial parameters (Angle of Progression, Head Perineum Distance, Midline Angle, Cervix Dilatation) to monitor birth outcomes compared to traditional invasive vaginal examinations.
Primary Outcome is the incidence of clinical chorioamnionitis. Secondary Outcome measures include mode of delivery and neonatal outcomes such as neonatal admission.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 356
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sonography Only Sonography in labour The use of ultrasound parameters to asses the progress of labour from admission to delivery. Namely, Angle of Progression, Head Perineum Distance, Midline Angle and Cervix Dilatation at 3-4 hour intervals until delivery.
- Primary Outcome Measures
Name Time Method Maternal Leucocytosis In the course of labour from admission until delivery in 6 hour intervals Percentage. Incidence of maternal leucocytosis (white blood cell count \>15,000 leukocytes per microliter of blood) in patients within the group
Maternal Tachycardia Incidence In the course of labour from admission until delivery in 3-4 hour intervals Percentage. Incidence of \>100 beats per minute as maternal pulse measurement in patients within the group
Uterine tenderness In the course of labour from admission until delivery 3-4 hour intervals Percentage. The incidence of uterine tenderness on palpation during the course of labour in patients within the group
Fetal Tachycardia In the course of labour from admission until delivery Percentage.The incidence of fetal tachycardia (\>160 beats per minute) on continuous Cardiotocographic Monitoring in patients within the group
Maternal Fever Incidence In the course of labour from admission until delivery in 3-4 hour intervals Percentage. Incidence of Fever \>37.8°C measured with a thermometer in patients within the group
Foul-smelling amniotic fluid In the course of labour from admission until delivery Percentage . The incidence of foul-smelling amniotic fluid on clinical examination in patients with in the group
- Secondary Outcome Measures
Name Time Method Incidence of Caesarean section In the course of labour until delivery Percentage.The incidence of Caesarean section (No. of Cesareans as a percentage of the Group total)
Average age Upon admission for delivery Number (years) measured per patient and the average within the group.
Incidence of estimated blood loss >1000 ml In the course of labour until delivery and up to 24 hours postpartum Percentage.The incidence of estimated blood loss \>1000 millilitres (No. of cases as a percentage of the total in the group)
Incidence of Neonatal Admission Up to 6 weeks postpartum Percentage. The incidence of neonatal admission in patients within the groups
Incidence of Instrumental Delivery In the course of labour until delivery Percentage.The incidence of instrumental deliveries (No. of instrumental deliveries as a percentage of the total in the group)
Completed weeks of pregnancy Upon admission for delivery Number (weeks) measured per patient and the average within the group.
Maternal weight Upon admission for delivery Number (kilograms) measured per patient and the average within the group.
Maternal height Upon admission for delivery Number (centimetres) measured per patient and the average within the group.
Previous pregnancy Upon admission for delivery Number measured per patient and the average within the group.
Incidence of Vaginal Examinations In the course of labour until delivery Percentage. The number of vaginal examinations performed in labour on average per patient within the group.
Maternal Satisfaction Scores On admission and after delivery Linkert scores. Questionnaire on maternal views on the use of examination in labour. (Linkert scores from 1-6 with increasing scale)
Incidence of antibiotics usage In the course of labour until delivery and up to 24 hours postpartum Percentage.The incidence of antibiotic use (No. of cases as a percentage of the total in the group)
Neonatal weight Up to 30 Minutes after birth Number. Gramms measures on weighing on a scale
Trial Locations
- Locations (1)
Charité University Hospital
🇩🇪Berlin, Germany