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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06261710
Other study ID # EA2_253_23
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 27, 2024
Est. completion date February 1, 2030

Study information

Verified date February 2024
Source Charite University, Berlin, Germany
Contact Larry Hinkson, FRCOG
Phone 030450664710
Email Larry.Hinkson@charite.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 356
Est. completion date February 1, 2030
Est. primary completion date February 1, 2029
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Sonography in labour
Using intrapartum sonography parameters in labour

Locations

Country Name City State
Germany Charité University Hospital Berlin

Sponsors (1)

Lead Sponsor Collaborator
Larry Hinkson

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Ghi T, Eggebo T, Lees C, Kalache K, Rozenberg P, Youssef A, Salomon LJ, Tutschek B. ISUOG Practice Guidelines: intrapartum ultrasound. Ultrasound Obstet Gynecol. 2018 Jul;52(1):128-139. doi: 10.1002/uog.19072. — View Citation

Tita AT, Andrews WW. Diagnosis and management of clinical chorioamnionitis. Clin Perinatol. 2010 Jun;37(2):339-54. doi: 10.1016/j.clp.2010.02.003. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Incidence of Chorioamnionitis on Placenta Histologie Percentage. Incidence of Histological Chorioamnionitis on histological examination of the placenta in patients within the group After delivery up to 6 weeks postpartum
Primary Maternal Fever Incidence Percentage. Incidence of Fever >37.8°C measured with a thermometer in patients within the group In the course of labour from admission until delivery in 3-4 hour intervals
Primary Maternal Tachycardia Incidence Percentage. Incidence of >100 beats per minute as maternal pulse measurement in patients within the group In the course of labour from admission until delivery in 3-4 hour intervals
Primary Maternal Leucocytosis Percentage. Incidence of maternal leucocytosis (white blood cell count >15,000 leukocytes per microliter of blood) in patients within the group In the course of labour from admission until delivery in 6 hour intervals
Primary Uterine tenderness Percentage. The incidence of uterine tenderness on palpation during the course of labour in patients within the group In the course of labour from admission until delivery 3-4 hour intervals
Primary Fetal Tachycardia Percentage.The incidence of fetal tachycardia (>160 beats per minute) on continuous Cardiotocographic Monitoring in patients within the group In the course of labour from admission until delivery
Primary Foul-smelling amniotic fluid Percentage . The incidence of foul-smelling amniotic fluid on clinical examination in patients with in the group In the course of labour from admission until delivery
Secondary Average age Number (years) measured per patient and the average within the group. Upon admission for delivery
Secondary Maternal weight Number (kilograms) measured per patient and the average within the group. Upon admission for delivery
Secondary Maternal height Number (centimetres) measured per patient and the average within the group. Upon admission for delivery
Secondary Completed weeks of pregnancy Number (weeks) measured per patient and the average within the group. Upon admission for delivery
Secondary Previous pregnancy Number measured per patient and the average within the group. Upon admission for delivery
Secondary Incidence of Vaginal Examinations Percentage. The number of vaginal examinations performed in labour on average per patient within the group. In the course of labour until delivery
Secondary Incidence of Caesarean section Percentage.The incidence of Caesarean section (No. of Cesareans as a percentage of the Group total) In the course of labour until delivery
Secondary Incidence of Instrumental Delivery Percentage.The incidence of instrumental deliveries (No. of instrumental deliveries as a percentage of the total in the group) In the course of labour until delivery
Secondary Incidence of estimated blood loss >1000 ml Percentage.The incidence of estimated blood loss >1000 millilitres (No. of cases as a percentage of the total in the group) In the course of labour until delivery and up to 24 hours postpartum
Secondary Incidence of antibiotics usage Percentage.The incidence of antibiotic use (No. of cases as a percentage of the total in the group) In the course of labour until delivery and up to 24 hours postpartum
Secondary Incidence of Neonatal Admission Percentage. The incidence of neonatal admission in patients within the groups Up to 6 weeks postpartum
Secondary Neonatal weight Number. Gramms measures on weighing on a scale Up to 30 Minutes after birth
Secondary Maternal Satisfaction Scores Linkert scores. Questionnaire on maternal views on the use of examination in labour. (Linkert scores from 1-6 with increasing scale) On admission and after delivery
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