Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations

Labor Complication Clinical Trial

— SOFIE  

Official title:

Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06261710
• Other study ID #: EA2_253_23
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Labor Complication
• Obstetric Labor Complications

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