Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations (SOFIE)

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.

Study Overview

• Status: Recruiting
• Conditions: Labor Complication
• Intervention / Treatment: Other: Sonography in labour

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.

• Study Type: Interventional
• Enrollment (Estimated): 356
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Larry Hinkson, FRCOG; Phone Number: 030450664710; Email: Larry.Hinkson@charite.de

Study Locations

• Germany
  • Berlin, Germany
    • Recruiting
    • Charite University Hospital
    • Contact: Larry Hinkson, FRCOG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sonography Only; 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.	Other: Sonography in labour; Using intrapartum sonography parameters in labour
No Intervention: Traditional; The traditional use of internal vaginal examination to assess cervix dilatation, fetal head position, station and orientation within the pelvis during the course of labour as routinely performed every 3-4 hours in labour and until delivery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average age	Number (years) measured per patient and the average within the group.	Upon admission for delivery
Maternal weight	Number (kilograms) measured per patient and the average within the group.	Upon admission for delivery
Maternal height	Number (centimetres) measured per patient and the average within the group.	Upon admission for delivery
Completed weeks of pregnancy	Number (weeks) measured per patient and the average within the group.	Upon admission for delivery
Previous pregnancy	Number measured per patient and the average within the group.	Upon admission for delivery
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
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
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
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
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
Incidence of Neonatal Admission	Percentage. The incidence of neonatal admission in patients within the groups	Up to 6 weeks postpartum
Neonatal weight	Number. Gramms measures on weighing on a scale	Up to 30 Minutes after birth
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Larry Hinkson
• Investigators: Principal Investigator: Larry Hinkson, FRCOG, Charité University Hospital Department of Obstetrics

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): February 27, 2024
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2030

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Chorioamnionitis; Sonography
• Additional Relevant MeSH Terms: Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor Complications
• Other Study ID Numbers: EA2_253_23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No