Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations

NCT ID: NCT06261710

Last Updated: 2024-02-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 356 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-27
• Study Completion Date: 2030-02-01

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.

Conditions

Labor Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sonography in labour

Intervention Type: OTHER

Using intrapartum sonography parameters in labour

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sonography in labour

Using intrapartum sonography parameters in labour

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Pregnant women of at least 18 years of age with a singleton in the cephalic position

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Larry Hinkson

OTHER

Sponsor Role: lead

Responsible Party

Larry Hinkson

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Larry Hinkson, FRCOG

Role: PRINCIPAL_INVESTIGATOR

Charité University Hospital Department of Obstetrics

Locations

Charité University Hospital

Berlin, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Larry Hinkson, FRCOG

Role: CONTACT

Larry.Hinkson@charite.de

030450664710

Facility Contacts

Larry Hinkson, FRCOG

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 20569811 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29974596 (View on PubMed)

Other Identifiers

EA2_253_23

Identifier Type: -

Identifier Source: org_study_id