Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations

NCT06261710 | Recruiting DMC

• 1 other identifier: EA2_253_23
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Complication

Keywords

Chorioamnionitis; Sonography

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (13)

• Average age

  Upon admission for delivery

• Maternal weight

  Upon admission for delivery

• Maternal height

  Upon admission for delivery

• Completed weeks of pregnancy

  Upon admission for delivery

• Previous pregnancy

  Upon admission for delivery

Other Outcomes (1)

• Incidence of Chorioamnionitis on Placenta Histologie

  After delivery up to 6 weeks postpartum

Study Arms (2)

Sonography Only

EXPERIMENTAL

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

Traditional

NO INTERVENTION

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.

Interventions

Sonography in labour OTHER

Using intrapartum sonography parameters in labour

Sonography Only

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Larry Hinkson: lead

Study Sites (1)

Charité University Hospital

Berlin, Germany

RECRUITING

Related Publications (2)

• 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.

  PMID: 20569811 BACKGROUND

• 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.

  PMID: 29974596 BACKGROUND

MeSH Terms

Conditions

Obstetric Labor Complications; Chorioamnionitis

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Fetal Membranes, Premature Rupture; Placenta Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Larry Hinkson, FRCOG

  Charité University Hospital Department of Obstetrics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Larry Hinkson, FRCOG

CONTACT

030450664710; Larry.Hinkson@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 15, 2024
• Study Start: February 27, 2024
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2030
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)