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NCT Number: NCT06261710

Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations

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.

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Key information

Conditions

Labor Complication Chorioamnionitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Membranes, Premature Rupture Obstetric Labor Complications Placenta Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Charité University Hospital

Berlin, Germany

Location status: Recruiting

Location contact

Larry Hinkson, FRCOG

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sonography in labour

Other

Using intrapartum sonography parameters in labour

Primary outcomes

  1. Maternal Fever Incidence

    Time frame: In the course of labour from admission until delivery in 3-4 hour intervals

    Percentage. Incidence of Fever >37.8°C measured with a thermometer in patients within the group

  2. Maternal Tachycardia Incidence

    Time frame: In the course of labour from admission until delivery in 3-4 hour intervals

    Percentage. Incidence of >100 beats per minute as maternal pulse measurement in patients within the group

  3. Maternal Leucocytosis

    Time frame: In the course of labour from admission until delivery in 6 hour intervals

    Percentage. Incidence of maternal leucocytosis (white blood cell count >15,000 leukocytes per microliter of blood) in patients within the group

  4. Uterine tenderness

    Time frame: In the course of labour from admission until delivery 3-4 hour intervals

    Percentage. The incidence of uterine tenderness on palpation during the course of labour in patients within the group

  5. Fetal Tachycardia

    Time frame: In the course of labour from admission until delivery

    Percentage.The incidence of fetal tachycardia (>160 beats per minute) on continuous Cardiotocographic Monitoring in patients within the group

  6. Foul-smelling amniotic fluid

    Time frame: In the course of labour from admission until delivery

    Percentage . The incidence of foul-smelling amniotic fluid on clinical examination in patients with in the group

Secondary outcomes

  1. Average age

    Time frame: Upon admission for delivery

    Number (years) measured per patient and the average within the group.

  2. Maternal weight

    Time frame: Upon admission for delivery

    Number (kilograms) measured per patient and the average within the group.

  3. Maternal height

    Time frame: Upon admission for delivery

    Number (centimetres) measured per patient and the average within the group.

  4. Completed weeks of pregnancy

    Time frame: Upon admission for delivery

    Number (weeks) measured per patient and the average within the group.

  5. Previous pregnancy

    Time frame: Upon admission for delivery

    Number measured per patient and the average within the group.

  6. Incidence of Vaginal Examinations

    Time frame: In the course of labour until delivery

    Percentage. The number of vaginal examinations performed in labour on average per patient within the group.

  7. Incidence of Caesarean section

    Time frame: In the course of labour until delivery

    Percentage.The incidence of Caesarean section (No. of Cesareans as a percentage of the Group total)

  8. Incidence of Instrumental Delivery

    Time frame: In the course of labour until delivery

    Percentage.The incidence of instrumental deliveries (No. of instrumental deliveries as a percentage of the total in the group)

  9. Incidence of estimated blood loss >1000 ml

    Time frame: In the course of labour until delivery and up to 24 hours postpartum

    Percentage.The incidence of estimated blood loss >1000 millilitres (No. of cases as a percentage of the total in the group)

  10. Incidence of antibiotics usage

    Time frame: In the course of labour until delivery and up to 24 hours postpartum

    Percentage.The incidence of antibiotic use (No. of cases as a percentage of the total in the group)

  11. Incidence of Neonatal Admission

    Time frame: Up to 6 weeks postpartum

    Percentage. The incidence of neonatal admission in patients within the groups

  12. Neonatal weight

    Time frame: Up to 30 Minutes after birth

    Number. Gramms measures on weighing on a scale

  13. Maternal Satisfaction Scores

    Time frame: On admission and after delivery

    Linkert scores. Questionnaire on maternal views on the use of examination in labour. (Linkert scores from 1-6 with increasing scale)

Other outcomes

  1. Incidence of Chorioamnionitis on Placenta Histologie

    Time frame: After delivery up to 6 weeks postpartum

    Percentage. Incidence of Histological Chorioamnionitis on histological examination of the placenta in patients within the group

Study contacts

Contact information is provided by the study sponsor or research team.

Larry Hinkson, FRCOG

CONTACT

[email protected]

030450664710

Sponsors and collaborators

Lead sponsor

Larry Hinkson

Other

Registry information

Acronym: SOFIE

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Feb 15, 2024
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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