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Recruiting NCT06261710

Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations

No phase Interventional Labor Complication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sonography in labour.
Who it may be relevant to
Registry conditions: Labor Complication. Basic parameters: 18 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Other Sonography in labour
    Using intrapartum sonography parameters in labour

Primary outcome measures

  • Maternal Fever Incidence [Time frame: In the course of labour from admission until delivery in 3-4 hour intervals]
  • Maternal Tachycardia Incidence [Time frame: In the course of labour from admission until delivery in 3-4 hour intervals]
  • Maternal Leucocytosis [Time frame: In the course of labour from admission until delivery in 6 hour intervals]
  • Uterine tenderness [Time frame: In the course of labour from admission until delivery 3-4 hour intervals]
  • Fetal Tachycardia [Time frame: In the course of labour from admission until delivery]
  • Foul-smelling amniotic fluid [Time frame: In the course of labour from admission until delivery]
Secondary outcome measures (12)
  • Average age [Time frame: Upon admission for delivery]
  • Maternal weight [Time frame: Upon admission for delivery]
  • Maternal height [Time frame: Upon admission for delivery]
  • Completed weeks of pregnancy [Time frame: Upon admission for delivery]
  • Previous pregnancy [Time frame: Upon admission for delivery]
  • Incidence of Vaginal Examinations [Time frame: In the course of labour until delivery]
  • Incidence of Caesarean section [Time frame: In the course of labour until delivery]
  • Incidence of Instrumental Delivery [Time frame: In the course of labour until delivery]
  • Incidence of estimated blood loss >1000 ml [Time frame: In the course of labour until delivery and up to 24 hours postpartum]
  • Incidence of antibiotics usage [Time frame: In the course of labour until delivery and up to 24 hours postpartum]
  • Incidence of Neonatal Admission [Time frame: Up to 6 weeks postpartum]
  • Neonatal weight [Time frame: Up to 30 Minutes after birth]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Germany · 1 center
  • Charité University Hospital — Berlin

Publications

  • 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
  • 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

Identifiers

NCT: NCT06261710 · EA2_253_23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗