Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations

Larry Hinkson356 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

356

Conditions

Labor Complication

Interventions

Sonography in labourOTHER

Using intrapartum sonography parameters in labour

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Charité University Hospital

Berlin, Germany

RECRUITING

Outcomes

Primary Outcomes

Maternal Fever Incidence

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

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

Secondary Outcomes

Average age

Central Contacts

Larry Hinkson, FRCOG

CONTACT

030450664710 Larry.Hinkson@charite.de

Data from ClinicalTrials.gov

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