Clinical trial NCT06261710: Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations
Official title: Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Labor Complication
Keywords: Chorioamnionitis
Sonography
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 356
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Maternal Fever Incidence
timeFrame: In the course of labour from admission until delivery in 3-4 hour intervals
measure: Maternal Tachycardia Incidence
timeFrame: In the course of labour from admission until delivery in 3-4 hour intervals
measure: Maternal Leucocytosis
timeFrame: In the course of labour from admission until delivery in 6 hour intervals
measure: Uterine tenderness
timeFrame: In the course of labour from admission until delivery 3-4 hour intervals
measure: Fetal Tachycardia
timeFrame: In the course of labour from admission until delivery
measure: Foul-smelling amniotic fluid
timeFrame: In the course of labour from admission until delivery
Secondary outcomes:
measure: Average age
timeFrame: Upon admission for delivery
measure: Maternal weight
timeFrame: Upon admission for delivery
measure: Maternal height
timeFrame: Upon admission for delivery
measure: Completed weeks of pregnancy
timeFrame: Upon admission for delivery
measure: Previous pregnancy
timeFrame: Upon admission for delivery
measure: Incidence of Vaginal Examinations
timeFrame: In the course of labour until delivery
measure: Incidence of Caesarean section
timeFrame: In the course of labour until delivery
measure: Incidence of Instrumental Delivery
timeFrame: In the course of labour until delivery
measure: Incidence of estimated blood loss >1000 ml
timeFrame: In the course of labour until delivery and up to 24 hours postpartum
measure: Incidence of antibiotics usage
timeFrame: In the course of labour until delivery and up to 24 hours postpartum
measure: Incidence of Neonatal Admission
timeFrame: Up to 6 weeks postpartum
measure: Neonatal weight
timeFrame: Up to 30 Minutes after birth
measure: Maternal Satisfaction Scores
timeFrame: On admission and after delivery
Other outcomes:
measure: Incidence of Chorioamnionitis on Placenta Histologie
timeFrame: After delivery up to 6 weeks postpartum
Locations:
city: Berlin
country: Germany
facility: Charité University Hospital
Study officials:
affiliation: Charité University Hospital Department of Obstetrics
name: Larry Hinkson, FRCOG
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.