Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Labor Complication
- Sponsor
- Larry Hinkson
- Enrollment
- 356
- Locations
- 1
- Primary Endpoint
- Maternal Leucocytosis
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Larry Hinkson
Principal Investigator
Charite University, Berlin, Germany
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
Outcomes
Primary Outcomes
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
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
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
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
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
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
- Average age(Upon admission for delivery)
- Incidence of estimated blood loss >1000 ml(In the course of labour until delivery and up to 24 hours postpartum)
- Incidence of Neonatal Admission(Up to 6 weeks postpartum)
- Incidence of Caesarean section(In the course of labour until delivery)
- Incidence of Instrumental Delivery(In the course of labour until delivery)
- Maternal weight(Upon admission for delivery)
- Maternal height(Upon admission for delivery)
- Previous pregnancy(Upon admission for delivery)
- Incidence of Vaginal Examinations(In the course of labour until delivery)
- Completed weeks of pregnancy(Upon admission for delivery)
- Maternal Satisfaction Scores(On admission and after delivery)
- Incidence of antibiotics usage(In the course of labour until delivery and up to 24 hours postpartum)
- Neonatal weight(Up to 30 Minutes after birth)