Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations
ConditionLabor Complication
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorLarry Hinkson
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Emergency situations such as maternal or fetal bleeding
Indication for urgent delivery by caesarean section
Pathological cardiotocogram
non-cephalic positions
Trial design
Design model
Parallel
Treatments tested in this trial
Sonography in labour
Other interventionUsing intrapartum sonography parameters in labour
Treatment groups
356 Participants
are divided into 2 treatment groupsGroup A: Sonography OnlyExperimental treatment 1 intervention
Group B: TraditionalNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 intervals2
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 intervals3
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 intervals4
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 intervalsSecondary outcomes
1
Average age
Number (years) measured per patient and the average within the group.
Time frame
Upon admission for delivery2
Maternal weight
Number (kilograms) measured per patient and the average within the group.
Time frame
Upon admission for delivery3
Maternal height
Number (centimetres) measured per patient and the average within the group.
Time frame
Upon admission for delivery4
Completed weeks of pregnancy
Number (weeks) measured per patient and the average within the group.
Time frame
Upon admission for deliveryOther outcomes
1
Incidence of Chorioamnionitis on Placenta Histologie
Percentage. Incidence of Histological Chorioamnionitis on histological examination of the placenta in patients within the group
Time frame
After delivery up to 6 weeks postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
Larry Hinkson
Lead sponsor
Charite University, Berlin, Germany
Sponsor institution
Source ClinicalTrials.gov