Labor Complication
Conditions
Keywords
Chorioamnionitis, Sonography
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.
Interventions
OTHERSonography in labour
Using intrapartum sonography parameters in labour
Sponsors
Larry Hinkson
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Foul-smelling amniotic fluid | 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 |
| Uterine tenderness | 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 | 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 | 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 |
| Maternal Tachycardia Incidence | 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 |
| Maternal Leucocytosis | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Vaginal Examinations | In the course of labour until delivery | Percentage. The number of vaginal examinations performed in labour on average per patient within the group. |
| Incidence of Caesarean section | In the course of labour until delivery | Percentage.The incidence of Caesarean section (No. of Cesareans as a percentage of the Group total) |
| Incidence of Instrumental Delivery | In the course of labour until delivery | Percentage.The incidence of instrumental deliveries (No. of instrumental deliveries as a percentage of the total in the group) |
| Incidence of estimated blood loss >1000 ml | In the course of labour until delivery and up to 24 hours postpartum | Percentage.The incidence of estimated blood loss \>1000 millilitres (No. of cases as a percentage of the total in the group) |
| Incidence of Neonatal Admission | Up to 6 weeks postpartum | Percentage. The incidence of neonatal admission in patients within the groups |
| Neonatal weight | Up to 30 Minutes after birth | Number. Gramms measures on weighing on a scale |
| Maternal Satisfaction Scores | On admission and after delivery | Linkert scores. Questionnaire on maternal views on the use of examination in labour. (Linkert scores from 1-6 with increasing scale) |
| Incidence of antibiotics usage | In the course of labour until delivery and up to 24 hours postpartum | Percentage.The incidence of antibiotic use (No. of cases as a percentage of the total in the group) |
| Average age | Upon admission for delivery | Number (years) measured per patient and the average within the group. |
| Maternal weight | Upon admission for delivery | Number (kilograms) measured per patient and the average within the group. |
| Maternal height | Upon admission for delivery | Number (centimetres) measured per patient and the average within the group. |
| Completed weeks of pregnancy | Upon admission for delivery | Number (weeks) measured per patient and the average within the group. |
| Previous pregnancy | Upon admission for delivery | Number measured per patient and the average within the group. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Chorioamnionitis on Placenta Histologie | After delivery up to 6 weeks postpartum | Percentage. Incidence of Histological Chorioamnionitis on histological examination of the placenta in patients within the group |
Countries
Germany
Contacts
Primary ContactLarry Hinkson, FRCOG
Outcome results
None listed