Labor Complication Clinical Trial
— SOFIEOfficial title:
Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations
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.
Status | Recruiting |
Enrollment | 356 |
Est. completion date | February 1, 2030 |
Est. primary completion date | February 1, 2029 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Charité University Hospital | Berlin |
Lead Sponsor | Collaborator |
---|---|
Larry Hinkson |
Germany,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Incidence of Chorioamnionitis on Placenta Histologie | Percentage. Incidence of Histological Chorioamnionitis on histological examination of the placenta in patients within the group | After delivery up to 6 weeks postpartum | |
Primary | Maternal Fever Incidence | Percentage. Incidence of Fever >37.8°C measured with a thermometer in patients within the group | In the course of labour from admission until delivery in 3-4 hour intervals | |
Primary | Maternal Tachycardia Incidence | Percentage. Incidence of >100 beats per minute as maternal pulse measurement in patients within the group | In the course of labour from admission until delivery in 3-4 hour intervals | |
Primary | Maternal Leucocytosis | Percentage. Incidence of maternal leucocytosis (white blood cell count >15,000 leukocytes per microliter of blood) in patients within the group | In the course of labour from admission until delivery in 6 hour intervals | |
Primary | Uterine tenderness | Percentage. The incidence of uterine tenderness on palpation during the course of labour in patients within the group | In the course of labour from admission until delivery 3-4 hour intervals | |
Primary | Fetal Tachycardia | Percentage.The incidence of fetal tachycardia (>160 beats per minute) on continuous Cardiotocographic Monitoring in patients within the group | In the course of labour from admission until delivery | |
Primary | Foul-smelling amniotic fluid | Percentage . The incidence of foul-smelling amniotic fluid on clinical examination in patients with in the group | In the course of labour from admission until delivery | |
Secondary | Average age | Number (years) measured per patient and the average within the group. | Upon admission for delivery | |
Secondary | Maternal weight | Number (kilograms) measured per patient and the average within the group. | Upon admission for delivery | |
Secondary | Maternal height | Number (centimetres) measured per patient and the average within the group. | Upon admission for delivery | |
Secondary | Completed weeks of pregnancy | Number (weeks) measured per patient and the average within the group. | Upon admission for delivery | |
Secondary | Previous pregnancy | Number measured per patient and the average within the group. | Upon admission for delivery | |
Secondary | Incidence of Vaginal Examinations | Percentage. The number of vaginal examinations performed in labour on average per patient within the group. | In the course of labour until delivery | |
Secondary | Incidence of Caesarean section | Percentage.The incidence of Caesarean section (No. of Cesareans as a percentage of the Group total) | In the course of labour until delivery | |
Secondary | Incidence of Instrumental Delivery | Percentage.The incidence of instrumental deliveries (No. of instrumental deliveries as a percentage of the total in the group) | In the course of labour until delivery | |
Secondary | Incidence of estimated blood loss >1000 ml | Percentage.The incidence of estimated blood loss >1000 millilitres (No. of cases as a percentage of the total in the group) | In the course of labour until delivery and up to 24 hours postpartum | |
Secondary | Incidence of antibiotics usage | Percentage.The incidence of antibiotic use (No. of cases as a percentage of the total in the group) | In the course of labour until delivery and up to 24 hours postpartum | |
Secondary | Incidence of Neonatal Admission | Percentage. The incidence of neonatal admission in patients within the groups | Up to 6 weeks postpartum | |
Secondary | Neonatal weight | Number. Gramms measures on weighing on a scale | Up to 30 Minutes after birth | |
Secondary | Maternal Satisfaction Scores | Linkert scores. Questionnaire on maternal views on the use of examination in labour. (Linkert scores from 1-6 with increasing scale) | On admission and after delivery |
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