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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sonography Only | Experimental | The use of ultrasound parameters to asses the progress of labour from admission to delivery. Namely, Angle of Progression, Head Perineum Distance, Midline Angle and Cervix Dilatation at 3-4 hour intervals until delivery. |
|
| Traditional | No Intervention | The traditional use of internal vaginal examination to assess cervix dilatation, fetal head position, station and orientation within the pelvis during the course of labour as routinely performed every 3-4 hours in labour and until delivery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sonography in labour | Other | Using intrapartum sonography parameters in labour |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Average age | Number (years) measured per patient and the average within the group. | Upon admission for delivery |
| Maternal weight | Number (kilograms) measured per patient and the average within the group. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Larry Hinkson, FRCOG | Contact | 030450664710 | Larry.Hinkson@charite.de |
| Name | Affiliation | Role |
|---|---|---|
| Larry Hinkson, FRCOG | Charité University Hospital Department of Obstetrics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité University Hospital | Recruiting | Berlin | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20569811 | Background | 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. | |
| 29974596 | Background | 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. |
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| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D002821 | Chorioamnionitis |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005315 | Fetal Diseases |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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| Upon admission for delivery |
| Maternal height | Number (centimetres) measured per patient and the average within the group. | Upon admission for delivery |
| Completed weeks of pregnancy | Number (weeks) measured per patient and the average within the group. | Upon admission for delivery |
| Previous pregnancy | Number measured per patient and the average within the group. | Upon admission for delivery |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Incidence of Neonatal Admission | Percentage. The incidence of neonatal admission in patients within the groups | Up to 6 weeks postpartum |
| Neonatal weight | Number. Gramms measures on weighing on a scale | Up to 30 Minutes after birth |
| 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 |
| D005322 | Fetal Membranes, Premature Rupture |
| D010922 | Placenta Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D055585 |
| Physical Phenomena |