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Data Safety Monitoring Committee recommended stopping the trial due to futility.
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Investigators will perform a multicentric randomized controlled trial comparing the effect of transabdominal and transperineal ultrasound in pregnant women in the second stage of labor, in whom it was decided an operative delivery. Our objective is to evaluate the impact of intrapartal ultrasound measurements, as an auxiliary to clinical evaluation, in the efficacy of an instrumental delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | The study group will be constituted by pregnant women in whom the operative delivery will be preceded by a transabdominal and transperineal ultrasound to evaluate fetal head position and fetal head station, by means of determination of the 'angle of progression'. |
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| Control group | No Intervention | The control group will be constituted by pregnant women in whom the operative delivery will be carried out based solely on clinical criteria, namely transvaginal digital examination. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transabdominal and transperineal ultrasound | Other | Transabdominal ultrasound, for determining fetal head position, is performed with the pregnant women in supine position after bladder emptying, with the transducer placed transversely on the suprapubic region of the maternal abdomen. For the sonographic determination of the fetal descent we will perform a transperineal ultrasound achieved by placing the ultrasound transducer on the perineum in a mid sagittal position between the labia below the pubic symphysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal and neonatal morbidity | Severe postpartum hemorrhage, perineal trauma, prolonged hospital stay | 2 years |
| Neonatal morbidity | low 5-minute Apgar score, umbilical artery metabolic acidosis, birth trauma and neonatal intensive care unit admission | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joana Barros, MD | University of Lisbon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Hospitalar Lisboa Norte - Hospital Santa Maria | Lisbon | Portugal |
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| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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