Role of Intrapartum Ultrasound in Instrumental Delivery
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|ClinicalTrials.gov Identifier: NCT02899481|
Recruitment Status : Terminated (Data Safety Monitoring Committee recommended stopping the trial due to futility.)
First Posted : September 14, 2016
Last Update Posted : June 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Obstetric Labor Complications||Other: Transabdominal and transperineal ultrasound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||222 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Role of Intrapartum Ultrasound in the Efficacy of an Instrumental Delivery|
|Actual Study Start Date :||September 2016|
|Actual Primary Completion Date :||March 2019|
|Actual Study Completion Date :||March 2019|
Experimental: Study group
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'.
Other: Transabdominal and transperineal ultrasound
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.
No Intervention: Control group
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.
- Maternal and neonatal morbidity [ Time Frame: 2 years ]Severe postpartum hemorrhage, perineal trauma, prolonged hospital stay
- Neonatal morbidity [ Time Frame: 2 years ]low 5-minute Apgar score, umbilical artery metabolic acidosis, birth trauma and neonatal intensive care unit admission
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02899481
|Centro Hospitalar Lisboa Norte - Hospital Santa Maria|
|Principal Investigator:||Joana Barros, MD||University of Lisbon|