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Role of Intrapartum Ultrasound in Instrumental Delivery

Role of Intrapartum Ultrasound in the Efficacy of an Instrumental Delivery

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02899481
Enrollment
222
Registered
2016-09-14
Start date
2016-09-30
Completion date
2019-03-31
Last updated
2020-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstetric Labor Complications

Brief summary

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.

Interventions

OTHERTransabdominal 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.

Sponsors

University of Lisbon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* pregnant women at term, in labor (≥ 37 weeks of gestation dated by a first trimester ultrasound * live singleton pregnancy * fetus in a cephalic presentation * in the second stage of labor, after the decision to perform an instrumental delivery

Exclusion criteria

* fetal malformations * emergency situation

Design outcomes

Primary

MeasureTime frameDescription
Maternal and neonatal morbidity2 yearsSevere postpartum hemorrhage, perineal trauma, prolonged hospital stay
Neonatal morbidity2 yearslow 5-minute Apgar score, umbilical artery metabolic acidosis, birth trauma and neonatal intensive care unit admission

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026