Role of Intrapartum Ultrasound in Instrumental Delivery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Obstetric Labor Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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'.

Group Type EXPERIMENTAL

Transabdominal and transperineal ultrasound

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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