Role of Intrapartum Ultrasound in Instrumental Delivery

Universidade de Lisboa

Status: Terminated

Conditions: Obstetric Labor Complications

Treatments: Other: Transabdominal and transperineal ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT02899481

CC-157

Details and patient eligibility

About

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.

Enrollment: 222 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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222 participants in 2 patient groups

Study group

Experimental group

Description:

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'.

Treatment:

Other: Transabdominal and transperineal ultrasound

Control group

No Intervention group

Description:

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.