Sonographic Evaluation of Fetal Growth in the Third Trimester of Low-risk Pregnancy: a Randomized Trial

NCT03200665 | Completed

• 1 other identifier: FCTUltrasoundIUGR
• Study Type: interventional
• Target: 1,093
• Locations: 1 country
• Sites: 1

Brief Summary

Sonographic fetal weight estimation at the last weeks of third trimester in low-risk pregnancies is an effective method for diagnosis of fetal growth restriction (FGR) permitting close surveillance and timely delivery. The need for a systematic ultrasound evaluation at the last weeks of a low-risk pregnancy and the best time to perform it remains controversial. The most commonly used clinical screening tool in this population is the serial measurement of symphysis-fundus distance, which is a method of a variable and low sensitivity for detection of FGR. In Portugal, in accordance with guidelines of Direcção Geral de Saúde from 2015, fetal growth restriction screening in low risk pregnancies is performed with an ultrasound for fetal weight estimation at 30th-33rd weeks. Nonetheless, recent data from randomized trials showed that FGR detection rate was superior at 36 vs 32 weeks' gestation. In cases of severe FGR, detection rate was also superior at 36 vs 32 weeks' gestation. In a prior retrospective study, our group analyzed 1429 term low risk pregnancies and the investigators concluded that small for gestational age term babies (birthweight \< 10th centile) had a statistically significant higher rate of operative deliveries for intrapartum fetal distress than appropriate for gestational age as well as a higher rate of admission to neonatal intensive care unit. Moreover the investigators compared the same outcomes within small for gestational age neonates with antepartum detection at 30th-33rd weeks ultrasound vs undetected (normal 30th-33rd weeks ultrasound). Antepartum detection of small for gestational age neonates showed a statistically significant lower rate of operative deliveries for intrapartum fetal distress than undetected small for gestational age neonates. The investigators will conduct a prospective randomized clinical trial with the aim to evaluate if a 35th-37th weeks after the standard of care ultrasound in low risk pregnancies is effective in improving the detection rate of FGR and in reducing cesarean deliveries for intrapartum fetal distress and admission to neonatal intensive care unit.

Conditions

Condition of Fetal Growth or Malnutrition (Diagnosis)

Outcome Measures

Primary Outcomes (1)

• To increase the detection rate of late fetal growth restriction in low risk pregnancies

  Diagnosis of fetal growth restriction is defined as birthweight under 10th centile according to gestational age

  It will be assessed when the baby is delivered (about 5 weeks after intervention) by comparing antenatal fetal weight estimation centiles of both ultrasounds with birthweight centiles and evaluate which ultrasound is more accurate

Secondary Outcomes (1)

• To decrease the rate of cesarean and instrumental deliveries indicated by intrapartum hypoxia

  It will be assessed after delivery (about 5 weeks after intervention)

Study Arms (2)

Ultrasound 35-36 (6 / 7 days weeks)

EXPERIMENTAL

The patients that are randomized to this group, besides accomplishing the standard of care of national guidelines (third trimester ultrasound at 30-32 (6 / 7 days weeks)) will be submitted to an additional third trimester ultrasound at 35-36 (6 / 7 days weeks).

Diagnostic Test: Ultrasound 35-36 (6 / 7 days weeks)

Standard of Care

NO INTERVENTION

This is the control group that will be managed in accordance to national guidelines of screening of late fetal growth restriction in low risk pregnancies: third trimester ultrasound at 30-32 (6 / 7 days weeks).

Interventions

Ultrasound 35-36 (6 / 7 days weeks) DIAGNOSTIC_TEST

An obstetric ultrasound will be performed at 35-36 (6 / 7 days weeks) including biometric parameters and functional parameters of the fetus

Ultrasound 35-36 (6 / 7 days weeks)

Eligibility Criteria

• Age: 15 Years - 45 Years
• Gender Eligibility Details: Patient eligibility is based on gender identity because we will include only pregnant women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Single fetus pregnancy

You may not qualify if:

• Diabetes
• Hypertension
• Pre-eclampsia
• Autoimmune diseases
• Antecedent of fetal growth restriction or pre-eclampsia
• Placental anomalies
• Fetal malformations
• Chromosome anomalies
• TORCH Infections

Sponsors & Collaborators

• Hospital de Santa Maria, Portugal: lead
• Fundação para a Ciência e a Tecnologia: collaborator

Study Sites (1)

CHLN, Hospital de Santa Maria

Lisbon, 1649-035, Portugal

Location

MeSH Terms

Conditions

Malnutrition; Disease

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Catarina Policiano

  CHLN, Hospital de Santa Maria. Faculdade de Medicina da Universidade de Lisboa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2017
• First Posted: June 27, 2017
• Study Start: July 1, 2015
• Primary Completion: November 1, 2019
• Study Completion: January 1, 2020
• Last Updated: January 21, 2020

Record last verified: 2020-01

Locations

PT (1)