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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03200665
Date of registration: 24/06/2017
Prospective Registration: No
Primary sponsor: Hospital de Santa Maria, Portugal
Public title: Sonographic Evaluation of Fetal Growth in the Third Trimester of Low-risk Pregnancy: a Randomized Trial
Scientific title: Sonographic Evaluation of Fetal Growth in the Third Trimester of Low-risk Pregnancy: a Randomized Trial
Date of first enrolment: July 2015
Target sample size: 1093
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03200665
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Screening. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Portugal
Contacts
Name:     Catarina Policiano
Address: 
Telephone:
Email:
Affiliation:  CHLN, Hospital de Santa Maria. Faculdade de Medicina da Universidade de Lisboa
Key inclusion & exclusion criteria

Inclusion Criteria:

- Single fetus pregnancy

Exclusion Criteria:

- Diabetes

- Hypertension

- Pre-eclampsia

- Autoimmune diseases

- Antecedent of fetal growth restriction or pre-eclampsia

- Placental anomalies

- Fetal malformations

- Chromosome anomalies

- TORCH Infections



Age minimum: 15 Years
Age maximum: 45 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Condition of Fetal Growth or Malnutrition (Diagnosis)
Intervention(s)
Diagnostic Test: Ultrasound 35-36 (6 / 7 days weeks)
Primary Outcome(s)
To increase the detection rate of late fetal growth restriction in low risk pregnancies [Time Frame: 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 Outcome(s)
To decrease the rate of cesarean and instrumental deliveries indicated by intrapartum hypoxia [Time Frame: It will be assessed after delivery (about 5 weeks after intervention)]
Secondary ID(s)
FCTUltrasoundIUGR
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Fundação para a Ciência e a Tecnologia
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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