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Trial Outcomes & Findings for Third Trimester Screening of Fetal Growth Restriction (NCT NCT05787054)

NCT ID: NCT05787054

Last Updated: 2025-04-30

Results Overview

Rate of newborns with a Birth Weight \<10 th centile according to International Prescriptive Charts who were prenatally identified

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

813 participants

Primary outcome timeframe

at birth

Results posted on

2025-04-30

Participant Flow

Participant milestones

Participant milestones
Measure
Single Scan
Single scan at 28-32 weeks Third trimester ultrasound: Single scan versus Longitudinal scan
Longitudinal Scan
Longitudinal scan at 28-32 AND 35-37 weeks Third trimester ultrasound: Single scan versus Longitudinal scan
Overall Study
STARTED
407
406
Overall Study
COMPLETED
396
394
Overall Study
NOT COMPLETED
11
12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Third Trimester Screening of Fetal Growth Restriction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Single Scan
n=396 Participants
Single scan at 28-32 weeks Third trimester ultrasound: Single scan versus Longitudinal scan
Longitudinal Scan
n=394 Participants
Longitudinal scan at 28-32 AND 35-37 weeks Third trimester ultrasound: Single scan versus Longitudinal scan
Total
n=790 Participants
Total of all reporting groups
Age, Continuous
30.7 years
n=99 Participants
30.7 years
n=107 Participants
30.7 years
n=206 Participants
Sex: Female, Male
Female
396 Participants
n=99 Participants
394 Participants
n=107 Participants
790 Participants
n=206 Participants
Sex: Female, Male
Male
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants
n=99 Participants
5 Participants
n=107 Participants
9 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
390 Participants
n=99 Participants
389 Participants
n=107 Participants
779 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
n=99 Participants
0 Participants
n=107 Participants
2 Participants
n=206 Participants
Region of Enrollment
Italy
396 participants
n=99 Participants
394 participants
n=107 Participants
790 participants
n=206 Participants

PRIMARY outcome

Timeframe: at birth

Population: sensibility of two screening protocols

Rate of newborns with a Birth Weight \<10 th centile according to International Prescriptive Charts who were prenatally identified

Outcome measures

Outcome measures
Measure
Single Scan
n=396 Participants
Single scan at 28-32 weeks Third trimester ultrasound: Single scan versus Longitudinal scan
Longitudinal Scan
n=394 Participants
Longitudinal scan at 28-32 AND 35-37 weeks Third trimester ultrasound: Single scan versus Longitudinal scan
Rate of Small for Gestational Age at Birth Identified Antenatally
28 Participants
46 Participants

SECONDARY outcome

Timeframe: at birth

Population: Odds Ratio for Cesarean section

Rate of patients undergoing C section rather than spontaneous vaginal birth

Outcome measures

Outcome measures
Measure
Single Scan
n=396 Participants
Single scan at 28-32 weeks Third trimester ultrasound: Single scan versus Longitudinal scan
Longitudinal Scan
n=394 Participants
Longitudinal scan at 28-32 AND 35-37 weeks Third trimester ultrasound: Single scan versus Longitudinal scan
Rate of Cesarean Section in the Two Groups
84 Participants
76 Participants

SECONDARY outcome

Timeframe: up to 40 days after birth

Population: rate of neonatal admission into intensive care unit

rate of admission into neonatal intensive care unit

Outcome measures

Outcome measures
Measure
Single Scan
n=396 Participants
Single scan at 28-32 weeks Third trimester ultrasound: Single scan versus Longitudinal scan
Longitudinal Scan
n=394 Participants
Longitudinal scan at 28-32 AND 35-37 weeks Third trimester ultrasound: Single scan versus Longitudinal scan
Rate of Adverse Outcomes
15 Participants
4 Participants

Adverse Events

Single Scan

Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths

Longitudinal Scan

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Alessandra Familiari

Catholic University of the Sacred Heart, Fondazione Policlinico Gemelli

Phone: +393285887422

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place