Use of Customized GROW Charts for Detection of SGA in Low Risk Woman.

NCT04764461 | Unknown DMC

• 1 other identifier: FMH01
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective randomised control trial to evaluate the effectiveness of customised growth charts for detection of small for gestational age fetus in low risk women, in comparison to conventional standard of care.

Conditions

Small for Gestational Age at Delivery

Keywords

Small for gestational age; SGA; GROW Chart; Low risk

Outcome Measures

Primary Outcomes (1)

• Change in detection rate of SGA in low risk women using GROW charts

  detection rate of Small for gestational age in control and intervention group

  1.5 years

Secondary Outcomes (6)

• Change in perinatal outcomes between control and Intervention group in low risk women.

  1.5 years

• Rate of Apgar score at the time of birth

  1.5 years

• Rate of Type of labor in control and intervention group

  1.5 years

• Rate of mode of delivery in the control and Intervention group

  1.5 years

• Rate of newborns requiring hospital admissions for postnatal care

  1.5 years

Study Arms (2)

Control Group

NO INTERVENTION

The control group will continue with the standard practice of antenatal care using Mc Donald's rule for fundal heights measurements.

Intervention Group

EXPERIMENTAL

Intervention group will follow the same antenatal visit plan as the control group with the use of customised GROW Charts for fundal height measurements.

Other: Use of customised GROW Charts

Interventions

Use of customised GROW Charts OTHER

Intervention group will follow the same antenatal visit plan and two ultrasounds will be offered (NT 11-13+6 weeks \& anomaly scan 19-22 weeks of gestation) in routine. A third trimester scan will not be offered in routine to Intervention group. Serial SFH measurements will be plotted against estimated date of delivery at each review from 26 weeks of gestation on the customized GROW chart already attached in the maternity notes. On each visit patient will be examined after emptying bladder in a semi-recumbent position, using non-elastic tape with cm side hidden; measurement will be taken from the fundus to upper margin of pubic symphysis. Abnormal SFH measurements, when plotted below the 10th or does not follow its trajectory on customized growth charts will be referred for growth scan suspecting SGA. SFH plotted above 90th centile will also be referred for growth scan, as a part of antenatal care.

Intervention Group

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• low risk woman with singleton pregnancy.

You may not qualify if:

• Pregnant woman with chronic hypertension, Diabetes Mellitus, Autoimmune disorders
• Fetus with chromosomal
• Fetus with structural defects
• Multiple gestation
• Pregnancy with fibroids uterus
• BMI \>35.

Sponsors & Collaborators

• Fatima Memorial Hospital: lead
• Fetal Medicine Research Center, Spain: collaborator

Study Sites (1)

Fatima Memorial College of Medicine and Dentistry

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Study Design

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

Study Record Dates

• First Submitted: February 14, 2021
• First Posted: February 21, 2021
• Study Start: February 14, 2021
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)