Routine late trimester scan for the detection of small babies in low risk pregnancies

Not Applicable

Recruiting

• Conditions: Neonatal Diseases; Pregnancy and Childbirth; Fetal growth restriction, Small for gestational age fetus

• Registration Number: PACTR201802003075138
• Lead Sponsor: Sikolia Wanyonyi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-12
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 226

Inclusion Criteria

a)Aged ¿18 and <40 years;
b)Body Mass Index (BMI) ¿18.5 and <30 kg/m2 ¿¿
c)Singleton pregnancy
d)A known lass menstrual period (LMP) with regular cycles or a having had a dating/Crow Rump Length (CRL) scan between 11-14 weeks
e)No relevant past medical history (refer to screening form), with no need for long- term medication (including fertility treatment and over-the-counter medicines, but ¿excluding routine iron, folate, calcium, iodine or multivitamin supplements)¿¿
f)No use of tobacco or recreational drugs after becoming pregnant
g)No alcohol use since ¿becoming pregnant
h)No more than one miscarriage in the 2 previous consecutive pregnancies
i)No previous pregnancy affected by pre-eclampsia/eclampsia, HELLP syndrome or ¿a related pregnancy-associated condition
j)Negative urinalysis at booking ¿
k)No diagnosis or treatment for anemia 3 months before or after becoming pregnant
l)Not in an occupation with risk of exposure to chemicals or toxic substances, or ¿very physically demanding activity ¿
m)Plans to deliver at AKUH

Exclusion Criteria

a)Congenital anomalies
b)Abnormal glucose tolerance test (GTT) in current pregnancy
c)Any form of pregnancy induced hypertension
d)Obstetric cholestasis
e)Low lying placenta/placenta previa, who need scheduled follow-up scans
f)Suspected early onset fetal growth restriction on regular ultrasound monitoring

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of fetal growth restricted fetus;proportion of small for gestational age fetus

Secondary Outcome Measures

Name	Time	Method
Birthweight in grams;Umbilical artery PH<7.1;Apgar core of less than 7 at 5 minutes;admission to NICU;Stillbirth;Caesarean section;operative vaginal delivery