Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201802003075138 Date of Approval: 12/02/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Routine late trimester scan for the detection of small babies in low risk pregnancies
Official scientific title Routine late trimester scan for the detection of small for gestational age and growth restricted fetuses in low risk pregnancy ¿ A randomized controlled trial
Brief summary describing the background and objectives of the trial The use of late trimester ultrasound in low risk pregnancy populations has been a subject of debate for long with some units advocating selective application while others still recommend universal screening. There is no clear evidence to support routine late trimester ultrasound in low risk pregnant women with the sole aim of improving perinatal outcomes. However, this does not translate into clinical practice. Many individual practitioners will still offer low risk women a late trimester scan. The rationale for requesting this scan has been to monitor growth and assess for fetal well-being at a time when decisions made could significantly prevent adverse outcomes such as still births and birth asphyxia. This is informed by the fact that the greatest risk of both prenatal and intrapartum fetal death is seen in babies not suspected to have been growth restricted antenatally. Fetal growth restriction can only be objectively detected by ultrasound since the sensitivity and specificity of both symphysio-fundal height (SFH) measurement and abdominal palpation are poor. Therefore one can conclude that the use of late trimester scans in low risk pregnancies is the only means available to detect fetuses at risk of stillbirth. It is against this background that we propose to further explore the impact of routine late trimester ultrasound in low risk women using an intervention-based approach in a unit with non- standardised fetal growth monitoring techniques. The main objective is to compare the proportion of small for gestation age and fetal growth restricted fetuses detected in women offered a mandatory ultrasound to those undergoing routine care. We aim to eventually develop local guidelines, which will either recommend or dispute the routine use of late trimester obstetric ultrasound in low risk pregnancy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Fetal growth restriction, Small for gestational age fetus,Neonatal Diseases,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 02/04/2018
Actual trial start date 25/07/2018
Anticipated date of last follow up 11/01/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 226
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using computer generated allocation sequence Sealed opaque envelops Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group No ultrasound group/ Routine antenatal care At 36 weeks gestation N/A The participants will be offered routine antenatal care as is currently done. Fetal growth will be assessed using abdominal palpation and symphysio-fundal height measurements. Only those with suspected small fetus will be offered a confirmatory scan. Subsequent management will be as per current unit protocol for low risk pregnancy . 113 Active-Treatment of Control Group
Experimental Group Growth Ultrasound scan with Doppler studies. At 36 weeks gestation N/A The participants will be offered a mandatory obstetric scan at 36 weeks assessing for growth, umbilical artery, uterine artery, middle cerebral artery and cerebro-placental ratio. Those with either small for gestational age fetus or fetal growth restriction based on predefined criteria will either undergo delivery or expectant management with close surveillance as per established protocols. 113 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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 18 Year(s) 39 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/04/2018 Aga Khan University
Ethics Committee Address
Street address City Postal code Country
3rd Parklands Avenue, PO BOX 30270 NAIROBI 1234 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of fetal growth restricted fetus 36 weeks At birth
Primary Outcome proportion of small for gestational age fetus at 36 weeks At Birth
Secondary Outcome Birthweight in grams At birth
Secondary Outcome Umbilical artery PH<7.1 Birth
Secondary Outcome Apgar core of less than 7 at 5 minutes birth
Secondary Outcome admission to NICU Birth
Secondary Outcome Stillbirth Birth
Secondary Outcome Caesarean section Birth
Secondary Outcome operative vaginal delivery birth
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aga Khan University Hospital 3rd Parklands Avenue; PO BOX 30270 Nairobi 00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Aga Khan University 3rd Parklands Avenue; PO BOX 30270 Nairobi 00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sikolia Wanyonyi Aga Khan University; PO BOX 30270 Nairobi 00100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Eunice Atsali Aga Khan University; PO BOX 30270 Nairobi 00100 Kenya
Marleen Temmerman Aga Khan University; PO BOX 30270 Nairobi 00100 Kenya
Sudhir Vinayak Aga Khan University; PO BOX 30270 Nairobi 00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sikolia Wanyonyi sikolia.wanyonyi@aku.edu +254703124803 3rd Parklands Avenue, PO BOX 30270
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Senior Instructor
Role Name Email Phone Street address
Public Enquiries Sikolia Wanyonyi sikolia.wanyonyi@aku.edu +254703124803 3rd Parklands Avenue, PO BOX 30270
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Senior Instructor
Role Name Email Phone Street address
Scientific Enquiries Sikolia Wanyonyi sikolia.wanyonyi@aku.edu +254703124803 3rd Parklands Avenue, PO BOX 30270
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Senior Instructor
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information