Perinatal Mortality Clinical Trial
Official title:
Machine Learning From Fetal Flow Waveforms to Predict Adverse Perinatal Outcomes
The aim of this study is to get a proof of concept for using a computational model of fetal
haemodynamics, combined with machine learning based on Doppler patterns of the fetal
cardiovascular, cerebral and placental flows, to identify those at increased risk of adverse
perinatal outcomes such as stillbirth, perinatal mortality and other neonatal morbidities.
We will also compare the sensitivity and specificity of UmbiFlow device with the machine
learning model in predicting adverse perinatal outcomes
Pakistan is one of the countries where stillbirth rate (43/1000 total births) and neonatal
mortality rate (55/1000 live births) are among the highest in the world. The figures for
perinatal mortality remained unchanged between Pakistan Demographic and Health Survey (PDHS)
1990-91 and PDHS 2012-13. It is hence important to evaluate new techniques to identify
high-risk pregnant women who can then subsequently receive personalized care to improve
perinatal outcomes. Fetal blood flow waveforms assessed via Doppler ultrasound to indicate
wellbeing of the fetus have been in practice for nearly four decades. Abnormal blood flow
patterns in the fetal circulation detected by Doppler ultrasound may indicate poor fetal
prognosis. These tracings will then be incorporated in a computational model and combined
with machine learning, will be used to predict adverse perinatal outcomes.
This will be a prospective one group cohort study for a period of twelve months which will be
based in Ibrahim Hyderi, a peri-urban settlement of approximately 70,000 on the south east of
Karachi. The sample size for this study has been calculated based on the outcomes of the
pregnancy and was estimated to be 525 pregnant women.
Recruitment - Household surveillance will be done by community health workers (CHWs) in the
catchment area in a sequential manner to identify pregnant women. Eligible women between
22-34 weeks of gestation on last menstrual period (LMP) will then be explained regarding the
purpose of the study and invited for an ultrasound scan.
First and enrollment visit - The first visit window for the ultrasound scan will be between
22-26 weeks of gestation. This window is selected because pregnancies at risk may be better
identified and also visualization of fetal cardiac flow is possible. Based on the rigorous
surveillance, we anticipate that most women will be in this window. The following information
will be collected:
- Socio-demographic information
- Medical history, including exposure to tobacco, gravidity, parity, past obstetric
history (including number of miscarriages, stillbirths or neonatal deaths) and comorbid
conditions (pre-eclampsia, diabetes mellitus)
- Maternal anthropometry (height, weight and mid-upper arm circumference)
- Maternal blood pressure
- Hemoglobin of the mother
- Symphysiofundal height will be measured
- Standard obstetric Doppler evaluation including the four primary ultrasound measures of
fetal growth—head circumference, biparietal diameter, abdominal circumference, and femur
length is routinely performed for all pregnant women presenting at the center. These
parameters will be used to estimate fetal weight (automatically calculated by the
machine).
- Focused Fetal Doppler Echocardiography - These would include transabdominal measurements
of the Doppler velocity of the umbilical artery, the middle cerebral artery (MCA),
ductus arteriosus, fetal aortic isthmus (AoI) and left and right ventricular outflow
tracts
- UmbiFlow - Umbilical artery continuous wave Doppler image will also be obtained on these
women. The device will generate graphs for the flow pattern and calculate the resistance
index for the flow.
Second visit - The second visit window of ultrasound scan will be between 30-34 weeks of
gestation. This will be applicable for all women who have had their first scan during 22-26
weeks of gestation as well as newly enrolled women during 30-34 weeks of gestational age.
Cardiotocography (CTG) will be performed for all recruited women during the second visit
followed by the Doppler examination. The same procedures as described in the first visit will
be done.
Follow up - We will obtain contact information (phone number) from all enrolled women. A
trained research midwife will be responsible for making phone calls, as well as performing
household visits at pre-specified intervals for immediate and early identification of the
pregnancy outcome. A team of CHWs will perform home visits to the baby at post-natal day 1
and 6 and questions related to delayed cry, neonatal sepsis and hospital course (if any) will
be collected and the weight and length of the baby will be recorded.
Verbal autopsy - The VA team will visit the family after the grieving period (at least 14
days after the death). VA will be performed using a structured tool
(http://www.who.int/healthinfo/statistics/WHO_VA_2012_RC1_Instrument.pdf ).
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