1.1 Subjects
(1) Inclusion criteria: who received prenatal examination from the obstetric clinic of our hospital the epidemic period of novel coronavirus on January 2020 to December 2020, and low-risk pregnant women who received prenatal examination at 34 weeks (all pregnancy test indicators were within the normal range, without pregnancy complications and complications) were enrolled. High-risk pregnant women (combined with gestational diabetes, hypertension, maternal immune disorders, fetal growth restriction, history of adverse pregnancy and delivery, or the presence of factors considered clinically high-risk) were enrolled at 32 weeks. And pregnant women with singleton pregnancy; age 18–45 years; primipara.
(2) Exclusion criteria: confirmed twin pregnancy, fetal malposition, fetal arrhythmia, pregnant women with psychiatric disorders, systemic diseases and their critical illnesses that prevented them from completing monitoring; inability to use the monitoring system properly and automatic withdrawal of pregnant women during the study.
(3) Grouping:The subjects were randomly divided into two groups by their wishes. They were divided into two groups —the routine antenatal examination or the "Internet-based home health management system" mode. Control group: Routine obstetric checkups. experimental group: "Internet-based home health management system" model. There was no statistically significant difference (P > 0.05) between the two groups in terms of general information such as age, gestational age, number of pregnancies and deliveries, education level, and high-risk factors, so they were comparable.
1.2 Equipment and methods
The control group performed fetal movement count at home by themselves and went to the hospital regularly for routine prenatal examination, and went to the hospital immediately for prenatal fetal heart monitoring non-stress test (NST) when abnormal fetal heartbeat on auscultation, abnormal fetal movement, and time beyond the expected delivery date. In the control group, an ultrasonic Doppler EFM instrument (model: eFM-30) was used for fetal heart monitoring.
The experimental group used the “October baby remote EFM system”(produced by Shenzhen Lekangning Technology Co., LTD.)rented by the hospital for monitoring, pregnant women used the system to monitor themselves at home, and transmitted the measured data signals to the system's backend server "cloud platform" through the cell phone APP, the backend server will AI intelligent interpretation of the monitoring results, and timely send SMS messages to notify the medical staff to review the data. The server will then send the doctor's diagnosis to the pregnant woman's cell phone via SMS. If there is any abnormality, online guidance and question & answer(Q&A) will be given to pregnant women in time. The pilot group requires pregnant women to monitor (including remote fetal heart rate monitoring, blood pressure, blood glucose and weight) ≥ 2 times per week, and the app reports the results and provides internet consultation guidance in the first time.
1.3 Monitoring items and methods
1.3.1 Fetal movement and fetal heart monitoring
(1) Abnormal fetal movement: the number of fetal movement < 10 times/2h or 50% increase or decrease compared with the previous 3h is abnormal ;
(2) Abnormal fetal heart rate: fetal heart rate > 160 beats/min or < 110 beats/min .
(3) NST abnormalities: ①baseline abnormalities, fetal heart rate > 160 beats/min or < 110 beats/min. ②baseline variability abnormalities: baseline variability 6–25 beats/min is normal variability, amplitude fluctuations disappear as variability absence, < 5 beats/min is minor variability, > 25 beats/min is significant variability. ③ Moderate to severe variability deceleration: There is no fixed relationship between deceleration and contractions, baseline rate increases, amplitude decrease increases, fetal heart rate deceleration > 60 beats/min, duration > 60s. ④ Acceleration abnormality: 20min < 1 acceleration more than 15 beats/min, duration 15s[16].
Monitoring method: the test group monitored the fetal movement count at a fixed time every morning, noon and night, and self-monitored once a day at a fixed time. Pregnant women are required to empty their bladder when performing fetal heart monitoring, avoid monitoring after exercise, avoid fasting and starvation, half an hour after meal is appropriate, and taking the left side lying position is preferred. Pregnant women are required to count fetal movement within the specified time, listen to fetal heartbeat 3 times for 20min each time, if pregnant women feel abnormal fetal movement or other discomfort (such as panic, poor breathing, etc.), perform fetal heart monitoring in time, the time can be extended in abnormal situation. When abnormal results of fetal heartbeat or fetal movement are found, contact the hospital and perform fetal umbilical blood flow monitoring and ultrasound examination in time to observe and treat the abnormal condition.
1.3.2 Blood pressure
Hypertension in pregnancy:
Inclusion and exclusion criteria for out-of-hospital blood pressure monitoring during pregnancy:
Inclusion criteria: Refer to the Guidelines for Self-monitoring of Blood Pressure in pregnancy issued by the Royal Society of Obstetricians and Gynecologists (RCOG) in 2020[17].
Exclusion criteria: Required hospitalized pregnant women such as severe hypertension and preeclampsia[17].
(1) Systolic blood pressure ≧ 140mmHg and/or diastolic blood pressure ≧ 90mmHg, or blood pressure is elevated ≧ 25/15mmHg compared with pre-pregnancy or early pregnancy, and blood pressure is measured at least twice, 6 hours apart. Severe pre-eclampsia blood pressure is systolic blood pressure ≧ 160mmHg and/or diastolic blood pressure ≧ 110mmHg.
(2) Dynamic 24h mean systolic blood pressure (24hSBP) ≧ 130 and/or 24h mean diastolic blood pressure (24hDBP) ≧ 80mmHg, daytime mean systolic blood pressure (dSBP) ≧ 135 and/or daytime mean diastolic blood pressure (dDBP) ≧ 85mmHg, nighttime mean systolic blood pressure (nSBP) ≧ 120 and/or nighttime mean diastolic blood pressure (nDBP) ≧ 70mmHg[18].
Blood pressure monitoring method: pregnant women in the test group with blood pressure cuff to the left upper elbow 2cm-3cm brachial artery; gestational hypertension for 24 hours a week fixed day, 6:00–22:00, night 22:00–6:00,24hSBP, 24hDBP, dSBP, dDBP, nSBP, nDBP.All the measurement results are input into the remote monitoring system, the diastolic blood pressure is less than 40mmHg, the systolic blood pressure is greater than 220mmHg is invalid, and the measured data is greater than 80% of the total is valid.The background server analyzes the blood pressure in time, sends the data to the medical staff for review, and if there is any abnormality, give the pregnant women online guidance and answer questions in time.
1.3.3 blood glucose
Gestational diabetes mellitus (GDM):
(1)75g oral glucose tolerance test (OGTT) 1, 2h after taking sugar, 3 blood glucose values should be less than 5.1, 10.0, 8.5mmol/L (92, 180, 153mg/dl) respectively.
(2) fasting plasma glucose (FPG) ≧ 5.1mmol/L, directly diagnosed as GDM, without OGTT; FPG < 4.4mmol/L (80mg/dl), the possibility of GDM is very small, without OGTT; FPG ≧ 4.4mmol/L and < 5.1mmol/L
(3) glycated hemoglobin HbA1c ≧ 6.5% [19–20].
Monitoring method: the pregnant women in the test group monitored fasting plasma glucose once a week at a fixed time; among them, the pregnant women with gestational diabetes mellitus monitored blood glucose at seven time points: fasting, two hours after breakfast, two hours before lunch, two hours after lunch, two hours before dinner, two hours after dinner and before bedtime at a fixed time day a week. If abnormal blood glucose levels are found, the hospital will be contacted in time for the appropriate online consultation and the appropriate observation and treatment.
1.3.4 weight
In women with normal pre-pregnancy Body Mass Index (BMI) (18.5 ~ 24.9 kg/m2), the average weight gain during pregnancy is 12.5 kg in singleton pregnancies, but the rate of weight gain varies during different periods of pregnancy. In 2009, the Institute of Medicine (IOM) recommended that the range of gestational weight gain (GWG) during pregnancy be determined according to the pre-pregnancy BMI of the pregnant woman, The IOM recommended that the appropriate range of GWG for pregnant women with pre-pregnancy BMI less than 18.5kg/m2, 18.5-24.9kg/m2, 25.0-29.9kg/m2 and 30.0kg/m2 or more should be 12.5-18kg, 11.5-16kg, 7-11.5kg and 5-9kg respectively[21–22].
Monitoring method: the test group will record their weight at least twice a week, calculate the body mass index and mark it in the weight management scale. Then compare it with the weight gain recommendation for pregnant women issued by IOM according to their pregnancy weeks, and transmit the data to the "cloud platform". Finally, the back-end server will intelligently give corresponding nutritional guidance according to their weight to control the weight of pregnant women within a reasonable range.
1.3.5 Online multidisciplinary team (MDT)
A comprehensive and personalized approach to maternal management during pregnancy, labor and delivery and postpartum must be implemented. Anhui Maternal and Child Health Hospital, as the Anhui Province Critical Maternity Treatment Center, is the first in the province to implement a seamless MDT model for outpatient and inpatient care in maternal and child health hospitals, providing scientific, continuous and objective diagnosis and treatment services for pregnancy assessment and delivery services during childbirth.
We firstly based on basic conditions, pregnancy abnormalities and delivery, and then based on environmental and social factors, especially pregnancy complications, to establish a high-risk maternal score for pregnant women in the control and test groups. According to the level of high risk, the risk factors can be divided into 5 points, 10 points, 20 points factors to assess. Meanwhile, according to the high risk of maternal risk degree, maternal of high risk will be divided into green, yellow, orange, and red, each grade given different check, follow-up and intervention. In the control group, the MDT evaluation team established by the outpatient department of our hospital (composed of experts in high-risk obstetrics outpatient department, experts in gynecology, pediatrics, internal medicine, and surgery) conducted a preliminary assessment on the person with the orange and red markers of high-risk pregnant women, and decided whether to start the MDT procedure. The hospital is equipped with MDT clinic at fixed time and place to conduct intervention and diagnosis and treatment for pregnant women. First-time pregnant women are treated through the hospital MDT assessment team outpatient service, established a family health management system to identify high-risk patients for online MDT specialist diagnosis and treatment, and collected information about high-risk maternal screening at home in time. By online experts on the MDT, high-risk pregnant women will be supervised at any time for intervention, guidance and preliminary treatment, prompt hospitalization if necessary.
1.3.6 Psychosomatic assessment criteria
The subjects were grouped according to a random numbered table at enrollment, the general, social, postnatal depression risk factors, and obstetric conditions were investigated two weeks after enrollment and measured using the Hospital Anxiety and Depression Scale (HADS); the HADS was used again two weeks after enrollment; and the Edinburgh Postnatal Depression Scale (EPDS) was used to measure 3–7 d postpartum. A score of D or A ≥ 7 on the HADS scale indicates symptoms of depression or anxiety during pregnancy. 10 items on the EPDS, each with a 4-point scale (0–3), and a total score of > 9 are considered suspicious for postnatal depression. receive psychological counseling, and ≥ 13 was considered as having depressive symptoms [23–24].
1.5 Neonatal outcome analysis
(1) Amniotic fluid contamination: The grading method included brownish-yellow color of amniotic fluid, dense, with particles indicating degree III; yellowish-green or dark green color of amniotic fluid indicating degree II; yellowish or light green color of amniotic fluid indicating degree I.
(2) Neonatal asphyxia: Apgar score was applied to assess the physical condition of neonates in both groups, including heart rate, muscle tone, respiration, skin color, reflexes, movement and other items, with a score of 10 out of 10. The scores included 8–10 (normal), 4–7 (mild asphyxia), and 0–3 (severe asphyxia).
(3) Umbilical cord abnormality: the umbilical cord is too short, tangled, twisted.
(4) Weight: including low weight babies: newborns weighing < 2500g at birth; huge babies: fetuses weighing 4000g or more.
(5) Preterm birth: those terminated at > 28 weeks to < 37 weeks gestation.
(6) Neonatal ischemic-hypoxic encephalopathy (HIE).
(7) Neonatal pneumonia.
(8) Transfer rate to pediatrics.