Reduced-visit antenatal care model combined with telemedicine for low-risk pregnant women: protocol for a randomised controlled trial

Abstract

Introduction

Antenatal care (ANC) is a critical measure to reduce maternal and perinatal morbidity and mortality. However, there are issues of too many visits and cumbersome procedures of ANC in many maternity hospitals of China. In the past 2 years, reduced-visit ANC models combined with remote monitoring have been recommended and implemented at most hospitals in China during the COVID-19 pandemic. Nevertheless, due to limited evaluations of the cost-effectiveness, policy-makers remain confused on how to appropriately integrate online delivery strategies with routine models to improve ANC quality and efficiency sustainably at scale. This trial aims to evaluate the effectiveness, acceptability and cost of a reduced-visit ANC model combined with telemedicine.

Methods and analysis

A single-blind, randomised controlled trial will be conducted among low-risk pregnant women at Peking University Third Hospital in Beijing. 1476 patients (738 in each group) would be required, and they will be randomly assigned in a 1:1 ratio to receive the reduced-visit ANC combined with telemedicine services or the routine ANC. The primary outcome is the composite rate of adverse maternal and perinatal outcomes which will be extracted from the medical records. Secondary outcomes include acceptability of ANC models, which is assessed by satisfaction with ANC, pregnancy-related stress and ANC costs measured from the perspectives of both service providers and demanders. Both intention-to-treat and per-protocol analyses will be performed. Non-inferiority tests will be used to compare the two ANC models for the primary outcome. A cost-effectiveness analysis comparing the two ANC models will be conducted by estimating the incremental cost-effectiveness ratios.

Ethics and dissemination

This study was approved by the ethical review committee of the Peking University Third Hospital (Beijing, China). The results of this study will be published in peer-reviewed scientific journals and presented at relevant academic conferences.

Trial registration number

NCT05290467.

Correspondence to Dr Yuan Wei; [email protected]

STRENGTHS AND LIMITATIONS OF THIS STUDY

• First randomised controlled trial to systematically evaluate the effectiveness, acceptability and cost of a reduced-visit antenatal care (ANC) model combined with telemedicine services.

• It is strengthened by using a rigorous randomised controlled trial design and is expected to provide sound evidence for optimising ANC delivery strategies with information and communication technology, in response to the long-standing issue of poor ANC experience and the emerging issue of excessive medicalisation in China.

• Clinicians and patients could not be blinded.

Introduction

China is now in the critical transition period of obstetric services, shifting from ending preventable maternal deaths to ensuring high-quality and equitable obstetric services.^{1 2} Over the past decades, China has seen remarkable achievements in reducing maternal mortality rate (MMR), from 94.7 cases per 100 000 livebirths in 1990 to 16.9 cases per 100 000 livebirths in 2020.³ According to the five-stage obstetric transition model recommended by WHO,² to further reduce MMR, critical measures in this stage are improving quality of care and efficiency within health systems¹; another emerging issue in this stage is the increasing role of excessive medicalisation as a threat to quality and improved health outcomes.²

Antenatal care (ANC) is a critical strategy to reduce maternal and perinatal morbidity and mortality through a series of timely and appropriate evidence-based practices including risk identification, prevention and management of pregnancy-related or concurrent diseases, health education and health promotion.⁴ A minimum of 8 ANC contacts is recommended by the 2016 WHO ANC model,⁴ and 7–11 ANC visits are recommended by the Chinese Society of Obstetrics and Gynecology (CSOG).⁵ These visits or contacts can facilitate timely assessment of maternal and fetal well-being and provision of interventions needed. However, there are issues of too many visits and cumbersome procedures of ANC in many maternity hospitals of China, especially in urban areas.^{6 7}

In addition, according to a survey conducted to evaluate the National Healthcare Improvement Initiative (2016–2017), including 3802 outpatients in the Department of Obstetrics and Gynecology of 30 provincial maternal and child hospitals, 34.96% and 23.09% patients reported their dissatisfaction with long waiting times and cumbersome outpatient procedures, respectively.⁸ Because of the lack of data, it is difficult to say that the increased prenatal examination must be unnecessary, but many visits are only for health services that can be completely completed through telemedicine, such as visits for doctors to review the examination results. Too-intensive ANC visits and cumbersome procedures may increase the physical and psychological pressure of pregnant women and the cost of access to health services. This also contributes to wastage of medical resources, heavy workloads of physicians, and medical disputes and has a negative impact on the capacity of health systems to deliver quality ANC.^{9 10}

Telemedicine using information and communication technology has been gradually changing the health service delivery strategies and is expected to contribute to improving the patient experience of care, improving service efficiency and reducing healthcare costs.^{11 12} Telemedicine use during the COVID-19 pandemic is occurring on a large scale and at a high speed.¹³ During the epidemic, reduced-visit ANC models combined with remote monitoring have been recommended and implemented at many hospitals in China to meet the demands of epidemic prevention and response.^14–16 Several studies have shown the benefits of telemedicine for gestational weight management, blood pressure monitoring and interventions for gestational diabetes mellitus, indicating the feasibility of remote monitoring in pregnant women.^{13 17–20} However, the cost of intervention provision and utilisation is rarely measured, and there is a lack of evaluation of the telemedicine delivery strategy of the overall ANC model. Due to limited evaluations of their cost-effectiveness, policy-makers remain confused on how to appropriately integrate telemedicine components and delivery strategies with routine healthcare models to improve ANC quality and efficiency sustainably at scale.²¹

Strategies combining routine and telemedicine may become the trend of health service delivery with the development of information and communication technology in the future.^{11 12 22 23} In this situation, evaluating the effectiveness, cost and acceptability of these delivery strategies is of great significance to further optimise the ANC services for a positive pregnancy experience and improve maternal and fetal health outcomes.

Aims and objective

This study aims to evaluate the effectiveness, acceptability and cost of a reduced-visit ANC model combined with telemedicine services. Our findings can provide sound evidence for optimising ANC delivery strategies with information and communication technology, in response to the long-standing issue of poor ANC experience and the emerging issue of excessive medicalisation in China.

Hypotheses

We hypothesise that for low-risk pregnant women, the reduced-visit ANC model combined with telemedicine services (A) is effective as a routine ANC model in preventing adverse maternal and perinatal outcomes, (B) can result in greater ANC satisfaction and reduce pregnancy-related stress and (C) can reduce ANC provision and utilisation cost, compared with the routine ANC model.

Methods and analysis

Study design

A single-centre, single-blind, 1:1 randomised controlled trial (RCT) will be conducted to compare the reduced-visit ANC model combined with telemedicine services with the routine ANC model for effectiveness, acceptability and cost among low-risk pregnant women. According to the study objectives and hypotheses, the primary outcome will be adverse maternal and perinatal outcomes for non-inferiority analysis, and the secondary outcomes will be acceptability and cost for superiority analysis. The flow diagram of the study is presented in figure 1.

Figure 1. Flow chart of the study. PESPC, Patient Expectations and Satisfaction with Prenatal Care.

Setting

The study will be conducted at the Department of Obstetrics and Gynecology, Peking University Third Hospital in Beijing, China. Peking University Third Hospital is a grade III level A general hospital with 37 clinical departments and 10 medical detection departments. The Department of Obstetrics and Gynecology has 64 obstetricians, 30 midwives and 63 nurses and serves approximately 5000 pregnant women annually for quality care throughout their pregnancy, childbirth and the postnatal period. Since 2018, the hospital has fully launched an online and offline integrated medical service model covering prediagnosis, during diagnosis and postdiagnosis and provided rich online medical services for patients, including appointment, consultation, prescription, health science popularisation and other functions. As of 20 October 2020, there were more than 400 doctors providing online services and more than 450 000 registered patients.

Patient and public involvement

Patients were not involved in the design, or conduct, or reporting, or dissemination plans of this research. The National Center for Healthcare Quality Management in Obstetrics, the National Clinical Research Center for Obstetrics and Gynecology and the administration office of the hospital was involved in the design and management of the study. The authors plan to send a summary of the results to these departments and undertake extensive knowledge exchange work with the National Health Commission of the People’s Republic of China. The results of the article will be also summarised in the official website of the National Center for Health Care Quality Management in Obstetrics and media press releases from the Peking University, and presented at relevant conferences. According to the findings, suggestions will be provided to governments and hospitals for the quality monitoring of online healthcare services.

Participants

Recruitment

Pregnant women who complete the first antenatal examination will be assessed for eligibility using a specialised case report form for eligibility assessment, and those eligible women will be informed and invited to participate by an obstetric nurse. Written informed consent will be obtained, and participants will be assigned a study identification code based on consecutive enrolment. Recruitments are expected to occur over a 36-month period, commencing in March 2022.

Inclusion criteria

Pregnant women meeting the following criteria are eligible: aged 19–34 years, ≤8 weeks of gestation, registered and scheduled for ANC and delivery at Peking University Third Hospital, and documented as low risk (see the definition of high-risk pregnancy in exclusion criteria).

Exclusion criteria

Exclusion criteria include any of the following pregnancy-related or medical conditions: multifetal gestation, circulatory diseases, respiratory diseases, nephropathy, inflammatory bowel disease, hepatopathy, coagulopathies, immunodeficiency conditions, mental health disorders, genetic disorders and other conditions judged by obstetricians as high-risk pregnancy.

Sample size

The sample size is calculated based on the expected improvement of the primary outcome, which is considered as the most important endpoint. Given the estimated composite rate of 12% for maternal and perinatal adverse outcomes, a sample size of 1476 patients (738 in each group) would be required with 5% (two-sided) type I error, 80% power and 10% attrition using a 5% non-inferiority margin.

Randomisation and allocation

Participants will be randomly assigned in a 1:1 ratio to receive the reduced-visit ANC combined with telemedicine services or the routine ANC, by the research assistant blinded to participants’ characteristics through opening a matching sealed opaque envelope in which the arm allocation is concealed. Randomisation will be performed by an independent statistician through a computer program, and randomised permuted blocks of varying sizes will be used to maintain balance.

Masking and blinding

ANC allocation will be concealed from investigators who will enrol and assign the participants. Participants and care providers will not be masked to the allocation because of the nature of the ANC, while the outcome assessors and data statistical analysts will be blinded.

Intervention and control

The 2016 WHO ANC model consists of a minimum of eight ANC contacts, with the first contact scheduled to take place in the first trimester (up to 12 weeks of gestation), two contacts scheduled at 20 and 26 weeks of gestation in the second trimester and five contacts scheduled at 30, 34, 36, 38 and 40 weeks of gestation in the third trimester.⁴ The CSOG recommends 6 ANC visits occurring between 6–13 weeks, 14–19 weeks, 20–24 weeks, 25–28 weeks, 29–32 weeks and 33–36 weeks of gestations and 1–5 ANC visits occurring between 37 and 41 weeks .⁵

In this present trial, ANC will be provided by obstetricians and is required to be provided in accordance with the study protocol. Health education will be provided online by midwives. Obstetricians will schedule appointments for the succeeding contacts/visits of the participants. CSOG-recommended prenatal care services will be provided to both the experimental and control groups, using different delivery strategies. Participants in the control group will be scheduled for 13 routine ANC visits, and those in the experimental group will be scheduled for 6 outpatient visits and additional 7 times of services through an online medical service platform. The obstetricians/midwives will train pregnant women how to monitor and record their weight, heart rate, blood pressure, urinary protein, blood glucose and fetal movement at home. Video chats will be used at online ANC contacts to ensure service quality and accuracy of monitoring the results. The service schedules of the two groups are shown in figure 2.

Figure 2. Scheduled ANC contacts for pregnant women receiving routine ANC and those receiving reduced-visit ANC with remote monitoring. ANC, antenatal care; CSOG, Chinese Society of Obstetrics and Gynecology.

Follow-up and data collection

The participants will be followed up until delivery. Sociodemographic characteristics will be collected after recruitment, including maternal age, ethnicity, educational level and household income. ANC time, type and practices will be recorded in detail using a specialised ANC record form after each visit/contact. Maternal and perinatal outcomes, as the primary outcome of the study, will be extracted from the medical records. Secondary outcomes include acceptability of ANC models, which is assessed by satisfaction with ANC and pregnancy-related stress, and ANC cost, which is measured from the perspective of both service providers and demanders.

Outcome measures, except for ANC records, will be conducted by research assistants who are blinded to the allocation. All data collection tools will be reviewed by the research team or validated in a pilot study. The questionnaire instructions will be written in plain Chinese. Face-to-face interviews or telephone interview with participants will be conducted by uniformly trained investigators to measure cost, satisfaction and pregnancy-related stress. All data will be immediately input, saved and transmitted to statisticians by means of an electronic questionnaire application, which had a basic logic and integrity-checking function to enable investigators to correct errors and supplement omissions in a timely manner.

The principal investigators (PIs) and research team will closely supervise activities throughout the intervention and study periods. A supervisory board consisting of obstetricians, midwives and public health professionals will be established to monitor the overall conduct of the trial. Regular research meetings will be held every half month in the first 6 months and every month thereafter, to find and solve issues in the research process at any time. The PIs and supervisory board will regularly monitor adherence to the study protocol and data collection processes. All data collectors will be uniformly trained. During the study period, the research team will reselect about 5% of the participants to re-extract their health outcomes. Intravariability of outcome measurements will be tested by comparing the data collected by the research team and the enumerators. If inconsistencies are noted, the research team will conduct refresher training for enumerators.

Outcomes

Primary outcome

Maternal and perinatal outcomes: The primary outcome of the study, which will be used to address the effectiveness and safety of the adapted ANC model, is the composite rate of maternal and perinatal outcomes defined as the occurrence of any of the following events: maternal death, loss of pregnancy, stillbirth, neonatal death, maternal severe complications (such as gestational hypertension, pre-eclampsia/eclampsia, anaemia, preterm delivery, indicated and emergency caesarean section, puerperal infection, third-degree or fourth-degree perineal lacerations, uterine rupture, postpartum haemorrhage, blood transfusion, hysterectomy, stroke, organ failure and admittance to the intensive care unit (ICU)), fetal and neonatal severe complications (such as fetal growth restriction, low birth weight, macrosomia, birth trauma, neonatal infection, 5 min Apgar scores <7 points, and referral and admittance to the neonatal ICU), when applicable, and any other pregnancy-associated complications. Health outcomes will be extracted from medical records after each ANC visit or contact.

Secondary outcome

Satisfaction with ANC: Expectations and satisfaction with ANC will be measured using the Patient Expectations and Satisfaction with Prenatal Care (PESPC) instrument. The PESPC, developed by Omar et al,²⁴ consists of 41 items categorised into 2 subscales consisting of 8 dimensions: personalised care (4 items), complete care (4 items), provider continuity (2 items), and other services (2 items) in the expectation subscale and information (7 items), provider care (6 items), staff interest (6 items), and system characteristics (10 items) in the satisfaction subscale.²⁴ The response options of each item range from 1 (strongly agree) to 6 (strongly disagree), with no neutral response option. The PESPC was found to be a valid and reliable self-report instrument of ANC quality.^{24 25} We will measure pregnant women’s expectations with prenatal care at 8 weeks of gestation and measure their satisfaction with prenatal care after each visit/contact at gestational age of 16, 22, 30 and 37 weeks. Before use, the PESPC will be translated and culturally adapted into a Chinese version, and its psychometric properties will be examined in Chinese pregnant women.

Pregnancy-related stress: Pregnancy-related stress will be measured at 8 and 36 weeks of gestation using the Pregnancy Stress Rating Scale (PSRS), which has been well validated and widely used. The PSRS was initially developed in 1983 and revised and validated in 2015 by Chen.²⁶ The revised PSRS consists of 36 items indicating potentially stressful pregnancy-related events and anticipated events during the labour, delivery and immediate postpartum periods, which may come from the following: (A) seeking safe passage for mother and child through pregnancy, labour and delivery, (B) infant care and changing family relationships, (C) maternal role identification, (D) social support seeking and (E) altered physical appearance and function. The revised PSRS is found to be psychometrically sound in assessing prenatal stress in Chinese women.^{26 27}

ANC cost: ANC costs will be measured from the perspectives of both service providers and demanders after each ANC visit or contact at gestational age of 16, 22, 30 and 37 weeks. For a pregnant woman during the entire pregnancy, the cost of providing routine ANC is calculated by multiplying the average time spent by clinicians and nurses with their average hourly income, and the cost of obtaining ANC is calculated by summing the following items: (A) direct medical costs, (B) multiplying participants’ average delayed working hours due to antenatal examination during the whole pregnancy by the average hourly income of Beijing residents and (C) other incremental costs, including transportation costs and delayed income of other family members. The ANC provision and utilisation costing forms will be initially developed by our research team and then revised by an expert panel consisting of obstetricians, midwives, nurses, health economists and questionnaire experts.

Statistical analysis

Both intention-to-treat and per-protocol analyses will be performed to account for participants with protocol violations. Satisfaction with ANC, pregnancy-related stress, cost and health outcomes will be compared using an independent t-test or analysis of variance for continuous variables and the χ² test or Fisher’s exact test for nominal variables. Non-inferiority tests will be used for comparing incidence of primary outcomes in the two groups by taking a one-sided test of 2.5% and a non-inferiority value of 5% and superiority analysis will be used for comparing the secondary outcomes in the two groups. Multivariable adjusted analyses will be performed to detect the differences more accurately after adjusting for baseline characteristics.

A cost-effectiveness analysis comparing the two ANC models will be conducted by estimating the incremental cost-effectiveness ratios (ICERs) from the perspective of both providers and pregnant women. ICERs are computed by dividing the incremental costs with the differences between the intervention and control groups in primary and secondary outcomes. A sensitivity analysis will be conducted to assess the sensitivity of the cost-effectiveness results with respect to variations in key parameters, including cost.

Safety and monitoring

A safety monitoring board, including experts in or representatives in the fields of obstetrics and neonatology, will be established. Participants developing any complications during pregnancy will be treated according to the conventional clinical pathway, regardless of their allocation.

Ethics and dissemination

All process of this study was reviewed and approved by the Peking University Third Hospital Medical Science Research Ethics Committee (M2021227). Informed consent will be obtained from all participants before enrolment (consent form as in online supplemental file 1).

The results of this study will be published in peer-reviewed scientific journals and presented at relevant academic conferences. For generalisation of the findings, we plan to do the following:

• To promote the adapted ANC model in our hospital and provide pregnant women with the opinions of the ANC delivery strategy, if the safety of the adapted ANC model is verified.

• To report the results to health policy-makers in the local government and provide suggestions for the quality monitoring of online healthcare services.

• To expand the programme to different regions and hospitals of varying grades.

Discussion

The integration of telemedicine into care-delivery systems provides exciting opportunities to enhance healthcare capability, health promotion and disease prevention. However, telemedicine remains an emerging field in China. More solid evidence of clinical quality and efficiency savings is warranted before the new care-delivery model is accepted by doctors, patients and policy-makers.

Telemedicine has been used in pregnancy for monitoring and management of complications such as gestational diabetes mellitus and hypertension,^{13 17–20} but rarely implemented for delivering whole ANC. This study first determines the effectiveness, acceptability and cost of a reduced-visit ANC model combined with telemedicine. This study is strengthened using a rigorous RCT design with optimal allocation concealment and is expected to provide sound evidence for health policy-makers to improve ANC delivery strategies and quality. In our trial, we cautiously did not include high-risk pregnancies because we are not sure whether their routine ANC visits can be replaced by telemedicine. However, studies are warranted to explore huge potential benefits of telemedicine for high-risk pregnancies and rural pregnant women. The study by Lockhart et al found that telemedicine assisted in the diagnosis of high-risk pregnant women and the alternatives to remote ICU greatly improved the accessibility of ICU treatment management.²⁸

Our study has several limitations. First, the study will be implemented in a single setting with high capability of clinical care in urban areas, which would limit the generalisation of the findings. Second, the study will be adequately powered to detect statistical differences in the composite rate of maternal and perinatal outcomes, but may be underpowered to detect differences in adverse outcomes with infrequent occurrence. Larger multicentre studies are warranted to evaluate the scalability of the adapted ANC model in different health systems.

In summary, this study is the first RCT designed to evaluate the effectiveness, acceptability and cost of a reduced-visit ANC model combined with telemedicine services. Our findings can provide sound evidence for optimising ANC delivery strategies with information and communication technology, in response to the long-standing issue of poor ANC experience and the emerging issue of excessive medicalisation in China.

Ethics statements

Patient consent for publication

Not applicable.

Footnote

HS, YingW, BD and DL contributed equally.

Contributors YuanW and YZ are the principle investigator and has led all stages of the study design. HS, YingW, BD and DL drafted the manuscript. SM, XWa, ZL, WH; CL; YJ, PY, LC, XG, YipeiW and XWu participated in the design of the study and the protocol writing. All of the authors read and approved the final submitted manuscript.

Funding The work was supported by Capital’s Funds for Health Improvement and Research (CFH2022-2G-4099) and Mechanism and Intervention Strategies of Internet Hospital on the Efficacy of Outpatient System in Large Public Hospitals (NSFC 72204005).

Disclaimer The funders had no role in study design, data collection, data analysis, data interpretation, and in the writing and submitting of this report. The corresponding authors had full access to all data and final responsibility for the decision to submit for publication.

Competing interests None declared.

Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

Provenance and peer review Not commissioned; externally peer reviewed.

Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

References

¹ Qiao J, Wang Y, Li X, et al. A lancet Commission on 70 years of women’s reproductive, maternal, newborn, child, and adolescent health in China. Lancet 2021; 397: 2497–536. doi:10.1016/S0140-6736(20)32708-2

² Souza JP, Tunçalp Ö, Vogel JP, et al. Obstetric transition: the pathway towards ending preventable maternal deaths. BJOG 2014; 121 Suppl 1: 1–4. doi:10.1111/1471-0528.12735

³ National Health Commission of China. China Health Statistical Yearbook 2021. Beijing: China Union Medical College Press, 2021: 1–424.

⁴ WHO. WHO recommendations on antenatal care for a positive pregnancy experience. Geneva: World Health Organization, 2016.

⁵ CSOG. Guidelines for Preconception and prenatal care (2018). Chinese Journal of Obstetrics and Gynecology 2018; 53: 7–13. doi:10.3760/cma.j.issn.0529-567x.2018.01.003

⁶ Feng XL, Zhang Y, Hu X, et al. Tracking progress towards universal health coverage for essential health services in China, 2008-2018. BMJ Glob Health 2022; 7: e010552. doi:10.1136/bmjgh-2022-010552

⁷ Shen M, Wu Y, Xiang X. Hukou-based rural-urban disparities in maternal health service utilization and delivery modes in two Chinese cities in Guangdong province. Int J Equity Health 2021; 20: 145. doi:10.1186/s12939-021-01485-4

⁸ Zhi L. Analysis of visiting experience and associated factors of overall satisfaction of obstetrics and Gynecology and pediatric outpatients in provincial maternal and children’s tertiary hospitals in China. Peking Union Medical College; 2019.

⁹ Chinese Medical Doctor Association. The 2017 white paper on Chinese medical doctor’s professional situation. 2018. Available: http://www.cmda.net/rdxw2/11526.jhtml [Accessed 22 Sep 2020 ].

¹⁰ Macpherson I, Roqué-Sánchez MV, Legget Bn FO, et al. A systematic review of the relationship factor between women and health professionals within the multivariant analysis of maternal satisfaction. Midwifery 2016; 41: 68–78. doi:10.1016/j.midw.2016.08.003

¹¹ Tuckson RV, Edmunds M, Hodgkins ML. Telehealth. N Engl J Med 2017; 377: 1585–92. doi:10.1056/NEJMsr1503323

¹² Dorsey ER, Topol EJ. State of Telehealth. N Engl J Med 2016; 375: 1400. doi:10.1056/NEJMc1610233

¹³ Palmer KR, Tanner M, Davies-Tuck M, et al. Widespread implementation of a low-cost Telehealth service in the delivery of antenatal care during the COVID-19 pandemic: an interrupted time-series analysis. Lancet 2021; 398: 41–52. doi:10.1016/S0140-6736(21)00668-1

¹⁴ National Health Commission of China. Notice on the prevention and control of pneumonia epidemic caused by novel Coronavirus in children and pregnant women. 2020. Available: http://www.nhc.gov.cn/fys/s7902/202002/de2d62a5711c41ef9b2c4b6f4d1f2136.shtml [Accessed 16 Feb 2020 ].

¹⁵ Maternal and Fetal Experts Committee, Chinese Physician Society of Obstetrics and Gynecology, Chinese Medical Doctor Association. Proposed management of 2019-novel Coronavirus infection during pregnancy and Puerperium. Chin J Perinat Med 2020; 23: 73–9. doi:10.3760/cma.j.issn.1007-9408.2020.02.001

¹⁶ National Health Commission of China. Notice on strengthening the treatment and safety of delivery for pregant women during the prevention and control of COVID-19 epidemic. 2020. Available: http://www.nhc.gov.cn/fys/s3581/202002/4f80657b346e4d6ba76e2cfc3888c630.shtml [Accessed 16 Feb 2020 ].

¹⁷ Aiken A, Lohr PA, Lord J, et al. Effectiveness, safety and acceptability of no-test medical abortion (termination of pregnancy) provided via Telemedicine: a national cohort study. BJOG 2021; 128: 1464–74. doi:10.1111/1471-0528.16668

¹⁸ Carbillon L, Benbara A, Fermaut M, et al. The incorporation of Telehealth in high-risk pregnancy follow-up needs tailored optimized care scheduled in a strict care protocol. Am J Obstet Gynecol 2021; 225: 586. doi:10.1016/j.ajog.2021.06.094

¹⁹ Slomski A. Telehealth reduces excess weight gain in pregnancy. JAMA 2020; 324: 327. doi:10.1001/jama.2020.11670

²⁰ Butler Tobah YS, LeBlanc A, Branda ME, et al. Randomized comparison of a reduced-visit prenatal care model enhanced with remote monitoring. Am J Obstet Gynecol 2019; 221: 638. doi:10.1016/j.ajog.2019.06.034

²¹ Jhass AS, Majeed A. Need for evidence on Telehealth providers. BMJ 2016; 352: i1332. doi:10.1136/bmj.i1332

²² Dorsey ER, Topol EJ. Telemedicine 2020 and the next decade. lancet. Lancet 2020; 395: 859. doi:10.1016/S0140-6736(20)30424-4

²³ Barnett ML, Ray KN, Souza J, et al. Trends in Telemedicine use in a large commercially insured population, 2005-2017. JAMA 2018; 320: 2147–9. doi:10.1001/jama.2018.12354

²⁴ Omar MA, Schiffman RF, Bingham CR. Development and testing of the patient expectations and satisfaction with prenatal care instrument. Res Nurs Health 2001; 24: 218–29. doi:10.1002/nur.1024

²⁵ Heaman MI, Sword WA, Akhtar-Danesh N, et al. Quality of prenatal care questionnaire: instrument development and testing. BMC Pregnancy Childbirth 2014; 14: 188. doi:10.1186/1471-2393-14-188

²⁶ Chen CH. Revision and validation of a scale to assess pregnancy stress. J Nurs Res 2015; 23: 25–32. doi:10.1097/jnr.0000000000000047

²⁷ Dan L, Ping W, Junsheng L. Reliability and validity of pregnancy stress rating scale. Psychol Res 2013; 6: 64–9. doi:10.3969/j.issn.2095-1159.2013.02.010

²⁸ Lockhart EM, Hincker A, Klumpner TT, et al. Consultation, surveillance, monitoring, and intensive care (COSMIC): a novel 4-tier program to identify and monitor high-risk obstetric patients from the clinic to critical care. Anesth Analg 2019; 128: 1354–60. doi:10.1213/ANE.0000000000004141