Reduced-visit Antenatal Care Model

NCT05290467 | Unknown DMC

• 1 other identifier: PUTHOGO2ORCT
• Study Type: interventional
• Target: 1,762
• Locations: 1 country
• Sites: 1

Brief Summary

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 year, the COVID-19 pandemic has brought huge impacts on the health systems, but also gives a valuable chance to review healthcare delivery strategies. Reduced-visit antenatal care models combined with remote monitoring have been recommended and implemented at most hospitals in China during the pandemic, particularly for low-risk pregnant women. However, due to limited evaluations of the cost-effectiveness, policymakers remain confused on how to appropriately integrate online delivery strategies with routine models to improve ANC quality and efficiency sustainably at scale. This is a single-blind, randomized controlled trial, conducted among low-risk pregnant women at Peking University Third Hospital in Beijing, to evaluate the effectiveness, acceptability, and cost of a reduced-visit ANC model combined with online monitoring compared to the routine ANC model. Participants will be randomly assigned in a 1:1 ratio to receive 12 routine ANC visits or the new ANC model consist of 9 outpatient visits and three online services with remote monitoring on their weight, heart rate, blood pressure, urinary protein, blood glucose, and fetal movement. CSOG-recommended ANC services will be provided to all participants. According to the study objectives and hypotheses, the primary outcome is adverse maternal and perinatal outcomes for non-inferiority analysis, and the secondary outcomes are acceptability and cost for superiority analysis.

Conditions

Antenatal Care; Telehealth Services

Outcome Measures

Primary Outcomes (1)

• A composite rate of adverse maternal and perinatal outcomes

  The primary outcome, which will be used to address the effectiveness and safety of the adapted ANC model, is the composite rate of adverse 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, preeclampsia/eclampsia, anemia, preterm delivery, indicated and emergency cesarean section, puerperal infection, third- or fourth-degree perineal lacerations, uterine rupture, postpartum hemorrhage, blood transfusion, hysterectomy, stroke, organ failure, and admittance to the 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), and any other pregnancy-associated complications. Health outcomes will be extracted from medical records after each ANC visit or contact.

  Health outcomes listed as the primary outcome will be extracted from the medical record within one week after delivery or termination of pregnancy.

Secondary Outcomes (3)

• Satisfaction with antenatal care

  Pregnant women's satisfaction with prenatal care will be measured within one week after delivery or termination of pregnancy by calculating average score of PESPC performed at each ANC visit or contact.

• Pregnancy-related stress

  Pregnancy-related stress will be measured within one week after delivery or termination of pregnancy by calculating average score of PSRS performed at 12, 26, and 36 weeks of gestation.

• Antenatal care cost

  ANC costs will be measured from the perspectives of both service providers and pregnant women after delivery or termination of pregnancy.

Study Arms (2)

control group

NO INTERVENTION

ANC will be provided by obstetricians, and 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 the control group. Participants will be scheduled for 12 routine ANC visits.

experimental group

EXPERIMENTAL

ANC will be provided by obstetricians, and 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 the experimental group. Participants will be scheduled for 9 outpatient visits and additional 3 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. Message, audio and video chats will be used at online ANC contacts to ensure service quality and accuracy of monitoring the results.

Behavioral: Online antenatal care

Interventions

Online antenatal care BEHAVIORAL

ANC will be provided by obstetricians, and 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 12 routine ANC visits, and those in the experimental group will be scheduled for 9 outpatient visits and additional 3 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. Messages, audio and video chats will be used at online ANC contacts to ensure service quality and accuracy of monitoring the results.

experimental group

Eligibility Criteria

• Age: 19 Years - 34 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Includes any of the following pregnancy-related or medical conditions: pregnancies by in vitro fertilization, multifetal gestation, BMI ≥28, diabetes, hypertension disorders, thyroid diseases, circulatory diseases, respiratory diseases, nephropathy, inflammatory bowel disease, hepatopathy, coagulopathies, immunodeficiency conditions, mental health disorders, genetic disorders, \>2 pregnancy losses, history of preterm delivery at \<37 weeks of gestation or stillbirth, and other conditions judged by obstetricians as high-risk pregnancy.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Peking University: collaborator
• Peking University China Center for Health Development Studies: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100083, China

Location

Related Publications (1)

• Shi H, Wang Y, Dang B, Li D, Ma S, Wang X, Li Z, Hao W, Li C, Jiang Y, Yuan P, Chen L, Gong X, Wang Y, Wu X, Zhao Y, Wei Y. Reduced-visit antenatal care model combined with telemedicine for low-risk pregnant women: protocol for a randomised controlled trial. BMJ Open. 2023 Jul 21;13(7):e067110. doi: 10.1136/bmjopen-2022-067110.

  PMID: 37479506 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: ANC allocation will be concealed from investigators who will enroll 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: ANC will be provided by obstetricians, and 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 12 routine ANC visits, and those in the experimental group will be scheduled for 9 outpatient visits and additional 3 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. Message, audio and video chats will be used at online ANC contacts to ensure service quality and accuracy of monitoring the results.

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: March 22, 2022
• Study Start: March 20, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 22, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Requested data for public purpose or research transparency will be provided via the corresponding author after 36 months following trial completion.
• Access Criteria: Requested data for public purpose or research transparency will be provided via the corresponding author. The e-mail address is weiyuanbysy@163.com.

Locations

CN (1)