Reduced-visit Antenatal Care Model

NCT05290467 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1762

Last updated 2022-06-22

No results posted yet for this study

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

Interventions

BEHAVIORAL

Online antenatal care

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.

Sponsors & Collaborators

  • Peking University

    collaborator OTHER
  • Peking University China Center for Health Development Studies

    collaborator UNKNOWN
  • Peking University Third Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
34 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-20
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05290467 on ClinicalTrials.gov