ISRCTN ISRCTN90722773
DOI https://doi.org/10.1186/ISRCTN90722773
Sponsor Fudan University
Funder Project HOPE
Submission date
23/04/2026
Registration date
27/04/2026
Last edited
27/04/2026
Recruitment status
Not yet recruiting
Overall study status
Ongoing
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Han Xu
Public, Scientific

Fudan University, No. 130 Dong'an Road, Xuhui District
Shanghai
200032
China

Phone +86 15821569975
Email xh02186@163.com
Ms Hong Jiang
Principal investigator

Fudan University, No. 130 Dong'an Road, Xuhui District
Shanghai
200032
China

ORCiD logoORCID ID 0000-0002-2810-8000
Phone +86 21 6417 9976
Email h_jiang@fudan.edu.cn

Study information

Primary study designInterventional
AllocationNon-randomized controlled trial
MaskingOpen (masking not used)
ControlUncontrolled
AssignmentParallel
PurposeSupportive care
Scientific titleEffectiveness of respectful maternity care interventions in China
Study objectives
Ethics approval(s)

Approved 06/01/2026, Ethics Committee of the School of Public Health, Fudan University (Fudan University, No. 130 Dong'an Road, Xuhui District, Shanghai, 200032, China; +86 21 5423 7051; gwkyb@fudan.edu.cn), ref: H2026004

Health condition(s) or problem(s) studiedRespectful maternity care
InterventionThe intervention group will firstly receive Training of Trainers (TOT). Then the expanded training for the intervention group will be held in local areas. Based on the WHO Respectful Maternity Care guidelines, and other evidence-based maternal and child health care guidelines, the training material package will be developed with the overall goal of improving Respectful Maternity Care provided. The core components will include elaborating the core elements of Respectful Maternity Care at the knowledge level, internalizing its values and concepts at the attitude level, and applying communication and care giving skills at the behavioral level. The training will cover all domains of the Respectful Maternity Care.
1. Dignity and respect
2. Communication
3. Autonomous decision-making
4. Mistreatment and violence
5. Supportive care
6. Privacy and confidentiality

In the control group, routine maternity care practices will be provided.

Both the intervention and the control group will be followed up for nine to twelve months.
Intervention typeOther
Primary outcome measure(s)
  1. Score of respectful maternity care measured using RMC Scale at baseline, nine to twelve months after intervention
Key secondary outcome measure(s)
  1. Maternal satisfaction measured using Maternal Satisfaction Questionnaire at baseline, nine to twelve months after intervention
  2. Healthcare providers’ behavior measured using Healthcare Providers’ RMC Knowledge Assessment Questionnaire at pre-training, post-training
Completion date31/12/2027

Eligibility

Participant type(s)
Age groupAdult
Lower age limit18 Years
Upper age limit60 Years
SexAll
Target sample size at registration6000
Key inclusion criteriaHealth providers of maternity care:
1. Being a maternity care provider in participating hospitals

Postpartum women:
1. Age ≥18 years
2. Able to communicate verbally and in writing
3. Utilized antenatal, intrapartum or/and postpartum care in participating hospitals
Key exclusion criteriaPostpartum women:
1. Presence of mental illness
2.Inability to communicate
3. Attended two or more hospitals for antenatal care
Date of first enrolment06/05/2026
Date of final enrolment31/08/2026

Locations

Countries of recruitment

  • China

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
IPD sharing plan

Editorial Notes

24/04/2026: Trial's existence confirmed by Ethics Committee of the School of Public Health, Fudan University.