Helping pregnant women with medical complications and their partners feel prepared to go home from hospital after birth
| ISRCTN | ISRCTN49865499 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49865499 |
| Sponsor | Bengbu Medical University |
| Funder | Bengbu Medical University |
- Submission date
- 10/03/2026
- Registration date
- 12/03/2026
- Last edited
- 12/03/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
This study looks at how to help pregnant women with medical complications and their partners feel more prepared to go home from hospital after the birth. Women with high risk pregnancies may leave hospital before they feel fully recovered, so clear information, practical skills and emotional support can help them manage their health and their baby’s care at home. The study aims to find out whether a structured support programme for both partners improves how ready they feel to leave hospital compared with usual care.
Who can participate?
Women aged 21 to 39 years with a high risk pregnancy who give birth at full term and who can communicate clearly. Their partners can also take part if they are aged 18 years or older and are the main caregiver. People with severe physical or mental illness cannot take part.
What does the study involve?
Participants are randomly assigned to receive either usual care or a special support programme. Usual care includes health education from nurses, printed information and app based materials. The support programme involves one to one sessions with a trained obstetric nurse. These sessions include videos, practical exercises, and the chance to ask questions. There are two sessions during the hospital stay, one session on the day of discharge, and follow up phone or online calls at 7 days after discharge and again at 42 days after birth. Each session lasts between 15 and 60 minutes.
What are the possible benefits and risks of participating?
Taking part may help couples feel more confident and more prepared to care for the mother and baby after leaving hospital. The risks are expected to be low, as the intervention involves education and support rather than medical procedures.
Where is the study run from?
The study is run at the First Affiliated Hospital of Bengbu Medical University in Bengbu, China.
When is the study starting and how long is it expected to run for?
The first participants joined on 1 May 2025 and recruitment ended on 30 September 2025. The study was completed on 30 October 2025.
Who is funding the study?
The study is funded by Bengbu Medical University (China)
Who is the main contact?
Mrs Tingting Lu, 286237072@qq.com
Contact information
Principal investigator, Scientific, Public
No. 2600, Donghai Avenue, Bengbu City, Anhui Province
Bengbu
233004
China
 ORCID ID |
0009-0002-2880-3828 |
|---|---|
| Phone | +86 18715259959 |
| 286237072@qq.com |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Blinded (masking used) | |
| Control | Active | |
| Assignment | Parallel | |
| Purpose | Treatment | |
| Scientific title | Construction and application of a dyadic discharge preparation intervention program for high-risk pregnant women and their spouses based on the Information–Motivation–Behavioral theory | |
| Study objectives | As a special group in obstetrics, the post-discharge health management of high-risk parturients directly affects maternal and infant safety. With the advancement of medical reform and the shortening of hospital stays, parturients often need to return home before their physical and mental conditions are fully recovered, which imposes higher requirements on the discharge preparedness of both parturients and their spouses. In view of this, this study aims to explore the impact of a dyadic discharge preparedness intervention program based on the Information-Motivation-Behavioral Skills Model on high-risk parturients and their spouses. | |
| Ethics approval(s) |
Approved 10/04/2025, Bengbu Medical University (No. 2600, Donghai Avenue, Bengbu City, Anhui Province, Bengbu, 233004, China; +86 552-3173208; ykyc2012@163.com), ref: Approval No. [2025] 191 | |
| Health condition(s) or problem(s) studied | High-risk pregnancy and discharge readiness. | |
| Intervention | The control group continued with routine care. A one-on-one intervention was adopted. The main methods of health education included oral health education by nurses, distribution of health education manuals, and education through the 317 Nurse APP. The main content covered perinatal health care, disease education, dietary and activity guidance, newborn care, discharge instructions, and regular follow-up visits. This study established a multidisciplinary educational team comprising two obstetric nursing specialists, six obstetric nurses, one psychological counseling specialist, one clinical nutritionist, and two research assistants.Obstetricians provide medical support. Obstetric nurses participate in program development and health education implementation. Psychological counseling specialists conducted psychological interventions. Clinical nutritionists were responsible for developing nutritional plans. Two research assistants were responsible for data collection and analysis. To ensure the objectivity of data analysis and interpretation of results, they did not participate in any trial-related educational or training activities throughout the entire process. Prior to the intervention, a one-week training program for obstetric nurses was conducted, covering the IMB theory, the dyadic coping theory, the key intervention points, and the important considerations. Following the training, an assessment was conducted. Only after passing the test could the obstetric nurses begin providing educational sessions to the study participants. This intervention employed a one-on-one approach, ensuring each study participant receives comprehensive care from a dedicated obstetric nurse throughout the entire process. Methods included video playback, hands-on practice, scenario simulations, and Q&A sessions. Within 24 hours of admission, the multidisciplinary team conducted an initial assessment of the study subjects. The obstetric nurse then performed the first intervention.Two bedside interventions were conducted during the hospitalization phase, each lasting 30 to 60 minutes. The third intervention was conducted on the day of discharge and lasted 40 minutes. Telephone and online follow-up visits were conducted 7 days after discharge and 42 days postpartum, each lasting 15–20 minutes. Randomization process: We adopted a cluster controlled randomized test design, with hospital wards acting as the randomization units. This strategy was adopted to reduce the likelihood of intervention contamination between the two groups. Each ward was allocated to the intervention or control group using a computer-generated 1:1 simple random sequence, administered by an independent research assistant. During the trial, all participants admitted to the ward received the corresponding study protocol. Outcome collectors and data analysts were unaware of all implementation processes. | |
| Intervention type | Behavioural | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
| |
| Completion date | 30/10/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 21 Years |
| Upper age limit | 39 Years |
| Sex | All |
| Target sample size at registration | 80 |
| Total final enrolment | 77 |
| Key inclusion criteria | High-risk pregnant women: 1. Pregnant women who meet the diagnostic criteria for high-risk pregnancy and deliver at full term 2. Age ≥18 years 3. Clear consciousness, with independent communication ability 4. Voluntary participation in the study Spouses: 1. Spouses who are the primary caregivers 2. Age ≥18 years 3. Aware of this study and willing to take part in the study |
| Key exclusion criteria | High-risk pregnant women: 1. Those accompanied by severe physical diseases or psychiatric disorders. Spouses: 1. Those accompanied by severe physical and mental illnesses and unable to independently complete the study. |
| Date of first enrolment | 01/05/2025 |
| Date of final enrolment | 30/09/2025 |
Locations
Countries of recruitment
- China
Study participating centre
Bengbu
233004
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | Informed Consent Form | 12/03/2026 | No | No | |
| Other files | Informed Consent Form (Chinese) | 12/03/2026 | No | No | |
| Protocol file | 12/03/2026 | No | No |
Additional files
- 49176 Chinese Version of Informed Consent Form.pdf
- Informed Consent Form (Chinese)
- 49176 Informed Consent Form.pdf
- Informed Consent Form
- 49176 study protocol.pdf
- Protocol file
Editorial Notes
12/03/2026: Trial's existence confirmed by Bengbu Medical University.
