Modified antenatal care for healthy pregnant women with low risk for adverse outcomes
| ISRCTN | ISRCTN14422582 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14422582 |
- Submission date
- 15/03/2021
- Registration date
- 21/04/2021
- Last edited
- 14/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
The standard antenatal care (SAC) program in Sweden is optional, free of charge with a high attendance rate of almost 100%.
A modified antenatal care program (MAC) to pregnant women with low risks supports distributing resources to those who need them most. The proportion of women with moderate or high risk for complications during pregnancy and childbirth giving birth nowadays is increasing due to e.g. obesity, advanced age or diseases. It is therefore important to individualize the antenatal visits to a higher extent and make possibilities for those women that are in need of more visits with the midwives.
Who can participate?
All healthy pregnant women aged 18 years and over defined as low risk
What does the study involve?
Participants will be allocated to the SAC or the MAC program.
The SAC program (visits to a midwife in gestational week 6-10, 12-15, 25, 29, 32, 35, 37, 39, 41) will be compared with the MAC program (visits to a midwife in gestational week 6-10, 12-15, 29,35,38 and video meetings in gestational week 25, 40).
What are the possible benefits and risks of participating?
No additional risks or benefits
Where is the study run from?
Department of Obstetrics and Gynecology and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden
When is the study starting and how long is it expected to run for?
October 2019 to October 2026
Who is funding the study?
Medical Research Council of Southeast Sweden FORSS-939956
Who is the main contact?
Dr Caroline Lilliecreutz, caroline.lilliecreutz@regionostergotland.se
Contact information
Scientific
Womens Clinic floor 14
University Hospital
Linköping
58185
Sweden
 ORCID ID |
0000-0001-9491-9728 |
|---|---|
| Phone | +46 101033160 |
| caroline.lilliecreutz@regionostergotland.se |
Study information
| Study design | Interventional cluster randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | No participant information sheet available |
| Scientific title | Modified antenatal care (MAC) program for healthy pregnant women with low risk for adverse outcomes – a stepped wedge cluster noninferiority randomised trial |
| Study acronym | MAC-study |
| Study objectives | 1. The modified antenatal care (MAC) program has not more negative maternal and fetal outcomes than the present standard antenatal care (SAC) program. 2. The modified antenatal care (MAC) program has not more negative patient related experience measurement (PREM) outcomes than the present standard antenatal care (SAC) program. |
| Ethics approval(s) | 1. Approved 29/11/2020, Stockholm avdelning 2 medicin (Box 2110, Uppsala, 75002 Uppsala, Sweden; +46 (0)10-4750800; registrator@etikprovning.se), ref: Dnr 2022-06144-02 2. Approved 29/11/2022, Stockholm avdelning 2 medicin (Stockholm avdelning 2 medicin, Stockholm, Stockholm avdelning 2 medicin, Sweden; Stockholm avdelning 2 medicin; registrator@etikprovning.se), ref: Dnr 2022-06144-02 |
| Health condition(s) or problem(s) studied | Antenatal care for healthy pregnant women with low risk for complications |
| Intervention | This is a noninferiority trial with the aim to determine if the MAC program does not differ in quality and safety compared with the SAC program in terms of maternal and neonatal outcome. The stepped wedge randomised controlled design is mainly used to evaluate the clinical routine implementation and therefore chosen for this study. All sites ( clusters) are in the end adopting the MAC program. A modified antenatal care program for healthy pregnant women with low-risk för complications with 4 inhouse visits, 2 ultrasounds and 2 digital meetings will be compared with the standard care program with 8 in house visits and 2 ultrasounds. At the beginning of the study, all 3 clusters will adopt the same standard care program and in the end, all 3 clusters will adopt the modified care program. The duration of the programs is around 42 weeks. |
| Intervention type | Mixed |
| Primary outcome measure | Intrauterine growth restriction during pregnancy (yes/no) collected from the Swedish Pregnancy Register and from reviewing patients medical records after recruitment |
| Secondary outcome measures | Collected from the Swedish Pregnancy Register and from reviewing patients medical records after recruitment: 1. Number of visits to the antenatal care clinic 2. Number of video meetings 3. Number of visits to the delivery unit 4. Number of midwives involved during the antenatal care 5. Number of inpatient care admissions 6. Pregnancy-induced Hypertension 7. Preeclampsia 8. Eclampsia 9. Breastfeeding at 4 weeks and 6 months 10. Participation in-group education during pregnancy Smoking during pregnancy 11. Number of women with recommended weight gain during pregnancy 12. Treatment of Fear of childbirth 13. Treatment of mental ill-health 14. Symptoms of postpartum depression 2 months after childbirth 15. Induction of labour 16. Number of vaginal, vacuum or caesarean deliveries 17. Number of pregnant women who had to change program due to higher risk complications or for other reasons 18. Intrauterin fetal death 19. Small for gestational age 20. Large for gestational age 21. Gestational week at childbirth 22. Admission to neonatal intensive care unit 23. Apgar < 4 at 5 minutes 24. PREM: expectations, fulfilment of expectations, accessibility, communication, information, sense of security, participation, support, overall satisfaction measured using a questionnaire in gestational week 38. |
| Overall study start date | 01/10/2019 |
| Completion date | 01/10/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 3 clusters with approx 1,800, 1,980 and 720 patients each |
| Total final enrolment | 5374 |
| Key inclusion criteria | All healthy pregnant women defined as low risk |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 01/10/2020 |
| Date of final enrolment | 01/10/2023 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Linköping
58185
Sweden
Sponsor information
Research council
Forskningsrådet I Sydöstra Sverige
Linköping
581 91
Sweden
| Phone | +46 (0)73-0917985 |
|---|---|
| agneta.andersson@regionostergotland.se | |
| Website | https://www.researchweb.org/is/en/forss |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Medical Research Council of Southeast Sweden, FORSS
- Location
- Sweden
Results and Publications
| Intention to publish date | 01/10/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 08/04/2022 | 11/04/2022 | Yes | No |
Editorial Notes
14/04/2025: Total final enrolment added.
11/04/2025: Ethics approval details added.
14/03/2024: The following changes were made to the study record:
1. Ethics approval details added.
2. The recruitment start date was changed from 01/02/2021 to 01/10/2020.
3. The recruitment end date was changed from 01/02/2023 to 01/10/2023.
11/04/2022: Publication reference added.
15/03/2021: Trial's existence confirmed by Swedish Ethical Review Authority (Etikprövningsmyndigheten)
