Modified antenatal care for healthy pregnant women with low risk for adverse outcomes

ISRCTN	ISRCTN14422582
DOI	https://doi.org/10.1186/ISRCTN14422582
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Medical Research Council of Southeast Sweden
Funder	Forskningsrådet i Sydöstra Sverige

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Dr Caroline Lilliecreutz
Scientific

Womens Clinic floor 14
University Hospital
Linköping
58185
Sweden

ORCID ID	0000-0001-9491-9728
Phone	+46 101033160
Email	caroline.lilliecreutz@regionostergotland.se

Study information

Primary study design	Interventional
Study design	Interventional cluster randomized trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
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(s)	Intrauterine growth restriction during pregnancy (yes/no) collected from the Swedish Pregnancy Register and from reviewing patients medical records after recruitment
Key secondary outcome measure(s)	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.
Completion date	01/10/2026

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	4440
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 University Hospital

Department of Obstetrics and Gynecology and Department of Biomedical and Clinical Sciences
Linköping
58185
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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)