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

Modified antenatal care (MAC) program for healthy pregnant women with low risk for adverse outcomes – a stepped wedge cluster noninferiority randomised trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14422582

Enrollment

4440

Registered

2021-04-21

Start date

2020-10-01

Completion date

Unknown

Last updated

2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antenatal care for healthy pregnant women with low risk for complications Pregnancy and Childbirth

Interventions

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 w

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: All healthy pregnant women defined as low risk

Exclusion criteria

Exclusion criteria: Does not meet the inclusion criteria

Design outcomes

Primary

Measure	Time frame
Intrauterine growth restriction during pregnancy (yes/no) collected from the Swedish Pregnancy Register and from reviewing patients medical records after recruitment	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 18, 2026