Health LiteracyMAMAACTNCT03751774
The MAMAACT Intervention
A study testing MAMAACT in people with Health Literacy and Stillbirth, run by University of Copenhagen at 19 sites in Denmark.
Trial summary
Inequalities in stillbirth, infant and child mortality as well as other reproductive health outcomes have been reported among ethnic minority groups in Denmark. The MAMAACT study aims to improve the communication between non-Western immigrant women and midwives regarding body symptoms that need prompt reaction, and… Read more about this study
- Who is it for?
- Ages 13 to 50 years, women only
- Conditions the study is for
- Health Literacy, Stillbirth, Apgar; 0-3 at 1 Minute
- What is being tested?
- MAMAACT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,153 participants
- Where
- 19 sitesDenmark
- Study dates
- 1 May 2019to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clusters: All maternity wards in Denmark defined as having one midwife heading the unit. Thus, Odense and Svendborg maternity wards are considered one cluster
- Survey: Women attending the malformation scan in the specified calender weeks at the specific maternity ward, pregnancy week 18+0 to 22+0 during the malformation scan, able to participate in a phone interview in Danish, Arabic, English, Turkish, Somali or Urdu
Who cannot join
- Cluster: All maternity wards invited
- Survey: Women out of the gestational age range specified above, women who could not speak the selected languages
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Denmark19 sites
The maternity ward in Aabenraa, Sygehus Soenderjylland
Aabenraa, 6200
The maternity ward in Aalborg, Aalborg Universitetshospital
Aalborg, 9100
The maternity ward in Aarhus, Aarhus Universitetshospital
Aarhus, 8200
The maternity ward in Esbjerg, Sydvestjysk Sygehus
Esbjerg, 6700
The maternity ward in Herlev, Herlev Hospital
Herlev, 2730
The maternity ward in Herning, Hospitalsenheden Vest
Herning, 7400
The maternity ward in Hillerød, Nordsjællandshospital Hillerød
Hillerød, 3400
The maternity ward in Hjoerring, Regionshospitalet Nord
Hjørring, 9800
The maternity ward in Holbaek, Holbaek Sygehus
Holbæk, 4300
The maternity ward in Horsens, Regionshospitalet Horsens
Horsens, 8700
The maternity ward in Hvidovre, Hvidovre hospital
Hvidovre, 2650
The maternity ward in Kolding, Sygehus Lillebaelt
Kolding, 6000
The maternity ward in Næstved, Næstved Sygehus
Næstved, 4700
The maternity ward in Nykøbing Falster, Nykøbing Falster Sygehus
Nykøbing Falster, 4800
The maternity ward in Odense, Odense Universitetshospital
Odense, 5000
The maternity ward in Randers, Regionshospitalet Randers
Randers, 8930
The maternity ward in Bornholm, Bornholms Hospital
Rønne, 3700
The maternity ward in Roskilde, Sjaellands Universitetshospital Roskilde
Roskilde, 4000
The maternity ward in Viborg, Regionshospitalet Viborg
Viborg, 8800
About this study
Official title: The National Danish MAMAACT Intervention
Inequalities in stillbirth, infant and child mortality as well as other reproductive health outcomes have been reported among ethnic minority groups in Denmark. The MAMAACT study aims to improve the communication between non-Western immigrant women and midwives regarding body symptoms that need prompt reaction, and thus improve perinatal health. 19 of 21 maternity wards in Denmark participate in the study. By simple randomization 10 maternity wards have been selected to the intervention group and 9 maternity wards to the control group. The intervention consist of post graduate training of midwives in intercultural competence and use of health education materials (leaflet and app) on pregnancy warning signs. The intervention will be implemented in the antenatal care from October 2018- September 2019. The training is expected to reach 350 midwives working with antenatal care and 27000 pregnant women, of whom 2700 are expected to be non-Western migrant women. The effect of the MAMAACT intervention will be analyzed by assessing women's ability to actively engage with health care providers (primary outcome), women's knowledge about warning signs of pregnancy complications and health system navigation using survey data. Secondary outcomes are 5-minute Apgar score, umbilical-cord blood gas analysis, transfer to a neonatal intensive care unit, gestational age at birth, fetal birthweight according to gestational age and ICD-10 code for sign of asphyxia.
MAMAACTs overall target group is all pregnant women, and the specific target group is women of non-Western origin. Therefore, the outcomes of the trial will be analysed for both the total population and for the effects among non-Western immigrant women specifically.
Hypothesis: Training of midwives in intercultural competence and increased attention to communication of warning signs of pregnancy during antenatal care will improve the communication and interaction between women and midwives, improve health literacy of the women and enable them to better access the relevant care in case of a pregnancy complication, which will then increase survival and health of newborn children.
Read the detailed description
The intervention is a complex intervention and designed as a cluster randomised trial. 19 maternity wards participate and by simple randomization within thee groups of maternity wards according to the proportion of non-Western migrant women giving birth, 10 clusters are in the intervention group and 9 in the control group.
The effectiveness of the intervention will be analysed in a difference-in-difference design, where the change in outcomes from before to after intervention period at the intervention sites are compared to the change at the control sites. Cross sectional surveys will be conducted before and after the implementation of the intervention.
Participants for the pre-implementation survey will be enrolled from May to July 2018. Participants for the post-implementation survey will be enrolled from May to July 2019. Only participants from the post-implementation survey at the intervention sites will be exposed to the intervention. The start date for the enrollment of participants exposed to the intervention will therefore be May 1st 2019.
The primary trial outcome is studied using telephone surveys with pregnant women recruited through the antenatal care services. The questionnaire will include validated items on the health literacy dimension actively engagement with health care providers (5 items) and health system navigation (5 items). Women are recruited when they attend for the week 20 ultra sound scan and will be interviewed between pregnancy week 30+0 and 38+7. The questionnaires are managed in six languages (Danish, Arabic, English, Turkish, Somali and Urdu, and bilingual and trained interviewers conduct the interviews.
Using unpublished data from pregnant women at Hvidovre Hospital in 2016 (n=407), Danish born women are found to have a mean level of the relevant health literacy dimension on 4.16 and non-Western migrant women have a significantly lower mean at 3.97. The goal is that the MAMAACT intervention will to improve the mean level of the non-Western migrant women to the level of the Danish born women at baseline, thus an effect on 0.2 on the mean of the dimension are to be shown. A recent Danish cluster randomized trial aiming at improved breast feeding by improving the guidance of new mothers at maternity wards has reported intra-cluster correlation coefficients (ICC) under 0.005.
For the sample size calculation an estimation with 10 cluster in the control group and 10 clusters in the intervention group were used, however after recruitment and randomization 9 wards were in the control group and 10 in the intervention group. With an ICC on 0.005 with 10 clusters in the intervention arm and 10 clusters in the control arm an effect on 0.1 with a strength of 80 % can be detected if data from 2580 of the total population before and after the intervention (1290 from the intervention before and after and 1290 from the control group before and after) is collected.
With an ICC on 0.005 with 10 clusters in the intervention arm and 10 clusters in the control arm an effect on 0.2 with a strength of 80 % can be detected if data is collected from 500 non-Western women before and after the intervention (250 from the intervention both before and after and 250 from the control group both before and after).
Based on telephone survey data, effects on the skills in health system navigation among the women will also be analysed.
The overall effects of the MAMAACT intervention on stillbirth and neonatal health will be analysed by the medical birth registry and obstetric databases. Stillbirth is defined as death of a child without any signs of life after 22 completed weeks of gestation. Neonatal death is defined as death of a child after live birth before 1 months of age. No significant effects on these outcomes are expected due to low numbers in the short intervention period. Secondary trial outcomes are 5-minute Apgar score, umbilical-cord blood gas analysis, transfer to a neonatal intensive care unit, gestational age at birth, fetal birthweight according to gestational age, ICD-10 code for sign of asphyxia, and pregnancy complications (preeclampsia).
All effectiveness analysis will be using an intention-to-treat approach and will account for the clustering of individuals and potential confounding in a controlled mixed effect regression.
The implementation of the intervention will be analyzed using qualitative data. The resarch questions are: How do midwives and non-Western immigrant women react to the MAMAACT intervention across Denmark? Which barriers exist in the organisation of antenatal care, and how do they affect the national implementation of the MAMAACT intervention? What are non-Western immigrant women's everyday life conditions in Denmark, and how do they affect women's responses to potential pregnancy complications?
- Being tested
- MAMAACT
- Medical subject headings
- Stillbirth, Asphyxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAMAACTBehavioural
Post graduate training and health education materials
| Study group | Role | What they receive |
|---|---|---|
| MAMAACT | Experimental | Training of midwives in intercultural communication. A 6 hours course and 2 one hour booster sessions. Distribution of health education materials on warnings signs of pregnancy and health system navigation to pregnant women during antenatal care visits. Receives: Behavioral: MAMAACT |
| Control | No intervention | Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actively engagement with health care providers
Increased mean score of the domain (5 item scale) among non-Western migrant women in Denmark. The Health Literacy domain of Actively engagement with health care providers, validated in the Health Literacy Questionnaire
Measured: Assessed among women in prenancy week 30+0 to 38+7
Secondary outcomes (8)
Apgar score at 5 minutes
Increased mean of apgar score at 5 minutes among non-Western migrant women. Using nation wide registers
Measured: Mean Apgar scores at five minutes after birth
Ability to navigate the health system
Increased ability to navigate the health system among non-Western migrant, women assessed using the validated Health Literacy Questionnaire domain on Health System Navigation (5 item scale)
Measured: Assessed among women in pregnancy week 30+0 to 38+7
Knowledge on pregnancy warning signs
Increased knowledge on what to do in case of vaginal bleeding, severe headache and deep vein thrombosis during pregnancy among non-Western migrant women. Survey data
Measured: Assessed among women in pregnancy week 30+0 to 38+7
Umbilical-cord blood gas analysis
Improvements in the mean umbilical-cord blood gas levels as signs of asphyxia for non-Western migrant women in a time phase before the intervention with the period of implementation. Using nation wide registers
Measured: Umbilical-cord blood gas analysis taken after the delivery of the baby, within the 30 minutes
Transfer to a neonatal intensive care unit
Reduced number of non-Western new born children admitted to neonatal unit. Using nation wide registers
Measured: Transferral at the day of delivery or the day after
ICD-10 code for sign of asphyxia
Reduced number of non-Western children having the ICD10 code for sign of asphyxia. Using nation wide registers
Measured: Assessed within the first minute after delivery
Maternal pregnancy complications
Reduced proportion of severe maternal pregnancy complications, focus on preeclampsia
Measured: Assessed from pregnancy week 12 up till one week after delivery
A composite score for stillbirth, neonatal death and neonatal near miss
The composite score is defined as having one or more of the following outcomes: stillbirth, neonatal death (death at age 0-28 completed days from birth) and the infant focused outcomes above (outcome 2 (apgar score at 5 minutes), 5 (umbilical-cord blood gas ), 6 (transfer to a neonatal intensive care unit) and 7(ICD-10 code for sign of asphyxia)).
Measured: Assessed according to the specific outcomes with the maximum range of 28 days after birth for neonatal death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start1 May 2019
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health LiteracyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clusters (maternity wards) are randomized to either intervention or control (standard ANC). Intervention coverage 27000. Data collection for the primary and secondary trial outcomes includes 1.921 interviewed participants in the pre-intervention survey and 2.232 interviewed participants in the post-intervention survey.
- Masking
- None (open label)
- Enrolment
- 4,153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- 19 maternity wards, Migrant medical clinics (Odense and Hvidovre), TrygFonden, Denmark, Østifterne, Danske Regioner, Neighbourhood mothers, University College Copenhagen
- Responsible party
- Principal investigator, Sarah Fredsted Villadsen, University of Copenhagen
- Investigators
- Sarah F Villadsen, Ph.d., Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751774
- Sponsor's protocol ID
- MAMAACT
- Acronym
- MAMAACT
- Status last verified
- May 2022
- First submitted
- 12 Nov 2018
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rasmussen TD, Nybo Andersen AM, Ekstrom CT, Jervelund SS, Villadsen SF. Improving health literacy responsiveness to reduce ethnic and social disparity in stillbirth and infant health: A cluster randomized controlled effectiveness trial of the MAMAACT intervention. Int J Nurs Stud. 2023 Aug;144:104505. doi: 10.1016/j.ijnurstu.2023.104505. Epub 2023 May 1.
PubMed 37267853
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The National Danish MAMAACT Intervention
- ClinicalTrials.gov ID
- NCT03751774
- Acronym / sponsor ID
- MAMAACT / MAMAACT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,153 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- 19 maternity wards, Migrant medical clinics (Odense and Hvidovre), TrygFonden, Denmark, Østifterne, Danske Regioner, Neighbourhood mothers, University College Copenhagen
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inequalities in stillbirth, infant and child mortality as well as other reproductive health outcomes have been reported among ethnic minority groups in Denmark. The MAMAACT study aims to improve the communication between non-Western immigrant women and midwives regarding body symptoms that need prompt reaction, and thus improve perinatal health. 19 of 21 maternity wards in Denmark participate in the study. By simple randomization 10 maternity wards have been selected to the intervention group and 9 maternity wards to the control group. The intervention consist of post graduate training of midwives in intercultural competence and use of health education materials (leaflet and app) on pregnancy warning signs. The intervention will be implemented in the antenatal care from October 2018- September 2019. The training is expected to reach 350 midwives working with antenatal care and 27000 pregnant women, of whom 2700 are expected to be non-Western migrant women. The effect of the MAMAACT intervention will be analyzed by assessing women's ability to actively engage with health care providers (primary outcome), women's knowledge about warning signs of pregnancy complications and health system navigation using survey data. Secondary outcomes are 5-minute Apgar score, umbilical-cord blood gas analysis, transfer to a neonatal intensive care unit, gestational age at birth, fetal birthweight according to gestational age and ICD-10 code for sign of asphyxia.
MAMAACTs overall target group is all pregnant women, and the specific target group is women of non-Western origin. Therefore, the outcomes of the trial will be analysed for both the total population and for the effects among non-Western immigrant women specifically.
Hypothesis: Training of midwives in intercultural competence and increased attention to communication of warning signs of pregnancy during antenatal care will improve the communication and interaction between women and midwives, improve health literacy of the women and enable them to better access the relevant care in case of a pregnancy complication, which will then increase survival and health of newborn children.
Detailed description
The intervention is a complex intervention and designed as a cluster randomised trial. 19 maternity wards participate and by simple randomization within thee groups of maternity wards according to the proportion of non-Western migrant women giving birth, 10 clusters are in the intervention group and 9 in the control group.
The effectiveness of the intervention will be analysed in a difference-in-difference design, where the change in outcomes from before to after intervention period at the intervention sites are compared to the change at the control sites. Cross sectional surveys will be conducted before and after the implementation of the intervention.
Participants for the pre-implementation survey will be enrolled from May to July 2018. Participants for the post-implementation survey will be enrolled from May to July 2019. Only participants from the post-implementation survey at the intervention sites will be exposed to the intervention. The start date for the enrollment of participants exposed to the intervention will therefore be May 1st 2019.
The primary trial outcome is studied using telephone surveys with pregnant women recruited through the antenatal care services. The questionnaire will include validated items on the health literacy dimension actively engagement with health care providers (5 items) and health system navigation (5 items). Women are recruited when they attend for the week 20 ultra sound scan and will be interviewed between pregnancy week 30+0 and 38+7. The questionnaires are managed in six languages (Danish, Arabic, English, Turkish, Somali and Urdu, and bilingual and trained interviewers conduct the interviews.
Using unpublished data from pregnant women at Hvidovre Hospital in 2016 (n=407), Danish born women are found to have a mean level of the relevant health literacy dimension on 4.16 and non-Western migrant women have a significantly lower mean at 3.97. The goal is that the MAMAACT intervention will to improve the mean level of the non-Western migrant women to the level of the Danish born women at baseline, thus an effect on 0.2 on the mean of the dimension are to be shown. A recent Danish cluster randomized trial aiming at improved breast feeding by improving the guidance of new mothers at maternity wards has reported intra-cluster correlation coefficients (ICC) under 0.005.
For the sample size calculation an estimation with 10 cluster in the control group and 10 clusters in the intervention group were used, however after recruitment and randomization 9 wards were in the control group and 10 in the intervention group. With an ICC on 0.005 with 10 clusters in the intervention arm and 10 clusters in the control arm an effect on 0.1 with a strength of 80 % can be detected if data from 2580 of the total population before and after the intervention (1290 from the intervention before and after and 1290 from the control group before and after) is collected.
With an ICC on 0.005 with 10 clusters in the intervention arm and 10 clusters in the control arm an effect on 0.2 with a strength of 80 % can be detected if data is collected from 500 non-Western women before and after the intervention (250 from the intervention both before and after and 250 from the control group both before and after).
Based on telephone survey data, effects on the skills in health system navigation among the women will also be analysed.
The overall effects of the MAMAACT intervention on stillbirth and neonatal health will be analysed by the medical birth registry and obstetric databases. Stillbirth is defined as death of a child without any signs of life after 22 completed weeks of gestation. Neonatal death is defined as death of a child after live birth before 1 months of age. No significant effects on these outcomes are expected due to low numbers in the short intervention period. Secondary trial outcomes are 5-minute Apgar score, umbilical-cord blood gas analysis, transfer to a neonatal intensive care unit, gestational age at birth, fetal birthweight according to gestational age, ICD-10 code for sign of asphyxia, and pregnancy complications (preeclampsia).
All effectiveness analysis will be using an intention-to-treat approach and will account for the clustering of individuals and potential confounding in a controlled mixed effect regression.
The implementation of the intervention will be analyzed using qualitative data. The resarch questions are: How do midwives and non-Western immigrant women react to the MAMAACT intervention across Denmark? Which barriers exist in the organisation of antenatal care, and how do they affect the national implementation of the MAMAACT intervention? What are non-Western immigrant women's everyday life conditions in Denmark, and how do they affect women's responses to potential pregnancy complications?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clusters (maternity wards) are randomized to either intervention or control (standard ANC). Intervention coverage 27000. Data collection for the primary and secondary trial outcomes includes 1.921 interviewed participants in the pre-intervention survey and 2.232 interviewed participants in the post-intervention survey.
| Arm | Type | Receives |
|---|---|---|
| MAMAACT | Experimental | Behavioral: MAMAACTTraining of midwives in intercultural communication. A 6 hours course and 2 one hour booster sessions. Distribution of health education materials on warnings signs of pregnancy and health system navigation to pregnant women during antenatal care visits. |
| Control | No intervention | –Care as usual |
Who may qualify
- Ages
- 13 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Clusters: All maternity wards in Denmark defined as having one midwife heading the unit. Thus, Odense and Svendborg maternity wards are considered one cluster
- Survey: Women attending the malformation scan in the specified calender weeks at the specific maternity ward, pregnancy week 18+0 to 22+0 during the malformation scan, able to participate in a phone interview in Danish, Arabic, English, Turkish, Somali or Urdu
Key exclusion criteria (2 listed)
- Cluster: All maternity wards invited
- Survey: Women out of the gestational age range specified above, women who could not speak the selected languages
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAMAACTPost graduate training and health education materials | Behavioural | MAMAACT |
Primary outcome
Actively engagement with health care providers
Time frame: Assessed among women in prenancy week 30+0 to 38+7
Increased mean score of the domain (5 item scale) among non-Western migrant women in Denmark. The Health Literacy domain of Actively engagement with health care providers, validated in the Health Literacy Questionnaire
8 secondary outcomes
Apgar score at 5 minutes
Time frame: Mean Apgar scores at five minutes after birth
Ability to navigate the health system
Time frame: Assessed among women in pregnancy week 30+0 to 38+7
Knowledge on pregnancy warning signs
Time frame: Assessed among women in pregnancy week 30+0 to 38+7
Umbilical-cord blood gas analysis
Time frame: Umbilical-cord blood gas analysis taken after the delivery of the baby, within the 30 minutes
Transfer to a neonatal intensive care unit
Time frame: Transferral at the day of delivery or the day after
ICD-10 code for sign of asphyxia
Time frame: Assessed within the first minute after delivery
Maternal pregnancy complications
Time frame: Assessed from pregnancy week 12 up till one week after delivery
A composite score for stillbirth, neonatal death and neonatal near miss
Time frame: Assessed according to the specific outcomes with the maximum range of 28 days after birth for neonatal death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Derived from this study: PubMed 37267853Rasmussen TD, Nybo Andersen AM, Ekstrom CT, Jervelund SS, Villadsen SF. Improving health literacy responsiveness to reduce ethnic and social disparity in stillbirth and infant health: A cluster randomized controlled effectiveness trial of the MAMAACT intervention. Int J Nurs Stud. 2023 Aug;144:104505. doi: 10.1016/j.ijnurstu.2023.104505. Epub 2023 May 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah F Villadsen, Ph.d. principal investigator
University of Copenhagen
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAMAACT in people with Health Literacy and Stillbirth, run by University of Copenhagen at 19 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actively engagement with health care providers (time frame: Assessed among women in prenancy week 30+0 to 38+7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03751774, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.