Trial Outcomes & Findings for A Co-created Self-care and Informal Support Intervention Study Among Women With GDM in Vietnam (NCT NCT05744856)
NCT ID: NCT05744856
Last Updated: 2026-02-10
Results Overview
Number of Participants who delivered newborns with birth weight above or equal to the 90th percentile according to gender and gestational age based on the INTERGROWTH-21st birthweight chart
COMPLETED
NA
435 participants
Delivery (up to study month 7 after enrolment/Gestational age 40)
2026-02-10
Participant Flow
Participant milestones
| Measure |
Standard GDM Care
After being diagnosed with GDM, standard care includes counseling on nutrition and physical activity. All patients are referred to an endocrinologist at the General Hospital, yet this is not covered by insurance unless the patients have received a referral letter from a health station. The endocrinologist will perform blood glucose measurements (venous blood sample) once every four weeks at the General Hospital until gestational week 36, after which it will be monitored once a week until delivery. The cut-off for c-section is 3800g (no matter the mother's GDM status).
Treatment recommended by the endocrinologist may include home-monitoring of blood glucose and insulin treatment in the most severe cases. The home-monitoring requires that the women are able to buy the glucometer and test strips themselves.
|
Self-care With Informal Support
Standard care + "Self-care/informal support" intervention
The women in the intervention group will receive standard care and the self-care/informal support intervention.
The "self-care/informal support intervention" will be developed at participatory co-creation workshops involving women with GDM, their informal support persons, and health care staff.
The intervention will include educational pamphlets regarding GDM and digital GDM education through videos and text messages. Further, digital coaching will be conducted and networking among intervention participants via the Vietnamese messaging app Zalo. In addition, each woman will be invited to include one informal support person in the intervention activities.
GDM education will concern coaching on diet and exercise during pregnancy and after delivery and coaching on breastfeeding and infant/child nutrition.
|
|---|---|---|
|
Overall Study
STARTED
|
233
|
202
|
|
Overall Study
COMPLETED
|
230
|
199
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Co-created Self-care and Informal Support Intervention Study Among Women With GDM in Vietnam
Baseline characteristics by cohort
| Measure |
Standard GDM Care
n=226 Participants
After being diagnosed with GDM, standard care includes counseling on nutrition and physical activity. All patients are referred to an endocrinologist at the General Hospital, yet this is not covered by insurance unless the patients have received a referral letter from a health station. The endocrinologist will perform blood glucose measurements (venous blood sample) once every four weeks at the General Hospital until gestational week 36, after which it will be monitored once a week until delivery. The cut-off for c-section is 3800g (no matter the mother's GDM status).
Treatment recommended by the endocrinologist may include home-monitoring of blood glucose and insulin treatment in the most severe cases. The home-monitoring requires that the women are able to buy the glucometer and test strips themselves.
|
Self-care With Informal Support
n=201 Participants
Standard care + "Self-care/informal support" intervention
The detailed content of the "self-care/informal support intervention" will be developed at participatory co-creation workshops involving pregnant women with GDM, their informal support persons, and health care staff.
It is expected that intervention will include educational pamphlets regarding GDM and digital GDM education through videos and text messages. Further, digital coaching will be conducted and networking among intervention participants via the Vietnamese messaging app Zalo. In addition, each woman will be invited to include one informal support person in the intervention activities.
GDM education will concern coaching on diet and exercise during pregnancy and after delivery and coaching on breastfeeding and infant/child nutrition.
Self-care with informal support: The detailed content of the "self-care with informal support intervention" will be developed at participatory co-creation workshops involving pregnant women with GDM, their informal support persons, and health care staff.
|
Total
n=427 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
226 Participants
n=41 Participants
|
201 Participants
n=1581 Participants
|
427 Participants
n=4626 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Continuous
|
31.0 years
STANDARD_DEVIATION 5.5 • n=41 Participants
|
30.2 years
STANDARD_DEVIATION 5.2 • n=1581 Participants
|
30.6 years
STANDARD_DEVIATION 5.4 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
226 Participants
n=41 Participants
|
201 Participants
n=1581 Participants
|
427 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
226 Participants
n=41 Participants
|
201 Participants
n=1581 Participants
|
427 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Region of Enrollment
Vietnam
|
226 participants
n=41 Participants
|
201 participants
n=1581 Participants
|
427 participants
n=4626 Participants
|
|
Prepregnancy BMI
|
21.2 kg/m2
STANDARD_DEVIATION 2.5 • n=41 Participants
|
21.4 kg/m2
STANDARD_DEVIATION 2.8 • n=1581 Participants
|
21.3 kg/m2
STANDARD_DEVIATION 2.6 • n=4626 Participants
|
PRIMARY outcome
Timeframe: Delivery (up to study month 7 after enrolment/Gestational age 40)Population: Numbers of Participants reported here are smaller than those reported in the Participant Flow because for the outcome of large-for-gestational age, participants who lost to follow up or had stillbirth were excluded.
Number of Participants who delivered newborns with birth weight above or equal to the 90th percentile according to gender and gestational age based on the INTERGROWTH-21st birthweight chart
Outcome measures
| Measure |
Standard GDM Care
n=222 Participants
After being diagnosed with GDM, standard care includes counseling on nutrition and physical activity. All patients are referred to an endocrinologist at the General Hospital, yet this is not covered by insurance unless the patients have received a referral letter from a health station. The endocrinologist will perform blood glucose measurements (venous blood sample) once every four weeks at the General Hospital until gestational week 36, after which it will be monitored once a week until delivery. The cut-off for c-section is 3800g (no matter the mother's GDM status).
Treatment recommended by the endocrinologist may include home-monitoring of blood glucose and insulin treatment in the most severe cases. The home-monitoring requires that the women are able to buy the glucometer and test strips themselves.
|
Self-care With Informal Support
n=198 Participants
Standard care + "Self-care/informal support" intervention
The detailed content of the "self-care/informal support intervention" will be developed at participatory co-creation workshops involving pregnant women with GDM, their informal support persons, and health care staff.
It is expected that intervention will include educational pamphlets regarding GDM and digital GDM education through videos and text messages. Further, digital coaching will be conducted and networking among intervention participants via the Vietnamese messaging app Zalo. In addition, each woman will be invited to include one informal support person in the intervention activities.
GDM education will concern coaching on diet and exercise during pregnancy and after delivery and coaching on breastfeeding and infant/child nutrition.
Self-care with informal support: The detailed content of the "self-care with informal support intervention" will be developed at participatory co-creation workshops involving pregnant women with GDM, their informal support persons, and health care staff.
|
|---|---|---|
|
Large for Gestational Age (LGA)
|
23 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: Delivery (study month 7 after enrolment/Gestational age 40)Population: Numbers of Participants reported here are smaller than those reported in the Participant Flow because for the outcome of large-for-gestational age, participants who lost to follow up or had stillbirth were excluded.
Number of Participants who delivered newborns with birth weight above or equal to the 90th percentile according to gender and gestational age based on the INTERGROWTH-21st fetal weight formula.
Outcome measures
| Measure |
Standard GDM Care
n=222 Participants
After being diagnosed with GDM, standard care includes counseling on nutrition and physical activity. All patients are referred to an endocrinologist at the General Hospital, yet this is not covered by insurance unless the patients have received a referral letter from a health station. The endocrinologist will perform blood glucose measurements (venous blood sample) once every four weeks at the General Hospital until gestational week 36, after which it will be monitored once a week until delivery. The cut-off for c-section is 3800g (no matter the mother's GDM status).
Treatment recommended by the endocrinologist may include home-monitoring of blood glucose and insulin treatment in the most severe cases. The home-monitoring requires that the women are able to buy the glucometer and test strips themselves.
|
Self-care With Informal Support
n=198 Participants
Standard care + "Self-care/informal support" intervention
The detailed content of the "self-care/informal support intervention" will be developed at participatory co-creation workshops involving pregnant women with GDM, their informal support persons, and health care staff.
It is expected that intervention will include educational pamphlets regarding GDM and digital GDM education through videos and text messages. Further, digital coaching will be conducted and networking among intervention participants via the Vietnamese messaging app Zalo. In addition, each woman will be invited to include one informal support person in the intervention activities.
GDM education will concern coaching on diet and exercise during pregnancy and after delivery and coaching on breastfeeding and infant/child nutrition.
Self-care with informal support: The detailed content of the "self-care with informal support intervention" will be developed at participatory co-creation workshops involving pregnant women with GDM, their informal support persons, and health care staff.
|
|---|---|---|
|
Large for Gestational Age (LGA)
|
30 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: Recruitment (study month 0)Population: Number of Participants reported here were women who eligible for the intervention in the self-care with informal support.
Number of Participants eligible for the study who accepted to be included in the intervention arm.
Outcome measures
| Measure |
Standard GDM Care
n=202 Participants
After being diagnosed with GDM, standard care includes counseling on nutrition and physical activity. All patients are referred to an endocrinologist at the General Hospital, yet this is not covered by insurance unless the patients have received a referral letter from a health station. The endocrinologist will perform blood glucose measurements (venous blood sample) once every four weeks at the General Hospital until gestational week 36, after which it will be monitored once a week until delivery. The cut-off for c-section is 3800g (no matter the mother's GDM status).
Treatment recommended by the endocrinologist may include home-monitoring of blood glucose and insulin treatment in the most severe cases. The home-monitoring requires that the women are able to buy the glucometer and test strips themselves.
|
Self-care With Informal Support
Standard care + "Self-care/informal support" intervention
The detailed content of the "self-care/informal support intervention" will be developed at participatory co-creation workshops involving pregnant women with GDM, their informal support persons, and health care staff.
It is expected that intervention will include educational pamphlets regarding GDM and digital GDM education through videos and text messages. Further, digital coaching will be conducted and networking among intervention participants via the Vietnamese messaging app Zalo. In addition, each woman will be invited to include one informal support person in the intervention activities.
GDM education will concern coaching on diet and exercise during pregnancy and after delivery and coaching on breastfeeding and infant/child nutrition.
Self-care with informal support: The detailed content of the "self-care with informal support intervention" will be developed at participatory co-creation workshops involving pregnant women with GDM, their informal support persons, and health care staff.
|
|---|---|---|
|
The Feasibility of the Self-care Intervention [Recruitment]
|
202 Participants
|
—
|
PRIMARY outcome
Timeframe: Recruitment to post-partum evaluation (study month 0-10)Number of Participants included in the self-care intervention group who completed the study (delivery data and post-partum interview).
Outcome measures
| Measure |
Standard GDM Care
n=202 Participants
After being diagnosed with GDM, standard care includes counseling on nutrition and physical activity. All patients are referred to an endocrinologist at the General Hospital, yet this is not covered by insurance unless the patients have received a referral letter from a health station. The endocrinologist will perform blood glucose measurements (venous blood sample) once every four weeks at the General Hospital until gestational week 36, after which it will be monitored once a week until delivery. The cut-off for c-section is 3800g (no matter the mother's GDM status).
Treatment recommended by the endocrinologist may include home-monitoring of blood glucose and insulin treatment in the most severe cases. The home-monitoring requires that the women are able to buy the glucometer and test strips themselves.
|
Self-care With Informal Support
Standard care + "Self-care/informal support" intervention
The detailed content of the "self-care/informal support intervention" will be developed at participatory co-creation workshops involving pregnant women with GDM, their informal support persons, and health care staff.
It is expected that intervention will include educational pamphlets regarding GDM and digital GDM education through videos and text messages. Further, digital coaching will be conducted and networking among intervention participants via the Vietnamese messaging app Zalo. In addition, each woman will be invited to include one informal support person in the intervention activities.
GDM education will concern coaching on diet and exercise during pregnancy and after delivery and coaching on breastfeeding and infant/child nutrition.
Self-care with informal support: The detailed content of the "self-care with informal support intervention" will be developed at participatory co-creation workshops involving pregnant women with GDM, their informal support persons, and health care staff.
|
|---|---|---|
|
The Feasibility of the Self-care Intervention [Retention]
|
156 Participants
|
—
|
PRIMARY outcome
Timeframe: Study month 3 to 10 /Gestational age 24 to 12 weeks post-partumPopulation: The numbers of participants here were participant who provided responses of acceptability at post-partum interview.
Acceptability will be measured in a combined quantitative and qualitative study. It will be measured quantitatively via 5-point likert scales among the intervention group \[Range: 1-5; Minimum score: 1; Maximum score: 5; Higher score indicates high acceptability\]. It will be assessed qualitatively among a sub-group of the intervention group through a ethnographic study.
Outcome measures
| Measure |
Standard GDM Care
n=106 Participants
After being diagnosed with GDM, standard care includes counseling on nutrition and physical activity. All patients are referred to an endocrinologist at the General Hospital, yet this is not covered by insurance unless the patients have received a referral letter from a health station. The endocrinologist will perform blood glucose measurements (venous blood sample) once every four weeks at the General Hospital until gestational week 36, after which it will be monitored once a week until delivery. The cut-off for c-section is 3800g (no matter the mother's GDM status).
Treatment recommended by the endocrinologist may include home-monitoring of blood glucose and insulin treatment in the most severe cases. The home-monitoring requires that the women are able to buy the glucometer and test strips themselves.
|
Self-care With Informal Support
Standard care + "Self-care/informal support" intervention
The detailed content of the "self-care/informal support intervention" will be developed at participatory co-creation workshops involving pregnant women with GDM, their informal support persons, and health care staff.
It is expected that intervention will include educational pamphlets regarding GDM and digital GDM education through videos and text messages. Further, digital coaching will be conducted and networking among intervention participants via the Vietnamese messaging app Zalo. In addition, each woman will be invited to include one informal support person in the intervention activities.
GDM education will concern coaching on diet and exercise during pregnancy and after delivery and coaching on breastfeeding and infant/child nutrition.
Self-care with informal support: The detailed content of the "self-care with informal support intervention" will be developed at participatory co-creation workshops involving pregnant women with GDM, their informal support persons, and health care staff.
|
|---|---|---|
|
The Acceptability of the Self-care Intervention
|
3.9 score
Standard Deviation 0.7
|
—
|
SECONDARY outcome
Timeframe: Delivery (study month 7/Gestational age 40)Population: Number of participants reported here were women with singleton pregnancy and therefore are smaller than the numbers assigned in the Participant Flow.
Number of participants with spontaneous vaginal delivery, assisted vaginal delivery, planned c-section or emergency c-section
Outcome measures
| Measure |
Standard GDM Care
n=226 Participants
After being diagnosed with GDM, standard care includes counseling on nutrition and physical activity. All patients are referred to an endocrinologist at the General Hospital, yet this is not covered by insurance unless the patients have received a referral letter from a health station. The endocrinologist will perform blood glucose measurements (venous blood sample) once every four weeks at the General Hospital until gestational week 36, after which it will be monitored once a week until delivery. The cut-off for c-section is 3800g (no matter the mother's GDM status).
Treatment recommended by the endocrinologist may include home-monitoring of blood glucose and insulin treatment in the most severe cases. The home-monitoring requires that the women are able to buy the glucometer and test strips themselves.
|
Self-care With Informal Support
n=201 Participants
Standard care + "Self-care/informal support" intervention
The detailed content of the "self-care/informal support intervention" will be developed at participatory co-creation workshops involving pregnant women with GDM, their informal support persons, and health care staff.
It is expected that intervention will include educational pamphlets regarding GDM and digital GDM education through videos and text messages. Further, digital coaching will be conducted and networking among intervention participants via the Vietnamese messaging app Zalo. In addition, each woman will be invited to include one informal support person in the intervention activities.
GDM education will concern coaching on diet and exercise during pregnancy and after delivery and coaching on breastfeeding and infant/child nutrition.
Self-care with informal support: The detailed content of the "self-care with informal support intervention" will be developed at participatory co-creation workshops involving pregnant women with GDM, their informal support persons, and health care staff.
|
|---|---|---|
|
Mode of Delivery
Number of Participants who had C-section delivery
|
138 Participants
|
124 Participants
|
|
Mode of Delivery
Number of Participants with missing data
|
11 Participants
|
9 Participants
|
|
Mode of Delivery
Number of Participants who had vaginal delivery
|
77 Participants
|
68 Participants
|
SECONDARY outcome
Timeframe: Delivery (study month 7/Gestational age 40)Number of participants with spontaneous preterm birth or medical induced preterm birth
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Delivery (study month 7/Gestational age 40)The gestational age of newborns at delivery
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Delivery (study month 7/Gestational age 40)Birth weight of newborns measured in grams
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Delivery (study month 7/Gestational age 40)Number of newborns with birth weight above 4000g
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Delivery (study month 7/Gestational age 40)Number of newborns with birth weight above 3500g
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Delivery (study month 7/Gestational age 40)Newborns that are live-born (Yes/no)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Delivery (study month 7/Gestational age 40)Number of newborns below the 10th percentile for birth weight according to gestational age
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Delivery (study month 7/Gestational age 40)The Apgar score of newborns measured 1 and 5 minutes after delivery (score: 0-10)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Delivery (study month 7/Gestational age 40)Measurement of blood glucose (mmol/l) in newborns
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study month 0 and 6/Gestational age 12 and 36Change in delta weight (kilogram) among participants between gestational age 36 minus first measured/pre-gestational weight
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study month 3 and 7/Gestational age 24 and 40 (delivery)Change in delta score among participants between gestational age 24 and 40 (delivery)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study month 10 (12 weeks post-partum)Participants' breast feeding practices measured through ad hoc developed questions
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study month 3 and 10/Gestational age 24 and 12 weeks postpartumChange in delta score among participants measured through the Edinburgh postpartum depression scale (EPDS) \[10 items on 4-point scale ranging from 0-3\]
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study month 3,6 and 10/Gestational age 24, 36 and 12 weeks postpartumChange in delta score among participants measured through the Multidimensional Scale of Perceived Social Support scale (MSPSS) \[11 item 7-point scale ranging from 1-7\]
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study month 0, 3, 6 and 10/Gestational age 12, 24, 36 and 12 weeks postpartumChange in delta scores measured through WHO 5 Wellbeing index \[5 items on 6-point scale ranging from 0-5\]
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study month 3 and 6/Gestational age 24 and 36Difference in score between intervention and comparator group measured through the Self-care Agency Scale-Revised (ASAS-R) \[15 items on 5-point scale ranging from 1-5\]
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study month 6/Gestational age 36Difference in score between intervention and comparator group measured through the Summary of Diabetes Self- Care Activities (SDSCA) \[10 items on 8-point scale ranging 0-7\]
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Study month 3 and 6/Gestational age 24 and 36Change in diet measured through ad hoc developed questions
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Study month 3 and 6/Gestational age 24 and 36Change in physical activity measured through ad hoc developed questions
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Delivery (study month 7/Gestational age 40)Number of participants where episiotomy is performed during delivery
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Delivery (study month 7/Gestational age 40)Number of participants with Premature Primary Rupture of Membranes
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Study month 3/Gestational age 24Number of participants with GDM diagnosed according to WHO criteria
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Study month 3/Gestational age 24Number of pre-gestational and gestational risk factors for GDM prevalent among participants diagnosed with GDM (risk factor are defined as according to those known in the literature, e.g. age, BMI, family disposition, gestational weigh gain)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Study month 3 to 7/Gestational age 24 to 40 (delivery)Ethnographic study conducted among approximately 40 pregnant women with GDM and their informal support persons (20 from intervention group and 20 from control group)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Study month 3 to 7/Gestational age 24 to 40 (delivery)Ethnographic study conducted among approximately 40 pregnant women with GDM and their informal support persons (20 from intervention group and 20 from control group)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Study month 3 to 10/Gestational age 24 to 12 weeks post-partumEthnographic study conducted among approximately 20 pregnant women with GDM and their informal support persons (intervention group)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Study month 6/Gestational age 36The short form version of the Family Health Scale \[10 items on a 5-point scale ranging from 1-5\]. A total score of 0-5 indicates poor family health, 6-8 indicates moderate family health, and 9-10 indicates excellent family health
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Throughout whole study (study month 0-10)Direct economic costs (in Vietnamese Dong/VND and USD) and indirect costs (human ressources measured in hours) spent on developing the intervention
Outcome measures
Outcome data not reported
Adverse Events
Standard GDM Care
Self-care With Informal Support
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Thanh Nguyen
Thai Binh University for Medicine and Pharmacy
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place