Pregnant Women in All Gestational Ages Hospitalized for a Problem of PregnancyHAWAIINCT02601261

How Anxiety in Pregnant Hospitalized Women Change wIth Internet Use

An observational study of Pregnant Women in All Gestational Ages Hospitalized for a Problem of Pregnancy, run by University of Padova.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Investigating the influence of Internet use to the level of state anxiety in hospitalized women with pathological pregnancy. A recent research shown that the prevalence of antenatal anxiety changes during pregnancy at first trimester is 36.3%; the rate dropped to 32.3% at second trimester but increased again to 35.8%… Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Pregnant Women in All Gestational Ages Hospitalized for a Problem of Pregnancy
What is being tested?: At the first day of hospitalization the field investigator will submit to pregnant women in a pathological condition five questionnaires
Type of treatment: Pill or oral medicine
How many people: 105 participants
Where: No sites listed yet
Study dates: 1 Aug 2015to 31 Dec 2016
Phase: Observational
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 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Study population: The study has been powered to detect a difference on the average STAI state score (range 20-80) of 6 points between women with some access to internet during stay (at least 10 minutes/days of web browsing, besides e-mails) and those no accessing internet during stay. Assuming a Standard Deviation of the difference in STAI scores of about 8 points (art. 30-art. 33), and assuming that the ratio between the rate of women not using internet and that of women using internet is 0,42 (art. 31-art. 32) for specified alpha = 0.025 and power (1 - beta) of 90.0% a total of 109 women must be recruited (using a two-sample t-test with unknown variance). Data entry will be based on e-CRF running on the REDCAP Clinical Data Management System of the Service for Clinical Trials and Biometrics (Department of Cardiology, Thoracic and Vascular Sciences, University of Padova).

Who may be able to join

Italian speaking and reading ability;
Age > 18 years
Been hospitalized for a pathological pregnancy condition;
Having a twin pregnancy;
All gestational ages;
Having been transferred from other hospitals.

Who cannot join

Been under stressful family events (deaths, recent separation: self-reported)
With a diagnosis of a mental psychiatric diseases;
With a diagnosis of cancer pathology.

About this study

Investigating the influence of Internet use to the level of state anxiety in hospitalized women with pathological pregnancy.

A recent research shown that the prevalence of antenatal anxiety changes during pregnancy at first trimester is 36.3%; the rate dropped to 32.3% at second trimester but increased again to 35.8% at third trimester (art. 29).According to the World Health Organization, mental health disorders are the leading cause of disease burden in woman from 15 to 44 years (art.6). A Swedish study indicated that the incidence of moderate or extreme symptoms of anxiety and depression of pregnant woman during the first trimester is 15,6% (art. 3).

Read the detailed description

WHAT CAUSES ANXIETY IN PREGNANT WOMEN

Anxiety during pregnancy may expose the woman to a higher risk of a negative outcome in four different fields:

Fetal obstetric outcomes; 2. Neonatal outcomes; 3. Child development; 4. Risk to the woman.
The anxiety in pregnant woman may expose the fetus to a higher risk of spontaneous early labor, preterm delivery, lower birth weight, fetal distress, fetal growth restriction, risk for spontaneous abortion, risk of pre-eclampsia and for operative/instrumental deliveries. Furthermore could be a major risk for the uterine artery to have high resistance that could reduce blood flow to the fetus.
The neonates that had a mother with anxiety issues during pregnancy may have an higher risk of admission to neonatal ICU, have a lower Apgar score and small head circumference, growth retardation, slowed mental development and excessive crying, irritability, hostility and erratic sleep. The mother anxiety could also increase the possibility to have colic in the neonatal age.
On the other hand the maternity anxiety could have long-term negative effects on the child development. There are risks of negative effect on maternal-infant bonding, difficult with affect regulations, cognitive delays, behavioral and emotional difficulties, maladaptive and social interactions, cognitive delays, behavioral and emotional difficulties and maladaptive social interactions. Furthermore, the child could develop a major level of fear and anxiety during life, an insecure and disorganized attachment and lower IQ at age 15-15 years. Anxiety of the mothers during pregnancy could cause a non-optimal neuromotorial development of the child, a research demonstrated an association between the anxiety of the mother in late pregnancy and the infant behavior, his emotional problems and his difficult temperament during later infancy. To demonstrated the correlation between anxiety and negative outcomes during childhood a Belgian/Dutch study showed that the 14-15 years old person that had a mother with anxiety disorders reveals a major risk of impulsivity and cognitive disorders. Another study demonstrated the connection between antenatal anxiety and behavioral/emotional problems of a four years old child. Another probable negative outcome of the pregnant anxiety is the asthma during childhood. A study demonstrated that the baby with a anxious mother has an higher risk to the use of antibiotic, to have respiratory and skin illnesses in the first year of the life than the child born from a mother without anxiety disorder.
It is very important underline to that anxiety during pregnancy has a negative effect not only on the fetus and child but also on the mother as well. Many researches demonstrated a link between prenatal anxiety and postpartum depression, psychiatric complications, and a higher risk of preeclampsia. In addition, the mother suffering of anxiety requires more examination from an obstetrician and most of all require an elective caesarean section. Other negative outcomes are poor nutrition, impaired self-care of the mother, failure to follow medical and prenatal guidelines, and major exposure to use alcohol, drugs and tobacco.

INTERNET INFORMATION In 2004 the 4,5% of the researches of internet were about medical information and, in 2009, the 61% of adult Internet users in the United States searched for health-related information. The Internet allows people to have an immediately health information and also pregnant woman search information about pregnancy and connected problems. For example women affected with nausea and vomiting during early pregnancy search online how this problem could be treated. On the other hand, not all information available on the Internet are regulated, nor are always reliable or current.

Conditions: Pregnant Women in All Gestational Ages Hospitalized for a Problem of Pregnancy
Being tested: At the first day of hospitalization the field investigator will submit to pregnant women in a pathological condition five questionnaires
Keywords: pregnant, gestational ages, hospitalized, problem of pregnancy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

At the first day of hospitalization the field investigator will submit to pregnant women in a pathological condition five questionnairesOther
Some of these questionnaires will have to be completed every day and others every other day:
1. The Internet questionnaire is divided in two parts. The first one investigates the use of internet at home and it will be administered only once, the second part will investigate the internet use at the hospital, in the case the women have a personal smartphone, tablet or personal computer (they are the owners) and it will be administered every other days.
2. The questionnaire is aimed to understand the quality of life (EQ-5D) will be administered only once, at the beginning of the hospitalization.
3. The STAI questionnaire is divided in to parts, the first part aims to determinate the state anxiety and it will be administered every other day, while the second part will discuss the anxiety itself, and has to completed only once.
4. The short questionnaire on critical events occurring during the day,
5. The short questionnaire with obstetric anamnesis.

Study groups in NCT02601261
Study group	Role	What they receive
Patients with some access to internet during stay		Not described Receives: Other: At the first day of hospitalization the field investigator will submit to pregnant women in a pathological condition five questionnaires
Patients without access to internet during stay		Not described Receives: Other: At the first day of hospitalization the field investigator will submit to pregnant women in a pathological condition five questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

The association between the use of Internet and the level of anxiety in pregnant hospitalized women.
During the first day of hospitalization, the field investigator administers to every patient participating to the study all five questionnaires and on each questionnaire, it will be indicated the day when it has been completed.
The study measures the level of state anxiety in hospitalized women with pathological pregnancy, influenced by internet use. The STAI questionnaire that evaluate the level of anxiety, is divided in to parts: the first part aims to determinate the state anxiety and it will be administered every other day, while the second part will discuss the anxiety itself, and has to completed only once.
Measured: 10 days

Secondary outcomes (3)

Using STAI questionnaire to evaluate how the level of anxiety changes during the hospitalization, in women with pathological pregnancy.
Measured: 10 days
Using Internet questionnaire to determinate the type of health information pregnant women are seeking online during and before the hospitalization and the number of them
Measured: 10 days
STAI questionnaire and Internet questionnaire used to compare the anxiety levels and the access to online health information between different subcategories: women having internet access during hospitalization and those who have not.
Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201531 Dec 2016

First posted10 Nov 2015 (estimated)
Study start1 Aug 2015
Primary completion31 Mar 2016
Study completion31 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Pregnant Women in All Gestational Ages Hospitalized for a Problem of PregnancyStudies 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: Observational
Observational model: Case-control
Time perspective: Cross-sectional
Enrolment: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02601261
Sponsor's protocol ID: HAWAII
Acronym: HAWAII
Status last verified: Apr 2021
First submitted: 29 Oct 2015
Last updated: 28 Apr 2021
Results posted: No
Data monitoring committee: No

Publications

Rubertsson C, Hellstrom J, Cross M, Sydsjo G. Anxiety in early pregnancy: prevalence and contributing factors. Arch Womens Ment Health. 2014 Jun;17(3):221-8. doi: 10.1007/s00737-013-0409-0. Epub 2014 Jan 18.
PubMed 24442712
van Batenburg-Eddes T, de Groot L, Huizink AC, Steegers EA, Hofman A, Jaddoe VW, Verhulst FC, Tiemeier H. Maternal symptoms of anxiety during pregnancy affect infant neuromotor development: the generation R study. Dev Neuropsychol. 2009;34(4):476-93. doi: 10.1080/87565640902964508.
PubMed 20183712
Field T, Diego M, Hernandez-Reif M, Figueiredo B, Deeds O, Ascencio A, Schanberg S, Kuhn C. Comorbid depression and anxiety effects on pregnancy and neonatal outcome. Infant Behav Dev. 2010 Feb;33(1):23-9. doi: 10.1016/j.infbeh.2009.10.004. Epub 2009 Nov 27.
PubMed 19945170
Fishell A. Depression and anxiety in pregnancy. J Popul Ther Clin Pharmacol. 2010 Fall;17(3):e363-9. Epub 2010 Oct 26.
PubMed 21041870
O'Connor TG, Heron J, Golding J, Beveridge M, Glover V. Maternal antenatal anxiety and children's behavioural/emotional problems at 4 years. Report from the Avon Longitudinal Study of Parents and Children. Br J Psychiatry. 2002 Jun;180:502-8. doi: 10.1192/bjp.180.6.502.
PubMed 12042228
Austin MP, Hadzi-Pavlovic D, Leader L, Saint K, Parker G. Maternal trait anxiety, depression and life event stress in pregnancy: relationships with infant temperament. Early Hum Dev. 2005 Feb;81(2):183-90. doi: 10.1016/j.earlhumdev.2004.07.001.
PubMed 15748973
Van den Bergh BR, Marcoen A. High antenatal maternal anxiety is related to ADHD symptoms, externalizing problems, and anxiety in 8- and 9-year-olds. Child Dev. 2004 Jul-Aug;75(4):1085-97. doi: 10.1111/j.1467-8624.2004.00727.x.
PubMed 15260866
O'Connor TG. Annotation: The 'effects' of parenting reconsidered: findings, challenges, and applications. J Child Psychol Psychiatry. 2002 Jul;43(5):555-72. doi: 10.1111/1469-7610.00046.
PubMed 12120853
Beijers R, Jansen J, Riksen-Walraven M, de Weerth C. Maternal prenatal anxiety and stress predict infant illnesses and health complaints. Pediatrics. 2010 Aug;126(2):e401-9. doi: 10.1542/peds.2009-3226. Epub 2010 Jul 19.
PubMed 20643724
Gao LL, Larsson M, Luo SY. Internet use by Chinese women seeking pregnancy-related information. Midwifery. 2013 Jul;29(7):730-5. doi: 10.1016/j.midw.2012.07.003. Epub 2012 Sep 5.
PubMed 22958935
Lee AM, Lam SK, Sze Mun Lau SM, Chong CS, Chui HW, Fong DY. Prevalence, course, and risk factors for antenatal anxiety and depression. Obstet Gynecol. 2007 Nov;110(5):1102-12. doi: 10.1097/01.AOG.0000287065.59491.70.
PubMed 17978126
Julian LJ. Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety and Depression Scale-Anxiety (HADS-A). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S467-72. doi: 10.1002/acr.20561. No abstract available.
PubMed 22588767
Minto C, Bauce B, Calore C, Rigato I, Folino F, Soriani N, Hochdorn A, Iliceto S, Gregori D. Is Internet use associated with anxiety in patients with and at risk for cardiomyopathy? Am Heart J. 2015 Jul;170(1):87-95, 95.e1-4. doi: 10.1016/j.ahj.2015.02.024. Epub 2015 Apr 9.
PubMed 26093868
Ibanez G, Charles MA, Forhan A, Magnin G, Thiebaugeorges O, Kaminski M, Saurel-Cubizolles MJ; EDEN Mother-Child Cohort Study Group. Depression and anxiety in women during pregnancy and neonatal outcome: data from the EDEN mother-child cohort. Early Hum Dev. 2012 Aug;88(8):643-9. doi: 10.1016/j.earlhumdev.2012.01.014. Epub 2012 Feb 22.
PubMed 22361259

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: How Anxiety in Pregnant Hospitalized Women Change wIth Internet Use
ClinicalTrials.gov ID: NCT02601261
Acronym / sponsor ID: HAWAII / HAWAII
Conditions: Pregnant Women in All Gestational Ages Hospitalized for a Problem of Pregnancy
Keywords: pregnant, gestational ages, hospitalized, problem of pregnancy
Study type: Observational
Recruitment status: Completed
Enrolment: 105 participants (actual)
Lead sponsor: University of PadovaUniversity, hospital or other
Collaborators: Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy, Azienda Per I Servizi Sanitari N. 6 Friuli Occidentale
Study start: 1 Aug 2015 (actual)
Primary completion: 31 Mar 2016 (actual)
Study completion: 31 Dec 2016 (actual)
First posted: 10 Nov 2015 (estimated)
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.

Investigating the influence of Internet use to the level of state anxiety in hospitalized women with pathological pregnancy.

Detailed description

WHAT CAUSES ANXIETY IN PREGNANT WOMEN

Anxiety during pregnancy may expose the woman to a higher risk of a negative outcome in four different fields:

Fetal obstetric outcomes; 2. Neonatal outcomes; 3. Child development; 4. Risk to the woman.
The anxiety in pregnant woman may expose the fetus to a higher risk of spontaneous early labor, preterm delivery, lower birth weight, fetal distress, fetal growth restriction, risk for spontaneous abortion, risk of pre-eclampsia and for operative/instrumental deliveries. Furthermore could be a major risk for the uterine artery to have high resistance that could reduce blood flow to the fetus.
The neonates that had a mother with anxiety issues during pregnancy may have an higher risk of admission to neonatal ICU, have a lower Apgar score and small head circumference, growth retardation, slowed mental development and excessive crying, irritability, hostility and erratic sleep. The mother anxiety could also increase the possibility to have colic in the neonatal age.
On the other hand the maternity anxiety could have long-term negative effects on the child development. There are risks of negative effect on maternal-infant bonding, difficult with affect regulations, cognitive delays, behavioral and emotional difficulties, maladaptive and social interactions, cognitive delays, behavioral and emotional difficulties and maladaptive social interactions. Furthermore, the child could develop a major level of fear and anxiety during life, an insecure and disorganized attachment and lower IQ at age 15-15 years. Anxiety of the mothers during pregnancy could cause a non-optimal neuromotorial development of the child, a research demonstrated an association between the anxiety of the mother in late pregnancy and the infant behavior, his emotional problems and his difficult temperament during later infancy. To demonstrated the correlation between anxiety and negative outcomes during childhood a Belgian/Dutch study showed that the 14-15 years old person that had a mother with anxiety disorders reveals a major risk of impulsivity and cognitive disorders. Another study demonstrated the connection between antenatal anxiety and behavioral/emotional problems of a four years old child. Another probable negative outcome of the pregnant anxiety is the asthma during childhood. A study demonstrated that the baby with a anxious mother has an higher risk to the use of antibiotic, to have respiratory and skin illnesses in the first year of the life than the child born from a mother without anxiety disorder.
It is very important underline to that anxiety during pregnancy has a negative effect not only on the fetus and child but also on the mother as well. Many researches demonstrated a link between prenatal anxiety and postpartum depression, psychiatric complications, and a higher risk of preeclampsia. In addition, the mother suffering of anxiety requires more examination from an obstetrician and most of all require an elective caesarean section. Other negative outcomes are poor nutrition, impaired self-care of the mother, failure to follow medical and prenatal guidelines, and major exposure to use alcohol, drugs and tobacco.

Study design

Observational model: Case-control
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
Patients with some access to internet during stay	–	Other: At the first day of hospitalization the field investigator will submit to pregnant women in a pathological condition five questionnaires
Patients without access to internet during stay	–	Other: At the first day of hospitalization the field investigator will submit to pregnant women in a pathological condition five questionnaires

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: The study has been powered to detect a difference on the average STAI state score (range 20-80) of 6 points between women with some access to internet during stay (at least 10 minutes/days of web browsing, besides e-mails) and those no accessing internet during stay. Assuming a Standard Deviation of the difference in STAI scores of about 8 points (art. 30-art. 33), and assuming that the ratio between the rate of women not using internet and that of women using internet is 0,42 (art. 31-art. 32) for specified alpha = 0.025 and power (1 - beta) of 90.0% a total of 109 women must be recruited (using a two-sample t-test with unknown variance). Data entry will be based on e-CRF running on the REDCAP Clinical Data Management System of the Service for Clinical Trials and Biometrics (Department of Cardiology, Thoracic and Vascular Sciences, University of Padova).

Key inclusion criteria (6 listed)

Italian speaking and reading ability;
Age > 18 years
Been hospitalized for a pathological pregnancy condition;
Having a twin pregnancy;
All gestational ages;

Key exclusion criteria (3 listed)

Been under stressful family events (deaths, recent separation: self-reported)
With a diagnosis of a mental psychiatric diseases;
With a diagnosis of cancer pathology.

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
At the first day of hospitalization the field investigator will submit to pregnant women in a pathological condition five questionnairesSome of these questionnaires will have to be completed every day and others every other day: 1. The Internet questionnaire is divided in two parts. The first one investigates the use of internet at home and it will be administered only once, the second part will investigate the internet use at the hospital, in the case the women have a personal smartphone, tablet or personal computer (they are the owners) and it will be administered every other days. 2. The questionnaire is aimed to understand the quality of life (EQ-5D) will be administered only once, at the beginning of the hospitalization. 3. The STAI questionnaire is divided in to parts, the first part aims to determinate the state anxiety and it will be administered every other day, while the second part will discuss the anxiety itself, and has to completed only once. 4. The short questionnaire on critical events occurring during the day, 5. The short questionnaire with obstetric anamnesis.	Other	Patients with some access to internet during stay, Patients without access to internet during stay

Primary outcome

The association between the use of Internet and the level of anxiety in pregnant hospitalized women.
Time frame: 10 days
During the first day of hospitalization, the field investigator administers to every patient participating to the study all five questionnaires and on each questionnaire, it will be indicated the day when it has been completed. The study measures the level of state anxiety in hospitalized women with pathological pregnancy, influenced by internet use. The STAI questionnaire that evaluate the level of anxiety, is divided in to parts: the first part aims to determinate the state anxiety and it will be administered every other day, while the second part will discuss the anxiety itself, and has to completed only once.

3 secondary outcomes

Using STAI questionnaire to evaluate how the level of anxiety changes during the hospitalization, in women with pathological pregnancy.
Time frame: 10 days
Using Internet questionnaire to determinate the type of health information pregnant women are seeking online during and before the hospitalization and the number of them
Time frame: 10 days
STAI questionnaire and Internet questionnaire used to compare the anxiety levels and the access to online health information between different subcategories: women having internet access during hospitalization and those who have not.
Time frame: 10 days

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 28 Apr 2021.
Background: PubMed 24442712Rubertsson C, Hellstrom J, Cross M, Sydsjo G. Anxiety in early pregnancy: prevalence and contributing factors. Arch Womens Ment Health. 2014 Jun;17(3):221-8. doi: 10.1007/s00737-013-0409-0. Epub 2014 Jan 18.
Background: PubMed 20183712van Batenburg-Eddes T, de Groot L, Huizink AC, Steegers EA, Hofman A, Jaddoe VW, Verhulst FC, Tiemeier H. Maternal symptoms of anxiety during pregnancy affect infant neuromotor development: the generation R study. Dev Neuropsychol. 2009;34(4):476-93. doi: 10.1080/87565640902964508.
Background: PubMed 19945170Field T, Diego M, Hernandez-Reif M, Figueiredo B, Deeds O, Ascencio A, Schanberg S, Kuhn C. Comorbid depression and anxiety effects on pregnancy and neonatal outcome. Infant Behav Dev. 2010 Feb;33(1):23-9. doi: 10.1016/j.infbeh.2009.10.004. Epub 2009 Nov 27.
Background: PubMed 21041870Fishell A. Depression and anxiety in pregnancy. J Popul Ther Clin Pharmacol. 2010 Fall;17(3):e363-9. Epub 2010 Oct 26.
Background: PubMed 12042228O'Connor TG, Heron J, Golding J, Beveridge M, Glover V. Maternal antenatal anxiety and children's behavioural/emotional problems at 4 years. Report from the Avon Longitudinal Study of Parents and Children. Br J Psychiatry. 2002 Jun;180:502-8. doi: 10.1192/bjp.180.6.502.
Background: PubMed 15748973Austin MP, Hadzi-Pavlovic D, Leader L, Saint K, Parker G. Maternal trait anxiety, depression and life event stress in pregnancy: relationships with infant temperament. Early Hum Dev. 2005 Feb;81(2):183-90. doi: 10.1016/j.earlhumdev.2004.07.001.
Background: PubMed 15260866Van den Bergh BR, Marcoen A. High antenatal maternal anxiety is related to ADHD symptoms, externalizing problems, and anxiety in 8- and 9-year-olds. Child Dev. 2004 Jul-Aug;75(4):1085-97. doi: 10.1111/j.1467-8624.2004.00727.x.
Background: PubMed 12120853O'Connor TG. Annotation: The 'effects' of parenting reconsidered: findings, challenges, and applications. J Child Psychol Psychiatry. 2002 Jul;43(5):555-72. doi: 10.1111/1469-7610.00046.
Background: PubMed 20643724Beijers R, Jansen J, Riksen-Walraven M, de Weerth C. Maternal prenatal anxiety and stress predict infant illnesses and health complaints. Pediatrics. 2010 Aug;126(2):e401-9. doi: 10.1542/peds.2009-3226. Epub 2010 Jul 19.
Background: PubMed 22958935Gao LL, Larsson M, Luo SY. Internet use by Chinese women seeking pregnancy-related information. Midwifery. 2013 Jul;29(7):730-5. doi: 10.1016/j.midw.2012.07.003. Epub 2012 Sep 5.
Background: PubMed 17978126Lee AM, Lam SK, Sze Mun Lau SM, Chong CS, Chui HW, Fong DY. Prevalence, course, and risk factors for antenatal anxiety and depression. Obstet Gynecol. 2007 Nov;110(5):1102-12. doi: 10.1097/01.AOG.0000287065.59491.70.
Background: PubMed 22588767Julian LJ. Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety and Depression Scale-Anxiety (HADS-A). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S467-72. doi: 10.1002/acr.20561. No abstract available.

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnant Women in All Gestational Ages Hospitalized for a Problem of Pregnancy, run by University of Padova.

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 6 inclusion and 3 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 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

The association between the use of Internet and the level of anxiety in pregnant hospitalized women. (time frame: 10 days). 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 NCT02601261, which also lists 14 linked publications.

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 28 Apr 2021.