Prenatal CareNCT02476214
Comparison of Group Guidance to Routine Care for Pregnant Women at Low Risk
A study testing group prenatal care in people with Prenatal Care, run by Meir Medical Center at 1 site in Israel.
Trial summary
Prenatal care is defined as pregnancy-related health care services provided to a women between conception and delivery. Early, comprehensive prenatal care can promote healthier pregnancies and can reduce the risk of some adverse birth outcomes by detecting and managing preexisting medical conditions, by providing… 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
- Prenatal Care
- What is being tested?
- group prenatal care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2015to Mar 2018
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women undergoing prenatal care in Maternal and Child Clinics that are a part of the trial
- Age 18+
- Women who speak and understand Hebrew
Who cannot join
- High risk pregnancies by criteria of Israeli Ministry of Health guidelines
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Prenatal Care With Group Guidance to Routine Care for Pregnant Women at Low Risk in Maternal and Child Health Clinics
Prenatal care is defined as pregnancy-related health care services provided to a women between conception and delivery. Early, comprehensive prenatal care can promote healthier pregnancies and can reduce the risk of some adverse birth outcomes by detecting and managing preexisting medical conditions, by providing health behavior advice, and by offering a gateway into the health care system for socially disadvantaged women . The customary approach for prenatal care includes routine individual care, which is provided by nurses and physicians in healthcare clinics and hospitals. Since 1995, citizens of Israel, have been entitled to health care services according to the National Health Insurance Law . Israeli citizens are covered by National Health Insurance, and get maternal and child preventive services including prenatal care by local Mother and Child Health Clinics . The prenatal care is individual. A nurse meets with every registered pregnant women, assess the medical and emotional condition and provide guidance related to the pregnancy week of the woman.
Since the 70, a number of group prenatal care intervention programs are described in the literature. Group prenatal care is designed to answer the recommended content for prenatal care for improving the quality of care and resulting in improved pregnancy outcome . The group prenatal care includes three important components: risk assessment. Guidance and support and combines them into the prenatal care22. Creation of the group provides a meeting place for pregnant women. A safe place for sharing and learning from each other and to build a community for mutual support .
Read more
The investigators hypothesize that, relative to women who receive standard individual prenatal care, the women who receive group prenatal care will be more likely to:
- Report higher levels of satisfaction. The investigators also anticipate higher levels of staff satisfaction within the intervention group medical staff.
- Higher levels of knowledge about pregnancy related issues (e.g., health behaviors during pregnancy, tests during pregnancy).
- Higher levels of compliance for recommended prenatal care screening tests (e.g., GCT, first and second trimester screening, US)
- have better perinatal outcomes: better health behaviors during pregnancy (e.g., nutrition, physical activity ext.'), better birth outcomes (e.g., preterm labor, low birthweight,), and better postpartum indicators (e.g., increased breastfeeding);
Read the detailed description
Prenatal care is defined as pregnancy-related health care services provided to a women between conception and delivery. Early, comprehensive prenatal care can promote healthier pregnancies and can reduce the risk of some adverse birth outcomes by detecting and managing preexisting medical conditions, by providing health behavior advice, and by offering a gateway into the health care system for socially disadvantaged women .
Since 1995, citizens of Israel, have been entitled to health care services according to the National Health Insurance Law . Israeli citizens are covered by National Health Insurance, and get maternal and child preventive services including prenatal care by local Mother and Child Health Clinics . The prenatal care is individual. A nurse meets with every registered pregnant women, assess the medical and emotional condition and provide guidance related to the pregnancy week of the woman. Since the 70', a number of group prenatal care intervention programs are described in the literature. Group prenatal care is designed to answer the recommended content for prenatal care for improving the quality of care and resulting in improved pregnancy outcome . The group prenatal care includes three important components: risk assessment. Guidance and support and combines them into the prenatal care22. Creation of the group provides a meeting place for pregnant women. A safe place for sharing and learning from each other and to build a community for mutual support . In our study, we would like to evaluate feasibility and effectiveness of group Prenatal Care for low risk pregnancies. We hypothesize that, relative to women who receive standard individual prenatal care, the women who receive group prenatal care will be more likely to:
- Report higher levels of satisfaction. We also anticipate higher levels of staff satisfaction within the intervention group medical staff.
- Higher levels of knowledge about pregnancy related issues (e.g., health behaviors during pregnancy, tests during pregnancy).
- Higher levels of compliance for recommended prenatal care screening tests (e.g., GCT, first and second trimester screening, US)
- have better perinatal outcomes: better health behaviors during pregnancy (e.g., nutrition, physical activity ext.'), better birth outcomes (e.g., preterm labor, low birthweight,), and better postpartum indicators (e.g., increased breastfeeding); The study is an open non-randomized community trial and will include 291 women. 73 of the participants will be in the intervention group. Women who are at high risk pregnancy, under 18 years old or does not speak Hebrew will be excluded. Every women that will arrive to an OBGYN for the first time in the pregnancy, would be asked to join the study. The women who agrees, will be offered either group prenatal care or individual routine prenatal care, depends on their gestational age and the optional group's gestational age. The women can also refuse to be in a group but still be in the control group, if she chooses to. For both arms, data will be collected thru questioners that will be answered at the beginning and at the end of the prenatal care. Data regarding the birth outcomes will be collected from medical files after birth.
In the intervention group: groups of 8-12 women who are in similar week of pregnancy / due date. The first group session will begin at 12-14 week (depends on gestational age at first OBGYN visit). The group meetings will be held once a month until 28 weeks of pregnancy. From 28 weeks and until the end of pregnancy or 40 weeks, it will be held once every two weeks (according to the Ministry of Health guidelines). The last session will be held approximately 6 weeks after birth. There will be about 10 group sessions. Each session will be around 90 minutes. At the beginning of every group meeting, the nurse will preform a short anamnesis and measures in private, followed by discussion and guidance. At the end of the session, if needed, women can have private time with the nurse.
- Conditions
- Prenatal Care
- Being tested
- group prenatal care
- Keywords
- group prenatal care, group guidance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group prenatal careBehavioural
Intervention group Groups of 8-12 women who are in similar week of pregnancy / due date. The first group session will begin at 12-14 week (depends on gestational age at first OBGYN visit). The group meetings will be held once a month until 28 weeks of pregnancy. From 28 weeks and until the end of pregnancy or 40 weeks, it will be held once every two weeks (according to the Ministry of Health guidelines). The last session will be held approximately 6 weeks after birth.
There will be about 10 group sessions. Each session will be around 90 minutes. At the beginning of every group meeting, the nurse will preform a short anamnesis and measures in private, followed by discussion and guidance. At the end of the session, if needed, women can have private time with the nurse.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Group prenatal care- receiving prenatal care through a group Receives: Behavioral: group prenatal care |
| Control group | No intervention | Individual prenatal care - receiving regular individual prenatal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Care satisfaction
satisfaction form centering care within staff will be assessed by a questionnaire (scale from 1 to 5).
Measured: 9 months
Care satisfaction
satisfaction form centering care within participants, will be assessed by a questionnaire (scale from 1 to 5).
Measured: 9 months
Knowledge
- Levels of knowledge about pregnancy related issues (e.g., health behaviors during pregnancy, tests during pregnancy). will be assessed by a questionnaire (percentage of correct answers).
Measured: 9 months
Adherence to medical recommendations
compliance for recommended prenatal care screening tests
Measured: 9 months
Breastfeeding rates
initiation and duration of breastfeeding (within first 6 weeks after delivery)
Measured: 9 months
Readiness for labor and delivery questionnaire
women's feeling of readiness for delivery
Measured: 9 months
Secondary outcomes (3)
Birth weight
infant weight (in grams) at birth
Measured: 9 months
Birth week
gestational age at birth
Measured: 9 months
Health behaviors during pregnancy
nutrition, physical activity thru the pregnancy, will be assessed by a questionnaire collecting information about behaviors.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prenatal CareStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnon D. Cohen, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476214
- Sponsor's protocol ID
- 006/2015ק
- Status last verified
- Mar 2019
- First submitted
- 30 Apr 2015
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Prenatal Care With Group Guidance to Routine Care for Pregnant Women at Low Risk in Maternal and Child Health Clinics
- ClinicalTrials.gov ID
- NCT02476214
- Acronym / sponsor ID
- 006/2015ק
- Conditions
- Prenatal Care
- Keywords
- group prenatal care, group guidance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 19 Jun 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.
Prenatal care is defined as pregnancy-related health care services provided to a women between conception and delivery. Early, comprehensive prenatal care can promote healthier pregnancies and can reduce the risk of some adverse birth outcomes by detecting and managing preexisting medical conditions, by providing health behavior advice, and by offering a gateway into the health care system for socially disadvantaged women . The customary approach for prenatal care includes routine individual care, which is provided by nurses and physicians in healthcare clinics and hospitals. Since 1995, citizens of Israel, have been entitled to health care services according to the National Health Insurance Law . Israeli citizens are covered by National Health Insurance, and get maternal and child preventive services including prenatal care by local Mother and Child Health Clinics . The prenatal care is individual. A nurse meets with every registered pregnant women, assess the medical and emotional condition and provide guidance related to the pregnancy week of the woman.
Since the 70, a number of group prenatal care intervention programs are described in the literature. Group prenatal care is designed to answer the recommended content for prenatal care for improving the quality of care and resulting in improved pregnancy outcome . The group prenatal care includes three important components: risk assessment. Guidance and support and combines them into the prenatal care22. Creation of the group provides a meeting place for pregnant women. A safe place for sharing and learning from each other and to build a community for mutual support .
The investigators hypothesize that, relative to women who receive standard individual prenatal care, the women who receive group prenatal care will be more likely to:
- Report higher levels of satisfaction. The investigators also anticipate higher levels of staff satisfaction within the intervention group medical staff.
- Higher levels of knowledge about pregnancy related issues (e.g., health behaviors during pregnancy, tests during pregnancy).
- Higher levels of compliance for recommended prenatal care screening tests (e.g., GCT, first and second trimester screening, US)
- have better perinatal outcomes: better health behaviors during pregnancy (e.g., nutrition, physical activity ext.'), better birth outcomes (e.g., preterm labor, low birthweight,), and better postpartum indicators (e.g., increased breastfeeding);
Detailed description
Prenatal care is defined as pregnancy-related health care services provided to a women between conception and delivery. Early, comprehensive prenatal care can promote healthier pregnancies and can reduce the risk of some adverse birth outcomes by detecting and managing preexisting medical conditions, by providing health behavior advice, and by offering a gateway into the health care system for socially disadvantaged women .
Since 1995, citizens of Israel, have been entitled to health care services according to the National Health Insurance Law . Israeli citizens are covered by National Health Insurance, and get maternal and child preventive services including prenatal care by local Mother and Child Health Clinics . The prenatal care is individual. A nurse meets with every registered pregnant women, assess the medical and emotional condition and provide guidance related to the pregnancy week of the woman. Since the 70', a number of group prenatal care intervention programs are described in the literature. Group prenatal care is designed to answer the recommended content for prenatal care for improving the quality of care and resulting in improved pregnancy outcome . The group prenatal care includes three important components: risk assessment. Guidance and support and combines them into the prenatal care22. Creation of the group provides a meeting place for pregnant women. A safe place for sharing and learning from each other and to build a community for mutual support . In our study, we would like to evaluate feasibility and effectiveness of group Prenatal Care for low risk pregnancies. We hypothesize that, relative to women who receive standard individual prenatal care, the women who receive group prenatal care will be more likely to:
- Report higher levels of satisfaction. We also anticipate higher levels of staff satisfaction within the intervention group medical staff.
- Higher levels of knowledge about pregnancy related issues (e.g., health behaviors during pregnancy, tests during pregnancy).
- Higher levels of compliance for recommended prenatal care screening tests (e.g., GCT, first and second trimester screening, US)
- have better perinatal outcomes: better health behaviors during pregnancy (e.g., nutrition, physical activity ext.'), better birth outcomes (e.g., preterm labor, low birthweight,), and better postpartum indicators (e.g., increased breastfeeding); The study is an open non-randomized community trial and will include 291 women. 73 of the participants will be in the intervention group. Women who are at high risk pregnancy, under 18 years old or does not speak Hebrew will be excluded. Every women that will arrive to an OBGYN for the first time in the pregnancy, would be asked to join the study. The women who agrees, will be offered either group prenatal care or individual routine prenatal care, depends on their gestational age and the optional group's gestational age. The women can also refuse to be in a group but still be in the control group, if she chooses to. For both arms, data will be collected thru questioners that will be answered at the beginning and at the end of the prenatal care. Data regarding the birth outcomes will be collected from medical files after birth.
In the intervention group: groups of 8-12 women who are in similar week of pregnancy / due date. The first group session will begin at 12-14 week (depends on gestational age at first OBGYN visit). The group meetings will be held once a month until 28 weeks of pregnancy. From 28 weeks and until the end of pregnancy or 40 weeks, it will be held once every two weeks (according to the Ministry of Health guidelines). The last session will be held approximately 6 weeks after birth. There will be about 10 group sessions. Each session will be around 90 minutes. At the beginning of every group meeting, the nurse will preform a short anamnesis and measures in private, followed by discussion and guidance. At the end of the session, if needed, women can have private time with the nurse.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: group prenatal careGroup prenatal care- receiving prenatal care through a group |
| Control group | No intervention | –Individual prenatal care - receiving regular individual prenatal care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women undergoing prenatal care in Maternal and Child Clinics that are a part of the trial
- Age 18+
- Women who speak and understand Hebrew
Key exclusion criteria (1 listed)
- High risk pregnancies by criteria of Israeli Ministry of Health guidelines
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 |
|---|---|---|
| group prenatal careIntervention group Groups of 8-12 women who are in similar week of pregnancy / due date. The first group session will begin at 12-14 week (depends on gestational age at first OBGYN visit). The group meetings will be held once a month until 28 weeks of pregnancy. From 28 weeks and until the end of pregnancy or 40 weeks, it will be held once every two weeks (according to the Ministry of Health guidelines). The last session will be held approximately 6 weeks after birth. There will be about 10 group sessions. Each session will be around 90 minutes. At the beginning of every group meeting, the nurse will preform a short anamnesis and measures in private, followed by discussion and guidance. At the end of the session, if needed, women can have private time with the nurse. | Behavioural | Intervention group |
Primary outcome
Care satisfaction
Time frame: 9 months
satisfaction form centering care within staff will be assessed by a questionnaire (scale from 1 to 5).
Care satisfaction
Time frame: 9 months
satisfaction form centering care within participants, will be assessed by a questionnaire (scale from 1 to 5).
Knowledge
Time frame: 9 months
- Levels of knowledge about pregnancy related issues (e.g., health behaviors during pregnancy, tests during pregnancy). will be assessed by a questionnaire (percentage of correct answers).
Adherence to medical recommendations
Time frame: 9 months
compliance for recommended prenatal care screening tests
Breastfeeding rates
Time frame: 9 months
initiation and duration of breastfeeding (within first 6 weeks after delivery)
Readiness for labor and delivery questionnaire
Time frame: 9 months
women's feeling of readiness for delivery
3 secondary outcomes
Birth weight
Time frame: 9 months
Birth week
Time frame: 9 months
Health behaviors during pregnancy
Time frame: 9 months
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 13 Mar 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group prenatal care in people with Prenatal Care, run by Meir Medical Center at 1 site in Israel.
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 3 inclusion and 1 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 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Care satisfaction (time frame: 9 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2019.