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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.

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

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
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.

Israel1 site
  • Clalit Health service

    Beersheba

Other trials in Israel

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:

  1. Report higher levels of satisfaction. The investigators also anticipate higher levels of staff satisfaction within the intervention group medical staff.
  2. Higher levels of knowledge about pregnancy related issues (e.g., health behaviors during pregnancy, tests during pregnancy).
  3. Higher levels of compliance for recommended prenatal care screening tests (e.g., GCT, first and second trimester screening, US)
  4. 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:

  1. Report higher levels of satisfaction. We also anticipate higher levels of staff satisfaction within the intervention group medical staff.
  2. Higher levels of knowledge about pregnancy related issues (e.g., health behaviors during pregnancy, tests during pregnancy).
  3. Higher levels of compliance for recommended prenatal care screening tests (e.g., GCT, first and second trimester screening, US)
  4. 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 groups in NCT02476214
Study groupRoleWhat they receive
Intervention groupExperimentalGroup prenatal care- receiving prenatal care through a group
Receives: Behavioral: group prenatal care
Control groupNo interventionIndividual prenatal care - receiving regular individual prenatal care

What is being measured

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

  1. Care satisfaction

    satisfaction form centering care within staff will be assessed by a questionnaire (scale from 1 to 5).

    Measured: 9 months

  2. Care satisfaction

    satisfaction form centering care within participants, will be assessed by a questionnaire (scale from 1 to 5).

    Measured: 9 months

  3. 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

  4. Adherence to medical recommendations

    compliance for recommended prenatal care screening tests

    Measured: 9 months

  5. Breastfeeding rates

    initiation and duration of breastfeeding (within first 6 weeks after delivery)

    Measured: 9 months

  6. Readiness for labor and delivery questionnaire

    women's feeling of readiness for delivery

    Measured: 9 months

Secondary outcomes (3)
  1. Birth weight

    infant weight (in grams) at birth

    Measured: 9 months

  2. Birth week

    gestational age at birth

    Measured: 9 months

  3. 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.

  1. First posted19 Jun 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionAug 2017
  4. Study completionMar 2018

Resources

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)
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

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.

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