Comparison of Group Guidance to Routine Care for Pregnant Women at Low Risk

NCT02476214 | Completed DMC

• 1 other identifier: 006/2015ק
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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 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:

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

Conditions

Prenatal Care

Keywords

group prenatal care, group guidance

Outcome Measures

Primary Outcomes (6)

• Care satisfaction

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

  9 months

• Care satisfaction

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

  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).

  9 months

• Adherence to medical recommendations

  compliance for recommended prenatal care screening tests

  9 months

• Breastfeeding rates

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

  9 months

• Readiness for labor and delivery questionnaire

  women's feeling of readiness for delivery

  9 months

Secondary Outcomes (3)

• Birth weight

  9 months

• Birth week

  9 months

• Health behaviors during pregnancy

  9 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Group prenatal care- receiving prenatal care through a group

Behavioral: group prenatal care

Control group

NO INTERVENTION

Individual prenatal care - receiving regular individual prenatal care

Interventions

group prenatal care BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women undergoing prenatal care in Maternal and Child Clinics that are a part of the trial
• Age 18+
• Women who speak and understand Hebrew

You may not qualify if:

• High risk pregnancies by criteria of Israeli Ministry of Health guidelines

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Clalit Health service

Beersheba, Israel

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: June 19, 2015
• Study Start: July 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: March 1, 2018
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

IL (1)