Childbirth ClassesNCT06184087
Childbirth Education on Upright Positions Mobility During Labor
A study testing Educational/Instructional in people with Childbirth Classes, run by Tel Aviv University at 1 site in Israel.
Trial summary
Background and study aims: A prospective quasi-experimental study will be conducted among nulliparous women from the ultra-orthodox Jewish community. Study design: While the control group participated in routine childbirth education, the intervention group learned with childbirth education that included interactive… Read more about this study
- Who is it for?
- Ages Up to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Childbirth Classes
- What is being tested?
- Educational/Instructional
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteIsrael
- Study dates
- 21 Nov 2020to 1 Mar 2023
- 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 Up to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Nulliparous women
Who cannot join
- High-risk pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Childbirth Education on Upright Positions and Mobility During Labor
Background and study aims: A prospective quasi-experimental study will be conducted among nulliparous women from the ultra-orthodox Jewish community.
Study design: While the control group participated in routine childbirth education, the intervention group learned with childbirth education that included interactive and constructive cognitive engagement activities. Participants in both groups completed a set of questionnaires regarding knowledge, attitudes, and self-efficacy.
Read the detailed description
Background: Upright labor positions and movement during labor have a positive effect on childbirth, yet the predominant labor positions are still horizontal. Therefore, it is important to explore how it is possible to improve childbirth education, particularly its instructional design, to strengthen women's self-efficacy toward the use of upright positions and mobility during labor. The aim of the study was to evaluate the impact of an instructional approach based on a cognitive engagement ICAP (Interactive, Constructive, Active, Passive) framework on the development of knowledge, attitudes, and self-efficacy expectations toward upright positions and mobility during labor.
Methods: A prospective quasi-experimental study was conducted among nulliparous women from the ultra-orthodox Jewish community (n=74). While the control group (n = 34) participated in routine childbirth education, the intervention group (n = 36) learned with childbirth education that included interactive and constructive cognitive engagement activities. Participants in both groups completed a set of questionnaires regarding knowledge, attitudes, and self-efficacy.
- Conditions
- Childbirth Classes
- Being tested
- Educational/Instructional
- Keywords
- childbirth education, upright positions, mobility during labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational/InstructionalOther
ICAP constructive-interactive engagement mode
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | The control group (n = 34) participated in routine childbirth education. The group received the same content via a childbirth class as the intervention group of five meetings (a total of 12.5 hours) given by a nurse midwife.
Women in the control group received a routine instructional approach which was based on lectures, videos, discussions, and practice/rehearsals. Receives: Other: Educational/Instructional |
| Intervention group | Experimental | The intervention group (n= 36) learned with childbirth education that included interactive and constructive cognitive engagement activities.
The intervention group received the same content as the control group (a total of 12.5 hours), however, the content regarding upright positions and mobility was instructed using the ICAP constructive-interactive engagement modes. Receives: Other: Educational/Instructional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy toward upright positions and mobility during labor
The Childbirth Self-Efficacy Inventory that was developed by Lowe (2000).The participants were asked to rank on a 1-10 Likert scale 18 listed behaviors for how much they can help to cope with labor.
Measured: The questionnaire was administered at the beginning of the childbirth course and again at the end of the fifth meeting of the childbirth course.
Secondary outcomes (2)
Attitudes towards upright positions and mobility during labor
Questionnaire that was constructed according to Ajzen (1991) which defines attitudes as the positive or negative evaluation of certain behavior. The questionnaire includes 6 items; the participants are asked to rank their attitudes on a seven-point Osgood differential semantic scale, where 1 represents negative attitudes, and 7 represents positive attitudes. Higher score means a stronger attitude toward upright positions and mobility during labor.
Measured: The questionnaire was administered at the beginning of the childbirth course and again at the end of the fifth meeting of the childbirth course.
Knowledge about positions and mobility during labor
Knowledge questionnaire about labor positions and mobility was developed and validated by the authors.
Measured: The questionnaire was administered at the beginning of the childbirth course and again at the end of the fifth meeting of the childbirth course.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start21 Nov 2020
- Primary completion1 Mar 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childbirth ClassesStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- A prospective quasi-experimental study
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Collaborators
- Hana Borrer
- Responsible party
- Principal investigator, Ilana Dubovi, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184087
- Sponsor's protocol ID
- TelAvivU_Childbirth education
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will be provided upon request
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childbirth Education on Upright Positions and Mobility During Labor
- ClinicalTrials.gov ID
- NCT06184087
- Acronym / sponsor ID
- TelAvivU_Childbirth education
- Conditions
- Childbirth Classes
- Keywords
- childbirth education, upright positions, mobility during labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Collaborators
- Hana Borrer
- Study start
- 21 Nov 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 28 Dec 2023 (actual)
- 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.
Background and study aims: A prospective quasi-experimental study will be conducted among nulliparous women from the ultra-orthodox Jewish community.
Study design: While the control group participated in routine childbirth education, the intervention group learned with childbirth education that included interactive and constructive cognitive engagement activities. Participants in both groups completed a set of questionnaires regarding knowledge, attitudes, and self-efficacy.
Detailed description
Background: Upright labor positions and movement during labor have a positive effect on childbirth, yet the predominant labor positions are still horizontal. Therefore, it is important to explore how it is possible to improve childbirth education, particularly its instructional design, to strengthen women's self-efficacy toward the use of upright positions and mobility during labor. The aim of the study was to evaluate the impact of an instructional approach based on a cognitive engagement ICAP (Interactive, Constructive, Active, Passive) framework on the development of knowledge, attitudes, and self-efficacy expectations toward upright positions and mobility during labor.
Methods: A prospective quasi-experimental study was conducted among nulliparous women from the ultra-orthodox Jewish community (n=74). While the control group (n = 34) participated in routine childbirth education, the intervention group (n = 36) learned with childbirth education that included interactive and constructive cognitive engagement activities. Participants in both groups completed a set of questionnaires regarding knowledge, attitudes, and self-efficacy.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective quasi-experimental study
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Other: Educational/InstructionalThe control group (n = 34) participated in routine childbirth education. The group received the same content via a childbirth class as the intervention group of five meetings (a total of 12.5 hours) given by a nurse midwife. Women in the control group received a routine instructional approach which was based on lectures, videos, discussions, and practice/rehearsals. |
| Intervention group | Experimental | Other: Educational/InstructionalThe intervention group (n= 36) learned with childbirth education that included interactive and constructive cognitive engagement activities. The intervention group received the same content as the control group (a total of 12.5 hours), however, the content regarding upright positions and mobility was instructed using the ICAP constructive-interactive engagement modes. |
Who may qualify
- Ages
- Up to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Nulliparous women
Key exclusion criteria (1 listed)
- High-risk pregnancy
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 |
|---|---|---|
| Educational/InstructionalICAP constructive-interactive engagement mode | Other | Control group, Intervention group |
Primary outcome
Self-efficacy toward upright positions and mobility during labor
Time frame: The questionnaire was administered at the beginning of the childbirth course and again at the end of the fifth meeting of the childbirth course.
The Childbirth Self-Efficacy Inventory that was developed by Lowe (2000).The participants were asked to rank on a 1-10 Likert scale 18 listed behaviors for how much they can help to cope with labor.
2 secondary outcomes
Attitudes towards upright positions and mobility during labor
Time frame: The questionnaire was administered at the beginning of the childbirth course and again at the end of the fifth meeting of the childbirth course.
Knowledge about positions and mobility during labor
Time frame: The questionnaire was administered at the beginning of the childbirth course and again at the end of the fifth meeting of the childbirth course.
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 Dec 2023.
- Individual participant dataSharing planned: Undecided. Will be provided upon request
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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 Educational/Instructional in people with Childbirth Classes, run by Tel Aviv University 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 1 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 28 Dec 2023. 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?
Self-efficacy toward upright positions and mobility during labor (time frame: The questionnaire was administered at the beginning of the childbirth course and again at the end of the fifth meeting of the childbirth course.). 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 28 Dec 2023.