Mother (Person)NCT01524419
Women's Involvement In Decision Making At Labor And Its Effect on Their Perceived Labor Process
An observational study of Mother (Person), run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
1. Increased women's involvement in decision making at labor process correlates with a positive perception of the labor process. 2. Increased maternal satisfaction with midwifery and gynecological care at labor correlates with a more positive perception of the labor process. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mother (Person)
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2012to Aug 2012
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: women after vaginal birth at term with no mechanical or surgical intervention and with no maternal or fetal complications
Who may be able to join
- Vaginal labor
- At term
- Hebrew/Arabic speakers
Who cannot join
- Mechanical or surgical intervention
- Maternal or fetal complications
Trial locations and contacts
1 site in 1 country.
Israel1 site
Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center
Hadera, Israel
Mordechai Hallak, M.D, Prof., 972-4-6304244, mottih@hy.health.gov.il
Merav Amos Chen, BA, 972-4-6276764, meravy30@gmail.com
About this study
- Increased women's involvement in decision making at labor process correlates with a positive perception of the labor process.
- Increased maternal satisfaction with midwifery and gynecological care at labor correlates with a more positive perception of the labor process.
Read the detailed description
The Interrelationship Between Women's Involvement In Decision Making In Labor And Their Perception Of The Labor Experience Labor is one of the most significant events in women's lives. The process and outcome of labor may have long term effects on the way women perceive the parenting role and their personal, emotional and physical capability. Each woman arrives to labor with a planned construct of beliefs, expectations and fantasies regarding the labor process and outcomes, which are driven from different cultural values and personal beliefs. The clinical reality does not always correlate with this emotional construct and with a woman's anticipated level of involvement in decision making at labor. Discrepancy between women's desired or expected labor processes and what happens in actuality may have a substantial impact on women's lives and on the way they will experience future births. The main goal of this research is to investigate the effects of labor process on women by examining the question whether women's involvement in decision making during labor has an effect on their perceived labor process.
The perceived labor process is a combination of a woman's level of engagement in decision making at labor, her perceived level of control in the labor process and the level of satisfaction from the obstetric caregivers (gynecologists and midwives). The participants of this research project shall be comprised of 100 women who were hospitalized during the two days immediately following labor and delivery in the maternity unit at Hillel Yaffe hospital, who gave birth in a normal delivery, at term (37 weeks of gestation) with no surgical or instrumental intervention and had no complications either to them or their babies. The participants will be given a self-replying questionnaire constructed especially for the purposes of this research project. The questionnaire is comprised of seven parts: (1) social-demographic information,(2) health background,(3) obstetric background,(4) the woman's perspective of labor process in general,(5) the woman's perspective of the progression of her actual labor,(6) the woman's evaluation of the attitude of obstetric caregivers (gynecologists and midwives) and (7) the level of control the woman had in decision making during labor and her perception of the labor experience. The research findings will be analyzed statistically using Statistical Package for the Social Sciences (SPSS) format. In addition to understanding the way women perceive their labor and delivery in terms of the level of involvement in decision making, these findings may also contribute to develop a therapeutic intervention tool to assist accommodating specific treatment to women in labor and childbirth according to the level of her desired involvement in decision making at birth, her viewpoint of therapeutic intervention and her expectations of the labor process.
- Conditions
- Mother (Person)
- Keywords
- spontaneous labor, term, surgical, mechanical, fetal or maternal complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| women after vaginal birth | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mother (Person)Studies 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
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Merav Amos Chen, BA, Study director, Hillel Yaffe Medical CenterMordechai Hallak, prof, Principal investigator, Hillel Yaffe Medical CenterElad Mei-Dan, dr, Study director, Hillel Yaffe Medical CenterMally ehrenfeld, prof, Study director, University of Tel-AvivTammy Schifter, dr, Study director, University of Tel-Aviv
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524419
- Sponsor's protocol ID
- 0004-12-HYMC
- Status last verified
- Jan 2012
- First submitted
- 25 Jan 2012
- Last updated
- 3 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's Involvement In Decision Making At Labor And Its Effect on Their Perceived Labor Process
- ClinicalTrials.gov ID
- NCT01524419
- Acronym / sponsor ID
- 0004-12-HYMC
- Conditions
- Mother (Person)
- Keywords
- spontaneous labor, term, surgical, mechanical, fetal or maternal complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Mar 2012
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 2 Feb 2012 (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.
- Increased women's involvement in decision making at labor process correlates with a positive perception of the labor process.
- Increased maternal satisfaction with midwifery and gynecological care at labor correlates with a more positive perception of the labor process.
Detailed description
The Interrelationship Between Women's Involvement In Decision Making In Labor And Their Perception Of The Labor Experience Labor is one of the most significant events in women's lives. The process and outcome of labor may have long term effects on the way women perceive the parenting role and their personal, emotional and physical capability. Each woman arrives to labor with a planned construct of beliefs, expectations and fantasies regarding the labor process and outcomes, which are driven from different cultural values and personal beliefs. The clinical reality does not always correlate with this emotional construct and with a woman's anticipated level of involvement in decision making at labor. Discrepancy between women's desired or expected labor processes and what happens in actuality may have a substantial impact on women's lives and on the way they will experience future births. The main goal of this research is to investigate the effects of labor process on women by examining the question whether women's involvement in decision making during labor has an effect on their perceived labor process.
The perceived labor process is a combination of a woman's level of engagement in decision making at labor, her perceived level of control in the labor process and the level of satisfaction from the obstetric caregivers (gynecologists and midwives). The participants of this research project shall be comprised of 100 women who were hospitalized during the two days immediately following labor and delivery in the maternity unit at Hillel Yaffe hospital, who gave birth in a normal delivery, at term (37 weeks of gestation) with no surgical or instrumental intervention and had no complications either to them or their babies. The participants will be given a self-replying questionnaire constructed especially for the purposes of this research project. The questionnaire is comprised of seven parts: (1) social-demographic information,(2) health background,(3) obstetric background,(4) the woman's perspective of labor process in general,(5) the woman's perspective of the progression of her actual labor,(6) the woman's evaluation of the attitude of obstetric caregivers (gynecologists and midwives) and (7) the level of control the woman had in decision making during labor and her perception of the labor experience. The research findings will be analyzed statistically using Statistical Package for the Social Sciences (SPSS) format. In addition to understanding the way women perceive their labor and delivery in terms of the level of involvement in decision making, these findings may also contribute to develop a therapeutic intervention tool to assist accommodating specific treatment to women in labor and childbirth according to the level of her desired involvement in decision making at birth, her viewpoint of therapeutic intervention and her expectations of the labor process.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women after vaginal birth | – | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- women after vaginal birth at term with no mechanical or surgical intervention and with no maternal or fetal complications
Key inclusion criteria (3 listed)
- Vaginal labor
- At term
- Hebrew/Arabic speakers
Key exclusion criteria (2 listed)
- Mechanical or surgical intervention
- Maternal or fetal complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2012.
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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.
Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center
Hadera, Israel
Merav Amos Chen, BA study director
Hillel Yaffe Medical Center
Mordechai Hallak, prof principal investigator
Hillel Yaffe Medical Center
Elad Mei-Dan, dr study director
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mother (Person), run by Hillel Yaffe 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 2 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: status not confirmed, as of the sponsor's last update on 3 May 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 3 May 2012; AzTrials last refreshed its copy on 6 Nov 2026.