PregnancyNCT02929875
The Effect of Educational Intervention on Delivery Type Selection in Pregnant Women at Kermanshah, Iran
A study testing Education based on TPB in people with Pregnancy, run by Ilam University of Medical Sciences.
Trial summary
In an experimental research, 100 nulliparous pregnant women who had referred to health care centers in Kermanshah were randomly selected and after taking Written Informed Consent letter, assigned into case and control groups. instruction based on TPB was provided just for the case group. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Education based on TPB
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Oct 2016
- 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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- consisted of nulliparous pregnant women with the gestational age of 28-36 weeks, women under 35 years old, informed consent of the mother and her husband, and no contraindications for normal childbirth.
Who cannot join
- Included the absence of women in continuous training sessions, premature delivery, and maternal unavailability during the completion of the questionnaires.
About this study
Official title: Assessing the Effect of Education Based on Theory of Planned Behavior (TPB) on Delivery Type Selection in Pregnant Women Referring to Kermanshah Health Centers at 1393
In an experimental research, 100 nulliparous pregnant women who had referred to health care centers in Kermanshah were randomly selected and after taking Written Informed Consent letter, assigned into case and control groups. instruction based on TPB was provided just for the case group. Afterwards, post-test was taken by both groups and the results were analyzed.
Read the detailed description
In an experimental research, 100 nulliparous pregnant women with the gestational age of 28-36 weeks who had referred to health care centers in Kermanshah (western Iran) were randomly selected and after taking Written Informed Consent letter, assigned into case and control groups. The inclusion criteria consisted of nulliparous pregnant women with the gestational age of 28-36 weeks, women under 35 years old, and no contraindications for normal childbirth. Exclusion criteria included the absence of women in continuous training sessions, premature delivery, and maternal unavailability during the completion of the questionnaires.
Three Training sessions each lasted for one hour during twenty days were hold for the case group. The first session was conducted to affect their attitude and provide favourable attitude towards natural delivery. The second session was allocated to presenting feasible methods for reducing pain in order to enhance mothers' perceived behavioral control. In the 3rd session the methods were exercised practically so that they could better employ them whenever needed during the parturition. As a result, the mothers' selection of the sort of delivery was checked out. In order to influence the subjective norm, pregnant women were also asked to transfer their knowledge to their husbands. The control group also received only routine training sessions by the midwives in the health care centers.
In each one-hour training session; 45 minutes was dedicated to listening to lectures, having colloquies, and discussing methods via using teaching aids such as pamphlets, and manuals. The last 15 minutes was allocated to summarizing the issues and answering mothers' questions.
At the end of the training sessions, the post-test was administered for both groups and the data were analyzed.
- Conditions
- Pregnancy
- Being tested
- Education based on TPB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education based on TPBBehavioural
Three Training sessions were given to the case group; each lasted for one hour, during a period of twenty days. During each one-hour training session a period of 45 minutes was dedicated to listening to lectures, having discussions, and discussing methods of using teaching aids such as pamphlets and manuals. The last 15 minutes was used to summarize issues and answer questions.
| Study group | Role | What they receive |
|---|---|---|
| Case (Educational based on TPB) | Experimental | Educational intervention delivered to subjects. The content of education includes:
Three training sessions were given to the case group; each lasted for one hour, during a period of twenty days. During each one-hour training session a period of 45 minutes was dedicated to listening to lectures, having discussions, and discussing methods of using teaching aids such as pamphlets and manuals. The last 15 minutes was used to summarize issues and answer questions. Receives: Behavioral: Education based on TPB |
| Control (No intervention) | No intervention | No educational intervention provided to subjects in control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of child birth by Vaginal/Natural Delivery method.
such data are registered officially in hospitals and health centers. we collect the data through seeing the documents
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study startDec 2015
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ilam University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeinab Ghazanfari, Ilam University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929875
- Sponsor's protocol ID
- 944012/99
- Status last verified
- Oct 2016
- First submitted
- 8 Oct 2016
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effect of Education Based on Theory of Planned Behavior (TPB) on Delivery Type Selection in Pregnant Women Referring to Kermanshah Health Centers at 1393
- ClinicalTrials.gov ID
- NCT02929875
- Acronym / sponsor ID
- 944012/99
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ilam University of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 11 Oct 2016 (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.
In an experimental research, 100 nulliparous pregnant women who had referred to health care centers in Kermanshah were randomly selected and after taking Written Informed Consent letter, assigned into case and control groups. instruction based on TPB was provided just for the case group. Afterwards, post-test was taken by both groups and the results were analyzed.
Detailed description
In an experimental research, 100 nulliparous pregnant women with the gestational age of 28-36 weeks who had referred to health care centers in Kermanshah (western Iran) were randomly selected and after taking Written Informed Consent letter, assigned into case and control groups. The inclusion criteria consisted of nulliparous pregnant women with the gestational age of 28-36 weeks, women under 35 years old, and no contraindications for normal childbirth. Exclusion criteria included the absence of women in continuous training sessions, premature delivery, and maternal unavailability during the completion of the questionnaires.
Three Training sessions each lasted for one hour during twenty days were hold for the case group. The first session was conducted to affect their attitude and provide favourable attitude towards natural delivery. The second session was allocated to presenting feasible methods for reducing pain in order to enhance mothers' perceived behavioral control. In the 3rd session the methods were exercised practically so that they could better employ them whenever needed during the parturition. As a result, the mothers' selection of the sort of delivery was checked out. In order to influence the subjective norm, pregnant women were also asked to transfer their knowledge to their husbands. The control group also received only routine training sessions by the midwives in the health care centers.
In each one-hour training session; 45 minutes was dedicated to listening to lectures, having colloquies, and discussing methods via using teaching aids such as pamphlets, and manuals. The last 15 minutes was allocated to summarizing the issues and answering mothers' questions.
At the end of the training sessions, the post-test was administered for both groups and the data were analyzed.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case (Educational based on TPB) | Experimental | Behavioral: Education based on TPBEducational intervention delivered to subjects. The content of education includes: Three training sessions were given to the case group; each lasted for one hour, during a period of twenty days. During each one-hour training session a period of 45 minutes was dedicated to listening to lectures, having discussions, and discussing methods of using teaching aids such as pamphlets and manuals. The last 15 minutes was used to summarize issues and answer questions. |
| Control (No intervention) | No intervention | –No educational intervention provided to subjects in control group |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- consisted of nulliparous pregnant women with the gestational age of 28-36 weeks, women under 35 years old, informed consent of the mother and her husband, and no contraindications for normal childbirth.
Key exclusion criteria (1 listed)
- Included the absence of women in continuous training sessions, premature delivery, and maternal unavailability during the completion of the questionnaires.
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 |
|---|---|---|
| Education based on TPBThree Training sessions were given to the case group; each lasted for one hour, during a period of twenty days. During each one-hour training session a period of 45 minutes was dedicated to listening to lectures, having discussions, and discussing methods of using teaching aids such as pamphlets and manuals. The last 15 minutes was used to summarize issues and answer questions. | Behavioural | Case (Educational based on TPB) |
Primary outcome
frequency of child birth by Vaginal/Natural Delivery method.
Time frame: 3 Months
such data are registered officially in hospitals and health centers. we collect the data through seeing the documents
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 1 Nov 2016.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Education based on TPB in people with Pregnancy, run by Ilam University of Medical Sciences.
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 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
frequency of child birth by Vaginal/Natural Delivery method. (time frame: 3 Months). 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 1 Nov 2016.