Family Planning ServicesNCT05530928
The Importance of Including Reproductive Life Plan Counseling During Contraceptive Counseling
A study testing Reproductive life plan counseling in people with Family Planning Services, run by Saint-Joseph University at 2 sites in Lebanon.
Trial summary
The reproductive life plan is a protocol intended to promote preconception planning, improve reproductive health and increase health knowledge. The aim of the study is to evaluate the importance of including the reproductive life plan counseling during contraceptive counseling. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Family Planning Services
- What is being tested?
- Reproductive life plan counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 2 sitesLebanon
- Study dates
- 10 Sep 2022to Feb 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged between 20 and 40 years old visiting the health center
Who cannot join
- Women that refuse to participate in the study
Trial locations and contacts
2 sites in 1 country.
Lebanon2 sites, 2 recruiting
- Recruiting
Contraceptive service center
Bekaa
Najla Bizri
- Recruiting
Contraceptive service center
Tyre
Najla Bizri
About this study
Official title: The Importance of Including Reproductive Life Plan Counseling During Contraceptive Counseling: a Randomized Controlled Trial
The reproductive life plan is a protocol intended to promote preconception planning, improve reproductive health and increase health knowledge. The aim of the study is to evaluate the importance of including the reproductive life plan counseling during contraceptive counseling.
Read the detailed description
The aim of the study is to evaluate the outcomes of the reproductive life plan counseling on knowledge about fertility and awareness of preconception health.
2 groups of women visiting a primary health care center for contraceptive counseling are formed: a control group that will receive the standard care (standard family planning counseling) and the intervention group that will receive the standard family planning counseling in addition to the reproductive life plan counseling.
The included women are aged between 20 and 40 years. They are informed about the study when they call the center to make their appointment. When they attend the center, they receive a written and oral information and they are also informed that participation is voluntary and that they can interrupt their participation at any time without explanation. The women who agree to participate will sign an informed consent.
The midwives will be trained to reproductive life plan counseling before the commencement of the study. They have access to a template with discussion points to choose from, depending on the woman's answer to the first question (Do you want children/more children in the future?). If the answer is "no" the counseling will focus on contraceptive methods and sexual health (avoiding sexually transmitted diseases). If the answer is "yes" the discussion will focus on preconception and reproductive health (avoiding alcohol and tobacco, taking folic acid at least one month before conception, avoiding under and overweight,...).
Randomization: sealed envelopes are prepared with notes for CG (control group) or IG (intervention group). Before starting the counseling, the midwife opens the envelope containing instructions for either CG or IG.
A questionnaire is filled by the women before starting the counseling session and another one 2 months after the intervention. The questionnaire contains questions about demographics, knowledge about fertility, preconception health and the use of contraceptives.
- Conditions
- Family Planning Services
- Being tested
- Reproductive life plan counseling
- Keywords
- Preconception health, Reproductive life plan, Family planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reproductive life plan counselingOther
The intervention group will receive in addition to the standard contraceptive counseling, a reproductive life plan counseling: midwives will discuss the different options with the woman depending if she wants or not more children, and she will give her general information about preconception health.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | This group will receive the standard care (standard family planning counseling) |
| Intervention Group | Other | This group will receive the standard family planning counseling + reproductive life plan counseling. Receives: Other: Reproductive life plan counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge about fertility
Unit of measure: The percentage of women who answer correctly the questions about fertility.
Measurement tool: Questionnaire using the following questions (probability of a 25-year-old woman becoming pregnant if she had unprotected intercourse, fecundity time of an ovum, the age of decline of woman's fertility, the chance of giving birth after in-vitro fertilization).
This outcome is compared between the intervention group and the control group.
Measured: 2 months
Awareness of preconception health
Unit of measure: The percentage of women who answer correctly the questions about preconception health.
Measurement tool: Questionnaire using the following questions (the importance for a woman to stop using tobacco, to refrain from alcohol, to be of normal weight, and to start with folic acid before a pregnancy).
This outcome is compared between the intervention group and the control group.
Measured: 2 months
Secondary outcomes (1)
The use of contraception
Unit of measure: The percentage of women who used contraceptive methods during their latest sexual intercourse.
Measurement tool: Questionnaire through questions about the usage of different contraception methods.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start10 Sep 2022
- Primary completionJan 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family Planning ServicesStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530928
- Sponsor's protocol ID
- Tfem/2022'/23
- Status last verified
- Dec 2022
- First submitted
- 1 Sep 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Including Reproductive Life Plan Counseling During Contraceptive Counseling: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05530928
- Acronym / sponsor ID
- Tfem/2022'/23
- Conditions
- Family Planning Services
- Keywords
- Preconception health, Reproductive life plan, Family planning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 10 Sep 2022 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 7 Sep 2022 (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.
The reproductive life plan is a protocol intended to promote preconception planning, improve reproductive health and increase health knowledge. The aim of the study is to evaluate the importance of including the reproductive life plan counseling during contraceptive counseling.
Detailed description
The aim of the study is to evaluate the outcomes of the reproductive life plan counseling on knowledge about fertility and awareness of preconception health.
2 groups of women visiting a primary health care center for contraceptive counseling are formed: a control group that will receive the standard care (standard family planning counseling) and the intervention group that will receive the standard family planning counseling in addition to the reproductive life plan counseling.
The included women are aged between 20 and 40 years. They are informed about the study when they call the center to make their appointment. When they attend the center, they receive a written and oral information and they are also informed that participation is voluntary and that they can interrupt their participation at any time without explanation. The women who agree to participate will sign an informed consent.
The midwives will be trained to reproductive life plan counseling before the commencement of the study. They have access to a template with discussion points to choose from, depending on the woman's answer to the first question (Do you want children/more children in the future?). If the answer is "no" the counseling will focus on contraceptive methods and sexual health (avoiding sexually transmitted diseases). If the answer is "yes" the discussion will focus on preconception and reproductive health (avoiding alcohol and tobacco, taking folic acid at least one month before conception, avoiding under and overweight,...).
Randomization: sealed envelopes are prepared with notes for CG (control group) or IG (intervention group). Before starting the counseling, the midwife opens the envelope containing instructions for either CG or IG.
A questionnaire is filled by the women before starting the counseling session and another one 2 months after the intervention. The questionnaire contains questions about demographics, knowledge about fertility, preconception health and the use of contraceptives.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –This group will receive the standard care (standard family planning counseling) |
| Intervention Group | Other | Other: Reproductive life plan counselingThis group will receive the standard family planning counseling + reproductive life plan counseling. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women aged between 20 and 40 years old visiting the health center
Key exclusion criteria (1 listed)
- Women that refuse to participate in the study
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 |
|---|---|---|
| Reproductive life plan counselingThe intervention group will receive in addition to the standard contraceptive counseling, a reproductive life plan counseling: midwives will discuss the different options with the woman depending if she wants or not more children, and she will give her general information about preconception health. | Other | Intervention Group |
Primary outcome
Knowledge about fertility
Time frame: 2 months
Unit of measure: The percentage of women who answer correctly the questions about fertility. Measurement tool: Questionnaire using the following questions (probability of a 25-year-old woman becoming pregnant if she had unprotected intercourse, fecundity time of an ovum, the age of decline of woman's fertility, the chance of giving birth after in-vitro fertilization). This outcome is compared between the intervention group and the control group.
Awareness of preconception health
Time frame: 2 months
Unit of measure: The percentage of women who answer correctly the questions about preconception health. Measurement tool: Questionnaire using the following questions (the importance for a woman to stop using tobacco, to refrain from alcohol, to be of normal weight, and to start with folic acid before a pregnancy). This outcome is compared between the intervention group and the control group.
1 secondary outcome
The use of contraception
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reproductive life plan counseling in people with Family Planning Services, run by Saint-Joseph University at 2 sites in Lebanon.
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: status not confirmed, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lebanon. 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?
Contact Samah Daou (009613851963, dawsamah@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge about fertility (time frame: 2 months). The study lists 2 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 28 Dec 2022.