The Importance of Including Reproductive Life Plan Counseling During Contraceptive Counseling

NCT ID: NCT05530928

Last Updated: 2022-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-10

Study Completion Date

2023-02-28

Brief Summary

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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

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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

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Family Planning Services

Keywords

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Preconception health Reproductive life plan Family planning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Control Group

This group will receive the standard care (standard family planning counseling)

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Group

This group will receive the standard family planning counseling + reproductive life plan counseling.

Group Type OTHER

Reproductive life plan counseling

Intervention Type OTHER

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.

Interventions

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Reproductive life plan counseling

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women aged between 20 and 40 years old visiting the health center

Exclusion Criteria

* Women that refuse to participate in the study
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Saint-Joseph University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Contraceptive service center

Bekaa, , Lebanon

Site Status RECRUITING

Contraceptive service center

Tyre, , Lebanon

Site Status RECRUITING

Countries

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Lebanon

Central Contacts

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Samah Daou

Role: CONTACT

Phone: 009613851963

Email: [email protected]

Facility Contacts

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Najla Bizri

Role: primary

Najla Bizri

Role: primary

Other Identifiers

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Tfem/2022'/23

Identifier Type: -

Identifier Source: org_study_id