Clinical trial NCT05530928: The Importance of Including Reproductive Life Plan Counseling During Contraceptive Counseling
Official title: The Importance of Including Reproductive Life Plan Counseling During Contraceptive Counseling: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Family Planning Services
Keywords: Preconception health
Reproductive life plan
Family planning
Lead sponsor: Saint-Joseph University
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 164
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Women that refuse to participate in the study

Primary outcomes:
measure: Knowledge about fertility
timeFrame: 2 months
measure: Awareness of preconception health
timeFrame: 2 months
Secondary outcomes:
measure: The use of contraception
timeFrame: 2 months
Other outcomes:
Locations:
city: Bekaa
country: Lebanon
facility: Contraceptive service center
city: Tyre
country: Lebanon
facility: Contraceptive service center
Study officials:
References: