NCT05530928

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

September 10, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

December 28, 2022

Status Verified

December 1, 2022

Enrollment Period

4 months

First QC Date

September 1, 2022

Last Update Submit

December 26, 2022

Conditions

Family Planning Services

Keywords

Preconception healthReproductive life planFamily planning

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    2 months

Secondary Outcomes (1)

  • The use of contraception

    2 months

Study Arms (2)

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.

Other: Reproductive life plan counseling

Interventions

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.

Intervention Group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBased on self-representation of gender identity
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Women that refuse to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Contraceptive service center

Bekaa, Lebanon

RECRUITING

Contraceptive service center

Tyre, Lebanon

RECRUITING

Central Study Contacts

Samah Daou

CONTACT

009613851963dawsamah@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2022

First Posted

September 7, 2022

Study Start

September 10, 2022

Primary Completion

January 1, 2023

Study Completion

February 1, 2023

Last Updated

December 28, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

LE(2)