Preconception Reproductive Knowledge Promotion (PREKNOP)

Study Overview
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Brief Summary
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This study examines the efficacy of the Preconception Reproductive Knowledge Promotion (PREKNOP) intervention, designed to promote women's reproductive health and positive pregnancy outcomes. The study's goal is to educate low-income women about reproductive changes related to their menstrual cycle. The main hypothesis of the study is that women who receive the PREKNOP intervention will report reduced risk of unplanned pregnancy and increased reproductive knowledge, self-efficacy about that knowledge, and pregnancy planning ability.

Detailed Description
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This study is a randomized, controlled trial of the PREKNOP intervention in a sample of 120 women 18-44 years old. Teams of nursing students and community health workers will administer the 12-month intervention. In addition to 10 home visits during which women will receive information on the female reproductive system and the expected monthly cyclical changes, PREKNOP will consist of use of ovulation test kits, a 12-month menstrual calendar, a digital thermometer, and educational brochures covering: the female reproductive anatomy, hormones and menstrual cycle, how to recognize ovulation period, various methods of birth control and how they work, and early pregnancy symptoms.

Official Title
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Efficacy Study of the Preconception Reproductive Knowledge Promotion Intervention

Conditions
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Pregnancy

Intervention / Treatment
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* Other: Knowing your body
* Behavioral: Healthy Lifestyle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: low-income women of childbearing age Exclusion Criteria: Menopause Hysterectomy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy Lifestyle<br>60 women randomly assigned to the control group | Behavioral: Healthy Lifestyle<br>* Women will receive educational materials on healthy lifestyle such as maintaining good nutrition and the importance of folic acid for women of childbearing age during the first visit. Participants will receive a total of 10 visits. The nursing student/community health workers team will continue to discuss topics related to promoting healthy lifestyle during subsequent visits.<br>|
| Other: Knowing your body<br>60 women randomly assigned to intervention group | Other: Knowing your body<br>* Women will receive the Knowing your body kit. The kit contains: 6 ovulation test strips, a 12 month menstrual log sheet/calendar, and a thermometer to help women determine their body temperature; and educational materials that contain information on female body parts involved in pregnancy, hormones and the menstrual cycle, how birth control works, body temperature changes, characteristics of cervical fluid, and adapting to pregnancy during the first trimester. Participants will receive a total of 10 visits. During the first visit, the nursing student/community health workers team will review the intervention kit and continue to discuss topics related to women's health during subsequent visits.<br>Behavioral: Healthy Lifestyle<br>* Women will receive educational materials on healthy lifestyle such as maintaining good nutrition and the importance of folic acid for women of childbearing age during the first visit. Participants will receive a total of 10 visits. The nursing student/community health workers team will continue to discuss topics related to promoting healthy lifestyle during subsequent visits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline reproductive knowledge of ovulation, menstrual cycle, peak fertile times, and early signs of pregnancy. | The investigators will measure if there is an increase in reproductive knowledge of ovulation time, menstrual cycle, peak fertile times, and early signs of pregnancy among the 120 participants in the study. The investigators will compare if there is higher increase in knowledge among the intervention group compared to the 60 participants in control group. | Baseline, 3, 6, 12, 18 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline number of unplanned pregnancies | The investigators will measure if there is a change in the number of unplanned pregnancies among the intervention group compared to the control group. | Baseline, 3 months, 6 months, 12 months, 18months, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menstrual cycle, Ovulation time, pregnancy recognition, Community-based participatory research, Unintended pregnancy