Many women despite being well-treated in proper dose, with proper drug and for proper duration, may not respond to different forms of prolactin normalizing drugs. This will lead to extension of the treatment duration up to months or even years. Doctors usually increase the dose of the drug with high possibility of side effects and even complications. Some doctors change drug group to another without any significant improvement of hyperprolactinemia. hyperprolactinemia can indicate a deeper issue, about 10 percent of the population has hyperprolactinemia. Life style, feeding habits and sexual behaviors are usually not included in the management protocols of hyperprolactinemia. Aim of the study: This study will be aimed to: 1. Evaluate the effect of nursing role in the management of hyperprolactinemia. 2. Give health education for women underlying forms of prolactin normalizing drugs for hyperprolactinemia. Hypothesis of the study: H1- Health education for women under drugs of hyperprolactinemia is effective in reduce level of prolactine. H0- Health education for women under drugs of hyperprolactinemia is not effective in reduce level of prolactin
Full Title of Study: “Nurse’s Role in the Management of Hyperprolactinemia: A Prospective Randomized Controlled Trial”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Health Services Research
- Masking: Single (Participant)
- Study Primary Completion Date: February 5, 2020
Subjects and methods: All women diagnosed to have hyperprolactinemia as diagnosed by one laboratory (lab of the Woman's Health University Hospital). Research Design: Prospective study (randomized controlled trial) . Setting: This study will be conducted at the out patient clinic of the Woman's Health University Hospital, Assiut University. Sample size: convenience sample started from April 2019 to April 2020 or reaching 100 cases, 50 in each arm. Tools of the study: Tool (1) Structured interviewing questionnaire include 1. Women's personal data will include: Name, age, residence, educational level, occupation, duration of marriage,Number of phone. 2. Medical history will include: the history of diabetes, hypertension, renal disease, cardiac disease, hepatic disease, and any other diagnosed medical disease. 8 3. Menstrual history will include: Age of menarche, Duration, Interval, and rhythm. 4. Infertility history will include: years of infertility, type of infertility, cause of it. 5. Obstetric history will include: number of gravidity, number of parity, number of abortion, No of living children, time since last delivery or abortion. 6. Medication history. Tool (2) Health education including: – Life style: Habits what to do. What not do. – Diet to eat to reduce prolactine level: – Diet to avoid to increase prolactine level . – Acts to avoid during sex practice. Tool (3): follow up (first visit after month with measurement of serum prolactin level again). Procedure Administrative phase: – An official permission will be obtained from the manager of Women health hospital after explaining the purpose of the study. – The study will be conducted at the out patient clinical Unit of Women health hospital and will include convenient sample of Women undergoing treatment using Cabergoline 0.5 mg twice weekly for one month. – the investigator will apply the randomized selection of the participant as the following: give the participant an envelope contains two choice of (A or B ). labeled papers then according to her choice she will engaged in the group: Group A will be take medications for hyperprolactinemia with nurse health education. and 9 group B will be will be take medications for hyperprolactinemia without nurse health education. Pilot study A pilot study will be carried out on 10% of the study sample to test the clarity of the study tool. The sample of pilot study will be excluded from the total sample if any modification done on the tools. The necessary modifications will be done if needed. Ethical considerations: 1. Research proposal will be approved from Ethical Committee in the Faculty of Nursing 2. There is no risk for study subject during application of the research. 3. The study will follow common ethical principles in clinical research. 4. Written consent will be obtained from patient or guidance that is willing to participate in the study. 5. confidentiality and anonymity will be assured. 6. study subjects have the right to refuse to participate and/or withdraw from the study without any rational any time 7. study subject privacy will be considered during collection of data. Statistical analysis Data entry and statistical analysis will be done using the statistical package for social science program (SPSS. version 22). Qualitative variables will be presented as number and percentage. Quantitative variables will be presented as mean +SD. Comparison between qualitative variables will be done by using chi-square. Comparison between quantitative variables will be done by using student t-test.
- Drug: Cabergoline 0.5Mg orally daily for 1 month plus health education by a nurse
- Women with hyperprolactiemia scheduled for cabergoline therapy 0.5 mg daily for one month will be offered health education by a nurse to help minimize prolactin level(group A)
- Drug: Cabergoline 0.5Mg orally daily for 1 month without health education by a nurse
- Women with hyperprolactiemia scheduled for cabergoline therapy 0.5 mg daily for one month will not offered health education by a nurse (group B)
Arms, Groups and Cohorts
- Active Comparator: Cabergoline with health education by a nurse
- Women with hyperprolactiemia scheduled for cabergoline therapy 0.5 mg twice weekly for one month plus health education by a nurse.
- Active Comparator: cabergoline without health education by a nurse
- Women with hyperprolactiemia scheduled for cabergoline therapy 0.5 mg twice weekly for one month without health education by a nurse.
Clinical Trial Outcome Measures
- Achievement of normoprolactinemia after one month of therapy of hyperprolactinemia
- Time Frame: 1 month
- response of hyperprolactinemic women to carbergoline o.5 mg for one month with or without health education by a nurse to achieve normoprolactinemia.
Participating in This Clinical Trial
1. Pathologic hyperprolactinemia due to any cause. 2. Non-pregnant. 3. Not lactating. Exclusion criteria:
1. Physiologic hyperprolactinemia. 2. Women who don't consent for follow up.
Gender Eligibility: Female
Minimum Age: 20 Years
Maximum Age: 40 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Woman’s Health University Hospital, Egypt
- Provider of Information About this Clinical Study
- Principal Investigator: Professor Atef Darwish, Professor of Obstetrics and Gynecology – Woman’s Health University Hospital, Egypt
- Overall Official(s)
- Atef M Darwish, Prof, Principal Investigator, Prof.
- Overall Contact(s)
- Atef M Darwish, 01001572723, firstname.lastname@example.org
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