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IRCT20220203053927N1 IRCT 2022-02-10 Shahroud University of Medical Sciences The effect of prenatal supportive care of midwives in pregnant women with chronic diseases The effect of prenatal supportive care of midwives in pregnant women with chronic diseases: Randomized Controlled Trial 2022-02-26 anticipated 204 Complete https://irct.ir/trial/61761 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible women will randomly assign into two groups of routine (individual) prenatal care or group prenatal care using block randomization with a block size of 4 and an allocation ratio of 1:1. Thus, after listing all possible situations of 4 blocks and assigning a number to each of them using a computer random number table with a 1: 1 ratio, participants will be allocated into two groups, namely routine prenatal care and supportive care care. For allocation concealment, each woman will receive a code and all codes will be kept in an opaque envelope until the time of intervention. Sequencing of allocation and preparation of envelopes will be done by a person that will not involve sampling and data collection. The researcher and the participant will not aware of the groups and the intervention that they received until the commencement of intervention. N/A prenatal supportive care. Intervention 1: InterIntervention group: Supportive prenatal care in the intervention group consists of 3 components: (1) active and passive telephone counseling before and after delivery, (2) coordination of care and case management, (3) continuous care buyDedicated midwife during pregnancy, during labor and delivery.Individuals in the prenatal care intervention group will receive the researcher in the specialized clinic of the selected hospital in weeks 30-24, 34-31, 37-35, 38, 39, 40.The researcher works in consultation with a perinatologist.At each visit, while examining the individual needs and desires of each woman, counseling and training appropriate to the gestational age will be provided individually and face to face.During the intervention period, the researcher will have one phone call per week with the participants and in each post-greeting call, she will examine three main areas: physical-mental health status and pregnancy health, evaluation-based recommendations, and discussion about Any other additional issues that are important to the mother.In this intervention, each participant can contact the midwife whenever they need to be consulted.Care coordination will be done by the researcher during the intervention period.The researcher identifies the specific needs and wants of each woman and discusses the optimal care of the woman with the obstetrician who is responsible for her medical care.The intervention group will be supported by the researcher as a companion midwife (Dola) from the beginning of the mother's hospitalization (beginning of the active phase of labor in the expansion of the cervix 3-4 cm) until the first 2 hours after delivery.The researcher will provide supportive measures for the mother during labor, classified into psychological, emotional, educational, and physical categories.The researcher will also be able to follow up and respond to maternal problems by phone and, if necessary, in person after the first 2 hours of labor. Intervention 2: Control group: The control group will receive routine care at the prenatal care clinic of the selected hospital by the resident on duty and under the supervision of a perinatologist. Routine pregnancy care based on national protocol includes 8 visits (in weeks 6-10, 20-16, 30-24, 34-31, 37-35, 38, 39, 40) which Based on the severity of the chronic disease and the risks associated with pregnancy, the treating physician will set up an individual care plan for each person's visit and care. Yes - There is a plan to make this available What will be shared: The data can be published after the completion of the dissertation When: One year after completing the dissertation To whom: Shahroud and Ahvaz University of Medical Sciences, Hospital Officials, Researchers Conditions: Data analysis through publication in scientific research journals in They will be available to others Where to obtain: solmaz mohammadi, E mail: sl.mohammadi89@yahoo.com How to obtain: The information will be available through the publication of the article. But if more information is needed, the request should be sent via email Comments:
public Zahra Motaghi
Haftam Tir Square - Shahroud University of Medical Sciences and Health Services
Shahroud Iran (Islamic Republic of) ۳۶۱۴۷-۷۳۹۴۳ +98 23 3239 5009 Zahra.motagy63@gmail.com Shahroud University of Medical Sciences scientific Solmaz Mohammadi
Golestan Alley, Dey Bin Bahman and Esfand St.No.116
Ahvaz Iran (Islamic Republic of) 6135935697 +98 61 3321 9122 sl.mohammadi89@yahoo.com Shahroud University of Medical Sciences Iran (Islamic Republic of) 1.Pregnant women with one or more chronic diseases that are diagnosed more than 6 months before pregnancy, with continued recurrence and need for medical treatment 2.Be between 16-20 weeks pregnant at the time of enrollment in the study 3.Single pregnancy 4.Be able to understand Persian speech and writing 5.To live in Ahvaz 6.Having a cell phone 7.Satisfaction to participate in the study no limit no limit Female 1.Self-report history of substance abuse 2.Self-report of mental disorder and use of psychiatric drugs 3.Reluctance to continue participating in the study O36.7 Maternal care for viable fetus in abdominal pregnancy N/A N/A InterIntervention group: Supportive prenatal care in the intervention group consists of 3 components: (1) active and passive telephone counseling before and after delivery, (2) coordination of care and case management, (3) continuous care buyDedicated midwife during pregnancy, during labor and delivery.Individuals in the prenatal care intervention group will receive the researcher in the specialized clinic of the selected hospital in weeks 30-24, 34-31, 37-35, 38, 39, 40.The researcher works in consultation with a perinatologist.At each visit, while examining the individual needs and desires of each woman, counseling and training appropriate to the gestational age will be provided individually and face to face.During the intervention period, the researcher will have one phone call per week with the participants and in each post-greeting call, she will examine three main areas: physical-mental health status and pregnancy health, evaluation-based recommendations, and discussion about Any other additional issues that are important to the mother.In this intervention, each participant can contact the midwife whenever they need to be consulted.Care coordination will be done by the researcher during the intervention period.The researcher identifies the specific needs and wants of each woman and discusses the optimal care of the woman with the obstetrician who is responsible for her medical care.The intervention group will be supported by the researcher as a companion midwife (Dola) from the beginning of the mother's hospitalization (beginning of the active phase of labor in the expansion of the cervix 3-4 cm) until the first 2 hours after delivery.The researcher will provide supportive measures for the mother during labor, classified into psychological, emotional, educational, and physical categories.The researcher will also be able to follow up and respond to maternal problems by phone and, if necessary, in person after the first 2 hours of labor. Control group: The control group will receive routine care at the prenatal care clinic of the selected hospital by the resident on duty and under the supervision of a perinatologist. Routine pregnancy care based on national protocol includes 8 visits (in weeks 6-10, 20-16, 30-24, 34-31, 37-35, 38, 39, 40) which Based on the severity of the chronic disease and the risks associated with pregnancy, the treating physician will set up an individual care plan for each person's visit and care. The length of hospital stay (mean and standard deviation) is measured from the time of admission to the study until 2 weeks after delivery. Timepoint: Evaluation of this outcome will be done 2 weeks after delivery. Method of measurement: medical records. World Health Organization 5-item Welfare Index. Timepoint: The evaluation will be performed at the beginning of the study (baseline), at 33-37 weeks of gestation and 6 weeks after delivery. Method of measurement: World Health Organization 5-item Welfare Scale World Health Organization 5-item Welfare Scale Questionnaire. Pregnancy and postpartum depression. Timepoint: The evaluation will be performed at the beginning of the study (baseline), at 33-37 weeks of gestation and 6 weeks after delivery. Method of measurement: Edinburgh Postpartum Depression Scale. Pregnancy worries. Timepoint: The evaluation will be done at the beginning of the study (baseline) and at 33-37 weeks of pregnancy. Method of measurement: Cambridge Pregnancy Anxiety Scale Questionnaire. Health-related quality of life. Timepoint: The evaluation will be performed at the beginning of the study (baseline), at 33-37 weeks of gestation and 6 weeks after delivery. Method of measurement: Health-related quality of life questionnaire. Quality prenatal care from the perspective of service recipients. Timepoint: Evaluation 6 weeks after delivery. Method of measurement: Quality of Prenatal Care Questionnaire. Satisfaction with childbirth. Timepoint: Evaluation 2 weeks after delivery. Method of measurement: Maki Maternity Satisfaction Scale. Economic consequences of health (use of health services). Timepoint: Evaluation 6 weeks after delivery. Method of measurement: Researcher-made questionnaire. Prenatal health behaviors. Timepoint: The evaluation will be done at the beginning of the study (baseline) and at 33-37 weeks of pregnancy. Method of measurement: Prenatal health behaviors scale. Consequences of pregnancy and childbirth. Timepoint: Evaluation 6 weeks after delivery. Method of measurement: Researcher-made questionnaire. Shahroud University of Medical Sciences Approved 2020-12-01 Shahroud University of Medical Sciences Shahroud ,7th of Tir Square - Shahroud University of Medical Sciences and Health Services Shahroud Semnan Iran (Islamic Republic of)