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临床试验/NCT04036786
NCT04036786已完成不适用

Evaluation of the Education and Counseling Program on Pregnant Women With Risk of Preeclampsia: A Prospective Randomized Controlled Trial

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi2 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2015年5月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
132
试验地点
2
主要终点
maternal and neonatal health

研究概览

简要总结

The aim of the study is to evaluate the effect of education and counseling program on healthy lifestyle behaviors, self-efficacy and maternal/neonatal consequences of pregnant women with risk of preeclampsia.

详细描述

Preeclampsia affects 3% to 5% of pregnancies, and is a pregnancy-specific syndrome; it leads to maternal, fetal and neonatal morbidity and mortality worldwide especially in developing countries. If not treated, pregnant woman may have many serious complications, such as pulmonary edema, eclampsia, stroke, placental abruption, and acute renal diseases . Babies born to mothers with preeclampsia have an increased risk of low Apgar scores, neonatal encephalopathy, seizures, neonatal intensive care admission, and neonatal deaths caused by preterm birth and low gestational age. Preeclampsia also affects the health-related quality of life negatively.

Since the etiology and pathogenesis of preeclampsia is unclear, it is very important to investigate the risk factors of preeclampsia to identify the pregnant women in the risk group, and to ensure more intensive care, observation and follow-ups. The known risk factors for preeclampsia include primiparity, advanced maternal age, family history of preeclampsia, previous preeclamptic pregnancy, autoimmune diseases, hypertension, history of thrombophilia, diabetes, in vitro fertilization, multifetal pregnancy, type I diabetes mellitus or type II diabetes mellitus and obesity..

It is known that the population has difficulty understanding even basic information related to health, and especially preeclampsia. Increasing the preeclampsia knowledge of women will help them to recognize early symptoms, and negative signs of preeclampsia, and may lead them to seek earlier individual care. Also, it is estimated that appropriate patient education and counseling for preeclampsia may prevent half of the most serious consequences related to maternal symptoms. This estimation is supported by a study, that women diagnosed with preeclampsia receiving proper and timely follow-up had fewer adverse events than those with delayed diagnosis. Preeclampsia education and counseling subjects may include recommendations for increasing awareness (preeclampsia signs and signs of danger, follow-up at home) and lifestyle modifications (physical activity, coping with stress, nutrition advices) to contribute to the prevention preeclampsia risks.

Although many studies have been carried out on medical treatment and improved outcomes in women with preeclampsia, there are limited studies about the consequences of education and counseling of pregnant women with risk of preeclampsia. Therefore, the objective of this study was to evaluate the effects of maternal and neonatal consequences of an education and counseling program on at-risk pregnant women.

Trial Design and Participants This study was a single-center, single-blinded, prospective randomized controlled trial (RCT), parallel-group RCT comparing the effects of a preeclampsia education and counseling program during pregnancy with standard antenatal care. Participants were 132 pregnant women with risk of preeclampsia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Having no major complication related to pregnancy
  • Carrying at least one of the risk factors of preeclampsia discussed in the literature
  • Being 12-20 gestational week
  • Ability to read and write in Turkish,
  • Volunteering to participate in the study.

排除标准

  • Having a miscarriage
  • Unable to read or write in Turkish
  • Moving to another city during the study
  • Changing the hospital for follow-ups or giving birth.

研究组 & 干预措施

study gorup

Experimental

The study was a prospective randomized trial with a control group (standard care group) and an intervention group, using a repeated measures design. Sixty six pregnant participants with preeclampsia risk were included in the control group and 66 pregnant participants with preeclampsia risk were included in the intervention (exercise) group.

干预措施: study group (Behavioral)

control group

Other

The study was a prospective randomized trial with a control group (standard care group) and an intervention group, using a repeated measures design. Sixty six pregnant participants with preeclampsia risk were included in the control group and 66 pregnant participants with preeclampsia risk were included in the intervention (exercise) group.

干预措施: standard care (Behavioral)

结局指标

主要结局

maternal and neonatal health

时间窗: an average of six months

We used postpartum data collection form. After birth, in both groups maternal (preeclampsia development status, prenatal and postnatal blood pressure values and laboratory findings) and neonatal outcomes (first and fifth APGAR scores, baby's intensive care need, respiratory distress, birth weight and intra-uterine growth retardation) were collected with the postpartum data collection form, using information the women themselves, and information in their files.

次要结局

  • Health Promoting Lifestyle Profile-II (HPLP-II)(up to 22 weeks (4 times))
  • Self-efficacy Scale (SES)(up to 22 weeks (4 times))

研究者

发起方
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Meltem Ugurlu

Assistant Proffessor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

研究点 (2)

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