Education and Counseling Program on Pregnant Women With Risk of Preeclampsia
Condition: Pregnancy
MeSH terms: Pre-Eclampsia
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      We recruited the pregnant women between 12-20 gestational weeks at Obstetrics outpatient
      clinic in Ankara Gulhane Education and Research Hospital during routine antenatal care
      between May 2015 and March 2016. The eligibility criteria were as follows: having no major
      complication related to pregnancy and carrying at least one of the risk factors of
      preeclampsia discussed in the literature (American College of Obstetricians and
      Gynecologists, 2013; Bilano et al., 2014; Lisonkova and Joseph, 2013). The exclusion criteria
      included; having a miscarriage, unable to read or write in Turkish, moving to another city
      during the study, and changing the hospital for follow-ups or giving birth.

      The sample size was calculated using the G Power 3.1.2 version computer package program
      according to the comparison of the self-efficacy-adequacy scale mean difference between the
      groups. So that 95% confidence interval and 80% power would be achieved as a mean size of
      effect, it was calculated that each group should consist of 45 pregnant women.

      Randomization and Participation We selected totally 144 pregnant women at the beginning of
      the study. Later, 12 women did not meet eligibility criteria due to the diagnosis of
      pregnancy-related complications in the study period (five pregnant women dropped out of the
      study, and seven pregnant women planned to give birth in a different hospital). Finally, 132
      pregnant women who met the eligibility criteria agreed to participate in this study and we
      randomized them as shown in Figure 1 Flow Chart. Eligible women were randomly allocated
      (ratio 1:1) into either a control group or study group following an allocation concealment
      process using an automatic computer-generated number table. After the randomization process,
      13 pregnant women in control group and 19 pregnant women in study group were excluded from
      the study due to either moving to another city or having the miscarriage.

      Ethics committee permission was obtained from the ethical committee of Ankara Gulhane
      Education and Research Hospital with the code 1491-2658-13/16484-303. As they involved human
      participants, all procedures were conducted in accordance with the ethical standards of the
      Declaration of Helsinki. We informed the women with risk of preeclampsia and who fulfilled
      the inclusion criteria about the study procedure, and obtained written informed consent.

      Data collection The demographic information, obstetric and general health history were
      recorded for both groups at the first assessment. We applied Health Promoting Lifestyle
      Profile-II (HPLP II), the Self-Efficacy Scale (SES), pregnant and fetal follow-up forms 4
      times during pregnancy. Finally, data of the women and their infants/newborn within
      postpartum 48 hours were collected.

      In both groups, we recorded necessary information at every follow-up session within
      approximately 30 minutes (10 minutes for data collection for control & study group, 20
      minutes for education and counseling for study group). We arranged first assessment and
      follow-up sessions between 12-20, 23-28, 29-34, 35-40 weeks of gestation.

      The first version of the HPLP scale, was developed by Walker et al. in 1987 and revised in
      1996 (Walker et al., 1987). The validity and reliability of the HPLP II in Turkish was tested
      by Bahar et al. and found to have a high level of validity and reliability (Bahar et al.,
      2008). The HPLP II questionnaire consist of 52 items and six dimensions, and it uses a
      four-point Likert scale from 1, indicating 'never', to 4, 'routinely'. Possible total scores
      on the questionnaire range from 52 to 208. Cronbach's alpha coefficient of the scale was
      0.92.

      The first version of the SES, developed by Shrer et al. in 1982 and the validity and
      reliability of the SES scale in Turkish was tested by Gozum and Aksayan in 1999 (Gözüm and
      Aksayan, 1999; Sherer et al., 1982). The SES consist of 23 items and uses a five-point Likert
      scale, in which 1 indicates "never defines me" and to 5, "defines me very well". Possible
      total scores on the questionnaire range from 23 to 115. Cronbach's alpha coefficient of the
      scale was 0.89.

      We recorded the information, including presence of edema, feeling of movement of the baby,
      physical activity and breathing exercises in both groups on the pregnant and fetal follow-up
      form. In addition to these, we measured the blood pressure as well as non-stress test from
      the 34th gestation week. Pregnant women in the study group were asked to complete a daily
      follow-up form, recording their blood pressure, weight, edema, infant movement, and any
      problems. For each follow-up, the forms were collected and new forms were given and necessary
      reminders were made about regular filling.

      Finally, 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.

      Interventions Preeclampsia education and counseling program: We prepared a preeclampsia
      education booklet in accordance with the literature, (American College of Obstetricians and
      Gynecologists, 2013; Kasawara et al., 2012; Lisonkova and Joseph, 2013; You et al., 2012b).
      The content of the booklet was guided by the opinion of experts. It was written in easily
      understandable language and contained attractive and colorful illustrations. This booklet
      contents were definition and risk factors for the development of preeclampsia, maternal and
      fetal damages, recommendations for preventing its development (diet, rest, study, exercise,
      coping with stress techniques), follow-up of symptoms at home (blood pressure, weight and
      edema follow-up, counting fetal movements), danger signs, drug use, follow up in hospital,
      risk of developing in subsequent pregnancies, and its results. Pregnant women in the study
      group were given education and counseling at four times in addition to standard care, using
      the preeclampsia education booklet, in a special place. The participants' questions were
      answered, and each received a copy of the booklet. Pregnant women in the control group
      received standard prenatal care. Necessary reminders were made to attend regular follow-ups
      and their questions were answered during these. The researcher allowed participants to call
      her for consultations at any time.

      Statistical analysis Data were analyzed using IBM SPSS version 22.0 (IBM Corp., Armonk, NY,
      USA) and p<0.05 was considered statistically significant. Descriptive statistics for the
      variables determined by counting; number and percentage (%); for the variables determined by
      measurement, mean±standard deviation (X ± SD), median and minimum-maximum (min-max) values
      were used. The conformity of continuous variables to normal distribution was evaluated by
      Kolmogorov Smirnov Test. To compare the groups for discrete variables; Chi-Square Test or
      Fisher Exact Test, for continuous variables; Student t Test or Mann-Whitney U Test were used.
      ANOVA was used for group comparisons for repeated measurements, and Bonferroni Test was used
      as post-hoc test. The error level was determined as 0.05 for all analyzes.
    

Intervention name(s): study group; standard care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): We prepared a preeclampsia education booklet in accordance with the literature,The content of the booklet was guided by the opinion of experts. It was written in easily understandable language and contained attractive and colorful illustrations. This booklet contents were definition and risk factors for the development of preeclampsia, maternal and fetal damages, recommendations for preventing its development (diet, rest, study, exercise, coping with stress techniques), follow-up of symptoms at home (blood pressure, weight and edema follow-up, counting fetal movements), danger signs, drug use, follow up in hospital, risk of developing in subsequent pregnancies, and its results. Pregnant women in the study group were given education and counseling at four times in addition to standard care, using the preeclampsia education booklet, in a special place. The participants' questions were answered, and each received a copy of the booklet.; standard pregnancy follow up
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: pre-eclampsia; pregnancy; healthy lifestyle; self efficacy