Education and Counseling Program on Pregnant Women With Risk of Preeclampsia

NCT04036786 | Completed DMC

• 1 other identifier: 05555807841
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy

Keywords

pre-eclampsia; pregnancy; healthy lifestyle; self efficacy

Outcome Measures

Primary Outcomes (1)

• maternal and neonatal health

  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.

  an average of six months

Secondary Outcomes (2)

• Health Promoting Lifestyle Profile-II (HPLP-II)

  up to 22 weeks (4 times)

• Self-efficacy Scale (SES)

  up to 22 weeks (4 times)

Study Arms (2)

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.

Behavioral: study group

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.

Behavioral: standard care

Interventions

study group BEHAVIORAL

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.

study gorup

standard care BEHAVIORAL

standard pregnancy follow up

control group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gulhane Tip Fakultesi: lead

Study Sites (1)

Meltem Uğurlu

Ankara, 06018, Turkey (Türkiye)

Location

Related Publications (10)

• Allen R, Rogozinska E, Sivarajasingam P, Khan KS, Thangaratinam S. Effect of diet- and lifestyle-based metabolic risk-modifying interventions on preeclampsia: a meta-analysis. Acta Obstet Gynecol Scand. 2014 Oct;93(10):973-85. doi: 10.1111/aogs.12467.

  PMID: 25138651 BACKGROUND

• merican College of Obstetricians and Gynecologists, 2013. ACOG Guidelines: Hypertension in pregnancy, Washington, DC. https://doi.org/doi: 10.1097/01.AOG.0000437382.03963.88

  BACKGROUND

• ACOG Committee Opinion No. 650: Physical Activity and Exercise During Pregnancy and the Postpartum Period. Obstet Gynecol. 2015 Dec;126(6):e135-e142. doi: 10.1097/AOG.0000000000001214.

  PMID: 26595585 BACKGROUND

• Bilano VL, Ota E, Ganchimeg T, Mori R, Souza JP. Risk factors of pre-eclampsia/eclampsia and its adverse outcomes in low- and middle-income countries: a WHO secondary analysis. PLoS One. 2014 Mar 21;9(3):e91198. doi: 10.1371/journal.pone.0091198. eCollection 2014.

  PMID: 24657964 BACKGROUND

• Blyton DM, Skilton MR, Edwards N, Hennessy A, Celermajer DS, Sullivan CE. Treatment of sleep disordered breathing reverses low fetal activity levels in preeclampsia. Sleep. 2013 Jan 1;36(1):15-21. doi: 10.5665/sleep.2292.

  PMID: 23288967 BACKGROUND

• Gharaibeh M, Al-Ma'aitah R, Al Jada N. Lifestyle practices of Jordanian pregnant women. Int Nurs Rev. 2005 Jun;52(2):92-100. doi: 10.1111/j.1466-7657.2005.00257.x.

  PMID: 15842321 BACKGROUND

• Kasawara KT, do Nascimento SL, Costa ML, Surita FG, e Silva JL. Exercise and physical activity in the prevention of pre-eclampsia: systematic review. Acta Obstet Gynecol Scand. 2012 Oct;91(10):1147-57. doi: 10.1111/j.1600-0412.2012.01483.x. Epub 2012 Jul 24.

  PMID: 22708966 BACKGROUND

• Lange EM, Shah AM, Braithwaite BA, You WB, Wong CA, Grobman WA, Toledo P. Readability, content, and quality of online patient education materials on preeclampsia. Hypertens Pregnancy. 2015;34(3):383-90. doi: 10.3109/10641955.2015.1053607. Epub 2015 Jul 8.

  PMID: 26153628 BACKGROUND

• Meles E, Giannattasio C, Failla M, Gentile G, Capra A, Mancia G. Nonpharmacologic treatment of hypertension by respiratory exercise in the home setting. Am J Hypertens. 2004 Apr;17(4):370-4. doi: 10.1016/j.amjhyper.2003.12.009.

  PMID: 15062893 BACKGROUND

• Mol BWJ, Roberts CT, Thangaratinam S, Magee LA, de Groot CJM, Hofmeyr GJ. Pre-eclampsia. Lancet. 2016 Mar 5;387(10022):999-1011. doi: 10.1016/S0140-6736(15)00070-7. Epub 2015 Sep 2.

  PMID: 26342729 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Proffessor

Model Details: 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.

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 30, 2019
• Study Start: May 5, 2015
• Primary Completion: March 30, 2016
• Study Completion: June 20, 2016
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: after the study published in a journal

Locations

TU (1)