Expectant Management of Severe Preeclampsia in Pregnant Women Remote from Term: A Randomised Controlled Study

Objective This study was undertaken to test the effects of acupuncture on insomnia in a group of pregnant women under real life conditions, and to compare the results with a group of patients undergoing conventional treatment alone (sleep hygiene). Methods A total of 30 conventionally treated pregnant women were allocated at random into groups with or without acupuncture. Seventeen patients formed the study group and 13 the control group. The pregnant women scored the severity of insomnia using a Numerical Rating Scale from 0 to 10. Women were followed up for eight weeks and interviewed five times, at two-week intervals. Results Eight women dropped out, five in the study group and three in the control group. The study group reported a larger reduction on insomnia rating (5.1) than the control group (0.0), a difference which was statistically significant (P=0.0028). Average insomnia scores decreased by at least 50% over time in nine (75%) patients in the study group and in three (30%) of the control group. Conclusion The results of this study suggest that acupuncture alleviates insomnia during pregnancy and further research is justified.

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Improved pregnant women’s understanding of research information by an enhanced informed consent form: a randomised controlled study nested in neonatal research

Archives of Disease in Childhood - Fetal and Neonatal Edition ◽

10.1136/archdischild-2017-312615 ◽

2017 ◽

Vol 103 (5) ◽

pp. F403-F407 ◽

Cited By ~ 4

Author(s):

Nut Koonrungsesomboon ◽

Chanchai Traivaree ◽

Sangkae Chamnanvanakij ◽

Pimchitr Rungtragoolchai ◽

Yawana Thanapat ◽

...

Keyword(s):

Informed Consent ◽

Pregnant Women ◽

Primary Endpoint ◽

Consent Form ◽

School Level ◽

Controlled Study ◽

Ethical Review ◽

Informed Consent Form ◽

Randomised Controlled Study ◽

Randomised Controlled

ObjectiveThis study aimed to test the applicability and effectiveness of the enhanced informed consent form (ICF) methodology, proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), in neonatal research requiring maternal consent.DesignA single-centre open-label randomised controlled study.SettingAntenatal care clinics at Phramongkutklao Hospital, Thailand.Patients234 pregnant women who were at risk of preterm labour were enrolled; 232 individuals completed the study.InterventionsThe participants were randomly assigned to read either the SIDCER ICF or the conventional ICF.Main outcome measuresThe participants’ understanding of essential trial-related information was assessed using 25 closed-ended questions. The primary endpoint was the proportion of the participants who obtained the satisfactory level of understanding at 80% (score of ≥20/25).Results72.5% (87/120) of the participants in the SIDCER ICF group and 59.8% (67/112) of the conventional ICF group achieved the primary endpoint (relative risk (RR)=1.212, 95% CI 1.005 to 1.462, p=0.041). The superiority of the SIDCER ICF over the conventional ICF was significant, particularly among the participants whose education was at the high school level or below (63.5% vs 44.1%, RR=1.441, 95% CI 1.022 to 2.030, p=0.031).ConclusionsThe SIDCER ICF methodology is applicable to neonatal research requiring maternal consent. The SIDCER ICF significantly improved the understanding of pregnant women, particularly among those with lower levels of education. The present study confirms the value of the SIDCER ICF methodology in research involving individuals with a limited academic background.

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