title: Efficacy of advice from healthcare professionals to pregnant women on avoiding constrictive clothing around the trunk: a study protocol for a randomised controlled trial.
abstract: BACKGROUND
  As a component of midwife care, eliminating clothing that constricts the trunk has been shown to markedly elevate the uterine fundus, soften the uterus and abdomen, and reduce the abdominal wall tension in women admitted to hospital due to the risk of miscarriage or premature delivery. However, no prospective study has conclusively verified the efficacy of avoiding constrictive clothes around the trunk in pregnant women. We aim to verify the efficacy of instructing pregnant women to wear loose clothing that does not constrict the trunk to reduce the risk of premature birth and improve quality of life (QoL) during pregnancy.
  
  
  METHODS
  We will conduct a randomised controlled trial of pregnant women scheduled to deliver at the National Center for Child Health and Development in Tokyo, Japan. A total of 616 pregnant women, from whom written informed consent will be obtained, will be allocated randomly to an intervention group or a control group. Women in the control group will be provided with anaemia prevention leaflets at 20 weeks' gestation and skin-care leaflets at 30 weeks' gestation. Women in the intervention group will be provided with the same leaflets and will also receive health advice from health professionals to avoid constrictive clothing around the trunk. The primary outcome will be a difference between these groups in the frequency of any one of the following category variables: (1) cervical length <30 mm up to 28 weeks' gestation, (2) hospital admission for threatened premature delivery, or (3) premature delivery. Secondary outcomes will include QoL during pregnancy, maternal state of health, and status of fetal development.
  
  
  BACKGROUND
  The Institutional Review Board and Ethics Committee at the National Center for Child Health and Development, Japan, has approved this study. Our findings will be widely disseminated through conference presentations and peer-reviewed publications.
  
  
  BACKGROUND
  UMIN000016853.
authors.affiliation: Department of Health Policy, National Center for Child Health and Development, Tokyo, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Takehara
authors.affiliation: Department of Nursing, National Center for Child Health and Development, Tokyo, Japan.
authors.forename: Sachiko
authors.initials: S
authors.lastname: Kato
authors.affiliation: Division of Obstetrics, Center of Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan.
authors.forename: Aiko
authors.initials: A
authors.lastname: Sasaki
authors.affiliation: Division of Obstetrics, Center of Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan.
authors.forename: Seung Chik
authors.initials: SC
authors.lastname: Jwa
authors.affiliation: Division of Bioethics, National Center for Child Health and Development, Tokyo, Japan.
authors.forename: Naoko
authors.initials: N
authors.lastname: Kakee
authors.affiliation: Division of Obstetrics, Center of Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan.
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Sago
authors.affiliation: Department of Nursing, National Center for Child Health and Development, Tokyo, Japan.
authors.forename: Yuko
authors.initials: Y
authors.lastname: Noguchi
authors.affiliation: Department of Nursing, National Center for Child Health and Development, Tokyo, Japan.
authors.forename: Tomoko
authors.initials: T
authors.lastname: Aoki
authors.affiliation: Department of Education for Clinical Research, National Center for Child Health and Development, Tokyo, Japan.
authors.forename: Eisuke
authors.initials: E
authors.lastname: Inoue
authors.affiliation: Department of Nursing, National Center for Child Health and Development, Tokyo, Japan.
authors.forename: Chieko
authors.initials: C
authors.lastname: Nitta
authors.affiliation: Department of Nursing, National Center for Child Health and Development, Tokyo, Japan.
authors.forename: Yumiko
authors.initials: Y
authors.lastname: Ishii
mesh_terms: D000328:Adult; D003020:Clothing / Q000009:adverse effects*; D037001:Directive Counseling; D005260:Female; D015438:Health Behavior; D006801:Humans; D007564:Japan / Q000453:epidemiology; D011247:Pregnancy; D011248:Pregnancy Complications / Q000517:prevention & control*; D037841:Pregnant People / Q000523:psychology*; D011295:Prenatal Care / Q000379:methods*; D011446:Prospective Studies; D011788:Quality of Life / Q000523:psychology*; D014041:Tokyo / Q000453:epidemiology
keywords: EPIDEMIOLOGY; PREVENTIVE MEDICINE