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临床试验/NCT04780087
NCT04780087已完成不适用

Experiences by Pregnant Power Athletes, and Health Related Outcomes in Mother and Infants, After Resistance Exercise Training During Pregnancy

Ostfold University College1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
53
试验地点
1
主要终点
Urinary incontinence during pregnancy

研究概览

简要总结

Despite the increase in numbers of women who engage in heavy, free-weight resistance exercise training (e.g. powerlifting, weightlifting, cross fit), the knowledge on how such exercise may affect fertility, pregnancy and birth outcomes is poor. Based on observational and associational studies of pregnant women in labour, recommendations are not to lift more than 11 kg in external load after mid-term, or to lift more than a total of 100 kg during a day. Ignoring such recommendations is associated to increased risk of miscarriage and preeclampsia, and of low birthweight and premature birth, respectively. As such, fit women who continue to exercise during pregnancy, are met with scepticism and warnings, resulting in shame and insecurity. Such attitudes may also result in physical inactivity during pregnancy, being on the contrary of what is recommended for a healthy pregnancy and delivery. Elite athletes may additionally be deprived from an early return to sport if not being able to keep exercise intensity close to pre-pregnancy period. With poor knowledge on how fit, strong women respond to high external loads during pregnancy exercise, recommendations are to follow the general guidelines.

The aim of this observational study, is to explore how regular resistance exercise training may affect fertility, and how high external loads in resistance exercise training during pregnancy in resistance trained women affect; a)their pregnancy and birth outcome, and b)health of the women and their children up to 12 months post-delivery.

详细描述

Pregnant women who are experienced in heavy, free-weight resistance exercise training, and who choose to continue their exercise regimes during pregnancy, are recruited in social media to regularly respond to an online questionnaire on personal health, foetus development, and the newborn child health.

A reference group of pregnant women being regularly physical active (still not lifting free weights of high loads) are concurrently recruited.

All will respond to questionnaire at mid-term, and week 23, 30 and 40 of pregnancy. During maternity leave the women will be asked to respond to questionnaires at 1 month, 3 months, 6 months and 12 months post-delivery.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Being pregnant
  • Group of interest: Being experienced with heavy, free-weight resistance exercise training, and aiming to continue exercise at comparable level during pregnancy
  • Reference group: being regularly physical active before pregnancy (i.e. at least 2 work- outs per week), but not experienced in heavy, free-weight resistance exercise training

排除标准

  • Any known metabolic condition or contraindication on doing physical activity during pregnancy (i.e. miscarriages, bleedings).

结局指标

主要结局

Urinary incontinence during pregnancy

时间窗: At pregnancy week 23, 30 and 40

Number of participants reporting any urinary incontinence, and if it occurs; if it is only during increased abdominal pressure (coughing, laughing), or heavy lifting (choosing from a list of "always", only during increased abdominal pressure, only during lifting of heavy load)

Anal insufficiency before pregnancy

时间窗: Any experience before pregnancy

Number of participants reporting any challenges with fecal incontinence

Delivery method

时间窗: At delivery time

Participants report the method for delivery, choosing from natural delivery, delivery with assistance (e.g. birth forceps, vacuum delivery), caesarean section.

Pregnancy complications at week 23

时间窗: During pregnancy up to week 23

Number of participants who report any complications during pregnancy, choosing from a list of alternatives (yes/no) (preeclampsia, nausea, fatigue, low back pain, pelvic pain, constipation, mood swings, birth anxiety, gestational depression, anemia, hypertension, pregnancy diabetes, foetus growth retardation)

Apgar score 5 minutes

时间窗: At delivery time (5 minutes post-delivery)

The Apgar score 5 minutes post-delivery. This test checks a baby's heart rate, muscle tone, and other signs to see if extra medical care or emergency care is needed. The test is usually given twice: once at 1 minute after birth, and again at 5 minutes after birth. Scores below 4 indicates need for lifesaving measures, and higher scores indicates better health.

Childs length at birth

时间窗: At delivery time

The length of the child

Miscarriage

时间窗: Previous and up to October 2023

Number of miscarriages

Pregnancy complications at week 40

时间窗: Pregnancy week 30 to 40

Number of participants who report any complications during pregnancy, choosing from a list of alternatives (yes/no) (preeclampsia, nausea, fatigue, low back pain, pelvic pain, constipation, mood swings, birth anxiety, gestational depression, anemia, hypertension, pregnancy diabetes, foetus growth retardation)

Childs weight at birth

时间窗: At delivery time

The weight of the child

Urinary incontinence after delivery

时间窗: Post-delivery: 1 month-, 3months-, 6 months- and 12 months

Number of participants reporting any urinary incontinence, and if it occurs; if it is only during increased abdominal pressure (coughing, laughing), or heavy lifting (choosing from a list of "always", only during increased abdominal pressure, only during lifting of heavy load)

Delivery week

时间窗: At delivery time

The selfreported pregnancy week for delivery

Pregnancy complications at week 30

时间窗: Pregnancy week 23 to 30

Number of participants who report any complications during pregnancy, choosing from a list of alternatives (yes/no) (preeclampsia, nausea, fatigue, low back pain, pelvic pain, constipation, mood swings, birth anxiety, gestational depression, anemia, hypertension, pregnancy diabetes, foetus growth retardation)

Anal insufficiency during pregnancy

时间窗: At pregnancy week 23, 30 and 40

Number of participants reporting any challenges with fecal incontinence

Injuries during pregnancy up to week 23

时间窗: During pregnancy up to week 23

Number of participants reporting on any exercise related injuries occuring during pregnancy, choosing from a list of anatomical locations

Injuries during pregnancy, up to week 40

时间窗: Pregnancy week 30 to 40

Number of participants reporting on any exercise related injuries occuring during pregnancy, choosing from a list of anatomical locations (yes/no)

Urinary incontinence before pregnancy

时间窗: Any experience before pregnancy

Number of participants reporting any challenges with urinary incontinence, and if it occurs; if it is only during increased abdominal pressure (coughing, laughing), or heavy lifting (choosing from a list of "always", only during increased abdominal pressure, only during lifting of heavy load)

Analgesic during delivery

时间窗: At delivery time

Number of participants reporting use of analgesic during delivery, and what type of analgesic (e.g. nitrous oxide, epidural)

Anal insufficiency after delivery

时间窗: Post-delivery: 1 month-, 3months-, 6 months- and 12 months

Number of participants reporting any fecal incontinence and if it has worsened after giving birth

Injuries during pregnancy, up to week 30

时间窗: Pregnancy week 23 to 30

Number of participants reporting on any exercise related injuries occuring during pregnancy, choosing from a list of anatomical locations

次要结局

  • Fertility(Before pregnancy)
  • Body weight at week 40(Pregnancy week 40)
  • Changes in exercise volume during pregnancy, up to week 30(During pregnancy, week 30)
  • Bloodpressure(At pregnancy week 23, 30 and 40, and at 1 month-, 3months-, 6 months- and 12 months postdelivery,)
  • Changes in exercise volume during pregnancy, up to week 40(During pregnancy, week 40)
  • Changes in external loads used in exercise training, up to week 23(During pregnancy, week 23)
  • Body weight post-delivery, 1month(Postpartum, 1 month after delivery)
  • Body weight post-delivery, 3 months(Postpartum, 3 months after delivery)
  • Body weight post-delivery, 6 months(Postpartum, 6 months after delivery)
  • Changes in exercise volume after pregnancy(Post-delivery: 1 month-, 3months-, 6 months- and 12 months)
  • Body weight at week 23(Pregnancy week 23)
  • Body weight at week 30(Pregnancy week 30)
  • Injuries from exercise during maternity leave(Post-delivery: 1 month-, 3months-, 6 months- and 12 months)
  • Body weight post-delivery, 12 months(Postpartum, 12 months after delivery)
  • Changes in external loads used in exercise training(Post-delivery: 1 month-, 3months-, 6 months- and 12 months)
  • Changes in exercise volume during pregnancy, up to week 23(During pregnancy, week 23)
  • Symphysis-fundus measure(At pregnancy week 23, 30 and 40)

研究者

发起方
Ostfold University College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Therese Fostervold Mathisen

Associate Professor

Ostfold University College

研究点 (1)

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