Clinical trial NCT04780087: Pregnant Women Doing Resistance Exercise Training
Official title: Experiences by Pregnant Power Athletes, and Health Related Outcomes in Mother and Infants, After Resistance Exercise Training During Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
Keywords: Pregnancy
Powerlifting
Weightlifting
Female athlete
Fertility
Delivery
Maternity leave
Resistance exercise training
Lead sponsor: Ostfold University College
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women included in "group of interest" are pregnant women who are experienced in heavy, free-weigth resistance exercise training (i.e. powerlifter, weightlifter, cross fit) who aim to continue exercise training during pregnancy.

Reference group are pregnant women with no experience in heavy, free-weight resistance exercise, but who are regurlarly physically active in any sport activity (at least 2 times per week), and who aim to continue to exercise during pregnancy.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Delivery week
timeFrame: At delivery time
measure: Delivery method
timeFrame: At delivery time
measure: Pregnancy complications at week 23
timeFrame: During pregnancy up to week 23
measure: Pregnancy complications at week 30
timeFrame: Pregnancy week 23 to 30
measure: Pregnancy complications at week 40
timeFrame: Pregnancy week 30 to 40
measure: Childs weight at birth
timeFrame: At delivery time
measure: Childs length at birth
timeFrame: At delivery time
measure: Apgar score 5 minutes
timeFrame: At delivery time (5 minutes post-delivery)
measure: Miscarriage
timeFrame: Previous and up to October 2023
measure: Urinary incontinence before pregnancy
timeFrame: Any experience before pregnancy
measure: Urinary incontinence during pregnancy
timeFrame: At pregnancy week 23, 30 and 40
measure: Urinary incontinence after delivery
timeFrame: Post-delivery: 1 month-, 3months-, 6 months- and 12 months
measure: Anal insufficiency before pregnancy
timeFrame: Any experience before pregnancy
measure: Anal insufficiency during pregnancy
timeFrame: At pregnancy week 23, 30 and 40
measure: Anal insufficiency after delivery
timeFrame: Post-delivery: 1 month-, 3months-, 6 months- and 12 months
measure: Injuries during pregnancy up to week 23
timeFrame: During pregnancy up to week 23
measure: Injuries during pregnancy, up to week 30
timeFrame: Pregnancy week 23 to 30
measure: Injuries during pregnancy, up to week 40
timeFrame: Pregnancy week 30 to 40
measure: Analgesic during delivery
timeFrame: At delivery time
Secondary outcomes:
measure: Body weight at week 23
timeFrame: Pregnancy week 23
measure: Body weight at week 30
timeFrame: Pregnancy week 30
measure: Body weight at week 40
timeFrame: Pregnancy week 40
measure: Body weight post-delivery, 1month
timeFrame: Postpartum, 1 month after delivery
measure: Body weight post-delivery, 3 months
timeFrame: Postpartum, 3 months after delivery
measure: Body weight post-delivery, 6 months
timeFrame: Postpartum, 6 months after delivery
measure: Body weight post-delivery, 12 months
timeFrame: Postpartum, 12 months after delivery
measure: Changes in external loads used in exercise training
timeFrame: During pregnancy
measure: Changes in external loads used in exercise training, up to week 23
timeFrame: During pregnancy, week 23
measure: Changes in external loads used in exercise training
timeFrame: Post-delivery: 1 month-, 3months-, 6 months- and 12 months
measure: Changes in exercise volume during pregnancy, up to week 23
timeFrame: During pregnancy, week 23
measure: Changes in exercise volume during pregnancy, up to week 30
timeFrame: During pregnancy, week 30
measure: Changes in exercise volume during pregnancy, up to week 40
timeFrame: During pregnancy, week 40
measure: Changes in exercise volume after pregnancy
timeFrame: Post-delivery: 1 month-, 3months-, 6 months- and 12 months
measure: Injuries from exercise during maternity leave
timeFrame: Post-delivery: 1 month-, 3months-, 6 months- and 12 months
measure: Fertility
timeFrame: Before pregnancy
measure: Bloodpressure
timeFrame: At pregnancy week 23, 30 and 40, and at 1 month-, 3months-, 6 months- and 12 months postdelivery,
measure: Symphysis-fundus measure
timeFrame: At pregnancy week 23, 30 and 40
Other outcomes:
measure: Use of supplements
timeFrame: At pregnancy week 23, 30 and 40, and at 1 month-, 3months-, 6 months- and 12 months postdelivery,
measure: Use of caffein (coffee, energydrinks, sodawater)
timeFrame: At pregnancy week 23, 30 and 40, and at 1 month-, 3months-, 6 months- and 12 months postdelivery,
measure: Intake of alcohol
timeFrame: At pregnancy week 23, 30 and 40, and at 1 month-, 3months-, 6 months- and 12 months postdelivery,
measure: Use of tobacco/cigarettes or snus
timeFrame: At pregnancy week 23, 30 and 40, and at 1 month-, 3months-, 6 months- and 12 months postdelivery,
measure: Use of any prescribed drugs
timeFrame: At pregnancy week 23, 30 and 40, and at 1 month-, 3months-, 6 months- and 12 months postdelivery,
Locations:
city: Fredrikstad
country: Norway
facility: Therese Fostervold Mathisen
Study officials:
affiliation: Østfold University College
name: Therese F Mathisen, PhD
role: PRINCIPAL_INVESTIGATOR
References: