NCT04780087

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2020

Completed
22 days until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2023

Completed
Last Updated

April 2, 2024

Status Verified

April 1, 2024

Enrollment Period

2.6 years

First QC Date

October 10, 2020

Last Update Submit

April 1, 2024

Conditions

Keywords

PregnancyPowerliftingWeightliftingFemale athleteFertilityDeliveryMaternity leaveResistance exercise training

Outcome Measures

Primary Outcomes (19)

  • Delivery week

    The selfreported pregnancy week for delivery

    At delivery time

  • Delivery method

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

    At delivery time

  • Pregnancy complications at 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)

    During pregnancy up to week 23

  • Pregnancy complications at week 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)

    Pregnancy week 23 to 30

  • Pregnancy complications at week 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)

    Pregnancy week 30 to 40

  • Childs weight at birth

    The weight of the child

    At delivery time

  • Childs length at birth

    The length of the child

    At delivery time

  • Apgar score 5 minutes

    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.

    At delivery time (5 minutes post-delivery)

  • Miscarriage

    Number of miscarriages

    Previous and up to October 2023

  • Urinary incontinence 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)

    Any experience before pregnancy

  • Urinary incontinence during pregnancy

    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)

    At pregnancy week 23, 30 and 40

  • Urinary incontinence after delivery

    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)

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

  • Anal insufficiency before pregnancy

    Number of participants reporting any challenges with fecal incontinence

    Any experience before pregnancy

  • Anal insufficiency during pregnancy

    Number of participants reporting any challenges with fecal incontinence

    At pregnancy week 23, 30 and 40

  • Anal insufficiency after delivery

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

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

  • Injuries 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

    During pregnancy up to week 23

  • Injuries during pregnancy, up to week 30

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

    Pregnancy week 23 to 30

  • Injuries during pregnancy, up to week 40

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

    Pregnancy week 30 to 40

  • Analgesic during delivery

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

    At delivery time

Secondary Outcomes (18)

  • Body weight at week 23

    Pregnancy week 23

  • Body weight at week 30

    Pregnancy week 30

  • Body weight at week 40

    Pregnancy week 40

  • Body weight post-delivery, 1month

    Postpartum, 1 month after delivery

  • Body weight post-delivery, 3 months

    Postpartum, 3 months after delivery

  • +13 more secondary outcomes

Other Outcomes (5)

  • Use of supplements

    At pregnancy week 23, 30 and 40, and at 1 month-, 3months-, 6 months- and 12 months postdelivery,

  • Use of caffein (coffee, energydrinks, sodawater)

    At pregnancy week 23, 30 and 40, and at 1 month-, 3months-, 6 months- and 12 months postdelivery,

  • Intake of alcohol

    At pregnancy week 23, 30 and 40, and at 1 month-, 3months-, 6 months- and 12 months postdelivery,

  • +2 more other outcomes

Study Arms (2)

Weight lifting women

Experienced resistance exercise trained and pregnant women

Reference women

Physically active pregnant women (not experienced with free weight lifting)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBased on sex, as this study evaluates the effects from resistance exercise training on pregnancy outcomes
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Therese Fostervold Mathisen

Fredrikstad, 1671, Norway

Location

Study Officials

  • Therese F Mathisen, PhD

    Østfold University College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 10, 2020

First Posted

March 3, 2021

Study Start

November 1, 2020

Primary Completion

June 25, 2023

Study Completion

June 25, 2023

Last Updated

April 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Data are kept within the research group

Locations