Pregnancy RelatedPREG_RETNCT04780087
Pregnant Women Doing Resistance Exercise Training
An observational study of Pregnancy Related, run by Ostfold University College at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- How many people
- 53 participants
- Where
- 1 siteNorway
- Study dates
- 1 Nov 2020to 25 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- Any known metabolic condition or contraindication on doing physical activity during pregnancy (i.e. miscarriages, bleedings).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Experiences by Pregnant Power Athletes, and Health Related Outcomes in Mother and Infants, After Resistance Exercise Training During Pregnancy
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.
Read the 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.
- Conditions
- Pregnancy Related
- Keywords
- Pregnancy, Powerlifting, Weightlifting, Female athlete, Fertility, Delivery, Maternity leave, Resistance exercise training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Weight lifting women | Experienced resistance exercise trained and pregnant women | |
| Reference women | Physically active pregnant women (not experienced with free weight lifting) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery week
The selfreported pregnancy week for delivery
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Pregnancy week 30 to 40
Childs weight at birth
The weight of the child
Measured: At delivery time
Childs length at birth
The length of the child
Measured: 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.
Measured: At delivery time (5 minutes post-delivery)
Miscarriage
Number of miscarriages
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Post-delivery: 1 month-, 3months-, 6 months- and 12 months
Anal insufficiency before pregnancy
Number of participants reporting any challenges with fecal incontinence
Measured: Any experience before pregnancy
Anal insufficiency during pregnancy
Number of participants reporting any challenges with fecal incontinence
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: At delivery time
Secondary outcomes (18)
Body weight at week 23
Participants report on body weight changes during pregnancy
Measured: Pregnancy week 23
Body weight at week 30
Participants report on body weight changes during pregnancy
Measured: Pregnancy week 30
Body weight at week 40
Participants report on body weight changes during pregnancy
Measured: Pregnancy week 40
Body weight post-delivery, 1month
Participants report on body weight changes after pregnancy
Measured: Postpartum, 1 month after delivery
Body weight post-delivery, 3 months
Participants report on body weight changes after pregnancy
Measured: Postpartum, 3 months after delivery
Body weight post-delivery, 6 months
Participants report on body weight changes after pregnancy
Measured: Postpartum, 6 months after delivery
Body weight post-delivery, 12 months
Participants report on body weight changes after pregnancy
Measured: Postpartum, 12 months after delivery
Changes in external loads used in exercise training
Participants report on changes in external loads used in exercise during pregnancy (% of normal loading used pre-pregnancy)
Measured: During pregnancy
Changes in external loads used in exercise training, up to week 23
Participants report on changes in external loads used in exercise during pregnancy (% of normal loading used pre-pregnancy)
Measured: During pregnancy, week 23
Changes in external loads used in exercise training
Participants report on changes in external loads used in exercise after pregnancy (% of normal loading used pre-pregnancy)
Measured: Post-delivery: 1 month-, 3months-, 6 months- and 12 months
Changes in exercise volume during pregnancy, up to week 23
Participants report on changes in exercise volume (number of sessions per week) during pregnancy
Measured: During pregnancy, week 23
Changes in exercise volume during pregnancy, up to week 30
Participants report on changes in exercise volume (number of sessions per week) during pregnancy
Measured: During pregnancy, week 30
Changes in exercise volume during pregnancy, up to week 40
Participants report on changes in exercise volume (number of sessions per week) during pregnancy
Measured: During pregnancy, week 40
Changes in exercise volume after pregnancy
Participants report on changes in exercise volume (number of sessions per week) after pregnancy
Measured: Post-delivery: 1 month-, 3months-, 6 months- and 12 months
Injuries from exercise during maternity leave
Reporting on any exercise related injuries occuring during maternity leave (up to 12 months post-delivery), choosing from a list of anatomical locations
Measured: Post-delivery: 1 month-, 3months-, 6 months- and 12 months
Fertility
Reports on any fertility problems or use of fertility techniques in order to become pregnant
Measured: Before pregnancy
Bloodpressure
Bloodpressure measures, and numbers above/below clinical cut offs (having hypo-or hypertension)
Measured: At pregnancy week 23, 30 and 40, and at 1 month-, 3months-, 6 months- and 12 months postdelivery,
Symphysis-fundus measure
symphysis fundus measure during pregnancy; as a measure for growth of the fetus, evaluated according to national/international standards
Measured: At pregnancy week 23, 30 and 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start1 Nov 2020
- Primary completion25 Jun 2023
- Study completion25 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostfold University College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Therese Fostervold Mathisen, Ostfold University College
- Investigators
- Therese F Mathisen, PhD, Principal investigator, Østfold University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780087
- Sponsor's protocol ID
- 170066
- Acronym
- PREG_RET
- Status last verified
- Apr 2024
- First submitted
- 10 Oct 2020
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are kept within the research group
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experiences by Pregnant Power Athletes, and Health Related Outcomes in Mother and Infants, After Resistance Exercise Training During Pregnancy
- ClinicalTrials.gov ID
- NCT04780087
- Acronym / sponsor ID
- PREG_RET / 170066
- Conditions
- Pregnancy Related
- Keywords
- Pregnancy, Powerlifting, Weightlifting, Female athlete, Fertility, Delivery, Maternity leave, Resistance exercise training
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Ostfold University CollegeUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 25 Jun 2023 (actual)
- Study completion
- 25 Jun 2023 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight lifting women | – | –Experienced resistance exercise trained and pregnant women |
| Reference women | – | –Physically active pregnant women (not experienced with free weight lifting) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Any known metabolic condition or contraindication on doing physical activity during pregnancy (i.e. miscarriages, bleedings).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Delivery week
Time frame: At delivery time
The selfreported pregnancy week for delivery
Delivery method
Time frame: 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
Time frame: 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)
Pregnancy complications at week 30
Time frame: 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)
Pregnancy complications at week 40
Time frame: 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
Time frame: At delivery time
The weight of the child
Childs length at birth
Time frame: At delivery time
The length of the child
Apgar score 5 minutes
Time frame: 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.
Miscarriage
Time frame: Previous and up to October 2023
Number of miscarriages
Urinary incontinence before pregnancy
Time frame: 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)
Urinary incontinence during pregnancy
Time frame: 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)
Urinary incontinence after delivery
Time frame: 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)
Anal insufficiency before pregnancy
Time frame: Any experience before pregnancy
Number of participants reporting any challenges with fecal incontinence
Anal insufficiency during pregnancy
Time frame: At pregnancy week 23, 30 and 40
Number of participants reporting any challenges with fecal incontinence
Anal insufficiency after delivery
Time frame: 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 23
Time frame: 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 30
Time frame: Pregnancy week 23 to 30
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
Time frame: 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)
Analgesic during delivery
Time frame: At delivery time
Number of participants reporting use of analgesic during delivery, and what type of analgesic (e.g. nitrous oxide, epidural)
18 secondary outcomes
Body weight at week 23
Time frame: Pregnancy week 23
Body weight at week 30
Time frame: Pregnancy week 30
Body weight at week 40
Time frame: Pregnancy week 40
Body weight post-delivery, 1month
Time frame: Postpartum, 1 month after delivery
Body weight post-delivery, 3 months
Time frame: Postpartum, 3 months after delivery
Body weight post-delivery, 6 months
Time frame: Postpartum, 6 months after delivery
Body weight post-delivery, 12 months
Time frame: Postpartum, 12 months after delivery
Changes in external loads used in exercise training
Time frame: During pregnancy
Changes in external loads used in exercise training, up to week 23
Time frame: During pregnancy, week 23
Changes in external loads used in exercise training
Time frame: Post-delivery: 1 month-, 3months-, 6 months- and 12 months
Changes in exercise volume during pregnancy, up to week 23
Time frame: During pregnancy, week 23
Changes in exercise volume during pregnancy, up to week 30
Time frame: During pregnancy, week 30
Changes in exercise volume during pregnancy, up to week 40
Time frame: During pregnancy, week 40
Changes in exercise volume after pregnancy
Time frame: Post-delivery: 1 month-, 3months-, 6 months- and 12 months
Injuries from exercise during maternity leave
Time frame: Post-delivery: 1 month-, 3months-, 6 months- and 12 months
Fertility
Time frame: Before pregnancy
Bloodpressure
Time frame: At pregnancy week 23, 30 and 40, and at 1 month-, 3months-, 6 months- and 12 months postdelivery,
Symphysis-fundus measure
Time frame: At pregnancy week 23, 30 and 40
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: No. Data are kept within the research group
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Therese F Mathisen, PhD principal investigator
Østfold University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by Ostfold University College at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delivery week (time frame: At delivery time). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.