- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04780087
Pregnant Women Doing Resistance Exercise Training (PREG_RET)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Fredrikstad, Norway, 1671
- Therese Fostervold Mathisen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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.
Description
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).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Weight lifting women
Experienced resistance exercise trained and pregnant women
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Reference women
Physically active pregnant women (not experienced with free weight lifting)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Delivery week
Time Frame: At delivery time
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The selfreported pregnancy week for delivery
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At delivery time
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Delivery method
Time Frame: At delivery time
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Participants report the method for delivery, choosing from natural delivery, delivery with assistance (e.g.
birth forceps, vacuum delivery), caesarean section.
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At delivery time
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Pregnancy complications at week 23
Time Frame: During pregnancy up to week 23
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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)
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During pregnancy up to week 23
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Pregnancy complications at week 30
Time Frame: Pregnancy week 23 to 30
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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)
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Pregnancy week 23 to 30
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Pregnancy complications at week 40
Time Frame: Pregnancy week 30 to 40
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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)
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Pregnancy week 30 to 40
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Childs weight at birth
Time Frame: At delivery time
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The weight of the child
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At delivery time
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Childs length at birth
Time Frame: At delivery time
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The length of the child
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At delivery time
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Apgar score 5 minutes
Time Frame: At delivery time (5 minutes post-delivery)
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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.
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At delivery time (5 minutes post-delivery)
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Miscarriage
Time Frame: Previous and up to October 2023
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Number of miscarriages
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Previous and up to October 2023
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Urinary incontinence before pregnancy
Time Frame: Any experience before pregnancy
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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)
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Any experience before pregnancy
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Urinary incontinence during pregnancy
Time Frame: At pregnancy week 23, 30 and 40
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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)
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At pregnancy week 23, 30 and 40
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Urinary incontinence after delivery
Time Frame: Post-delivery: 1 month-, 3months-, 6 months- and 12 months
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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)
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Post-delivery: 1 month-, 3months-, 6 months- and 12 months
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Anal insufficiency before pregnancy
Time Frame: Any experience before pregnancy
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Number of participants reporting any challenges with fecal incontinence
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Any experience before pregnancy
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Anal insufficiency during pregnancy
Time Frame: At pregnancy week 23, 30 and 40
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Number of participants reporting any challenges with fecal incontinence
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At pregnancy week 23, 30 and 40
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Anal insufficiency after delivery
Time Frame: Post-delivery: 1 month-, 3months-, 6 months- and 12 months
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Number of participants reporting any fecal incontinence and if it has worsened after giving birth
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Post-delivery: 1 month-, 3months-, 6 months- and 12 months
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Injuries during pregnancy up to week 23
Time Frame: During pregnancy up to week 23
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Number of participants reporting on any exercise related injuries occuring during pregnancy, choosing from a list of anatomical locations
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During pregnancy up to week 23
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Injuries during pregnancy, up to week 30
Time Frame: Pregnancy week 23 to 30
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Number of participants reporting on any exercise related injuries occuring during pregnancy, choosing from a list of anatomical locations
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Pregnancy week 23 to 30
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Injuries during pregnancy, up to week 40
Time Frame: Pregnancy week 30 to 40
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Number of participants reporting on any exercise related injuries occuring during pregnancy, choosing from a list of anatomical locations (yes/no)
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Pregnancy week 30 to 40
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Analgesic during delivery
Time Frame: At delivery time
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Number of participants reporting use of analgesic during delivery, and what type of analgesic (e.g.
nitrous oxide, epidural)
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At delivery time
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Body weight at week 23
Time Frame: Pregnancy week 23
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Participants report on body weight changes during pregnancy
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Pregnancy week 23
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Body weight at week 30
Time Frame: Pregnancy week 30
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Participants report on body weight changes during pregnancy
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Pregnancy week 30
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Body weight at week 40
Time Frame: Pregnancy week 40
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Participants report on body weight changes during pregnancy
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Pregnancy week 40
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Body weight post-delivery, 1month
Time Frame: Postpartum, 1 month after delivery
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Participants report on body weight changes after pregnancy
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Postpartum, 1 month after delivery
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Body weight post-delivery, 3 months
Time Frame: Postpartum, 3 months after delivery
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Participants report on body weight changes after pregnancy
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Postpartum, 3 months after delivery
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Body weight post-delivery, 6 months
Time Frame: Postpartum, 6 months after delivery
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Participants report on body weight changes after pregnancy
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Postpartum, 6 months after delivery
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Body weight post-delivery, 12 months
Time Frame: Postpartum, 12 months after delivery
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Participants report on body weight changes after pregnancy
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Postpartum, 12 months after delivery
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Changes in external loads used in exercise training
Time Frame: During pregnancy
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Participants report on changes in external loads used in exercise during pregnancy (% of normal loading used pre-pregnancy)
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During pregnancy
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Changes in external loads used in exercise training, up to week 23
Time Frame: During pregnancy, week 23
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Participants report on changes in external loads used in exercise during pregnancy (% of normal loading used pre-pregnancy)
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During pregnancy, week 23
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Changes in external loads used in exercise training
Time Frame: Post-delivery: 1 month-, 3months-, 6 months- and 12 months
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Participants report on changes in external loads used in exercise after pregnancy (% of normal loading used pre-pregnancy)
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Post-delivery: 1 month-, 3months-, 6 months- and 12 months
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Changes in exercise volume during pregnancy, up to week 23
Time Frame: During pregnancy, week 23
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Participants report on changes in exercise volume (number of sessions per week) during pregnancy
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During pregnancy, week 23
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Changes in exercise volume during pregnancy, up to week 30
Time Frame: During pregnancy, week 30
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Participants report on changes in exercise volume (number of sessions per week) during pregnancy
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During pregnancy, week 30
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Changes in exercise volume during pregnancy, up to week 40
Time Frame: During pregnancy, week 40
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Participants report on changes in exercise volume (number of sessions per week) during pregnancy
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During pregnancy, week 40
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Changes in exercise volume after pregnancy
Time Frame: Post-delivery: 1 month-, 3months-, 6 months- and 12 months
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Participants report on changes in exercise volume (number of sessions per week) after pregnancy
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Post-delivery: 1 month-, 3months-, 6 months- and 12 months
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Injuries from exercise during maternity leave
Time Frame: Post-delivery: 1 month-, 3months-, 6 months- and 12 months
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Reporting on any exercise related injuries occuring during maternity leave (up to 12 months post-delivery), choosing from a list of anatomical locations
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Post-delivery: 1 month-, 3months-, 6 months- and 12 months
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Fertility
Time Frame: Before pregnancy
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Reports on any fertility problems or use of fertility techniques in order to become pregnant
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Before pregnancy
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Bloodpressure
Time Frame: At pregnancy week 23, 30 and 40, and at 1 month-, 3months-, 6 months- and 12 months postdelivery,
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Bloodpressure measures, and numbers above/below clinical cut offs (having hypo-or hypertension)
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At pregnancy week 23, 30 and 40, and at 1 month-, 3months-, 6 months- and 12 months postdelivery,
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Symphysis-fundus measure
Time Frame: At pregnancy week 23, 30 and 40
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symphysis fundus measure during pregnancy; as a measure for growth of the fetus, evaluated according to national/international standards
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At pregnancy week 23, 30 and 40
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Use of supplements
Time Frame: At pregnancy week 23, 30 and 40, and at 1 month-, 3months-, 6 months- and 12 months postdelivery,
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Number of participants reporting use of dietary supplements, and what kind of supplements
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At pregnancy week 23, 30 and 40, and at 1 month-, 3months-, 6 months- and 12 months postdelivery,
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Use of caffein (coffee, energydrinks, sodawater)
Time Frame: At pregnancy week 23, 30 and 40, and at 1 month-, 3months-, 6 months- and 12 months postdelivery,
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Number of participants reporting use of caffein, and in what doses per day
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At pregnancy week 23, 30 and 40, and at 1 month-, 3months-, 6 months- and 12 months postdelivery,
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Intake of alcohol
Time Frame: At pregnancy week 23, 30 and 40, and at 1 month-, 3months-, 6 months- and 12 months postdelivery,
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Number of participants reporting intake of alcohol, and how regularly (choosing between no, daily, weekly, monthly)
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At pregnancy week 23, 30 and 40, and at 1 month-, 3months-, 6 months- and 12 months postdelivery,
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Use of tobacco/cigarettes or snus
Time Frame: At pregnancy week 23, 30 and 40, and at 1 month-, 3months-, 6 months- and 12 months postdelivery,
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Number of participants reporting any use
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At pregnancy week 23, 30 and 40, and at 1 month-, 3months-, 6 months- and 12 months postdelivery,
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Use of any prescribed drugs
Time Frame: At pregnancy week 23, 30 and 40, and at 1 month-, 3months-, 6 months- and 12 months postdelivery,
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Number of participants reporting any use, and what type of drug
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At pregnancy week 23, 30 and 40, and at 1 month-, 3months-, 6 months- and 12 months postdelivery,
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Therese F Mathisen, PhD, Østfold University College
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 170066
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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