PregnancyNCT03348332
Effect During Pregnancy and Intrapartum Health
A study testing Exercise pregnant women in people with Pregnancy, run by Technical University of Madrid at 1 site in Spain.
Trial summary
Assessing the role of moderate exercise in newborn intrapartum variables have showed to be crucial not only on prescribing exercise safely, but also on understanding its impact on the prevention of some cardio-metabolic diseases after labor. 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
- What is being tested?
- Exercise pregnant women
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2012to Sep 2016
- Phase
- Interventional
- 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
Who may be able to join
- Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines.
- Being able to communicate in spanish
- Giving birth at Hospital Universitario de Puerta de Hierro (Majadahonda); Hospital Universitario Severo Ochoa (Leganés).
Who cannot join
- Multiparity
- Obstetrician complications
- Being interested in the study after 18 weeks
- Not being regular in physical exercise program
- Younger than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Supervised Exercise During Pregnancy on Maternal and Newborn Intrapartum Health
Assessing the role of moderate exercise in newborn intrapartum variables have showed to be crucial not only on prescribing exercise safely, but also on understanding its impact on the prevention of some cardio-metabolic diseases after labor. Clarify this concept will be essential on reducing human risk for some chronic diseases through implementing supervised exercise programs during such a critical period.
Read the detailed description
The aim of this randomized controlled trial was to evaluate the effect of combined exercise (aerobic and strength exercise) on maternal and newborn intrapartum variables.
- Conditions
- Pregnancy
- Being tested
- Exercise pregnant women
- Keywords
- exercise, intrapartum, aerobic exercise, resistance exercise, wellbeing
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise pregnant womenBehavioural
A supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 10 to 39) was conducted. Each session consisted of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training. Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60 of maximal heart rate. All subjects wore a heart rate (HR) monitor during the training sessions to control the intensity.
| Study group | Role | What they receive |
|---|---|---|
| Sedentary pregnant women | No intervention | Pregnant women who do not exercise regularly during pregnancy |
| Exercise pregnant women | Experimental | Pregnant women who participate in a supervised exercise program Receives: Behavioral: Exercise pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage of labor
Duration stages of labor (min)
Measured: At the moment of delivery
Secondary outcomes (5)
Maternal gestational weight gain
Change from baseline in maternal gestational weight gain (g)
Measured: 40-42 weeks of gestation
Glucose state
Maternal glucose state (O´Sullivan test)
Measured: 24-26 weeks of gestation
Blood pressure
Maternal blood pressure during pregnancy (mmHg)
Measured: 12, 20 and 34 weeks of gestation
Gestational age
Gestational age (weeks)
Measured: At the moment of delivery
Birth weight
Newborn weight (g)
Measured: At the moment of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study startMar 2012
- Primary completionJun 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Perales Santaella, Technical University of Madrid
- Investigators
- Ruben Barakat Carballo, PhD, Study director, Universidad Politecnica de MadridMaría Perales Santaella, PhD, Principal investigator, Universidad Politecnica de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348332
- Sponsor's protocol ID
- Intrapartum assessment
- Status last verified
- Nov 2017
- First submitted
- 16 Nov 2017
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Supervised Exercise During Pregnancy on Maternal and Newborn Intrapartum Health
- ClinicalTrials.gov ID
- NCT03348332
- Acronym / sponsor ID
- Intrapartum assessment
- Conditions
- Pregnancy
- Keywords
- exercise, intrapartum, aerobic exercise, resistance exercise, wellbeing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- Technical University of MadridUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 20 Nov 2017 (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.
Assessing the role of moderate exercise in newborn intrapartum variables have showed to be crucial not only on prescribing exercise safely, but also on understanding its impact on the prevention of some cardio-metabolic diseases after labor. Clarify this concept will be essential on reducing human risk for some chronic diseases through implementing supervised exercise programs during such a critical period.
Detailed description
The aim of this randomized controlled trial was to evaluate the effect of combined exercise (aerobic and strength exercise) on maternal and newborn intrapartum variables.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedentary pregnant women | No intervention | –Pregnant women who do not exercise regularly during pregnancy |
| Exercise pregnant women | Experimental | Behavioral: Exercise pregnant womenPregnant women who participate in a supervised exercise program |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines.
- Being able to communicate in spanish
- Giving birth at Hospital Universitario de Puerta de Hierro (Majadahonda); Hospital Universitario Severo Ochoa (Leganés).
Key exclusion criteria (5 listed)
- Multiparity
- Obstetrician complications
- Being interested in the study after 18 weeks
- Not being regular in physical exercise program
- Younger than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise pregnant womenA supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 10 to 39) was conducted. Each session consisted of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training. Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60 of maximal heart rate. All subjects wore a heart rate (HR) monitor during the training sessions to control the intensity. | Behavioural | Exercise pregnant women |
Primary outcome
Stage of labor
Time frame: At the moment of delivery
Duration stages of labor (min)
5 secondary outcomes
Maternal gestational weight gain
Time frame: 40-42 weeks of gestation
Glucose state
Time frame: 24-26 weeks of gestation
Blood pressure
Time frame: 12, 20 and 34 weeks of gestation
Gestational age
Time frame: At the moment of delivery
Birth weight
Time frame: At the moment of delivery
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 20 Nov 2017.
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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.
Ruben Barakat Carballo, PhD study director
Universidad Politecnica de Madrid
María Perales Santaella, PhD principal investigator
Universidad Politecnica de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise pregnant women in people with Pregnancy, run by Technical University of Madrid at 1 site in Spain.
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 5 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 20 Nov 2017. 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 Spain. 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?
Stage of labor (time frame: At the moment of delivery). 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 20 Nov 2017.