ClinicalTrials.gg
CompletedNCT03348332Updated Nov 20, 2017

Effect During Pregnancy and Intrapartum Health

An interventional study of Exercise pregnant women in Pregnancy, sponsored by Technical University of Madrid. Completed at 1 site in Spain. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-20.

Sponsored by Technical University of Madrid · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 5 years 8 months after the study started (first participant enrolled Mar 2012, registered Nov 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
530
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 594 studies in Motor Activity with a site in Spain — 147 open to participants now, 183 under way, 1 of them phase 3. Motor Activity · Spain.

Enrollment
33rd of 537
530 · median 80
Started
2012
with 7 others
No phase
513 of 594
125 open now
Registered
116th of 594
by date

Among the 594 studies in Motor Activity with a site in Spain, this one is the 33rd largest by enrollment of the 537 interventional ones that give a count, is one of 8 that started in 2012, is one of 513 with no phase, and was the 116th registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

147 of the 594 studies in Motor Activity with a site in Spain are open now. Recruiting first, the newest first:

142 more — sign in →

All 147 open studies →

A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 18 Years to 45 Years · female · healthy volunteers too.

The full table on the hub →

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02

Study 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. 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.

03

Conditions studied

  • Pregnancy

Browse trials for

Keywords

  • exercise
  • intrapartum
  • aerobic exercise
  • resistance exercise
  • wellbeing
04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • Multiparity
  • Obstetrician complications
  • Being interested in the study after 18 weeks
  • Not being regular in physical exercise program
  • Younger than 18 years old
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
530 participants (actual)

Study arms

  • No intervention
    Sedentary pregnant women

    Pregnant women who do not exercise regularly during pregnancy

  • Experimental
    Exercise pregnant women

    Pregnant women who participate in a supervised exercise program

    Behavioral: Exercise pregnant women

Interventions

  • BehavioralExercise pregnant women

    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.

06

What researchers measure

Primary outcomes

  1. Stage of labor

    Duration stages of labor (min)

    Time frame: At the moment of delivery

Secondary outcomes

  1. Maternal gestational weight gain

    Change from baseline in maternal gestational weight gain (g)

    Time frame: 40-42 weeks of gestation

  2. Glucose state

    Maternal glucose state (O´Sullivan test)

    Time frame: 24-26 weeks of gestation

  3. Blood pressure

    Maternal blood pressure during pregnancy (mmHg)

    Time frame: 12, 20 and 34 weeks of gestation

  4. Gestational age

    Gestational age (weeks)

    Time frame: At the moment of delivery

  5. Birth weight

    Newborn weight (g)

    Time frame: At the moment of delivery

07

Study locations

1 site
  • Universidad Politécnica de Madrid
    Madrid, 28040, Spain
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2012 to primary completion in Jun 2015, 39 months.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 39 months is above that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 16, 2017
First posted
Nov 20, 2017
StartActual
Mar 2012
Primary completionActual
Jun 2015
CompletionActual
Sep 2016
Last update
Nov 20, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03348332
Lead sponsor
Technical University of Madrid
Responsible party
María Perales Santaella (PhD, Technical University of Madrid) — Principal investigator
First posted
Nov 20, 2017
Start date
Mar 2012
Primary completion
Jun 2015
Completion
Sep 2016
Last update
Nov 20, 2017

Study contacts

Ruben Barakat Carballo, PhD
study director · Universidad Politecnica de Madrid
María Perales Santaella, PhD
principal investigator · Universidad Politecnica de Madrid

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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