Clinical trial NCT01477372: Effect of Physical Exercise Program During Pregnancy on Excessive Weight Gain and Its Consequences
Official title: Effect of Physical Exercise Program During Pregnancy on Excessive Weight Gain and Its Consequences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Pregnancy
Exercise
Excessive weight gain
Outcomes
Urinary incontinence
Lead sponsor: Universidad Politecnica de Madrid
Sponsor class: OTHER
First posted: 2011-11-22
Enrollment: 320
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to assess the effectiveness of a moderated physical exercise program called Blooming Exercise Program (BEP) developed during pregnancy in order to control excessive maternal weight gain and its consequences. Additionally, other objectives of the study were to analyse the influence of BEP on urinary incontinence, on the other pregnancy outcomes and on the perception of the pregnant's health

Detailed description: BACKROUND: Pregnancy and delivery can condition significantly women's health. In particular, an excessive gain of weight during pregnancy constitutes a risk factor which may lead to (i) different alterations during pregnancy such as gestational diabetes or hypertension, (ii) foetus health problems (macrosomia), (iii) delivery complications (dystocia, prolonged labour and increased number of caesareans) and (iv) future health disorders for the woman (overweight, obesity and cardiovascular alterations). Furthermore, during pregnancy pelvic floor health problems, such as urinary incontinence (IU) may arise or worsen.

OBJECTIVES: The main aim of this study was to assess the effectiveness of a moderate physical exercise program called Blooming Exercise Program (BEP) developed during pregnancy in order to control excessive maternal weight gain and its consequences. Additionally, other objectives of the study were to analyse the influence of BEP on urinary incontinence, on the other pregnancy outcomes (maternal and foetal) and on the perception of the pregnant's health.

DESIGN: A randomized, controlled trial called has been conducted. 300 healthy pregnant women were recruited and divided into an intervention group (IG, n=100) and a control group (CG, n=200). The IG participated in BEP as from week 10-12 of gestation (at least 56 sessions through 22 weeks. 3 sessions per week). The CG did not participate in any supervised program addressed to pregnant women but received regular health care. Pregnancy outcomes regarding the mother and the new born, urinary incontinence and women's habits data were obtained and registered through initial interviews, medical records and two specific questionnaires on health and urinary incontinency (ICIQ-SF and King's).

Eligibility criteria: Inclusion Criteria:

* Healthy pregnant women
* Delivering in "Hospital Universitario de Fuenlabrada"
* At week 10-14 of gestation
* Able to attend 3 sessions per week until the end of the pregnancy

Exclusion Criteria:

* Contraindications appointed by ACOG
* Less than 56 sessions

Primary outcomes:
measure: Maternal weight gain
timeFrame: week 36-38 of gestation
Secondary outcomes:
measure: Excessive weight gain related risks (gestational diabetes, macrosomia, type of delivery)
timeFrame: week 36-38 of gestation
measure: Urinary incontinence
timeFrame: week 36-38 of gestation
measure: Other pregnancy outcomes (maternal and foetal)
timeFrame: week 36-38 of gestation
Other outcomes:
Locations:
city: Fuenlabrada
country: Spain
facility: Universitarian Hospital of Fuenlabrada
state: Madrid
Study officials:
affiliation: Universidad Politecnica de Madrid
name: Ruben O Barakat, PhD
role: STUDY_DIRECTOR
affiliation: Universidad Politecnica de Madrid
name: Mireia Peláez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pelaez M, Gonzalez-Cerron S, Montejo R, Barakat R. Protective Effect of Exercise in Pregnant Women Including Those Who Exceed Weight Gain Recommendations: A Randomized Controlled Trial. Mayo Clin Proc. 2019 Oct;94(10):1951-1959. doi: 10.1016/j.mayocp.2019.01.050.