PregnancyNCT02460185
Role of Maternal Physical Exercise on Spontaneous Labor Onset
A study testing Study group: Maternal Physical Exercise in people with Pregnancy and Labour Onset and Length Abnormalities, run by Centro Hospitalar Lisboa Norte at 1 site in Portugal.
Trial summary
Evaluate the effects of the practice of maternal physical exercise on the term of pregnancy as a method to enhance spontaneous labor. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Labour Onset and Length Abnormalities
- What is being tested?
- Study group: Maternal Physical Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePortugal
- Study dates
- May 2015to Jan 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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 38 weeks low-risk pregnant women
- singleton cephalic fetus
- without previous cesarean delivery
Who cannot join
- pathological pregnancy
- twin pregnancy
- previous cesarean section
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Departamento de Obstetricia, Ginecologia e Medicina da Reprodução
Lisbon, 1600
About this study
Official title: The Role of Maternal Physical Exercise on Spontaneous Labor Onset - A Randomized Clinical Trial
Evaluate the effects of the practice of maternal physical exercise on the term of pregnancy as a method to enhance spontaneous labor.
Read the detailed description
At 38 weeks low-risk pregnant women, with singleton cephalic fetus and without previous cesarean delivery, were randomized into 2 groups: a control group without maternal physical exercise practice and a study group with 30 minutes of walking, 3 times a week at 4 Km/h. Induction of labor was performed at 41 weeks
- Conditions
- Pregnancy, Labour Onset and Length Abnormalities
- Being tested
- Study group: Maternal Physical Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study group: Maternal Physical ExerciseBehavioural
Exercise: 30 minutes of walking, 3 times a week at 4 Km/h.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Without maternal physical exercise practice |
| Study Group | Active comparator | Behavioral: 30 minutes of walking, 3 times a week at 4 Km/h. Induction of labor was performed at 41 weeks. Receives: Behavioral: Study group: Maternal Physical Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of labor induction
Rate of labor induction will be analysed
Measured: 41 weeks
Secondary outcomes (3)
Gestational age on spontaneous labor onset
Gestational age will be analysed on spontaneous labor onset
Measured: 5 week
Active stage duration
Measured: 1 day
Cesarean section rate
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar Lisboa Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabel Pereira, Centro Hospitalar Lisboa Norte
- Investigators
- Isabel Barros Pereira, M.D., Principal investigator, Departamento de Obstetricia, Ginecologia e Medicina da Reprodução, Centro Hospitalar Lisboa Norte, Hospital de Santa Maria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460185
- Sponsor's protocol ID
- MPEX
- Status last verified
- Oct 2016
- First submitted
- 29 May 2015
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Pereira IB, Silva R, Ayres-de-Campos D, Clode N. Physical exercise at term for enhancing the spontaneous onset of labor: a randomized clinical trial. J Matern Fetal Neonatal Med. 2022 Feb;35(4):775-779. doi: 10.1080/14767058.2020.1732341. Epub 2020 Mar 29.
PubMed 32223479
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Maternal Physical Exercise on Spontaneous Labor Onset - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02460185
- Acronym / sponsor ID
- MPEX
- Conditions
- Pregnancy, Labour Onset and Length Abnormalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centro Hospitalar Lisboa NorteUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 2 Jun 2015 (estimated)
- 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.
Evaluate the effects of the practice of maternal physical exercise on the term of pregnancy as a method to enhance spontaneous labor.
Detailed description
At 38 weeks low-risk pregnant women, with singleton cephalic fetus and without previous cesarean delivery, were randomized into 2 groups: a control group without maternal physical exercise practice and a study group with 30 minutes of walking, 3 times a week at 4 Km/h. Induction of labor was performed at 41 weeks
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Without maternal physical exercise practice |
| Study Group | Active comparator | Behavioral: Study group: Maternal Physical ExerciseBehavioral: 30 minutes of walking, 3 times a week at 4 Km/h. Induction of labor was performed at 41 weeks. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 38 weeks low-risk pregnant women
- singleton cephalic fetus
- without previous cesarean delivery
Key exclusion criteria (3 listed)
- pathological pregnancy
- twin pregnancy
- previous cesarean section
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 |
|---|---|---|
| Study group: Maternal Physical ExerciseExercise: 30 minutes of walking, 3 times a week at 4 Km/h. | Behavioural | Study Group |
Primary outcome
Rate of labor induction
Time frame: 41 weeks
Rate of labor induction will be analysed
3 secondary outcomes
Gestational age on spontaneous labor onset
Time frame: 5 week
Active stage duration
Time frame: 1 day
Cesarean section rate
Time frame: 1 day
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 12 Oct 2016.
- Derived from this study: PubMed 32223479Pereira IB, Silva R, Ayres-de-Campos D, Clode N. Physical exercise at term for enhancing the spontaneous onset of labor: a randomized clinical trial. J Matern Fetal Neonatal Med. 2022 Feb;35(4):775-779. doi: 10.1080/14767058.2020.1732341. Epub 2020 Mar 29.
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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.
Isabel Barros Pereira, M.D. principal investigator
Departamento de Obstetricia, Ginecologia e Medicina da Reprodução, Centro Hospitalar Lisboa Norte, Hospital de Santa Maria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study group: Maternal Physical Exercise in people with Pregnancy and Labour Onset and Length Abnormalities, run by Centro Hospitalar Lisboa Norte at 1 site in Portugal.
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 3 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 12 Oct 2016. 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 Portugal. 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?
Rate of labor induction (time frame: 41 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02460185, which also lists 1 linked publication.
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 12 Oct 2016.