NCT02460185

Brief Summary

Evaluate the effects of the practice of maternal physical exercise on the term of pregnancy as a method to enhance spontaneous labor.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

8 months

First QC Date

May 29, 2015

Last Update Submit

October 10, 2016

Conditions

PregnancyLabour Onset and Length Abnormalities

Outcome Measures

Primary Outcomes (1)

  • Rate of labor induction

    Rate of labor induction will be analysed

    41 weeks

Secondary Outcomes (3)

  • Gestational age on spontaneous labor onset

    5 week

  • Active stage duration

    1 day

  • Cesarean section rate

    1 day

Study Arms (2)

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.

Behavioral: Study group: Maternal Physical Exercise

Interventions

Study group: Maternal Physical ExerciseBEHAVIORAL

Exercise: 30 minutes of walking, 3 times a week at 4 Km/h.

Study Group

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • weeks low-risk pregnant women
  • singleton cephalic fetus
  • without previous cesarean delivery

You may not qualify if:

  • pathological pregnancy
  • twin pregnancy
  • previous cesarean section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departamento de Obstetricia, Ginecologia e Medicina da Reprodução

Lisbon, 1600, Portugal

Location

Related Publications (1)

  • 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.

    PMID: 32223479DERIVED

Study Officials

  • Isabel Barros Pereira, M.D.

    Departamento de Obstetricia, Ginecologia e Medicina da Reprodução, Centro Hospitalar Lisboa Norte, Hospital de Santa Maria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

May 29, 2015

First Posted

June 2, 2015

Study Start

May 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

October 12, 2016

Record last verified: 2016-10

Locations

PT(1)