Prescribing Exercise as Medicine in Pregnancy | NCT03239054

Studies
Prescribing Exercise as Medicine in Pregnancy

NCT03239054

Sponsor

St. Louis University

Status

Withdrawn

Last Update Posted

Aug 2, 2018Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Pregnancy

Interventions

Physical activity
Control group

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

IRB issues

Expanded Access Info

Start Date

Jul 1, 2018Estimated

Primary Completion Date

Aug 31, 2020Estimated

Completion Date

Dec 1, 2020Estimated

First Submitted Date

Jul 23, 2017

First Submission Date that Met QC Criteria

Aug 2, 2017

First Posted Date

Aug 3, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2018

Last Update Posted Date

Aug 2, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a randomized controlled parallel arms trial. The purpose of this study is to evaluate if prescribing exercise in pregnancy can change maternal behavior towards exercise.

Detailed Description

This study is a randomized controlled parallel arms trial. The purpose of this study is to evaluate if prescribing exercise in pregnancy can change maternal behavior towards exercise. Once screened and consented, participants will be randomized to either the intervention or control group in a 1:1 fashion. The intervention group will receive the PARMED-X prescription and the control group will receive routine care as usual. Physical activity will be monitored with a Polar fitness tracking device.

Maternal and neonatal outcomes will be collected from the electronic medical record. Maternal outcomes include demographics, total gestational weight gain, pre-pregnancy body mass index (BMI), BMI at the time of delivery, mode of delivery, glucose screen value, presence or absence of gestational diabetes and presence or absence of hypertensive disorders of pregnancy. Neonatal outcomes include gestational age at delivery, birth weight, Apgar scores, arterial cord blood gases.

Psychological outcomes will also be assessed using several validated scales in pregnancy including The Edinburgh Postnatal Depression Scale (EPDS) and The State Trait Anxiety Inventory (STAI).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Group	Experimental	Participants in the study group will complete the Parmed-X Pregnancy form and be provided with a prescription for exercise.	Behavioral: Physical activity
Control Group	Other	The control group will be provided with the ACOG Pamphlet entitled "Exercise during pregnancy" and will be encouraged to become physically active during their pregnancy. They will receive routine care as scheduled.	Behavioral: Control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Physical activity	Behavioral	pregnancy prescription for physical activity as part of prenatal care can increase healthy exercise behaviors during pregnancy	Study Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PARmed-X: Change in number of steps (physical activity level)	change in number of steps (physical activity level)	1 year

Secondary Outcomes

Measure	Description	Time Frame
PARMed-X: Gestational Weight Gain	Gestational Weight Gain	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 to 45 years of age
Singleton pregnancy
Gestational age at or less than 20 0/7 weeks at the time of enrollment
Low risk pregnancy
Willing and able to participate in a more active lifestyle/exercise program
Smart phone able to add the "Flow mobile app".

Exclusion Criteria:

Twins or higher order multiple gestations
Known congenital anomaly
Underweight BMI ( BMI less than 18.50)
High risk pregnancy - ie. hypertension, pre-existing diabetes
Women with a known contraindication to exercise
Persistent 2nd or 3rd trimester vaginal bleeding
Hemodynamically significant heart disease
Restrictive lung disease
Incompetent cervix or cerclage
Placenta previa
Premature labor or rupture of membranes
Preeclampsia
Severe anemia
Poorly controlled hypertension, seizure disorder, or hyperthyroidism
Known intrauterine growth restriction
Not cleared for exercise by the "Contraindications to Exercise from PARMED-X" form
PAVS score greater than or equal to 150 minutes/week

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shilpa Babbar, MD	St. Louis University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Mary's Health Center		St Louis	Missouri	63117	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise
D035061	Control Groups

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided