NCT02967016

Brief Summary

To the best of the investigators knowledge the average level of physical activity (PA) of parturients recovering from a cesarean delivery or after a normal spontaneous vaginal delivery (NSVD) remains unknown. Taking in consideration that parturients are in a hypercoagulable state and that obstetric venous thromboembolism (VT) is one of the most common causes of maternal morbidity and mortality, ambulation is of utmost importance to anesthesiologists as well as obstetricians. In order to promote mobility, first the investigators need to learn the average parturients level of physical activity in the immediate post-partum period and up to 48 hours after delivery. This information may help us promote mobility in the immediate postpartum period, particularly for those that underwent a cesarean delivery since they are at higher risk of VT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 17, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
10 months until next milestone

Results Posted

Study results publicly available

June 19, 2020

Completed
Last Updated

June 19, 2020

Status Verified

June 1, 2020

Enrollment Period

2.3 years

First QC Date

October 28, 2016

Results QC Date

May 12, 2020

Last Update Submit

June 18, 2020

Conditions

Postpartum Disorder

Outcome Measures

Primary Outcomes (1)

  • Steps

    This will be measured in the numbers of steps registered by the accelerometer

    from 6 hours the after delivery until discharge or 48 hours whatever happens first

Secondary Outcomes (2)

  • Pain Score at Rest

    6 hours following delivery until 48 hours

  • Satisfaction Scores

    6 hours following delivery until 48 hours

Study Arms (2)

normal spontaneous vaginal delivery

EXPERIMENTAL

Both groups will be asked to wear a fitness tracker (Actigraph GT3X+).

Behavioral: Actigraph

Cesarean Delivery

EXPERIMENTAL

Both groups will be asked to wear a fitness tracker (Actigraph GT3X+).

Behavioral: Actigraph

Interventions

ActigraphBEHAVIORAL

following delivery a ActiGraph will be offered to patients to track their steps

Cesarean Deliverynormal spontaneous vaginal delivery

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women 18-45 years old giving birth after receiving a neuraxial analgesia/anesthesia technique. American Society of Anesthesiologists classification 1-2.

You may not qualify if:

  • History of chronic pain
  • Recent use of opioids (other than postpartum)
  • Emergency case requiring general anesthesia (GA) or conversion to GA
  • BMI \> 45
  • Need to perform more extensive surgery (i.e Hysterectomy) Need for the neonate to be admitted to NICU (This will prompt mothers to walk more frequently, and longer distances to visit the baby)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

University Hospital

Newark, New Jersey, 07103, United States

Location

MeSH Terms

Conditions

Puerperal Disorders

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Limitations and Caveats

Small sample size. No standardized post-delivery ambulation protocol at any of the institutions.

Results Point of Contact

Title
Dr. Antonio Gonzalez
Organization
Rutgers SUNJ
ajantoni@gmail.com
4133869415

Study Officials

  • Antonio Gonzalez-Fiol, MD

    Yale New Haven Hospital

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Director of Obstetric Anesthesia Department of Anesthesiology

Study Record Dates

First Submitted

October 28, 2016

First Posted

November 17, 2016

Study Start

April 1, 2017

Primary Completion

July 30, 2019

Study Completion

August 30, 2019

Last Updated

June 19, 2020

Results First Posted

June 19, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)