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Physical Activity After a Normal Spontaneous or Cesarean Delivery

18 giugno 2020 aggiornato da: Dongchen Li, MD, Rutgers, The State University of New Jersey

A Pilot Study: To Compare Physical Activity After a Normal Spontaneous or Cesarean Delivery by Use of a Actigraph GT3X

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Cesarean delivery is the most common surgery performed in the United States. Despite this fact, there is a paucity of literature looking into the implementation of enhanced recovery after surgery (ERAS) for patients undergoing this type of surgery. ERAS protocols have shown to improve recovery from surgery, decreasing complication and hospital length of stay. The pathway for enhanced recovery targets improving 3 factors that have been associated with increased hospital length of stay and complications. These factors are pain, immobilization and postoperative ileus. These factors, many times are inter-related. A patient in pain would tend not to ambulate as this may exacerbate the pain and discomfort. In order to alleviate pain, the patient would most likely receive an opioid for pain management and these medications are known to have undesirable side effects such as nausea, vomiting, sedation, respiratory depression, constipation and urinary retention. All of these adverse effects (AEs) may lead to complications or increased hospital length of stay.

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 we need to learn the average parturients level of physical acuity 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.

Given the lack of knowledge regarding the physical activity level of parturients in the postpartum period, the investigators have designed a pilot study to objectively measure their PA. Patients having a normal spontaneous vaginal delivery will serve as our control group. These patients are going through the same physiologic changes that their counterparts (CD patients) are going through, the only difference being the stress of surgery in the CD group.The use of Fitness trackers (i.e Fitbit(R), Actigraph GT3X +) has been used to measure and promote physical activity in a cardiac rehabilitation population, as well as in parturients self-identified as inactive. The investigators intend to use the Actigraph GT3X+ to measure the level of physical activity of 50 parturients (25 NSVD and 25 post CD). The information obtained, will help us tailor the anesthetic/analgesic management of parturients in such a way that promotes early ambulation and recovery. The investigators estimate that we need approximately a total of 50 patients, 25 per group to assess if there is a difference in the level of PA between parturients after a NSVD or CD. We will aim to recruit 60 patients 30 per group to account for missing data, protocol violations, equipment malfunction or patients drop outs.This will be a pilot, prospective study aimed at measuring the physical activity (PA) of American Society of Anesthesiologists (ASA) Classification I and II women aged 18 years and older, after a normal spontaneous vaginal (NSVD) or cesarean delivery (CD). Subjects will be ASA I and II women aged 18 years and older, knowing to have had either a NSVD or CD (under neuraxial anesthesia). After delivery, and assuring that mother and baby are stable, patients will be approached by a member of the study team to discuss the study and obtain informed consent. After obtaining informed consent, patients will be divided into Two (2) groups depending on the mode of delivery. Group 1 will be NSVD and group 2 will be CD patients. Patients will be provided with a fitbit- based Actigraph GT3X + hardware, 3 hours after delivery. Patients will be evaluated every 12 hours after delivery for a period of 48 hours. During these evaluation points, pain (visual analogue scores), factors affecting mobility, and level of satisfaction with their analgesia will be assessed. After 48 hours the Actigraph GT3X + will be interrogated and objective data, such as mean daily steps, will be obtained using the aforementioned software.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

50

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • District of Columbia
      • Washington, District of Columbia, Stati Uniti, 20037
        • George Washington University
    • New Jersey
      • Newark, New Jersey, Stati Uniti, 07103
        • University Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 45 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: normal spontaneous vaginal delivery
Both groups will be asked to wear a fitness tracker (Actigraph GT3X+).
following delivery a ActiGraph will be offered to patients to track their steps
Sperimentale: Cesarean Delivery
Both groups will be asked to wear a fitness tracker (Actigraph GT3X+).
following delivery a ActiGraph will be offered to patients to track their steps

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Steps
Lasso di tempo: from 6 hours the after delivery until discharge or 48 hours whatever happens first
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain Score at Rest
Lasso di tempo: 6 hours following delivery until 48 hours
This outcome will be measured using a visual analogue score (VAS). Patient will mark their pain on a 0-100 mm line with 0 been no pain and 100 mm worst pain.
6 hours following delivery until 48 hours
Satisfaction Scores
Lasso di tempo: 6 hours following delivery until 48 hours
This outcome will be measured using a visual analogue score (VAS). Patient will mark their satisfaction on a 0-100 mm line with 0 been not satisfied at all and 100 mm extremely satisfied.
6 hours following delivery until 48 hours

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: Antonio Gonzalez-Fiol, MD, Yale New Haven Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 aprile 2017

Completamento primario (Effettivo)

30 luglio 2019

Completamento dello studio (Effettivo)

30 agosto 2019

Date di iscrizione allo studio

Primo inviato

28 ottobre 2016

Primo inviato che soddisfa i criteri di controllo qualità

16 novembre 2016

Primo Inserito (Stima)

17 novembre 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 giugno 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 giugno 2020

Ultimo verificato

1 giugno 2020

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 20160001283

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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