Pregnancy-Induced Analgesia - A Longitudinal Study of DNIC
Přehled studie
Postavení
Podmínky
Detailní popis
Pregnancy-induced analgesia has been described in several studies (Gintzler 1980; Sander and Gintzler 1987; Jarvis et al. 1997). Obvious mechanisms underlying pregnancy-induced analgesia involve hormonal changes during gestation (Fillingim and Ness 2000). Existing studies during pregnancy and peripartum have focused on standard characteristics of nociception, using non-dynamic quantitative sensory testing such as pain threshold/tolerance or suprathreshold stimuli (Goolkasian and Rimer 1984; Sengupta and Nielsen 1984; Cogan and Spinnato 1986; Dunbar et al. 1988; Whipple et al. 1990; Shapira et al. 1995; Saisto et al. 2001; Bajaj et al. 2002; Carvalho et al. 2006; Ohel et al. 2007), with its relative limitations of studying only the afferent nociceptive input produced in the peripheral nervous system.
The two systems that are of prime importance in pain modulation within the CNS are the inhibitory system (descending noxious inhibitory control (DNIC)) and the excitatory system, with the balance of pain being more heavily influenced by the former (Godfrey and Mackey 2008).
The primary aim of this study is to use psychophysical tests to study both the inhibitory and excitatory pain pathways using the DNIC paradigm and temporal summation longitudinally during pregnancy, compared to an age-matched control group of non-pregnant women.
We added the In Vitro Fertilization (IVF) sub-population to the PIA study to study them as a control group (in addition to studying non-pregnant controls and pregnant women). We are studying this sub population prior to their egg retrieval procedure and a short phone survey with participants post egg-retrieval. If the subject becomes pregnant, we would recruit them to enroll in the PIA pregnant population cohort.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Lisa Y Flint, BS
- Telefonní číslo: (206) 543-7817
- E-mail: lyflint@u.washington.edu
Studijní místa
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California
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Stanford, California, Spojené státy, 94305
- Nábor
- Stanford University School of Medicine
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Kontakt:
- Brendan Carvalho, MBBCh
- Telefonní číslo: 650-861-8607
- E-mail: bcarvalho@stanford.edu
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Kontakt:
- Sebastian Ruehlmann, MD
- E-mail: ruehlmail@gmail.com
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Vrchní vyšetřovatel:
- Brendan Carvalho, MBBCh
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Washington
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Seattle, Washington, Spojené státy, 98195-6540
- Nábor
- University of Washington
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Vrchní vyšetřovatel:
- Ruth Landau, MD
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Kontakt:
- Ruth Landau, MD
- Telefonní číslo: 206-543-2187
- E-mail: rulandau@u.washington.edu
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Pregnant Cohort: Inclusion criteria for participation are (1) women aged between 18 and 45 yr, (2) nulliparous or ASA physical status class I or II women, (3) singleton pregnancy, (4) no more than 14 completed weeks gestational age at the time of enrollment into the study, (5) uncomplicated pregnancy, and (6) delivery planned to be conducted at UW/Stanford University.
- Non-pregnant Control Cohort: Inclusion criteria for participation are (1) women aged between 18 and 45 yr, (2) nulliparous or ASA physical status class I or II women, (3) and not planning on taking oral-contraceptives or carrying a hormonal-coated IUD.
Non-inclusion Criteria:
- Pregnant Cohort: Non-inclusion criteria are (1) multiparous women, (2) non-English speaking women (subjects have to be able to understand the DNIC procedure and answer questionnaires), (3) women unable to understand the concept of VNPS at the time of informed consent (involving mental health issues), (4) a history of anxiety or depression, or chronic consumption of opiates, antidepressants, or anticonvulsants; and (5) intake of opioids, acetaminophen, or NSAIDs 48h prior to the psychophysical test.
- Non-pregnant Control Cohort: Non-inclusion criteria are the same as the Pregnant Cohort as well as (6) irregular menstrual cycles (defined as < 21 days or > 35 days).
Exclusion Criteria:
- Pregnant Cohort: Exclusion criteria is a pregnancy complicated by preeclampsia or preterm delivery (< 37 weeks gestation).
- Non-pregnant Control Cohort: Exclusion criteria is development of irregular cycles.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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1. Pregnant Women
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2. Non-Pregnant Controls
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3. IVF controls
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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To use psychophysical tests to study both the inhibitory and excitatory pain pathways using the DNIC paradigm and temporal summation longitudinally during pregnancy, compared to an age-matched control group of non-pregnant women.
Časové okno: Pregnant Cohort - each trimester and postpartum; Control Cohort - twice a menstrual cycle, 4 cycles, over 7 months
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Pregnant Cohort - each trimester and postpartum; Control Cohort - twice a menstrual cycle, 4 cycles, over 7 months
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
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Questionnaires, pain scores, amount of analgesics required, overall experience of labor and delivery
Časové okno: Questionnaires - Same as Primary Outcome Measure; other three measures - at delivery
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Questionnaires - Same as Primary Outcome Measure; other three measures - at delivery
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Ruth Landau, MD, University of Washington
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 35811-A
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