Pregnancy-Induced Analgesia - A Longitudinal Study of DNIC
Recruitment status was Recruiting
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Pregnancy-Induced Analgesia - A Longitudinal Study of DNIC|
- 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. [ Time Frame: Pregnant Cohort - each trimester and postpartum; Control Cohort - twice a menstrual cycle, 4 cycles, over 7 months ] [ Designated as safety issue: No ]
- Questionnaires, pain scores, amount of analgesics required, overall experience of labor and delivery [ Time Frame: Questionnaires - Same as Primary Outcome Measure; other three measures - at delivery ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|1. Pregnant Women|
|2. Non-Pregnant Controls|
|3. IVF controls|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00867945
|Contact: Lisa Y Flint, BS||(206) firstname.lastname@example.org|
|United States, California|
|Stanford University School of Medicine||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Brendan Carvalho, MBBCh 650-861-8607 email@example.com|
|Contact: Sebastian Ruehlmann, MD firstname.lastname@example.org|
|Principal Investigator: Brendan Carvalho, MBBCh|
|United States, Washington|
|University of Washington||Recruiting|
|Seattle, Washington, United States, 98195-6540|
|Contact: Ruth Landau, MD 206-543-2187 email@example.com|
|Principal Investigator: Ruth Landau, MD|
|Principal Investigator:||Ruth Landau, MD||University of Washington|