Because epidural analgesia is extremely effective for controlling the pain of labor, it is now administered almost routinely to laboring women in many U.S. hospitals. According to Howell, Chalmers, and others, the widespread use of epidural analgesia has occurred in spite of a lack of randomized controlled trials (RCT) to examine its adverse effects for both women and their infants. This proposed RCT will examine the perinatal effects of epidural analgesia compared to the perinatal effects of a second, less-invasive technique for the management of labor pain -- continuous support by an experienced female labor companion (doula). The study will investigate the effects of these two obstetric pain management techniques on: (1) the incidence of cesarean delivery, 2) obstetric interventions during labor and delivery, 3) obstetric complications, 4) perinatal problems in the fetus and neonate, 5) labor length, 6) newborn behavior, 7) mothers' subjective experiences during labor and delivery, including perceptions of pain, and 8) mothers' attitudes toward their infants and their breastfeeding plans. Nulliparous women (n=750) with low-risk pregnancies admitted to Ben Taub Hospital (Houston) in active labor will be randomly assigned to one of three pain management groups: 1) doula support, 2) epidural analgesia, 3) control. Subjects will be observed throughout labor and delivery, and obstetric outcome variables will be recorded. Within 24 hours after delivery, evaluation of the mothers' interaction with their infants will be made, along with assessment of the newborns' behaviors. Five RCTs have demonstrated that doula support resulted in a significant reduction in labor length, cesarean delivery rate, perinatal problems, and the need for medication. In contrast, epidural analgesia has been correlated with increased cesarean and forceps delivery rates, maternal pyrexia, decreased neonatal responsiveness, and other adverse effects. In spite of the impressive positive results of doula support, the trend in obstetric care in the U.S. has been in the opposite direction -- toward the increased use of interventions, analgesia, and technology. This proposed RCT is necessary to assess the positive and negative effects of both techniques to manage the discomfort and anxiety of labor and delivery -- epidural analgesia and continuous doula support.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
5R01HD016915-10
Application #
2197386
Study Section
Human Development and Aging Subcommittee 3 (HUD)
Project Start
1984-09-01
Project End
1997-12-31
Budget Start
1994-01-01
Budget End
1994-12-31
Support Year
10
Fiscal Year
1994
Total Cost
Indirect Cost
Name
Case Western Reserve University
Department
Pediatrics
Type
Schools of Medicine
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106
McGrath, Susan K; Kennell, John H (2008) A randomized controlled trial of continuous labor support for middle-class couples: effect on cesarean delivery rates. Birth 35:92-7
Kennell, J H; Klaus, M H (1998) Bonding: recent observations that alter perinatal care. Pediatr Rev 19:4-12
Kennell, J; Klaus, M; McGrath, S et al. (1991) Continuous emotional support during labor in a US hospital. A randomized controlled trial. JAMA 265:2197-201
Kennell, J H; Klaus, M H (1988) The perinatal paradigm: is it time for a change? Clin Perinatol 15:801-13