Pharm/Biotech Resources

Outsourcing Guide

Cont. Education

Software/Reports

Training Courses

Web Seminars

Jobs

Buyer's Guide

Home Page

Pharm Patents /
Licensing

Pharm News

Federal Register

Pharm Stocks

FDA Links

FDA Warning Letters

FDA Doc/cGMP

Pharm/Biotech Events

Consultants

Advertiser Info

Newsletter Subscription

Web Links

Suggestions

Site Map
 

 
 

 

  Federal Register  

Link:  Pharm/Biotech Resources
 


Notice: NIH Consensus Development Conference on Vaginal Birth After 
Cesarean: New Insights; Notice
Federal Register: January 22, 2010 (Volume 75, Number 14)               
                  Page 3745-3746
Agency:  DEPARTMENT OF HEALTH AND HUMAN SERVICES
         National Institutes of Health


    Notice is hereby given by the National Institutes of Health (NIH) 
of the ``NIH Consensus Development Conference on Vaginal Birth After 
Cesarean: New Insights'' to be held March 8-10, 2010, in the NIH 
Natcher Conference Center, 45 Center Drive, Bethesda, Maryland 20892. 
The conference will begin at 8:30 a.m. on March 8 and 9 and at 9 a.m. 
on March 10, and it will be open to the public.
    Vaginal birth after cesarean (VBAC) is the delivery of a baby 
through the vagina after a previous cesarean delivery. For most of the 
20th century, once a woman had undergone a cesarean (the delivery of a 
baby through an incision made in the abdominal wall and uterus), many 
clinicians believed that all of her future pregnancies required 
delivery by cesarean as well. However, in 1980, an NIH Consensus 
Development Conference panel questioned the necessity of routine repeat 
cesarean deliveries and outlined situations in which VBAC could be 
considered. The option for a woman with a previous cesarean delivery to 
try to labor and deliver vaginally rather than plan a cesarean delivery 
was thus offered and exercised more often from the 1980s through the 
early 1990s. Since 1996, however, VBAC rates in the United States have 
consistently declined, while cesarean delivery rates have been steadily 
rising.
    The exact causes of these shifts are not entirely understood. A 
frequently cited concern about VBAC is the possibility of uterine 
rupture during labor because a cesarean delivery leaves a scar in the 
wall of the uterus at the incision site, which is weaker than other 
uterine tissue. Attempted VBAC may also be associated with endometritis 
(infection of the lining of the uterus), the need for a hysterectomy 
(removal of the uterus) or blood transfusion, as well as neurologic 
injury to the baby. However, repeat cesarean delivery may also carry a 
risk of bleeding or hysterectomy, uterine infections, and respiratory 
problems for the newborn. Having multiple cesarean deliveries may also 
be associated with placental problems in future pregnancies. Other 
important considerations that may influence decisionmaking include the 
number of previous cesarean deliveries a woman has experienced, the 
surgical incision used during previous cesarean delivery, the reason 
for the previous surgical delivery, her age, how far along the 
pregnancy is relative to her due date, and the size and position of her 
baby. Given the complexity of this issue, a thorough examination of the 
relative balance of benefits and harms to mother and baby will be of 
immediate utility to practitioners and pregnant mothers in deciding 
upon a planned mode of delivery.
    A number of nonclinical factors are involved in this decision as 
well and may be influencing the decline in VBAC rates. Some individual 
practitioners and hospitals in the U.S. have decreased or eliminated 
their use of VBAC. Professional society guidelines may influence 
utilization rates because some medical centers do not offer the 
recommended supporting services for a trial of labor after cesarean 
(e.g., immediate availability of a surgeon who can perform a cesarean 
delivery and on-site anesthesiologists). Information related to 
complications of an unsuccessful attempt at VBAC, medico-legal 
concerns, personal preferences of patients and clinicians, and 
insurance policies and economic considerations may all play a role in 
changing practice patterns. Improved understanding of the clinical 
risks and benefits and how they interact with legal, ethical, and 
economic forces to shape provider and patient choices about VBAC may 
have important implications for health services planning.
    To advance understanding of these important issues, the Eunice 
Kennedy Shriver National Institute of Child Health and Human 
Development and the Office of Medical Applications of Research of the 
NIH will convene a Consensus Development Conference from March 8 to 10, 
2010. The conference will address the following key questions:
     What are the rates and patterns of utilization of trial of 
labor after prior cesarean, vaginal birth after cesarean, and repeat 
cesarean delivery in the United States?
     Among women who attempt a trial of labor after prior 
cesarean, what are the vaginal delivery rate and the factors that 
influence it?
     What are the short- and long-term benefits and harms to 
the mother of attempting trial of labor after prior cesarean versus 
elective repeat cesarean delivery, and what factors influence benefits 
and harms?
     What are the short- and long-term benefits and harms to 
the baby of maternal attempt at trial of labor after prior cesarean 
versus elective repeat cesarean delivery, and what factors influence 
benefits and harms?
     What are the nonmedical factors that influence the 
patterns and utilization of trial of labor after prior cesarean?
     What are the critical gaps in the evidence for decision-
making, and what are the priority investigations needed to address 
these gaps?
    An impartial, independent panel will be charged with reviewing the 
available published literature in advance of the

[[Page 3746]]

conference, including a systematic literature review commissioned 
through the Agency for Healthcare Research and Quality. The first day 
and a half of the conference will consist of presentations by expert 
researchers and practitioners and open public discussions. On 
Wednesday, March 10, the panel will present a statement of its 
collective assessment of the evidence to answer each of the questions 
above. The panel will also hold a press telebriefing to address 
questions from the media. The draft statement will be published online 
later that day, and the final version will be released approximately 
six weeks later. The primary sponsors of this meeting are the NIH 
Eunice Kennedy Shriver National Institute of Child Health and Human 
Development and the NIH Office of Medical Applications of Research.
    Advance information about the conference and conference 
registration materials may be obtained from the NIH Consensus 
Development Program Information Center by calling 888-644-2667 or by 
sending e-mail to consensus@mail.nih.gov. The Information Center's 
mailing address is P.O. Box 2577, Kensington, Maryland 20891. 
Registration information is also available on the NIH Consensus 
Development Program Web site at http://consensus.nih.gov.

    Please Note:  The NIH has instituted security measures to ensure 
the safety of NIH employees, guests, and property. All visitors must 
be prepared to show a photo ID upon request. Visitors may be 
required to pass through a metal detector and have bags, backpacks, 
or purses inspected or x-rayed as they enter NIH buildings. For more 
information about the security measures at NIH, please visit the Web 
site at http://www.nih.gov/about/visitorsecurity.htm.


    Dated: January 11, 2010.
Raynard S. Kington,
Deputy Director, National Institutes of Health.
[FR Doc. 2010-859 Filed 1-21-10; 8:45 am]
BILLING CODE 4140-01-M
 

 
[ Outsourcing Guide ] [ Cont. Education ] [ Software/Reports ] [ Training Courses ]
[ Web Seminars ] [ Jobs ] [ Consultants ] [ Buyer's Guide ] [ Advertiser Info ]

[ Home ] [ Pharm Patents / Licensing ] [ Pharm News ] [ Federal Register ]
[ Pharm Stocks ] [ FDA Links ] [ FDA Warning Letters ] [ FDA Doc/cGMP ]
[ Pharm/Biotech Events ] [ Newsletter Subscription ] [ Web Links ] [ Suggestions ]
[ Site Map ]