Re: Route of delivery for breech presentation
From: art fougner, md (evsono@pipeline.com)
Wed Jul 12 16:39:48 2000
now for the definitive study - is C-section the ideal route of delivery
for all babies?
art
At Wed, 12 Jul 2000, John Robertson MD wrote:
>
>Here is the web site for that article.
>
>http://www.medicalpost.com/mdlink/english/members/medpost/data/3625/01B.HTM
>
>the text follows:
>
>VOLUME 36, NO. 25, July 4, 2000
>
>--------------------------------------------------------------------------------
>
>--------------------------------------------------------------------------------
>--
>--------------------------------------------------------------------------------
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> C-section best for breech
>--------------------------------------------------------------------------------
>Study comparing vaginal deliveries halted early due to success rates
>By Jenny Manzer
>MONTREAL – A worldwide investigation into whether vaginal deliveries or
>cesarean sections are best for breech births has ended early—C-sections
>have already come out on top.
>Data monitors for the Term Breech Trial requested the study be stopped
>in late April after an interim analysis showed a significant difference
>between the two groups, said principal investigator Dr. Mary Hannah,
>director of the Maternal, Infant and Reproductive Health Research Unit
>at the University of Toronto.
>"Two months ago we could say to the patients we don't really know which
>is better," said Dr. Hannah, professor of obstetrics and gynecology.
>"Now we can say to the patient that the study is no longer ongoing and
>that the trial was stopped because results showed elective cesarean
>section was better."
>The study objective was to determine if a planned C-section resulted in
>less risk of perinatal mortality or serious neonatal morbidity to the
>term breech fetus. The primary outcome is a composite of infant
>mortality, neonatal morbidity and serious maternal complications.
>Researchers also checked in with the mothers at three months and two
>years, collecting data on outcomes such as postpartum
>depression, pain, urinary and fecal incontinence, and the impact on
>sexual relations and breastfeeding.
>The infants were also followed up at two years to assess their
>developmental status.
>"That's what's important, how the babies do ultimately. And there are a
>lot of issues related to cesarean section and mode of delivery and the
>outcomes for mothers, and we don't have any information from any
>randomized studies on that—none," said Dr. Hannah.
>She said the study was a unique opportunity, and unlikely to be repeated
>in the near future due to the difficulty and the expense involved.
>Results from the more than $2-million study, funded by the Medical
>Research Council of Canada (now the Canadian Institute for Health
>Information) are expected this fall.
>"Publication, we hope, will be expedited, and we will have complete data
>for you we hope as early as the SOGC meeting in Ontario in November,"
>Dr. Hannah told colleagues at the Society of Obstetricians and
>Gynecologists of Canada (SOGC) annual clinical meeting here.
>Recruitment for the study, originally expected to last five years, began
>in early 1997. Women eligible for the study had a frank or complete
>breech presentation at 37 weeks or more, with a baby who appeared small
>enough to fit through her pelvis, and who had no evidence of a
>congenital defect. All those enrolled had exhausted the possibility of
>having the baby turned by external cephalic version. By late April,
>2,088 women had been recruited.
>Researchers had preplanned an interim analysis after the first 1,000
>women had been recruited. The data monitoring committee then requested
>a second interim analysis, which was completed using data from 1,600
>women.
>Following the second interim analysis, the data monitoring group
>requested that randomization be halted in keeping with the study
>protocol to stop if one group showed a statistically significant
>difference (p < 0.002).
>Asked if clinicians should stop doing vaginal breech deliveries until
>final results are available, Dr. Hannah said, "I would suggest that you
>inform patients this trial was stopped because cesarean was better, that
>we're waiting for the final results. I think that information should be
>available to women when they make their decision with you about what's
>best for them."
>The Term Breech Trial spanned the globe, with participants in more than
>25 countries from Argentina to Zimbabwe. Participating centres ensured
>the vaginal births were done by clinicians experienced and skilled at
>breech delivery.
>Noting the diversity of the participating centres, Dr. Hannah said the
>data monitoring committee did not feel the differences between the two
>study groups were related to isolated or small centres. "We will be
>looking at that in more detail," she added.
> "We need more information and we will have that shortly."
>
>--
>J.G.M.Robertson MD, 109-9181 Main St. Chilliwack, B.C. V2P 4M9
>(604) 793-9988 e-mail john.robertson@obgyn.net
>Who is wise and understanding among you? Let him show it by his good life,
>by deeds done in the humility that comes from wisdom. James 3 vs 13, NIV
>
--
art fougner, md
A series of 1000 cases begins with but a single anecdote.
