Re: BBC E-mail: Fears over premature birth drug
From: Betsy Hyde (elishyde@mindspring.com)
Sat Mar 11 18:34:58 2006
I just returned from the Contraceptive Technology conference in
Boston, and heard Sharon Hillier speak twice. She addressed both of
these studies, in which she was one of the authors.
Re the Carey study on BV, these were asymptomatic, low-risk pregnant
women. In addition, the treatment was not started until relatively
late in pregnancy. There is evidence that the upper genital tract is
involved earlier in gestation. She cited a number of other studies
(including a large meta-analysis of 10 studies including 3969 women)
indicating that treatment of BV in high risk women (those with prior
hx PTD) did significantly reduce the outcome of delivery at <37
weeks. Oral and topical metronidazole and oral clindamycin were all
shown to reduce PTD in high risk women. Topical clindamycin was shown
to have adverse effects, largely e.coli sepsis. I'll send the
references if anyone is interested.
She also addressed the Klebanoff NEJM article, on which she was also
an author,that showed failure of oral metronidazole to prevent PTD in
asymptomatic trich. There were several limitations of this study,
namely, at the time of randomization, only 70% if the subjects still
had trich, metronidazole was given off protocol to 12% of women in
the metronidazole treatment group and to 26% of the women in the
placebo group. 23% of the women in the placebo group went to outside
primary care providers and received treatment from them. The women in
the placebo group who went outside the trial and received
metronidazole from their primary care provider did NOT have the
increase in PTD that the true placebo group had.
--
Betsy Hyde CNM
Branford, CT
> .
>
> This was reported a number of years ago in the New England Journal
> of Medicine:
>
> N Engl J Med. 2000 Feb 24;342(8):534-40.
>
> Metronidazole to prevent preterm delivery in pregnant women with
> asymptomatic
> bacterial vaginosis. National Institute of Child Health and Human
> Development
> Network of Maternal-Fetal Medicine Units.
>
> Carey JC, Klebanoff MA, Hauth JC, Hillier SL, Thom EA, Ernest JM,
> Heine RP,
> Nugent RP, Fischer ML, Leveno KJ, Wapner R, Varner M.
>
> Department of Obstetrics and Gynecology, University of Oklahoma,
> Oklahoma City,
> USA.
>
> BACKGROUND: Bacterial vaginosis has been associated with preterm
> birth. In
> clinical trials, the treatment of bacterial vaginosis in pregnant
> women who
> previously had a preterm delivery reduced the risk of recurrence.
> METHODS: To
> determine whether treating women in a general obstetrical
> population who have
> asymptomatic bacterial vaginosis (as diagnosed on the basis of
> vaginal Gram's
> staining and pH) prevents preterm delivery, we randomly assigned
> 1953 women who
> were 16 to less than 24 weeks pregnant to receive two 2-g doses of
> metronidazole
> or placebo. The diagnostic studies were repeated and a second
> treatment was
> administered to all the women at 24 to less than 30 weeks'
> gestation. The
> primary outcome was the rate of delivery before 37 weeks'
> gestation. RESULTS:
> Bacterial vaginosis resolved in 657 of 845 women who had follow-up
> Gram's
> staining in the metronidazole group (77.8 percent) and 321 of 859
> women in the
> placebo group (37.4 percent). Data on the time and characteristics
> of delivery
> were available for 953 women in the metronidazole group and 966 in
> the placebo
> group. Preterm delivery occurred in 116 women in the metronidazole
> group (12.2
> percent) and 121 women in the placebo group (12.5 percent)
> (relative risk, 1.0;
> 95 percent confidence interval, 0.8 to 1.2). Treatment did not
> prevent preterm
> deliveries that resulted from spontaneous labor (5.1 percent in the
> metronidazole group vs. 5.7 percent in the placebo group) or
> spontaneous
> rupture of the membranes (4.2 percent vs. 3.7 percent), nor did it
> prevent
> delivery before 32 weeks (2.3 percent vs. 2.7 percent). Treatment with
> metronidazole did not reduce the occurrence of preterm labor,
> intraamniotic or
> postpartum infections, neonatal sepsis, or admission of the infant
> to the
> neonatal intensive care unit. CONCLUSIONS: The treatment of
> asymptomatic
> bacterial vaginosis in pregnant women does not reduce the
> occurrence of preterm
> delivery or other adverse perinatal outcomes.
>
> --
>
> and
>
> --
>
> N Engl J Med. 2001 Aug 16;345(7):487-93.
>
> Failure of metronidazole to prevent preterm delivery among pregnant
> women with
> asymptomatic Trichomonas vaginalis infection.
>
> Klebanoff MA, Carey JC, Hauth JC, Hillier SL, Nugent RP, Thom EA,
> Ernest JM,
> Heine RP, Wapner RJ, Trout W, Moawad A, Leveno KJ, Miodovnik M,
> Sibai BM, Van
> Dorsten JP, Dombrowski MP, O'Sullivan MJ, Varner M, Langer O,
> McNellis D,
> Roberts JM; National Institute of Child Health and Human
> Development Network of
> Maternal-Fetal Medicine Units.
>
> National Institute of Child Health and Human Development, Bethesda, MD
> 20892-7510, USA. mk90h@nih.gov
>
> BACKGROUND: Infection with Trichomonas vaginalis during pregnancy
> has been
> associated with preterm delivery. It is uncertain whether treatment of
> asymptomatic trichomoniasis in pregnant women reduces the
> occurrence of preterm
> delivery. METHODS: We screened pregnant women for trichomoniasis by
> culture of
> vaginal secretions. We randomly assigned 617 women with asymptomatic
> trichomoniasis who were 16 to 23 weeks pregnant to receive two 2-g
> doses of
> metronidazole (320 women) or placebo (297 women) 48 hours apart. We
> treated
> women again with the same two-dose regimen at 24 to 29 weeks of
> gestation. The
> primary outcome was delivery before 37 weeks of gestation. RESULTS:
> Between
> randomization and follow-up, trichomoniasis resolved in 249 of 269
> women for
> whom follow-up cultures were available in the metronidazole group
> (92.6
> percent) and 92 of 260 women with follow-up cultures in the placebo
> group (35.4
> percent). Data on the time and characteristics of delivery were
> available for
> 315 women in the metronidazole group and 289 women in the placebo
> group.
> Delivery occurred before 37 weeks of gestation in 60 women in the
> metronidazole
> group (19.0 percent) and 31 women in the placebo group (10.7
> percent) (relative
> risk, 1.8; 95 percent confidence interval, 1.2 to 2.7; P=0.004).
> The difference
> was attributable primarily to an increase in preterm delivery
> resulting from
> spontaneous preterm labor (10.2 percent vs. 3.5 percent; relative
> risk, 3.0; 95
> percent confidence interval, 1.5 to 5.9). CONCLUSIONS: Treatment of
> pregnant
> women with asymptomatic trichomoniasis does not prevent preterm
> delivery.
> Routine screening and treatment of asymptomatic pregnant women for
> this
> condition cannot be recommended.
>
> - - - -
>
> Date: Tue, 17 Jan 2006 07:22:20 -0600
> From: evsono@pipeline.com (art fougner, md)
> Subject: no subject received Sat, 11 Mar 2006 15:33:39 -0600
>
> Okun et al found a similar effect of metronidazole on the incidence of
> preterm birth.
>
> Obstet Gynecol. 2005 Apr;105(4):857-68.
>
> Art
>
> At Tue, 17 Jan 2006, Gail Neuman wrote:
>>
>> --
>> Gail Neuman saw this story on BBC News Online and thought you
>> should see it.
>>
>> ** Message **
>> Thoughts on this welcomed!
>>
>> ** Fears over premature birth drug **
>> A drug for pregnant women at risk of a premature birth may
>> actually do more
> harm than good, a study says.
>> < http://news.bbc.co.uk/go/em/fr/-/1/hi/health/4607344.stm >
>>
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>
> --
> art fougner, md
>
> "I knew I was going to take the wrong train, so I left early."
> Lawrence Peter Berra
>
