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Re: Double blind study using corticosteroid (prednisone) -- what are my risks?

From: Kathy (anonymous@obgyn.net)
Sun, 24 Sep 2000 04:13:21 -0500 (CDT)


Thank you, Dr. Braun. It's hard enough to control the diabetes with these two placentas, let alone add a steroid into the mix. When my husband heard your reply, that was it for him. :-) For me, as well. I talked to the PI for the study anyway, and it looks like from my viewpoint participating will only make a difficult pregnancy that much harder to deal with. It's not worth it to me. I'll just stick to the usual methods my doctors are using to be proactive with my preterm labor risks. Thanks again.

--
Kathy F.

At Fri, 22 Sep 2000, R. Daniel Braun, MD wrote: > >Steroids can make Diabetes much harder to control. Steroids can also >cause suppression of the immune system. Some of that is dose related. >Ask all of these questions of the P.I. (Principal Investigator) for the >study. Ask to see a copy of the IRB(Institutional Review Board) >approval of the study. If you don't get all of your questions >satisfactorily answered, don't sign up for the study. > >RDB > >At Fri, 22 Sep 2000, Kathy wrote: >> >>I've been asked, because of that positive fetal fibronectin test, to >>participate in a double-blind study. It's been ongoing for two years, >>and the purpose is to determine if treatment with corticosteroids >>can/will delay preterm labor. All the paperwork I was given I've read >>thoroughly, and the only side-effect mentioned is a supression of the >>Adrenal gland, apparently the gland that is responsible for causing the >>secretion of (secreting?) the ffn protein. This surprised me, because I >>know my sister is taking prednisone, the pill form being used in the >>study, for an auto-immune disorder that affects her liver, and she has >>had serious weight gain among other things. I also know that prednisone >>and other drugs of this type also surpress the immune system, which is >>of course why they are used for auto-immune disorders in the first >>place. But this isn't mentioned in any of the paperwork at all. The >>information also states that the only side-effect to the babies is >>possible adrenal suppression which can be monitored/taken care of by the >>baby's physician after birth. >> >>First, it seems to my uneducated, lay understanding, they have seriously >>and untruthfully downplayed the dangers of prednisone. But I don't know >>anywhere near enough about this drug and its effects on a pregnant woman >>(pg with twins) and her babies, for up to eight weeks. The paperwork >>does not tell me what the dosage is. Granted, I have a 50% chance of >>ending up in the control group and be given a placebo, so it won't >>matter. But then again, I might be given the drug, too. >> >>Could any of you kind doctors enlighten me further about the risks I'd >>be taking by participating in this study? I understand what the benefits >>could be, if their hypothesis is correct, and steroids do delay the >>onset of labor. But does this possible benefit outweigh the risks? I >>know, only I can decide that. But I really don't feel I've been given a >>fair picture of the risks and side-effects of this drug to make a >>fully-informed decision. I've been searching the web trying to find >>more info, but having little luck so far. What I have found makes me >>nervous. I have GD again with this pg, tachycardia (since my teens, off >>and on, especially when pg), hypothyroidism, and psoriatic arthritis >>(PA). What little info I've found indicates that diabetes and >>tachycardia could be problematic in taking prednisone, but in what way I >>don't know. I also know that prednisone is also used used to treat >>auto-immune related arthritises like my PA. But that's all I've been >>able to learn so far. >> >>Thanks for any information you can provide. I sure appreciate being >>able to come here and get such clear and precise answers to my >>questions!!! >> >>-- >>Kathy F. >> >-- >R.Daniel Braun, MD FACOG FOG > >**Note: Opinions expressed here are for educational purposes only >and, as such, do not constitute a physician-patient relationship. >This information is not intended to supplant the need for you to >consult with your physician prior to choosing therapeutic options >and/or interventions. > >**Private emails cannot be entertained due to time constraints, >consequently no private emails will receive a response. > >**Thank you for your understanding ;-) > >-------------------------------------------------------------------------------- > >-------------------------------------------------------------------------------- >-- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- >-------------------------------------------------------------------------------- >-------------------------------------------------------------------------------- >Please be aware that all e-mail on this forum is archived and can be viewed at >-------------------------------------------------------------------------------- >-------------------------------------------------------------------------------- >http://forums.obgyn.net/pregnancy-birth and is accessible to anybody on the >internet including internet search engines. This should be taken into >consideration before sending postings of a personal or confidential nature. >




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