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39I

SMFM Abstracts

A MULTICENTER RANDOMIZED CONTROLLED TRIAL OF NERVE STIMULATION THERAPY: SUBANALYSIS OF SEVERE NAUSEA AND VOMITING SYMPTOMS HUGH MILLER MD 1 , MARGARITA DE VECIANA 2, LAURA STEWART RN 3, ANDREI REBARBER MD 4, TODD ROSEN MD 4, R. NATHAN SLOTNICK MD5; 1University of Arizona, Obstetrics and Gynecology, Tucson, AZ; 2Eastern Virginia Medical School, Obstetrics & Gynecology, Norfolk, VA; 3Woodside Biomedical, Inc, Clinical Research, Carlesbad, CA; 4New York University, Obstetrics and Gynecology, New York, NY; 5Eastern Virginia Medical School, Obstetrics and Gynecology, Norfolk, VA

OBJECTIVE: While 80% of p r e g n a n t women suffer f rom nausea and vomiting in early pregnancy, fewer are severely affected. We demonstrated that nerve stinmlation tllerapy (NST) over the volar aspect of the wrist at the P6 point is eftective in the t reatment of mild-moderate nausea and vomiting in early pregnancy. Here we present data for those patients with severe symptoms.

STUDY DESIGN: A randomized placebo-controlled clinical trial including p regnan t women (n = 230) with mild to severe nausea & vomiting @ 6-12 weeks gestation. Patients were randomly assigned to receive a watch-like device for nerve stimulation therapy (ReliePoand®) or~ an othex~ise identical but non- stimulating placebo device. The primai T outcome measure was serf-recorded symptoms using the Rhodes Index of Nausea, Vomiting and Retching (INVR) at weeks one, two and three post ein'ollment. Secondary outcome measures were medication use, weight gain & urinary ketones.

RESULTS: 73 (39%) of the 187 women who completed the trial had severe symptoms at baseline. Occur rences of nausea, voinit ing and re tch ing was significantly decreased in the active band versus the control b a n d at each assessed week. The experience score was also significantly lower at the 2nd and 3rd week assessment in the active band versus the control band. There were no differeuces in medication use or m'inary ketone measurements.

CONCLUSION: Although patients do not repor t a decrease in symptoms with NST, it decreases the nmnber of vomiting episodes and improves weight gain.

Table

RELIEFBAND ® C O N T R O L p N = 45 N = 28 VALUE

Maternal age 29.3 + 5.1 29.7 _+ 6,1 NS Body mass index 24.8 -+ 4.8 26.7 -+ 8.0 NS Severe dehydrat ion 1 (2.2) 3 (10.7) ,15 Weight gain (%) 33 (74) 14 (50) .035 Weight gained (lbs) 3.3 _+ 5.8 0.6 _+ 3.9 .045

393

December 2901 A m J Obstet Gynecol

SCREENING FOR COMPLETE CONGENITAL HEART BLOCK AMONG FETUSES OF PATIENTS WITH SSA AND SSB ANTIBODIES DEIRDRE LYELL l, DAVID ROSENTHAL 2, YASSER EL-SAYED 3, MAURICE DRUZIN4; 1Stanford University, Maternal-Fetal Medicine, Stanford, CA; 2Stanford University, Pediatrics, Stanford, CA; 3Stanford University, Gynecology a n d Obstetrics, Stanford, CA; 4Stanford University, Obstetrics and Gynecology, Stanford, CA

OBJECTIVE: Maternal SSA (anti-Ro) and SSB (anti-La) antibodies can cross the placenta and damage the fetal cardiac conduct ion system, causing varying degrees of congenital hear t block (CHB). Some physicians treat all at-risk p r e g n a n t pat ients with empir ic dexamethasone or be tamethasone while screening with doppler auscultation. The incidence of CHB has been repor ted to be as high as 5%. We assessed cardiac funct ion using echocard iography among untreated patients at risk for CHB, and sought to define a screening protocol.

STUDY DESIGN: All patients between January 1998 and May 2001 with a history' of SSA or SSB antibodies were enrolled into the following screening protocol: fetal echocardiogram every two weeks from 16 to 24 weeks, and at 27 and 30 weeks. Parameters measured included pericardial effusion, shortening fraction, tricuspid regurgitation, heart rlaythm, and myocardial per formance index. In the event of deterioration of one or more indices, dexamethasone was to be administered.

RESULTS: Anmng 23 consecutive patients screened, none had evidence of impa i rmen t (95% CI: 0 to 0,13) in any of the parameters measured. No neonates had evidence of CHB. No patients received prophylactic steroids.

CONCLUSION: The incidence of congenital cardiac impairment among patients with a history of SSA and SSB antibodies is low and the diagnosis is often made af ter irreversible cardiac damage. An alternative to empir ic treatment, a screening protocol, is described. Given the potential ha rm of antenatal steroids, screening may be more valid than empiric steroid treat- ment.

392 COMPARISON OF MATERNAL SERUM THYROID STIMULATING IM- MUNOGLOBULIN AND FETAL THYROID SONOGRAPHY FOR THE DI- AGNOSIS OF NEONATAL THYROTOXICOSIS THOMAS WESTOVER 1, TUAN DINH 1, ROBIN PERRY1, ¿Cooper Hospi ta l /Rober t Wood Johnson Med School, Maternal Fetal Medicine, Camden, NJ

OBJECTIVE: To compare the sensitivity and specificity of maternal serum TSI with fetal thyroid sonography for the diagnosis of neonatal thyrotoxicosis.

STUDY DESIGN: We per formed a retrospective review of the perinatal u l t rasound database at a tert iary per inatal center. Using the terms hyper- thyroid, goiter and graves disease, we retrieved the records of 37 hyperthyroid patients f rom 1996-2000 who underwent maternal serum TSI measurements as well as second and third t r imester fetal thyroid sonography. We excluded patients who had transient biochemical hyperthyroidism due to hyperemesis. The fetal thyroid was imaged in a transvel~e plane through the fetal neck. Fetal goiter was defined as an abnormal enlargement of the anterior-posterior and lateral dimensions of the fetal thyroid gland.

RESULTS: 5 of 37 newborns were diagnosed as having neonatal thyro- toxicosis based on clinical a n d serologic assessments. The sensitivity and specificity of maternal sermn TSI was 100% and 88% respectively. No fetal goiters were seen sonographical ly between 18 and 23 weeks whereas the sensitivity and specificity of 28-33 week sonography was 100% and 97% respectively. These differences were non-signif icant possibly due to small sample sizes.

CONCLUSION: Although the sensitivity of maternal serum TSI and third trimester fetal thyroid sonography appear to be equally high, the false positive rate of sonography may be lower. If conf i rmed, this knowledge could be helpful in triaging the intensity of endocrinologic follow-up of these high risk newborns.

394 ROLE FOR BLAST I-IAART THERAPY AT TERM FOR POORLY ADHER- ENT HIV POSITIVE MOTHERS MICHELLE SMITH-LEVITIN 1, KAPLAN MARK 2, MARIA BAUTISTA3; ]North Shore University Hospital Health System, Maternal-Fetal Medicine, Manhasset, NY; -°North Shore University Hospital, Infectious Disease, Manhasset, NY; 3North Shore University Hospital, Neo- natology, Manhasset, NY

OBJECTIVE: To improve adherence by enrolling HIV positive mothers in a mult idiscipl inary t rea tment adhe rence (TA) p r o g r a m and to develop a t reatment strategy at term for women who fail the objective of obtaining an undetectable viral load (VL).

STUDY DESIGN: All pregnant HIV positive women presenting to NSUH for obstetrical care from 2/99~5/01 were enrolled in a multidisciplinary TA program. Patients were assigned a TA nurse who assured that medications were obtained and taken. Baseline CD4, VL, and HIV genotype were obtained on each patient. Treatment with antiviral medication was prescribed as clinically indicated, but always inc luded Zidowldine. Serial VL determinat ions were made. Mothers who had persistently detectable viral loads were loaded with new and potent antivirals (based on the genotype) the week pr ior to and dur ing delivery (blast HAART).

RESULTS: 35 women were enrolled. 28 cont inued the pregnancy. Of the 25 who have delivered, 8 were diagnosed dur ing the pregnancy. 2 were poorly adherent and 2 were started on medication after the second trimester. 3 had an infected neona te (1 poorly adheren t and both late starters). The PCR was positive at bir th in both late starters suggesting antenatal infection. The poorly adherent morn had a VL>750,000 and was poorly adherent with the neonatal Zidovudine. The PCR was positive at 3 months. 17 of the 25 knew they had HIV, and 6 were poorly adherent . None of these neonates were infected. All 8 poorly adherent patients received blast HAART. 1 achieved a VL<1000, and 4<10,000. O f the 17 adherent patients, 13 had VL<400, 1 had a VL of 3200, and 1 had a VL of 32,000 at term.

CONCLUSION: A nmhidisc ipl inary TA p r o g r a m coupled with blast HAART at term for non-adherent mothers achieves a low vertical transmission rate in HIV positive pregnant patients.