Bupropion SR for smoking cessation in pregnancy: a pilot study

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256 THE VALUE OF CONTINUOUS GLUCOSE MONITORING IN WOMEN WITH IDIOPATHIC MACROSOMIA AND/OR POLYHYDRAMNIOS AND NORMAL GLUCOSE SCREENING HEIDI PORTER 1 , SANDRA LOOKIN- LAND 2 , GEORGE SAADE 3 , MICHAEL BELFORT 4 , 1 Utah Valley Regional Medical Center, Provo, UT 2 UC-San Diego, San Diego, CA 3 University of Texas Medical Branch, Department of Obstetrics & Gynecology, Galveston, TX 4 Utah Valley Regional Medical Center, Department of Obstetrics & Gynecology, Salt Lake City, UT OBJECTIVE: To assess the relationship between real-time blood glucose concentrations and idiopathic macrosomia and/or polyhydramnios in women who have had a normal glucose screening test. STUDY DESIGN: Twenty women with idiopathic polyhydramnios and/or macrosomia (cases) and 20 women with normal pregnancy (control) were enrolled. Women in both groups had normal glucola and/or 3-hr GTT. All subjects were fitted with a real-time Continuous Glucose Monitoring System (CGMS; Medtronic MiniMed, Northridge, CA) for 72 hours in order to continuously monitor glucose concentration in the subcutaneous interstitial fluid. Average daily fasting blood glucose levels, pre- and postprandial blood glucose levels, the minimum and maximum blood glucose levels, as well as the duration and percentage of time that the subjects had blood glucose levels above 120 mg/dL and/or less than 60 mg/dL were compared between the 2 groups. RESULTS: There were no significant differences between the cases and controls in the analyzed parameters over the 72 hours of continuous glucose monitoring. CONCLUSION: Glucose intolerance in pregnant women with idiopathic polyhydramnios and/or macrosomia can be excluded if the usual glucose screening tests are negative. Continuous glucose monitoring does not appear to be of value in these patients. 257 HOW SAFE IS MODERN-DAY CESAREAN DELIVERY? CHI DOLA 1 , SHERRI LONGO 1 , LATASHA NELSON 1 , MARGARITA TERRASSA 1 , 1 Tulane Univer- sity School of Medicine, Obstetrics and Gynecology, New Orleans, LA OBJECTIVE: With rising overall cesarean delivery and the recent controversy of elective primary cesarean delivery, there is a need to readdress the morbidities associated with present technology. Therefore, we studied the incidence and type of postoperative morbidities associated with modern-day cesarean delivery. STUDY DESIGN: Retrospective analysis of medical data derived from women who underwent a cesarean delivery between 2000 and 2001. Maternal characteristics and postoperative morbidities were collected. Descriptive, Student’s t test, and chi-square analyses were performed. RESULTS: Two hundred twenty-three patients met inclusion criteria. The mean maternal age was 25.4 ± 6.9 years. Our study population had a body mass index of 34.1 ± 8.5 and they were mildly anemic prior to surgery with a hematocrit of 33.6 ± 3.8. The mean gestational age at delivery was 37.7 ± 3.6 weeks. Forty-nine percent had postoperative complications. The major postoperative morbidity was postoperative anemia (26%). Eleven percent had greater than 1000 mL of intraoperative blood loss. Twenty-two percent had postoperative infectious morbidities: endometritis (13%), urinary tract in- fection (5.8%), septic pelvic thrombophlebitis (2.2%), and pneumonia (1.3%). Superficial and deep wound breakdown occurred at 3.5%. Although rare, major complications did occur. There were two patients (.9%) with pulmonary edema and three patients (1.3%) who required a cesarean hysterectomy. Patients who underwent an elective cesarean delivery had a significantly decreased incidence of overall postoperative complications (33.3% vs 57.9%, respectively, P < .01). CONCLUSION: Although present technology has improved the safety of cesarean delivery, the incidence of postoperative complications remains significant. Therefore, is avoidance of vaginal birth for pelvic floor preservation worth the risks for postoperative morbidity associated with cesarean delivery? 258 ARE REPEAT COLPOSCOPIC EVALUATIONS OF ABNORMAL PAP SMEARS NECESSARY DURING PREGNANCY? CHI DOLA 1 , JOAN CHENG 1 , SHERRI LONGO 1 , MARGARITA TERRASSA 1 , LATASHA NELSON 1 , 1 Tulane University School of Medicine, Obstetrics and Gyneco- logy, New Orleans, LA OBJECTIVE: To evaluate the behavior of cervical dysplasia and determine the necessity of repeat colposcopic evaluations of abnormal Pap smears during pregnancy. STUDY DESIGN: A retrospective analysis was performed on data derived from pregnant patients with abnormal Pap smears. Records of initial, follow-up, and postpartum Pap smear results; colposcopic findings; and cervical biopsies when indicated were evaluated and compared for progression, regression, or no change in the dysplasia grade. Descriptive statistical analysis was performed. RESULTS: One hundred thirty-five patients met inclusion criteria. The mean maternal age was 23.0 ± 5.6 years. The ethnic population was mostly African American at 77%. Estimated gestational age at initial colposcopic examination was 25.2 ± 7.6 weeks. Eight patients (5.9%) had human immunodeficiency virus. Eighty-seven patients (64.4%) had a vaginal delivery. Initial prenatal Pap smear results included: ASCUS favors Reactive (2.2%), ASCUS favors SIL/HPV (62.2%), LGSIL (19.3%), HGSIL (13.3%), and other (5.1%). Of the 135 abnormal Pap smears, 94 (60.6%) had subsequent documented colposcopic examination which revealed: Normal exam (18.5%), CIN I (16.3%), CIN II (3.7%), CIN III (3.0%). When comparing the initial prenatal to the postpartum Pap smear results, 12 (8.9%) of the patients progressed to a higher grade of cervical dysplasia with none progressed to carcinoma, 41 (30.4%) remained unchanged, and 54 (40%) regressed to a lower grade of cervical dysplasia. Ten (7.4%) patients regressed from dysplasia to a non-dysplastic diagnosis. Of significance, 46 (34.1%) patients had a normal postpartum Pap smear. CONCLUSION: The majority of patients with abnormal prenatal Pap smears had documented postpartum regression of dysplasia or no change in dysplasia grading. These pregnant patients with low-grade dysplasia on Pap smears with adequate colposcopy may not require current standard of repeat evaluations during pregnancy. 259 BUPROPION SR FOR SMOKING CESSATION IN PREGNANCY: A PILOT STUDY HUGH MILLER 1 , JAMES RANGER-MOORE 2 , MARLA HINGTGEN 1 , 1 University of Arizona, Obstetrics and Gynecology, Tucson, AZ 2 University of Arizona, Tucson, AZ OBJECTIVE: To evaluate the efficacy of sustained-release (SR) bupropion as a pharmacologic aid for successful smoking cessation and 50% smoking reduction during pregnancy. STUDY DESIGN: We performed an IRB-approved double-blind, placebo- controlled, randomized clinical trial comparing a conventional behavioral smoking cessation intervention combined with either placebo or SR bupropion. Point prevalence abstinence and 50% reduction were established by self-report and confirmed with biochemical validation (normalized urinary cotinine [NUC] > 50 ng/mg considered significant). Pregnant smokers > 13 weeks’ gestation meeting specific criteria were enrolled in an 8-week intervention. Analysis was both intent to treat (ITT) and adjusted for dose response (ADR). RESULTS: Seventy-six patients were randomized, 43 (57%) to placebo and 33 (43%) to drug. Maternal age, ethnic distribution, education, socioeconomic status, ETS exposure, baseline Fagerstrom score, years smoked, prior quit attempts were not significantly different between groups. CONCLUSION: Bupropion SR achieves significant smoking reduction among pregnant smokers. Placebo (n = 43) SR bupropion (n = 33) P value Cigarettes per day 11.5 ± 8.1 10.1 ± 5.4 NS Baseline NUC (ng/mL) 1307 ± 1118 1243 ± 1042 NS 4-wk abstinence 2 (5) 5 (15) 0.24 8-wk abstinence 5 (13) 5 (15) NS ITT 4-wk reduction 6 (18) 15 (50) 0.008 ITT 8-wk reduction 11 (33) 13 (46) 0.43 ADR 4-wk reduction 7 (18) 6 (67) 0.008 ADR 8-wk reduction 16 (39) 6 (50) NS Volume 189, Number 6 Am J Obstet Gynecol SMFM Abstracts S133

Transcript of Bupropion SR for smoking cessation in pregnancy: a pilot study

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256 THE VALUE OF CONTINUOUS GLUCOSE MONITORING IN WOMENWITH IDIOPATHIC MACROSOMIA AND/OR POLYHYDRAMNIOS ANDNORMAL GLUCOSE SCREENING HEIDI PORTER1, SANDRA LOOKIN-LAND2, GEORGE SAADE3, MICHAEL BELFORT4, 1Utah Valley RegionalMedical Center, Provo, UT 2UC-San Diego, San Diego, CA 3University ofTexas Medical Branch, Department of Obstetrics & Gynecology, Galveston,TX 4Utah Valley Regional Medical Center, Department of Obstetrics &Gynecology, Salt Lake City, UT

OBJECTIVE: To assess the relationship between real-time blood glucoseconcentrations and idiopathic macrosomia and/or polyhydramnios in womenwho have had a normal glucose screening test.

STUDY DESIGN: Twenty women with idiopathic polyhydramnios and/ormacrosomia (cases) and 20 women with normal pregnancy (control) wereenrolled. Women in both groups had normal glucola and/or 3-hr GTT. Allsubjects were fitted with a real-time Continuous Glucose Monitoring System(CGMS; Medtronic MiniMed, Northridge, CA) for 72 hours in order tocontinuously monitor glucose concentration in the subcutaneous interstitialfluid. Average daily fasting blood glucose levels, pre- and postprandial bloodglucose levels, the minimum and maximum blood glucose levels, as well as theduration and percentage of time that the subjects had blood glucose levels above120 mg/dL and/or less than 60 mg/dL were compared between the 2 groups.

RESULTS: There were no significant differences between the cases andcontrols in the analyzed parameters over the 72 hours of continuous glucosemonitoring.

CONCLUSION: Glucose intolerance in pregnant women with idiopathicpolyhydramnios and/or macrosomia can be excluded if the usual glucosescreening tests are negative. Continuous glucose monitoring does not appear tobe of value in these patients.

257 HOW SAFE IS MODERN-DAY CESAREAN DELIVERY? CHI DOLA1, SHERRILONGO1, LATASHA NELSON1, MARGARITA TERRASSA1, 1Tulane Univer-sity School of Medicine, Obstetrics and Gynecology, New Orleans, LA

OBJECTIVE: With rising overall cesarean delivery and the recentcontroversy of elective primary cesarean delivery, there is a need to readdressthe morbidities associated with present technology. Therefore, we studied theincidence and type of postoperative morbidities associated with modern-daycesarean delivery.

STUDY DESIGN: Retrospective analysis of medical data derived fromwomen who underwent a cesarean delivery between 2000 and 2001. Maternalcharacteristics and postoperative morbidities were collected. Descriptive,Student’s t test, and chi-square analyses were performed.

RESULTS: Two hundred twenty-three patients met inclusion criteria. Themean maternal age was 25.4 ± 6.9 years. Our study population had a body massindex of 34.1 ± 8.5 and they were mildly anemic prior to surgery witha hematocrit of 33.6 ± 3.8. The mean gestational age at delivery was37.7 ± 3.6 weeks. Forty-nine percent had postoperative complications. Themajor postoperative morbidity was postoperative anemia (26%). Eleven percenthad greater than 1000 mL of intraoperative blood loss. Twenty-two percent hadpostoperative infectious morbidities: endometritis (13%), urinary tract in-fection (5.8%), septic pelvic thrombophlebitis (2.2%), and pneumonia (1.3%).Superficial and deep wound breakdown occurred at 3.5%. Although rare, majorcomplications did occur. There were two patients (.9%) with pulmonary edemaand three patients (1.3%) who required a cesarean hysterectomy. Patients whounderwent an elective cesarean delivery had a significantly decreased incidenceof overall postoperative complications (33.3% vs 57.9%, respectively, P < .01).

CONCLUSION: Although present technology has improved the safety ofcesarean delivery, the incidence of postoperative complications remainssignificant. Therefore, is avoidance of vaginal birth for pelvic floor preservationworth the risks for postoperative morbidity associated with cesarean delivery?

258 ARE REPEAT COLPOSCOPIC EVALUATIONS OF ABNORMAL PAPSMEARS NECESSARY DURING PREGNANCY? CHI DOLA1, JOANCHENG1, SHERRI LONGO1, MARGARITA TERRASSA1, LATASHANELSON1, 1Tulane University School of Medicine, Obstetrics and Gyneco-logy, New Orleans, LA

OBJECTIVE: To evaluate the behavior of cervical dysplasia and determinethe necessity of repeat colposcopic evaluations of abnormal Pap smears duringpregnancy.

STUDY DESIGN: A retrospective analysis was performed on data derivedfrom pregnant patients with abnormal Pap smears. Records of initial, follow-up,and postpartum Pap smear results; colposcopic findings; and cervical biopsieswhen indicated were evaluated and compared for progression, regression, or nochange in the dysplasia grade. Descriptive statistical analysis was performed.

RESULTS: One hundred thirty-five patients met inclusion criteria. Themean maternal age was 23.0 ± 5.6 years. The ethnic population was mostlyAfrican American at 77%. Estimated gestational age at initial colposcopicexamination was 25.2 ± 7.6 weeks. Eight patients (5.9%) had humanimmunodeficiency virus. Eighty-seven patients (64.4%) had a vaginal delivery.Initial prenatal Pap smear results included: ASCUS favors Reactive (2.2%),ASCUS favors SIL/HPV (62.2%), LGSIL (19.3%), HGSIL (13.3%), and other(5.1%). Of the 135 abnormal Pap smears, 94 (60.6%) had subsequentdocumented colposcopic examination which revealed: Normal exam (18.5%),CIN I (16.3%), CIN II (3.7%), CIN III (3.0%). When comparing the initialprenatal to the postpartum Pap smear results, 12 (8.9%) of the patientsprogressed to a higher grade of cervical dysplasia with none progressed tocarcinoma, 41 (30.4%) remained unchanged, and 54 (40%) regressed to a lowergrade of cervical dysplasia. Ten (7.4%) patients regressed from dysplasia toa non-dysplastic diagnosis. Of significance, 46 (34.1%) patients had a normalpostpartum Pap smear.

CONCLUSION: The majority of patients with abnormal prenatal Papsmears had documented postpartum regression of dysplasia or no change indysplasia grading. These pregnant patients with low-grade dysplasia on Papsmears with adequate colposcopy may not require current standard of repeatevaluations during pregnancy.

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Volume 189, Number 6Am J Obstet Gynecol

SMFM Abstracts S133

BUPROPION SR FOR SMOKING CESSATION IN PREGNANCY: A PILOTSTUDY HUGHMILLER1, JAMES RANGER-MOORE2, MARLA HINGTGEN1,1University of Arizona, Obstetrics and Gynecology, Tucson, AZ 2University ofArizona, Tucson, AZ

OBJECTIVE: To evaluate the efficacy of sustained-release (SR) bupropionas a pharmacologic aid for successful smoking cessation and 50% smokingreduction during pregnancy.

STUDY DESIGN: We performed an IRB-approved double-blind, placebo-controlled, randomized clinical trial comparing a conventional behavioralsmoking cessation intervention combined with either placebo or SR bupropion.Point prevalence abstinence and 50% reduction were established by self-reportand confirmed with biochemical validation (normalized urinary cotinine[NUC] > 50 ng/mg considered significant). Pregnant smokers > 13 weeks’gestation meeting specific criteria were enrolled in an 8-week intervention.Analysis was both intent to treat (ITT) and adjusted for dose response (ADR).

RESULTS: Seventy-six patients were randomized, 43 (57%) to placebo and33 (43%) to drug. Maternal age, ethnic distribution, education, socioeconomicstatus, ETS exposure, baseline Fagerstrom score, years smoked, prior quitattempts were not significantly different between groups.

CONCLUSION: Bupropion SR achieves significant smoking reductionamong pregnant smokers.

Placebo (n = 43) SR bupropion (n = 33) P value

Cigarettes per day 11.5 ± 8.1 10.1 ± 5.4 NSBaseline NUC (ng/mL) 1307 ± 1118 1243 ± 1042 NS4-wk abstinence 2 (5) 5 (15) 0.248-wk abstinence 5 (13) 5 (15) NSITT 4-wk reduction 6 (18) 15 (50) 0.008ITT 8-wk reduction 11 (33) 13 (46) 0.43ADR 4-wk reduction 7 (18) 6 (67) 0.008ADR 8-wk reduction 16 (39) 6 (50) NS