Pregnancy outcomes in women with Familial Mediterranean Fever receiving colchicine: Is amniocentesis justified?

Objective

To evaluate the outcome of pregnancies in women with familial Mediterranean fever (FMF) who are taking colchicine, and to reconsider the justification for amniocentesis in these women.

Methods

The outcome of 179 pregnancies in a group of women with FMF taking colchicine was compared with the outcome of 197 pregnancies in women with FMF who did not take colchicine during pregnancy and with 312 pregnancies in another cohort of healthy pregnant women of similar age and ethnicity.

Results

There was no difference in the 3 groups regarding early abortions, late abortions, or congenital malformations. There was a mild trend towards a better outcome for the colchicine‐treated group but these results did not reach statistical significance.

Conclusion

Treatment with colchicine during pregnancy in patients with FMF is beneficial in controlling the disease while not affecting the outcome of the pregnancy; therefore there is no justification for recommending amniocentesis in women taking colchicine solely because of this treatment.     

A single institutional experience with 43 pregnancies in essential thrombocythemia

OBJECTIVES: We describe the periconception circumstances and outcome of 43 consecutive pregnancies in an unselected group of young women with essential thrombocythemia (ET). PATIENTS AND METHODS: We retrospectively studied 74 consecutive cases of young women with ET seen at our institution, among whom 43 pregnancies occurred in 20 patients. Results: Of the 43 pregnancies, 22 (51%) were successful (21 term and 1 preterm live births) and 21 (49%) ended in miscarriages (1 ectopic pregnancy, 2 elective abortions, 16 first-trimester spontaneous abortions, 1 stillbirth at 22 wk, and 1 abruptio placentae at 33 wk). Management of ET at the time of conception included either no specific therapy (16 cases) or the use of aspirin alone (24 cases), a cytoreductive agent (2 cases), or heparin (1 case). There were no significant differences with respect to platelet count or the effect of treatment with aspirin, either at the time of conception or during the first trimester, among cases of successful pregnancies (22), all miscarriages (21), or first-trimester spontaneous abortions (16). The findings were similar when the analysis was restricted to only first-time pregnancies. In patients with multiple pregnancies, the outcome of a subsequent pregnancy was not predicted by the outcome of the first. In general, in successful cases the last two trimesters were mostly uneventful, with healthy offspring being reported in all cases. Conclusions: Pregnant patients with ET have an increased risk of first-trimester abortion which is not predictable by preconception platelet count or aspirin therapy. In addition, our experience does not support the use of prophylactic platelet apheresis during delivery.     

Overt and subclinical hypothyroidism complicating pregnancy.

We studied the evolution of 150 pregnancies corresponding to 114 women (16-39 years old) with primary hypothyroidism. Fifty-one pregnancies (34%) were conceived under hypothyroidism: 16 overt (X +/- standard deviation [SD], thyroxine [T4]: 2.44 +/- 0.7 microg/dL; thyrotropin [TSH]: 33.4 +/- 8.82 mIU/L), and 35 subclinical hypothyroidism (T4: 6.93 +/- 1.88 microg/dL; TSH: 12.87 +/- 8.43 mIU/L); 99 pregnancies were conceived under euthyroidism while undergoing thyroid therapy. When treatment with levothyroxine was inadequate, the outcome of pregnancy was abortion in 60% of overtly hypothyroid patients and in 71.4% of subclinically hypothyroid patients, premature delivery in 20% and 7.2% respectively, and term delivery in 20% and 21.4%, respectively. When treatment was adequate, 100% of overtly hypothyroid patients and 90.5% of subclinically hypothyroid patients carried pregnancies to term; there were no abortions in any of the groups. Abortions, premature and term deliveries in patients who were euthyroid on levothyroxine at the time of conception were 4%, 11.1% and 84.9% respectively. Of the patients receiving levothyroxine therapy before conception, 69.5% had to increase the dose (mean increase 46.2 +/- 29.6 microg/d). Of 126 evaluated newborns, 110 were delivered at term while 16 were premature. Eight newborns, 4 were premature, had congenital malformations (6.3%), and 4 died. Our results show that the evolution of pregnancies did not depend on whether the hypothyroidism was overt or subclinical but mainly on the treatment received. The adequate treatment of hypothyroidism during gestation minimizes risks and generally, makes it possible for pregnancies to be carried to term without complications.     

Outcome of pregnancy in type 1 diabetic patients treated with insulin lispro or regular insulin: an Italian experience

Some studies have shown that fetal outcome observed in patients using insulin lispro is much the same as in pregnant women using regular insulin. This study aims to analyze the Italian data emerging from a multinational, multicenter, retrospective study on mothers with type 1 diabetes mellitus before pregnancy, comparing those treated with insulin lispro for at least 3 months before and 3 months after conception with those treated with regular insulin. The data collected on pregnant women with diabetes attending 15 Italian centers from 1998 to 2001 included: HbA1c at conception and during the first and third trimesters, frequency of severe hypoglycemic episodes, spontaneous abortions, mode and time of delivery, fetal malformations and mortality. Seventy-two diabetic pregnancies treated with lispro and 298 treated with regular insulin were analyzed, revealing a trend towards fewer hypoglycemic episodes in the former, who also had a significantly greater reduction in HbA1c during the first trimester. The rate of congenital malformations was similar in the offspring of the two groups of women treated with insulin lispro or regular insulin. These findings suggest that insulin lispro could be useful for the treatment of hyperglycemia in type 1 diabetic pregnant women.     

Complications of pregnancy and child development after cessation of treatment with 6-mercaptopurine for inflammatory bowel disease

PURPOSE: 6-Mercaptopurine (6-MP) has proven efficacy in the therapy of inflammatory bowel disease. Its teratogenicity is demonstrated in animal studies when used at very high doses, whereas human data suggest that 6-MP at maintenance doses is safe. We report the outcome of 72 pregnancies in patients with inflammatory bowel disease who were previously treated with 6-MP with three different doses of 50, 75, and 100 mg/d, for a median duration of 18 months, along with long-term follow-up of the children. METHODS: We have compared the outcome of pregnancies and development of the offspring in the following two groups: group 1, patients with inflammatory bowel disease who conceived 6 months to 22 years after stopping 6-MP (median 72 months); and group 2, patients with inflammatory bowel disease who never received 6-MP prior to conception. All pregnancies were evaluated in terms of outcome: live full-term birth, premature delivery, stillbirth, spontaneous abortion, ectopic pregnancy, and therapeutic dilatation and curettage. Data on children were obtained regarding birth weight, congenital anomalies, and development. RESULTS: Group 1 included 72 pregnancies carried by 29 women. There were 51 live births (4 premature), 16 spontaneous abortions, 1 stillbirth, 2 therapeutic abortions due to abnormal amniocentesis, and 2 ectopic pregnancies. The total incidence of fetal loss was 29.2%. In group 2, 75 women had 140 pregnancies resulting in 120 live births (8 premature), 18 spontaneous abortions, and 2 stillbirths. There were no cases of ectopic pregnancies or abnormal amniocentesis. The total incidence of fetal loss was 14.3%. There was no increase in the incidence of developmental defects when the mothers had been treated with 6-MP prior to pregnancy. CONCLUSIONS: The incidence of fetal loss is higher in women with inflammatory bowel disease who had been previously treated with 6-MP compared with those who had not. Whether this was related to the older age at conception in 6-MP group, longer duration of disease, initially more severe disease, or use of 6-MP we cannot tell.     

Gold therapy in women planning pregnancy: outcomes in one center

OBJECTIVE: To review the experience and outcome of pregnancies in women taking gold while planning pregnancy. METHODS: We undertook a chart review of patients attending for gold injection and monitoring between January 1992 and April 2006. For women who became pregnant while being followed taking gold therapy, we extracted demographic, treatment, and disease activity data, information regarding pregnancy complications, outcome, and postpartum course. For details missing from the clinic records, patients were interviewed by the clinic nurse. RESULTS: Fourteen women experienced 20 pregnancies while being followed in the gold monitoring clinic. Mean age at the time of conception was 34.5 years (range 24-41), disease duration 8.5 years (1-16). Rheumatoid factor was positive in 9 of 14 women. Duration taking gold prior to conception was < 12 months in 7 pregnancies, 13-24 months in 4, 25-34 months in 2, and 2-10 years in 7 pregnancies. Four women continued taking gold until delivery. The rest of the women discontinued gold when they knew they were pregnant, with the exception of one who held her gold 4 weeks prior to conception. There were 5 spontaneous abortions in the first trimester; included were 2 spontaneous abortions in a woman with known Robertsonian chromosomal translocation. Sixteen babies were healthy including a pair of twins. One baby was born with weakness of one extraocular muscle requiring surgery; one had blocked tear ducts at birth. Rheumatoid arthritis (RA) flared during 3/15 completed pregnancies and postpartum and post-spontaneous abortion in 18/20 pregnancies. CONCLUSION: Our clinic experience and the published literature support the current practice that in patients with RA, gold may still be considered a treatment option in women planning pregnancy.     

Perinatal outcomes associated with the use of glargine during pregnancy

Aims Insulin glargine (IG), with its non‐peaking action profile, might be useful in diabetic pregnancy. However, data on its safety are limited and its use during pregnancy is not recommended. This study focused on the effects of IG on perinatal outcome, particularly to estimate the rate of congenital anomalies and birthweight. Methods This retrospective study included women with pre‐gestational diabetes who used IG before (at least 1 month) and during pregnancy. For all women we recorded data regarding maternal glycaemic control and pregnancy outcome. We also compared women treated with IG throughout pregnancy and women who stopped taking IG at an earlier stage. Results From 27 centres, 107 Type 1 diabetic pregnancies were identified. IG was started 10.3 ± 6.9 months before conception and in 57.4% of cases was stopped during the first trimester; 42.6% of women continued using it until the end of pregnancy. There were six abortions (four spontaneous and two induced) and five newborns (4.9%) with congenital anomalies. Glycaemic control, birthweight and the prevalence of macrosomia and neonatal morbidity were similar in women who used IG for the full term compared with those who stopped IG earlier during pregnancy. Conclusions This study, although limited, suggests that IG is safe and effective; the rate of congenital malformations was within the range expected for diabetic pregnancies treated with more traditional forms of insulin. IG used throughout pregnancy did not seem to influence birthweight or increase adverse outcomes.     

The safety of 6-mercaptopurine for childbearing patients with inflammatory bowel disease: a retrospective cohort study

BACKGROUND & AIMS: 6-mercaptopurine/azathioprine is effective in IBD patients. However, data regarding toxicity associated with pregnancy are lacking, raising both patients' and physicians' concerns and sometimes resulting in elective abortion. METHODS: To evaluate potential toxicity of 6-mercaptopurine (6-MP), we reviewed the records of 485 patients who had received the drug. We contacted 462, of whom 155 had conceived at least 1 pregnancy after developing IBD. Pregnancies were analyzed as to whether the patient had taken 6-MP before, or at the time of, conception. These were compared with IBD patients who had their pregnancies before taking 6-MP. We collected data on live births, spontaneous abortions, prematurity, abortions secondary to birth defects, major and minor congenital birth defects, infections, and neoplasia. Outcomes were analyzed comparing pregnancies from men and women who had taken or were currently taking 6-MP to controls. RESULTS: There was no statistical difference in conception failures (defined as a spontaneous abortion), abortion secondary to a birth defect, major congenital malformations, neoplasia, or increased infections among male or female patients taking 6-MP compared with controls (RR = 0.85 [0.47-1.55], P = 0.59). CONCLUSIONS: 6-MP use before or at conception or during pregnancy appears to be safe. Discontinuation of the drug before and during pregnancy is not indicated.     

Outcome of pregnancy in patients after repair of aortic coarctation.

AIMS: Nowadays, most women born with aortic coarctation reach childbearing age. However, data on outcome of pregnancy in women after repair of aortic coarctation are scarce. The aim of this study was to report on maternal and neonatal outcome of pregnancy in women after aortic coarctation repair. METHODS AND RESULTS: The CONCOR national registry on congenital heart disease in The Netherlands was reviewed for women of childbearing age (> or =18 years old) with a history of aortic coarctation repair. Medical history and maternal, obstetrical, and neonatal outcome were determined. Fifty-four of the 100 women included had a history of pregnancy. The 54 women had 126 pregnancies resulting in 98 successful pregnancies, 22 miscarriages, and six abortions. The success rate was estimated as 0.778 (SE 0.002) including abortions and 0.817 (SE 0.002) excluding abortions. There were 85 vaginal deliveries, seven vaginal deliveries with epidural analgesia, and six caesarean sections. There were two neonatal deaths. A total of 26 pregnancies were complicated by a hypertensive disorder of pregnancy. There were 21 pregnancies in 14 women complicated by hypertension and five pregnancies in four women complicated by pre-eclampsia. The hypertension- and pre-eclampsia-probabilities were estimated as 0.183 (SE 0.285) and 0.061 (SE 0.211), respectively. During pregnancy, five patients had an increase > or =15 mmHg across the site of repair at echocardiography, but only one patient required reintervention for recoarctation after delivery. Four of the 98 children (4%) had a congenital heart defect. CONCLUSION: Pregnancy is well tolerated in women after repair of aortic coarctation. However, an excess of miscarriages and hypertensive disorders of pregnancy were found.     

Pregnancy before and after the diagnosis of inflammatory bowel diseases: retrospective case-control study

BACKGROUND AND AIM: Inflammatory bowel diseases (IBD) commonly affect women during the reproductive years. The aim of the present study was to evaluate the reproductive histories of patients with ulcerative colitis (UC) and Crohn's disease (CD) considering pregnancies occurring before and after the diagnosis. METHOD: Case-control study evaluating IBD patients, interviewed by questionnaire about outcome of pregnancy and course of disease. RESULTS: A total of 502 pregnancies from 199 patients in the prediagnosis group and 121 pregnancies from 90 patients in the post-diagnosis group were respectively compared with 996 and 204 pregnancies recorded in a control population. In prediagnosis pregnancies, CD was associated with increased risk of preterm delivery (odds ratio [OR] 4.62, 95% confidence interval [CI] 2.77-7.73; P < 0.001 vs controls and OR 3.52, 95% CI 1.75-7.07; P < 0.001 vs UC) and lower birthweight (P < 0.001 vs UC and controls). In post-diagnosis pregnancies, the rate of live births was lower, but not statistically significant in IBD (OR 0.22, 95% CI 0.04-1.25; P = 0.08) and the birthweight was significantly lower in CD than in UC (P < 0.03) and in controls (P < 0.02). In post-diagnosis pregnancies, a higher incidence of congenital abnormalities was found in IBD patients (5.5% vs 0.0%). The spontaneous abortion rate and therapeutic abortions were significantly higher in post than in prediagnosis pregnancies. Neither disease activity at conception nor treatment appeared to influence the outcome of pregnancy. CONCLUSIONS: CD in the preclinical phase has some influence on pregnancy. In patients with IBD our data suggest that conception should not be discouraged. However, because of a modest increase in mild congenital abnormalities and abortions rates, pregnancy in IBD patients should be closely monitored.     

Outcome of pregnancies when fathers are treated with 6-mercaptopurine for inflammatory bowel disease

OBJECTIVE: The outcomes of pregnancies after maternal use of 6-mercaptopurine (6-MP) for inflammatory bowel disease (IBD) during pregnancy have been reported, but data are lacking for outcomes when the fathers use this drug. METHODS: Subjects were male patients with IBD seen at one center between 1970 and 1997. Patients and their wives were interviewed. Group 1 comprised pregnancies fathered by men who were taking 6-MP. This group was further subdivided into those conceived within 3 months of 6-MP use and those conceived at least 3 months after 6-MP was stopped. Group 2 comprised pregnancies fathered by men with IBD, similar in characteristics to group 1, who had not taken 6-MP before fertilization. Information was collected regarding the fathers, the mothers, and the pregnancies, as well as the health of the children, in a historical cohort study. RESULTS: There were 50 pregnancies in group 1 (13 in 1A and 37 in 1B) and 90 pregnancies in group 2. Four of the 13 pregnancies in group 1A were associated with complications. There were two spontaneous abortions, and two congenital anomalies including a missing thumb in one and acrania with multiple digital and limb abnormalities in the other. Risk of complications was significantly increased when compared with group 1B (p < 0.013) and group 2 (p < 0.002). CONCLUSION: The incidence of pregnancy-related complications was significantly increased when the fathers used 6-MP within 3 months of conception.     

Crohn's disease as a risk factor for the outcome of pregnancy

BACKGROUND/AIMS: To study the effects of Crohn's disease on the course of pregnancy and the influence of pregnancy on the activity of Crohn's disease. METHODOLOGY: The course of 35 pregnancies in 23 women with Crohn's disease were reviewed over a 12 years period. RESULTS: Nine pregnancies (25%) started when Crohn's disease was active. We observed 2 exacerbations among the 9 pregnancies with active disease and 7 exacerbations among the 26 pregnancies with quiescent disease: this represents a total exacerbation rate of 26% similar to non-pregnant women with Crohn's disease. The course of pregnancy was normal with a full-term delivery in 22 cases (63%). We observed 5 premature deliveries (14%), 5 spontaneous abortions (14%), 1 induced abortion (3%) and 2 liveborns with severe malformations (6%). Preterm delivery was significantly associated with reactivation of Crohn's disease during pregnancy (P = 0.009), whereas fetal loss was significantly associated with activity of Crohn's disease at the time of conception (P = 0.015). CONCLUSIONS: Pregnancy does not appear to influence the course of Crohn's disease. The relapse rate of Crohn's disease during pregnancy is similar to that of the general Crohn's disease population. Active Crohn's disease at the time of conception or reactivation during pregnancy are risk factors for abnormal pregnancy outcome.     

Neonatal outcome following buprenorphine maintenance during conception and throughout pregnancy

Aims To assess the effects of maternal buprenorphine treatment at conception and during pregnancy on neonates in terms of birth outcomes and neonatal abstinence syndrome (NAS). Design and setting Prospective, open‐label, out‐patient maintenance, case report study, conducted at the drug addiction out‐patient clinic at the University Hospital Vienna. Participants Two buprenorphine‐maintained pregnant women who had conceived during buprenorphine treatment. Both patients had previously given birth to healthy neonates following induction on to buprenorphine maintenance therapy in the second trimester. Measurements Mothers: urinalysis. Neonates: gestational age at delivery, Apgar scores, birth weight, length and NAS (Finnegan Scale). Findings Urinalyses were negative for both women for 25 and 38 months, respectively, during the pregnancy period. There were no complications during the course of the pregnancy. The newborns delivered by both women were healthy, birth outcomes were within normal ranges and there were no NAS symptoms requiring treatment. Conclusions To our knowledge this is the first report detailing the pregnancies of women treated with buprenorphine at the time of conception and investigated in a prospective study. The NAS noted in neonates born to buprenorphine‐maintained mothers appears to be less severe than the NAS observed in neonates born to methadone‐maintained mothers. These preliminary data indicate that, in our patient cohort, buprenorphine maintenance at the time of conception and during pregnancy did not seem to affect birth outcome measurements such as pregnancy complications, week of delivery, birth weight, length, umbilical pH or neurodevelopmental progress. Future prospective studies with larger study populations are warranted.     

Outcome of pregnancies in patients with complex pulmonary atresia.

OBJECTIVE: To evaluate the outcome of pregnancies in patients with complex pulmonary atresia, comparing those with and without previous radical surgical repair. DESIGN: A retrospective study of all pregnancies in women with complex pulmonary atresia registered on the Grown-up Congenital Heart Unit database between 1977 and 1994. SETTING: Referral centre for adolescents and adults with congenital heart disease. PATIENTS: Forty one pregnancies occurred in 15 patients. They were divided into two groups; group I, 26 pregnancies in nine patients before radical repair (cyanotic); group II, 15 pregnancies in seven women after radical surgical repair. RESULTS: In group I there were three terminations, 13 miscarriages, eight healthy children, and two neonatal deaths. Five children were born prematurely and all had low birthweights. In group II there were two miscarriages, 11 normal children, and two children with congenital heart disease. None was premature and all had normal birthweights. There were major complications in both groups: in group I there were two thromboembolic complications and one episode of heart failure; in group II there was one pulmonary embolism and one arrhythmic complication, five pregnancies in three patients were complicated by left ventricular failure that was persistent in one case and progressive in another, leading to death 13 months after delivery. CONCLUSIONS: Patients with complex pulmonary atresia, with or without surgical repair, who have no or mild symptoms, can have successful pregnancies. Surgical repair decreases fetal complications significantly. In both groups thrombotic disorders and heart failure must be prevented. Patients with residual systemic-pulmonary collaterals after surgical repair are particularly at risk of left ventricular failure.     

Fertility and Offspring of Alcoholic Women: An Unsuccessful Search for the Fetal Alcohol Syndrome

Forty married women in a psychiatric hospital with a diagnosis of alcoholism were interviewed to obtain details of their pregnancies and outcome of pregnancies with particular reference to spontaneous abortions, stillbirths, deaths, mental handicap and congenital abnormalities. Forty controls matched by age and with a diagnosis of endogenous depression were also interviewed. No significant differences were found in the fertility, outcome of pregnancy or state of the children. The probable reasons for this are discussed briefly and the introduction contains a review of some of the literature on the Fetal Alcohol Syndrome.     

St Vincent's Declaration 10 years on: outcomes of diabetic pregnancies.

AIMS: To monitor pregnancies in women with pregestational Type 1 diabetes for pregnancy loss, congenital malformations and fetal growth parameters, in a geographically defined area in the north west of England. METHODS: Population cohort study of 547 pregnancies in women with Type 1 diabetes from maternity clinics in 10 centres over a 5-year period (1995-1999 inclusive). Main outcome measures were numbers and rates of miscarriages, stillbirths, neonatal and post-neonatal deaths; prevalence of congenital malformations; birth weight in relation to gestational age. RESULTS: Among 547 pregnancies, there were six (1.1%) pairs of liveborn twins, 439 (80.3%) liveborn singletons; 72 (13.2%) spontaneous abortions, 14 (2.6%) stillbirths and 16 (2.9%) terminations. Four of the terminations were performed because of congenital malformations. Both the stillbirth rate (30.1/1000 total births (95% confidence interval (CI) 16.6-50.0)), and prevalence of congenital malformations (84.3/1000 live births (95% CI 60.3-113.8)) were significantly higher than the local population (P < 0.001). When corrected for gestational age, mean birth weight in the sample was 1.3 sd greater than that of infants of non-diabetic mothers (P = 0.12). Infants with congenital malformations weighed less than those without. CONCLUSION: In an unselected population, the infants of women with pregestational Type 1 diabetes mellitus have 6.4 times the reported risk of a congenital malformation and 5.1 times the reported risk of perinatal mortality than infants in the general population. Further improvements in the management of diabetes and pregnancy in these women are needed if the St Vincent's Declaration target is to be met.     

Pregnancy outcome in congenital dyserythropoietic anemia type I

Objectives: Congenital dyserythropoietic anemia type I (CDA I) is a rare inherited disease characterized by moderate to severe macrocytic anemia and abnormal erythroid precursors with nuclear chromatin bridges and spongy heterochromatin. Moderate to severe maternal anemia is a recognized independent risk factor for low birth weight (LBW) and complicated delivery. The aim of the study was to review the outcome of pregnancies in women with CDA I. Methods: The clinical and laboratory records of 28 spontaneous pregnancies in six Bedouin women with CDA I were reviewed. The results were compared with findings from a retrospective review of a large population‐based registry including all pregnancies in Bedouin women during the same 15‐yr period. Results: Eighteen pregnancies in women with CDA I (64%) were complicated. One pregnancy was aborted spontaneously in the first trimester and one resulted in a non‐viable fetus (stillborn at 26 wk). Cesarean section (CS) was performed in 10 pregnancies (36%). Eleven of the 26 newborns (42%) had a LBW: six were born prematurely and five were small for gestational age. The odds ratio for CS in women with CDA I compared with healthy Bedouin women was 4.5 [95% confidence interval (CI) 1.2–10.3], and for a LBW infant, 5.5 (95% CI 2.4–12.3). Careful follow‐up was associated with significantly better fetal outcome (P = 0.05). Conclusions: Pregnancies in women with CDA I are at high risk for delivery‐related and outcome complications. To improve fetal outcome, women with CDA I should be carefully monitored during pregnancy.     

A multicenter Italian study on pregnancy outcome in women with diabetes

Background and aimTo determine pregnancy outcome in women with type 1 and type 2 diabetes.Methods and resultsA prospective study was conducted in 33 centers in Italy between 1999 and 2003, mainly recording preterm delivery, stillbirths, neonatal mortality, congenital malformations and birthweight.Of the 668 women examined, 504 had type 1 diabetes and 164 had type 2. Pre-pregnancy counseling had been provided to 43.9% of the women who had type 1 diabetes and 29.1% of the women who had type 2 diabetes and correlated with a better HbA1c value throughout pregnancy. The preterm delivery rate was significantly higher in type 1 and 2 diabetics than in normal pregnant women and was related to HbA1c values higher than 8%, gestational hypertension, pre-eclampsia and the presence of retinopathy before pregnancy. The stillbirth and neonatal mortality rates were also higher in diabetic pregnant women (1.26% and 0.63%, respectively) than in Italian pregnancies in general (0.30% and 0.32%), and the same was true for major congenital malformations (4.9% for diabetic pregnancies, 0.86% for normal Italian pregnancies).ConclusionsIn our population, pregnancy in diabetic women was still associated with a high rate of stillbirths, neonatal mortality and congenital malformations. Unplanned pregnancies and non-optimal glycemia control may help explain the high rates of maternal and neonatal complications.     

Risk of ovarian failure and pregnancy outcome in patients with lupus nephritis treated with intravenous cyclophosphamide pulse therapy

This study was designed to investigate the risk of ovarian failure and the pregnancy outcomes in women treated with intravenous cyclophosphamide (IVCYC) pulse therapy for lupus nephritis. Sixty-seven women with proliferative lupus nephritis were studied. The clinical and laboratory data, SLEDAI and damage indices at IVCYC initiation, doses and numbers of IVCYC pulses, pregnancy and fetal outcomes were evaluated. During a follow-up of 74.4+/-20.6 months, amenorrhea occurred in 25 (37.3%) and was sustained permanently in 10 patients (14.9%). Thirteen women became pregnant with a total of 19 pregnancies. Seventeen pregnancies ended without complications and all babies were born healthy without any congenital anomalies or perinatal illnesses. Two pregnancies were terminated by induced abortion but no congenital anomaly was noted in these cases. Logistic regression analysis showed that old age, high damage index at the initiation of IVCYC pulse therapy and high cumulative dosage of IVCYC were the independent risk factors of ovarian failure, and that the presence of amenorrhea, regardless of its duration, was the risk factor of pregnancy failure. Pregnancy was possible with a favorable outcome after the withdrawal of IVCYC pulse therapy, unless amenorrhea develops.     

Congenital anomaly rate in offspring of mothers with diabetes treated with insulin lispro during pregnancy.

AIM: To determine the rate of major congenital anomalies in offspring of a large group of women with diabetes mellitus treated with insulin lispro (Humalog). METHODS: This multinational, multicentre, retrospective study included mothers with diabetes mellitus (diagnosed prior to conception) who were treated with insulin lispro for at least 1 month before conception and during at least the first trimester of pregnancy. Anomalies were assessed by two independent dysmorphologists not affiliated with the sponsor. RESULTS: The charts of 496 women were reviewed for 533 pregnancies resulting in 542 offspring (500 live births, 31 spontaneous and seven elective abortions, and four stillbirths). Mothers' characteristics: mean (+/- SD) age was 29.9 (+/- 5.2) years, 85.6% were Caucasian and 97.2% had Type 1 diabetes mellitus. Insulin lispro continued to be the main mealtime insulin for more than 96% of the women during the second and third trimester. The dysmorphologists determined that 27 (5.4%) offspring had major congenital anomalies and 2 (0.4%) offspring had minor congenital anomalies. CONCLUSIONS: The rate of major congenital anomalies was 5.4% [95% CI (3.45%, 7.44%)] for offspring of mothers with diabetes mellitus treated with insulin lispro before and during pregnancy. The current published rates of major anomalies in infants born to mothers with diabetes treated with insulin are between 2.1 and 10.9%. This suggests that the anomaly rate with insulin lispro treatment does not differ from the published major congenital anomaly rates for other insulin treatments.