Expulsion of Nova-T380, Multiload 375, and Copper-T380A contraceptive devices inserted during cesarean delivery.

OBJECTIVE: To compare the expulsion rate of Nova-T380, Multiload 375, and Copper-T380A intrauterine contraceptive devices (IUCDs) inserted during cesarean delivery. METHODS: A comparative randomized study was conducted between January 1, 2013, and June 30, 2014, in three maternity centers in Egypt and Saudi Arabia. All women scheduled for an elective cesarean and accepting intraoperative insertion of an IUCD were randomly allocated to receive the Nova-T380 (group 1), Multiload 375 (group 2), or Cu-T380A (group 3) using a computer-generated table. Researchers and participants were not masked to the type of IUCD. Follow-up was for 1 year. The primary outcome was IUCD expulsion (complete or partial [i.e. displacement]). RESULTS: Each group contained 40 participants. At 1 year, expulsion had been reported for 5 (13%) women in group 1, 2 (5%) in group 2, and 6 (15%) in group 3 (P>0.05 for all). The frequency of displacement was significantly lower in group 2 (5 [13%] participants) than in group 1 (15 [38%]; P=0.001) and group 3 (14 [35%]; P=0.008). CONCLUSION: Despite a comparable risk of expulsion following IUCD insertion during cesarean delivery, the Multiload 375 device showed the lowest risk of displacement.

Safety and efficacy of postoperative continuous intra-peritoneal wash with lactated Ringer's for minimizing post-myomectomy pelvic adhesions: a pilot clinical trial.

OBJECTIVES: To assess efficacy and safety of post-operative intra-peritoneal wash with lactated Ringer's for 48h after myomectomy in reduction of adhesions compared to routine intra-operative irrigation. Study design A prospective, randomized trial that included 52 eligible participants who had undergone abdominal myomectomy. Participants were randomly allocated to a treatment group (n=26) which was subjected to continuous peritoneal wash for 48h via two intraperitoneal drains, and a control group (n=26). The incidence of de novo adhesions and their severity and extent were scored at a second-look laparoscopy 8-10 weeks postoperatively. Adhesions were graded using the local adhesion barrier scoring system score. Adverse effects were also assessed and reported. RESULTS: There was no statistically significant difference in duration of hospital stay or in the incidence of adverse events. A significantly higher proportion of adhesion-free patients was found in the treatment group [11/23, 47.8%] compared to the control group [4/21, 19%] (P<0.01). The mean number of pelvic sites covered by adhesions was significantly lower in the treatment group than in the control group (2.2±0.3 versus 4.6±0.8, P<0.05). The total adhesion score was significantly lower in the treatment group than in the control group (2.1±0.5 versus 4.8±1.4, P<0.05) and the adhesion score was significantly lower at most of the individual anatomical sites. CONCLUSIONS: Application of postoperative intraperitoneal wash with lactated Ringer's solution for 48h may have reasonable safety and efficacy in minimizing postoperative pelvic de novo adhesions following abdominal myomectomy.

Pregnancy outcomes of expectant management of stable mild to moderate chronic hypertension as compared with planned delivery.

OBJECTIVE: To compare outcomes between elective delivery at 37 weeks of pregnancy and expectant management among pregnant women with mild to moderate chronic hypertension. METHODS: In a two-center study, 76 women with mild to moderate chronic hypertension were randomly allocated to planned delivery at 37 completed weeks (group A) or expectant management for spontaneous onset of labor or reaching 41 weeks (group B) between April 2012 and October 2013. Differences were compared by t test, χ(2) test, or Fisher exact test. Odds ratios (ORs) with 95% confidence interval (CIs) were determined. RESULTS: There were no differences in superimposed pre-eclampsia (SPE), severe hypertension, preterm delivery, placental abruption, oligohydramnios, intrauterine growth restriction, or perinatal mortality between the groups. Group B had higher gestational age at delivery (P=0.001) and birth weight (P=0.01), but lower cesarean (OR 3.4; 95% CI, 1.2-10.3; P=0.03) and neonatal care unit admission (OR 5.4; 95% CI, 1.4-21.0; P=0.01) rates. More women with SPE were diagnosed before than after 37 weeks in group B (P=0.01). Overall, patients who developed SPE had more adverse pregnancy outcomes than those who did not. CONCLUSION: Mild to moderate chronic hypertension could be managed expectantly up to 41 weeks if SPE did not develop.

Role of adiponectin and its receptor in prediction of reproductive outcome of metformin treatment in patients with polycystic ovarian syndrome.

AIMS: The aim of this study was to examine the effect of metformin on serum adiponectin and adiponectin receptor-1 (AdipoR1) and evaluate their role in prediction of ovulation in patients with polycystic ovarian syndrome (PCOS). MATERIAL AND METHODS: The study cohort included 68 PCOS patients with clomiphene citrate resistance (group 1) and 28 healthy women as controls (group 2). Baseline serum adiponectin, AdipoR1, total testosterone (T), and homeostasis model of insulin resistance (HOMA-IR) were measured in all participants. Group 1 received metformin (1500 mg/day) for 6 months followed by second blood sampling. RESULTS: Group 1 had significantly lower baseline adiponectin and AdipoR1 (P = 0.001) compared to group 2. During treatment, metformin resulted in conception in 5/68 (7%), ovulation in 33/68 (48%) and regular cycles in 41/68 (60%) patients. Group 1 showed post-metformin higher adiponectin and AdipoR1 (P = 0.01) and lower HOMA-IR (P = 0.006) and T (P = 0.001) compared to pre-treatment levels. Post-metformin ovulatory patients had higher adiponectin and AdipoR1 and lower HOMA-IR and T compared to anovulatory patients. Multivariate regression analysis in group 1 showed that only T and HOMA-IR were significant independent factors for predicting ovulatory cycles during metformin treatment (P = 0.04 and P = 0.05, respectively). CONCLUSIONS: Metformin treatment enhances both adiponectin activity and insulin sensitivity, resulting in a less hyperandrogenic state in patients with PCOS. Serum adiponectin and AdipoR1 are poor predictors of ovulatory outcome during treatment.

Does cutaneous lupus erythematosus have more favorable pregnancy outcomes than systemic disease? A two-center study.

OBJECTIVE: To compare pregnancy outcomes in cutaneous lupus erythematosus (CLE) with systemic lupus erythematosus (SLE) and healthy pregnant women. DESIGN: Cohort comparative study. SETTING: Two university maternity centers in Saudi Arabia and Egypt. POPULATION: Pregnant women with CLE and SLE and healthy pregnant women. METHODS: Over a three-year period, 201 participants were allocated to three groups: group 1 (n = 67) contained women with CLE, group 2 (n = 67) women with SLE, and group 3 healthy controls (n = 67). Diagnosis of lupus erythematosus was based on American College of Rheumatology criteria. All participants were followed until delivery. Lupus exacerbation was evaluated by Lupus Activity Index score. ANOVA and chi-squared tests were used to compare obstetrical and neonatal outcomes, and regression analysis was used to define independent factors of adverse pregnancy outcomes. MAIN OUTCOME MEASURES: Pregnancy losses, preterm labor, intrauterine growth restriction, preeclampsia, neonatal intensive care unit admissions, cesarean sections and lupus exacerbations. RESULTS: There was no significant difference between groups 1 and 3 in rates of pregnancy loss, preterm labor, preeclampsia, intrauterine growth restriction and neonatal intensive care admission. Group 1 had lower pregnancy loss (p = 0.005), growth restriction (p = 0.001), preeclampsia (p = 0.05), neonatal intensive care admissions (p = 0.001), cesarean section (p = 0.03), lupus exacerbations (p = 0.05) and anti-phospholipid antibodies (p = 0.02) compared with group 2. In groups 1 and 2, lupus exacerbation and anti-phospholipid antibodies were significant independent factors for adverse outcomes. CONCLUSIONS: Cutaneous lupus erythematosus means comparable pregnancy outcomes to those of the healthy population. Lower rates of disease exacerbation and anti-phospholipid antibodies are potential factors for better pregnancy outcome in CLE compared with SLE.

Intrapartum fetal asphyxia: study of umbilical cord blood lactate in relation to fetal heart rate patterns.

PURPOSES: To correlate between umbilical artery cord blood lactate and acid-base status with intrapartum fetal heart rate monitoring, and to measure the reliability of umbilical cord blood lactate for prediction of early neonatal outcome. METHODS: Sixty-six participants with intrapartum abnormal fetal heart rate monitoring and 60 participants with normal intrapartum recordings were recruited. The abnormal recordings included late onset, atypical variable and simple variable decelerations. After delivery, the arterial cord blood lactate, pH, actual base excess (ABE), and Apgar score were measured in all participants. RESULTS: There was significant inverse correlation between cord lactate and pH and ABE in all participants (correlation coefficient = -0.7, p < 0.0001). The cord lactate was significantly higher in the late onset and atypical variable decelerations groups compared to control (p < 0.0001). There was no significant correlation between the Apgar score and blood lactate in all groups; however, the sensitivity and specificity of cord lactate to predict low score at 5 min were higher in comparison to cord pH. CONCLUSIONS: Umbilical cord blood lactate is a reliable marker for intrapartum fetal asphyxia compared to cord acid-base status with better prediction for newborns with low Apgar score.

Comparison of double- and single-dose methotrexate protocols for treatment of ectopic pregnancy.

OBJECTIVE: To compare efficacy between double-dose methotrexate and single-dose methotrexate for treatment of tubal ectopic pregnancy (EP). METHODS: Between March 2008 and February 2011,157 patients who had tubal EP diagnosed by a non-laparoscopic approach and were hemodynamically stable were enrolled in a prospective study in Qassim, Saudi Arabia. The participants were randomized to receive either double-dose (50mg/m(2) intramuscularly on days 0 and 4; group 1) or single-dose (50mg/m(2) intramuscularly on day 0; group 2) methotrexate. Serum human chorionic gonadotropin (ß-hCG) levels were followed until negative. RESULTS: The overall success rate was comparable between groups 1 and 2 (88.6% versus 82.0%, P=0.1). The duration of follow up until negative ß-hCG was shorter in group 1 (P=0.001). Receiver operative characteristics showed that higher cut-off levels of ß-hCG and gestational mass diameter were associated with successful outcome in group 1. Among participants with initial ß-hCG of 3600-5500 mIU/mL, the success rate was higher in group 1 (P=0.03). There was no significant difference between groups in adverse effects. CONCLUSION: For treatment of EP, double-dose methotrexate had efficacy and safety comparable to that of single-dose methotrexate; it had better success among patients with moderately high ß-hCG and led to a shorter follow up.

Obstetrical and fetal outcomes of a new management strategy in patients with intra-hepatic cholestasis of pregnancy.

PURPOSES: To determine the incidence, obstetrical, and fetal complication rates of intrahepatic cholestasis of pregnancy (ICP) in patients managed expectantly to 40-weeks gestation. METHODS: In a prospective cohort study conducted between February 2008 and January 2010, a total of 21,960 pregnant women in Qassim Region of Saudi Arabia were screened for ICP using specific criteria for diagnosis. The course of pregnancy was monitored to 40-weeks gestation or spontaneous onset of labor, whichever comes first. The measured outcomes were compared with a cross-matched group of healthy pregnant women. Continuous variables were analyzed with t test, while χ(2) test was used for comparing percentages. RESULTS: The incidence of ICP was 0.35% (76/21,960). There was no significant difference between groups in gestational age at delivery, preterm labor, intrauterine fetal death, cesarean section, or respiratory distress syndrome. There was significantly higher intrapartum non-reassuring fetal heart rate patterns and meconium-stained amniotic fluid in ICP group (P < 0.01 and <0.0001, respectively). CONCLUSIONS: The incidence of ICP in this region is low compared to worldwide range. Expectant management to 40-weeks gestation is associated with obstetrical and fetal outcomes comparable to normal pregnancy; however, intrapartum fetal asphyxia is more likely.

Laparoscopic ovarian drilling in polycystic ovary syndrome: efficacy of adjusted thermal dose based on ovarian volume.

OBJECTIVE: To compare reproductive outcome of adjusted thermal dose on the basis of ovarian volume versus fixed-puncture dosage in laparoscopic ovarian drilling. DESIGN: Randomized controlled trial. SETTING: University Women's Health Center. PATIENT(S): One hundred twenty patients with polycystic ovary syndrome and clomiphene citrate resistance. INTERVENTION(S): Patients were assigned randomly to two groups of 60 women each. Group A received an adjusted thermal dose based on ovarian volume with use of a new model for dose calculation (60 J/cm(3) of ovarian tissue), and group B received 600 J per ovary through four ovarian holes regardless of size. One month afterward, the hormonal profile was reevaluated, and second-look laparoscopy was performed in patients who had not conceived by 6 months to evaluate adnexal adhesions. MAIN OUTCOME MEASURE(S): Ovulation, conception, and early abortion rates, cycle rhythm, and adnexal adhesions. RESULT(S): More patients resumed regular cycles in group A than in group B (87.9% vs. 75.4%). The ovulation and pregnancy rates were significantly higher in group A than in group B (81.8% vs. 62.2% and 51.7% vs. 36.8%, respectively). There was no significant difference between groups in early miscarriage rate or postdrilling adhesions. CONCLUSION(S): Adjusted diathermy dose based on ovarian volume for laparoscopic ovarian drilling of polycystic ovary syndrome has a better reproductive outcome compared with fixed thermal dosage.

Metformin versus laparoscopic ovarian drilling in clomiphene- and insulin-resistant women with polycystic ovary syndrome.

OBJECTIVE: To compare the hormonal-metabolic profiles and reproductive outcomes in clomiphene-resistant patients with polycystic ovary syndrome and insulin resistance between women receiving metformin and those undergoing laparoscopic ovarian drilling. METHODS: A total of 110 eligible participants were randomly allocated to diagnostic laparoscopy plus metformin therapy (group 1, n=55) or laparoscopic ovarian drilling (group 2, n=55). The t test was used for mean comparisons of hormonal-metabolic parameters and OGTT values before and after treatment. The chi(2) test was used for comparisons of ovulation, pregnancy, and abortion rates. RESULTS: Groups 1 and 2 showed a significant decline in testosterone, insulin-like growth factor-1 (P<0.001 vs P<0.001), and luteinizing hormone (P<0.05 vs P<0.001), while the glucose to insulin ratio was significantly increased (P<0.001 vs P<0.05) compared with baseline. Group 2 patients had more regular cycles and higher rates of ovulation and pregnancy compared with group 1: 76.4% [42/55] vs 58.2% [32/55], P<0.04; 50.8% [131/258] vs 33.5% [94/281], P<0.001; and 38.2% [21/55] vs 20.0% [11/55], P<0.03, respectively. The difference in the early abortion rate between the groups was not statistically significant. CONCLUSION: Although metformin results in a better attenuation of insulin resistance, laparoscopic ovarian drilling is associated with higher rates of ovulation and pregnancy.

Tactile cold scissor metroplasty as a novel backup method for hysteroscopic metroplasty.

OBJECTIVE: To study the operative, anatomic, and functional outcome of tactile cold scissor metroplasty (TCSM) as a backup method for hysteroscopic metroplasty. DESIGN: Case series with description of the technique. SETTING: Assiut University Women's Health Center. PATIENT(S): Three cases with failed hysteroscopic metroplasty out of 127 cases with uterine septa scheduled for hysteroscopic resection. INTERVENTION(S): The TCSM procedure was performed in three cases under direct laparoscopic monitoring. MAIN OUTCOME MEASURE(S): Operative time, complications, hysteroscopic appearance of the cavity, reproductive outcome, and reintervention rates. RESULTS: The TCSM procedure was performed successfully in the three cases with a short total operative time (10-12 minutes). Subsequent office hysteroscopic appearance was satisfactory. Patients were then followed up for a period of time ranging from 3 to 28 months. One case had a successful pregnancy outcome, one has an ongoing pregnancy, and the last one did not get pregnant so far. CONCLUSION(S): Tactile cold scissor metroplasty is a useful, safe, and effective backup procedure for hysteroscopic metroplasty.

Effect of short-term maternal fasting in the third trimester on uterine, umbilical, and fetal middle cerebral artery Doppler indices.

OBJECTIVE: To assess the effect of short-term maternal fasting on uterine, umbilical, and middle cerebral artery Doppler indices, and on maternal serum glucose levels and fetal behavior. METHODS: Maternal serum glucose levels, fetal biophysical profiles, and uterine, umbilical, and middle cerebral artery Doppler indices were assessed in 110 healthy women in the third trimester of pregnancy after fasting for 10-12 hours and 2 hours after a balanced meal. RESULTS: Maternal serum glucose levels, nonstress test results, fetal breathing movements, and biophysical profile improved after a meal compared with after fasting for 10-12 hours. Uterine, umbilical, and middle cerebral artery Doppler indices were not significantly different after fasting and after a meal. CONCLUSION: Short-term maternal fasting during the third trimester of pregnancy has no effect on uterine, umbilical, or fetal cerebral artery Doppler indices, and has a transient but significant effect on maternal serum glucose levels and fetal behavior.

Hysterosalpingo-contrast sonography versus radiographic hysterosalpingography in the evaluation of tubal patency.

OBJECTIVE: To compare the efficacy of hysterosalpingo-contrast sonography (HyCoSy) using a saline solution with that of radiographic hysterosalpingography (HSG) in the assessment of tubal patency. METHOD: We compared the findings obtained by the 2 methods with those obtained by standard diagnostic laparoscopy with the chromopertubation test in a study with 88 infertile women younger than 40 years. RESULTS: The sensitivity, specificity, and diagnostic accuracy of HyCoSy and HSG were similar, and 65 (74%) of the women reported the pain associated with HyCoSy as mild to moderate. CONCLUSION: The HyCoSy procedure is well tolerated and can be used as a primary tool for the evaluation of tubal patency in infertile women.