Methyldopa versus labetalol or no medication for treatment of mild and moderate chronic hypertension during pregnancy: a randomized clinical trial.

OBJECTIVE: to assess the maternal and fetal outcome in women with mild to moderate chronic hypertension on antihypertensive drug (methyldopa or labetalol) therapy compared to no medication. METHODS: This multicenter randomized clinical study was conducted at Menoufia University hospital, Shibin El-kom Teaching hospital at Menoufia governorate, Egypt.486 pregnant women with mild to moderate chronic hypertension were randomized into three groups; methyldopa group (n = 164), labetalol group (n = 160), and control or no medication group (n = 162) who were followed from the beginning of pregnancy till the end of puerperium to record maternal and fetal outcome. RESULTS: There was a highly significant difference between treatment groups (methyldopa and labetalol) and control group regarding the development of maternal severe hypertension, development of preeclampsia, renal impairment, presence of ECG changes, placental abruption, and repeated admission to hospital for blood pressure control (p < 0.001) with higher occurrence in the control (no treatment) group. Neonates in the labetalol group were more prone for the development of small for gestational age (SGA), neonatal hypotension, neonatal hyperbilirubinemia, and admission to NICU than their counterparts in the methyldopa and control groups (p < 0.001). The rate of prematurity was significantly higher in the control group than the treatment groups (p < 0.05). CONCLUSION: Treatment of mild to moderate chronic hypertension during pregnancy is beneficial in decreasing both maternal and fetal morbidity. The use of labetalol was associated with higher rates of SGA, neonatal hypotension, and neonatal hyperbilirubinemia compared to methyldopa or no medication.

Impact of Ultrasound-Guided Transvaginal Ovarian Needle Drilling Versus Laparoscopic Ovarian Drilling on Ovarian Reserve and Pregnancy Rate in Polycystic Ovary Syndrome: A Randomized Clinical Trial.

STUDY OBJECTIVE: To compare the impact of ultrasound-guided transvaginal ovarian needle drilling (TND) versus laparoscopic ovarian drilling (LOD) on ovarian reserve and pregnancy rate in patients with clomiphene citrate (CC)-resistant polycystic ovary syndrome (PCOS). DESIGN: A randomized clinical trial (Canadian Task Force classification I). SETTING: A university hospital. PATIENTS: Of 644 patients who presented at an infertility clinic, 246 with CC-resistant PCOS were randomized for treatment. INTERVENTIONS: Patients were randomly allocated to ultrasound-guided TND (n = 124) and LOD (n = 122). MEASUREMENTS AND MAIN RESULTS: Ovarian reserve parameters (serum antimüllerian hormone [AMH] and antral follicle count [AFC]) and pregnancy rate at 3 and 6 months were evaluated. At 3 months, patients in the LOD group experienced a significantly lower AMH (p < .001) and a higher ovulation rate (p < .05) with comparable AFC and pregnancy rate to patients in the TND group (p > .05) and a significant decrease in AMH and AFC within each individual group when compared with baseline (p < .001). At 6 months, patients in the LOD group experienced a significantly lower AMH (p < .001), lower AFC (p < .001), higher ovulation rate (p < .001) and higher pregnancy rate (p < .001) when compared with patients in the TND group. This effect started to diminish between the fourth and sixth month with an increase of AMH and AFC compared with baseline values (p < .05). CONCLUSIONS: Although TND is simple, safe, and less invasive than LOD, its effect on ovarian reserve appears to be transient and diminishes at 6 months. Multicenter studies are warranted to confirm efficacy as a second-line treatment in patients with CC-resistant PCOS.

Correlation between uterine artery Doppler indices and menstrual irregularities among levonorgestrel releasing intrauterine system and depot medroxyprogesterone acetate users: a prospective observational study.

OBJECTIVE: To ascertain whether menstrual irregularities among users of levonorgestrel releasing intrauterine system (LNG-IUS) and depot medroxyprogesterone acetate (DMPA), were associated with changes in uterine artery Doppler indices or not. METHODS: This three-year prospective observational study included 102 women using LNG-IUS and 104 women using DMPA for contraception. Participants were followed at regular intervals over three years with performance of transvaginal ultrasound to measure uterine artery pulsatility index (PI) and resistance index (RI) before starting the method and at six months, 12 months, two and three years thereafter. Data was collected and tabulated. RESULTS: Significant changes in uterine artery PI and RI were detected. PI indices were reduced after six months of use in both groups and elevated significantly at 12 months in both groups compared to initial values (p < .001) while RI significantly reduced after six months in both groups and elevated significantly at 12 months, two and three years in both groups compared to initial values (p < .001). Both PI and RI significantly reduced in women suffered abnormal uterine bleeding and significantly elevated in women experienced amenorrhea irrespective of the method used (p < .001). CONCLUSIONS: LNG-IUS and DMPA induce hemodynamic changes in the uterine arteries denoting positive correlation with menstrual irregularities. Larger multicentre studies are warranted to potentiate our findings.

Cyclic versus continuous medroxyprogesterone acetate for treatment of endometrial hyperplasia without atypia: a 2-year observational study.

OBJECTIVE: To assess the efficacy, safety and acceptability of cyclic medroxyprogesterone acetate (MPA) compared to continuous MPA for treatment of endometrial hyperplasia (EH) without atypia. MATERIALS AND METHODS: A prospective observational study conducted on premenopausal women with EH without atypia (n = 80) who were randomly assigned into two groups; 40 patients received cyclic 15 mg MPA and 40 patients received continuous 15 mg MPA. Follow-up endometrial sampling was done after 6 months. Primary outcome measure was regression of hyperplasia. Secondary outcome measures include side effects and patient acceptability. RESULTS: There was no significant difference between the two groups regarding regression of endometrial hyperplasia (90 % in the cyclic MPA group in comparison to 82.5 % in the continuous MPA group with p value >0.05). There was a significant higher women suffering from nausea, acne and menstrual changes in the continuous MPA group (p value <0.05). Cyclic MPA regimen was more acceptable to the patients in comparison to continuous MPA intake. CONCLUSIONS: Cyclic MPA regimen seems a safer and more acceptable therapy in comparison to continuous MPA regimen in patients with endometrial hyperplasia without atypia. Larger studies are warranted to confirm these results.

Comparison of intravaginal misoprostol and intracervical Foley catheter alone or in combination for termination of second trimester pregnancy.

OBJECTIVES: To examine the effectiveness, safety and acceptability of intravaginal misoprostol and intracervical Foley catheter alone or in combination for termination of second trimester pregnancy. METHODS: This clinical study was conducted on 90 pregnant patients intended for termination of pregnancy between 13 and 24 gestational weeks for any indication. Enrolled women are equally allocated into three groups: • Group I (Misoprostol group): a standard regimen of moistened misoprostol (400 µg) 4 hourly inserted vaginally. • Group II (Catheter group): intracervical Foley catheter inserted, inflated and placed on traction. • Group III (Combined group): intracervical Foley catheter inserted with a standard regimen of moistened misoprostol (400 µg) 4 hourly intravaginally was used. Procedure efficacy (defined as complete abortion performed on site), safety and acceptability were assessed. RESULTS: The induction to abortion interval was 7.5±1.25 h in the combined group, compared to 11.76±1.63 h in the misoprostol group and 19.76±1.52 h in the catheter group (p value<0.001) with a success rate of 100% and no major complications reported. CONCLUSIONS: The present results confirmed the high success rate with the shortest induction to abortion interval with a combined use of intracervical Foley catheter and misoprostol for termination of second trimester pregnancy.

Abdominal electromyography in laboring and non-laboring pregnant women at term and its clinical implications.

OBJECTIVE: To determine the patterns of uterine action potentials in laboring and non-laboring women at term using the non-invasive abdominal electromyography technique. METHODS: One hundred pregnant women at term who fulfilled the inclusion criteria were enrolled in the study and equally divided into two groups. Group I consisted of 50 women in active labor, while group II included 50 women not in labor. After enrollment, the cardiotocograph was applied to all women. Abdominal electromyographic recording was started and for every burst of action potential, we measured the amplitude, frequency and duration of action potential. The results were tabulated and statistically analyzed. RESULTS: Both groups were comparable in demographic characteristics. Four patterns of EMG were detected. The amplitude of action potentials was significantly higher in laboring compared to non-laboring women (77.44 ± 11.25 vs 13.71 ± 8.57, P < 0.001). Similar significantly longer durations of electrical bursts were also noted in laboring women (45.94 ± 8.77 vs 7.11 ± 4.68 s, P < 0.001). Specific electromyographic changes were noted in women passing from the non-laboring to laboring state and in women who required oxytocin augmentation during labor. CONCLUSION: Abdominal electromyography may help to distinguish between women in true active labor from those who are not. It also may help to identify women who will enter into labor within 24-72 h and those who require augmentation of labor.

Foley catheter versus intra-vaginal misoprostol for induction of labor in post-term gestations.

OBJECTIVE: To investigate whether a fluid filled intra-uterine extra-amniotic Foley catheter is an effective alternative to vaginal misoprostol in inducing labor in primigravid women with post-term gestations. PATIENTS AND METHODS: A prospective quasi-randomized controlled trial was designed and 100 primigravid women with post-term gestations were enrolled and equally allocated into two groups. A fluid filled intra-uterine extra-amniotic Foley catheter was inserted in women of group I. Women in group II received 25 microgram misoprostol vaginally every 4 h. Artificial rupture of membranes was performed for all women when their cervices reached 3-4 cm dilatation followed by oxytocin infusion if needed. The main primary outcome parameter was the induction to delivery interval. Results were tabulated and statistically analyzed. RESULTS: No significant difference was noted in any of the demographic data between both groups. The induction to delivery interval was shorter in the Foley group (897.36 ± 116.0 vs. 960.98 ± 94.18 min; P = 0.003). There were 34 cases which needed oxytocin augmentation in group I compared to 11 cases in group II (P < 0.01). Abnormal uterine activity occurred in three cases in the misoprostol group, but none in the Foley group. Ominous fetal heart rate was noted in one case in group I but three in group II. CONCLUSION: Fluid filled Foley catheter seems to be superior to 25 µg vaginal misoprostol regimen, when used to induce labor in primigravidae with post-term gestations with the advantage of having a shorter induction delivery interval, but more need for oxytocin augmentation.

Medication errors in the obstetrics emergency ward in a low resource setting.

OBJECTIVE: To investigate the patterns of medication errors in the obstetric emergency ward in a low resource setting. MATERIAL AND METHODS: This prospective observational study included 10,000 women who presented at the obstetric emergency ward, department of Obstetrics and Gynecology, Menofyia University Hospital, Egypt between March and December 2010. All medications prescribed in the emergency ward were monitored for different types of errors. The head nurse in each shift was asked to monitor each pharmacologic order from the moment of prescribing till its administration. Retrospective review of the patients' charts and nurses' notes was carried out by the authors of this paper. Results were tabulated and statistically analyzed. RESULTS: A total of 1976 medication errors were detected. Administration errors were the commonest error reported. Omitted errors ranked second followed by unauthorized and prescription errors. Three administration errors resulted in three Cesareans were performed for fetal distress because of wrong doses of oxytocin infusion. The rest of errors did not cause patients harm but may have lead to an increase in monitoring. Most errors occurred during night shifts. CONCLUSION: The availability of automated infusion pumps will probably decrease administration errors significantly. There is a need for more obstetricians and nurses during the nightshifts to minimize errors resulting from working under stressful conditions.