Mahmoud S. Zakherah

A randomized clinical trial of a levonorgestrel-releasing intrauterine system and a low-dose combined oral contraceptive for fibroid-related menorrhagia.

To compare the efficacy of a levonorgestrel‐releasing intrauterine system (LNG‐IUS) with that of a low‐dose combined oral contraceptive (COC) in reducing fibroid‐related menorrhagia.

Levonorgestrel-releasing intrauterine system compared to low dose combined oral contraceptive pills for idiopathic menorrhagia: a randomized clinical trial

BACKGROUND This study compared the efficacy of the levonorgestrel-releasing intrauterine system (LNG-IUS) to low dose combined oral contraceptive pills (COC) in the management of idiopathic menorrhagia. STUDY DESIGN A single-center, open, randomized clinical trial. One hundred twelve women complaining of excessive menstruation who desired contraception were randomized to receive LNG-IUS or COC. Treatment failure was defined as the need for medical or surgical treatment during the follow-up. Other outcomes included: menstrual blood loss (MBL) by alkaline hematin and by pictorial blood assessment chart (PBLAC), hemoglobin levels and assessment of lost days in which physical or mental health prevented participating women from performing usual activities. RESULTS At baseline, LNG-IUS (n=56) and COC (n=56) groups were comparable in age (mean ± S.D.) (39.3 ± 6.7 vs. 38.7 ± 5.2 years, p=.637), parity (median and range) [3(1-6.4) vs.3(2-6), p=.802] and BMI (mean ± S.D.) (29.6 ± 5.9 vs. 31.1 ± 5.7 kg/m(2), p=.175). Time to treatment failure was longer in LNG compared to COC group with a total of 6 (11%) patients who had treatment failure in the LNG-IUS compared to 18 (32%) in COC group with a hazard ratio of 0.30 (95% CI, 0.15-0.73, p=.007). Using alkaline hematin, the reduction in MBL (mean ± S.D.) was significantly more in the LNG-IUS group (87.4 ± 11.3%) compared to the COC group (34.9 ± 76.9%) (p=.013). Utilizing PBLAC scores, the reduction in the LNG-IUS (86.6 ± 17.0%) group was significantly more compared to the COC group (2.5 ± 93.2%) (p<.001). In the LNG-IUS group, increase in the hemoglobin and ferritin levels (mean ± S.D.) were noted (from 10.2 ± 1.3 to 11.4 ± 1.0 g/dL; p<.001; with reduction of the number of lost days (from 6.8 ± 2.6 to 1.6 ± 2.4 days, p=.003). CONCLUSION The LNG-IUS is a more effective therapy for idiopathic menorrhagia compared to COC.

Pictorial blood loss assessment chart in the evaluation of heavy menstrual bleeding: diagnostic accuracy compared to alkaline hematin.

Background/Aims: The pictorial blood assessment chart (PBAC) is a method for evaluation of menstrual blood loss (MBL). This study was conducted to evaluate the accuracy of the PBAC score in diagnosing MBL compared to alkaline hematin as a gold standard. Methods: Two cohorts were constructed: 30 women who reported ‘normal’ menses and 170 who reported ‘heavy’ menses. Evaluation of menstruation was performed using the PBAC score and by alkaline hematin. Results: Women who reported normal menses were younger (p = 0.071), had lower parity [median parity of 3 (range 1–6) vs. 4 (range 1–12), p < 0.001] and higher hemoglobin levels (11.1 ± 1.1 vs. 10.1 ± 1.6 g/dl, p < 0.001). PBAC scores and MBL by alkaline hematin were significantly correlated (Spearman r = 0.600, p < 0.001). The PBAC score of 150 had a ĸ of 0.593 (95% CI 0.480–0.687) and an area under the curve of 0.796 (95% CI 0.770–0.821). In a multivariable regression PBAC score >150, presence of blood clots and period duration >7 days were independent predicators of heavy menstrual bleeding with an overall area under the curve of 0.858 (95% CI 0.835–0.879). Conclusions: The PBAC score is a simple and accurate tool for semiobjective of MBL that can be used in clinical practice to aid the decision about treatment and follow-up.

Rectal misoprostol versus intravenous oxytocin for prevention of postpartum hemorrhage

To assess the effectiveness of 800 μg of rectal misoprostol compared with an intravenous infusion of 5 IU of oxytocin as prophylaxis against postpartum hemorrhage (PPH).

Distension versus traction in laparoscopically assisted balloon vaginoplasty for management of vaginal aplasia.

Creation of a neovagina in women with vaginal aplasia using laparoscopically assisted balloon vaginoplasty (LAB-V) has been described previously [1]. The creation of the neovagina depends on the traction and distension of the Foley catheter balloon. Alternative procedures such as sigmoid neovaginoplasty, McIndoe procedure, and peritoneoplasty are more technically demanding and have higher complication rates [1]. Preliminary results attest to the safety and effectiveness of LAB-V [1,2]. It is possible that traction contributes length to the neovagina, while distension contributes width. The most important contributing factor to satisfactory sexual intercourse is unknown. The aim of the present prospective study was to compare the effects of postoperative predominant traction and predominant distension on penetration and sexual satisfaction among women undergoing LAB-V and their partners. Eighteen women with vaginal aplasia were included in the study. Sexual satisfaction was measured using a visual analogue scale from zero to 100 and divided into 10 compartments, with 100 representing maximum satisfaction and 0 representing no satisfaction. Each womans partner was assessed using a similar scale to measure depth of penetration and sexual satisfaction. After counseling about the procedure and the alternatives, the patients were randomly allocated to either the predominant distension group (PD) or the predominant traction group (PT) after informed consent was obtained. Ethical approval was granted by the Department of Obstetrics and Gynecology. The operative procedure was the same for both groups [1] and was performed by one of the authors [AME]. Postoperative care consisted of preventing infection [1], and controlled traction and distension in each group but at different levels. In the PD group, the balloon was distended at 5 mL/day to a maximum of 40 mL reached on the seventh postoperative day. The catheter was then removed the following day. Tractionwas performed at a rate of 1 cm per day. In the PT group, traction was done daily using the catheter to the level of patient tolerance (maximum 3 cm) and controlled distension at a rate of 3 mL every other day. Counter traction was applied in both groups every 20–30 minutes during the

Enhancement balloon vaginoplasty for treatment of blind vagina due to androgen insensitivity syndrome

OBJECTIVE To evaluate the safety and feasibility of enhancement balloon vaginoplasty (EBV) in cases with blind vagina due to androgen insensitivity syndrome. DESIGN Case series with description of the technique. SETTING Womens Health Center, Assiut University, and Sohage Teaching Hospital, Sohage University. PATIENT(S) Three X,Y females (two cases presenting with apareunia and the third presenting with severe dyspareunia). INTERVENTION(S) Laparoscopy-assisted EBV. MAIN OUTCOME MEASURE(S) Operative time, complications, depth and width of neovagina, and functional status. RESULT(S) Our cases were currently married phenotypical females and had 46,X,Y karyotypes. They had well developed secondary sexual characters, but they presented with failure of intravaginal intercourse. EBV was performed successfully for three X,Y females. The total operative time was 38-45 minutes. No operative complications were reported, and there were no reported postoperative complications as a result of moving the direction of traction. The resultant neovaginas depths were 10, 11, and 12 cm, respectively. Sexual intercourse was set off on the day of discharge. Penetration and satisfaction scores increased up to 90 points for both partners. CONCLUSION(S) It was feasible and safe to move centrally the direction of traction and to move the point of catheter exit up with apparently better outcomes than conventional balloon vaginoplasty for treatment of blind vagina due to androgen insensitivity syndrome.

Modified balloon vaginoplasty: the fastest way to create a natural neovagina Minor changes in technique eliminate the need for customized instruments

We studied the feasibility of performing balloon vaginoplasty (BV) with conventional laparoscopic instruments through 2 modified techniques aiming at providing BV for open use. Three of 6 cases with vaginal aplasia were offered modified laparoscopically assisted balloon vaginoplasty (LAB-V) and the other 3 cases underwent modified retropubic balloon vaginoplasty (RBV). We measured operative time, complications, anatomical outcomes, functional outcomes, and re-intervention rates. Modified RBV and LAB-V were performed successfully in the 6 cases within 9-12 and 29-38 min, respectively. The neovagina depths were 8-10 and 9-12 cm, respectively. Anterior rectal wall needle puncture was encountered in 1 case of LAB-V group and posterior urethral wall puncture in an abnormally dilated urethra in 1 case of the RBV group; both cases passed uneventfully. Intercourse was initiated after removal of all catheters. The neovagina was a cosmetically appealing mimic to nature and stained with iodine up to its apex. It was feasible to perform balloon vaginoplasty operations without specialized instrument sets with comparable outcomes.

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 Womens 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.

Direct Trocar versus Veress Needle Entry for Laparoscopy: A Randomized Clinical Trial

Aims: To compare direct trocar (DT) to Veress needle (VN) entry for the creation of pneumoperitoneum during laparoscopy with regard to the duration of the procedure, volume of gas used, ease of performance, and frequency of complications. Design: A randomized clinical trial. Subjects and Methods: One thousand patients scheduled to undergo diagnostic laparoscopy were recruited for the study. They were randomly allocated to either DT entry (group A, n = 500) or VN (group B, n = 500) for pneumoperitoneum. The laparoscopic procedures were performed by the same surgeon. Outcomes: The duration of the procedure, volume of gas consumption, ease of performance and frequency of complications were analyzed. Results: Patients in the 2 groups had similar demographic characteristics. The mean duration of the procedure was significantly shorter in group A (2.2 ± 0.7 min, 95% CI 2.14–2.26) than in group B (8.2 ± 1.4 min, 95% CI 8.08–8.32; p < 0.0001). The mean gas consumption was significantly less in group A (2.6 ± 0.9 liters, 95% CI 2.52–2.68) than in group B (8.4 ± 2.6 liters, 95% CI 8.17–8.63; p < 0.0001). No major complications in both groups were encountered. Minor complications were significantly less in group A (0.4%, 95% CI 0.77–3.23) than in group B (14%, 95% CI 10.96–17.04; p < 0.0001). Conclusions: DT entry is a safe alternative to the VN entry technique for the creation of pneumoperitoneum. Such an approach has further advantages such as less cost and instrumentation and rapid creation of pneumoperitoneum.

Clinical application of fetal left modified myocardial performance index in the evaluation of fetal growth restriction

Abstract Objective: This study aims to evaluate cardiac function in fetuses with intrauterine growth restriction (IUGR) compared with healthy fetuses, using the left modified myocardial performance index (MPI) and the association between MPI and perinatal outcome. Methods: Pregnant women between 34 and 39 weeks of gestation, who met the criteria for IUGR and were scheduled for delivery at an Egyptian tertiary medical center, were prospectively enrolled in the study. Women in the same gestational-age group with uncomplicated pregnancies were included as a control group. MPI was measured in all fetuses. The IUGR group was analyzed based on normal and abnormal umbilical artery (UA) Doppler. Perinatal outcomes were recorded. Results: The mean left MPI was significantly higher in IUGR fetuses with abnormal UA Doppler (mean 0.58±SD 0.093) compared with healthy fetuses (mean 0.45±SD 0.070) (P<0.001). IUGR fetuses with abnormal left MPI showed significantly worse perinatal outcome and increased morbidity compared with the control group. IUGR fetuses with abnormal left MPI also showed significantly worse perinatal outcome compared with IUGR fetuses with normal MPI (whether the UA Doppler was normal or abnormal). The fetal MPI was associated with the severity of fetal compromise in IUGR fetuses based on the perinatal outcome. Conclusion: MPI is a potentially useful tool in evaluating fetuses with suspected IUGR, which is crucial in classifying IUGR pregnancies into critical and non-critical cases and in predicting neonatal outcome.