Diclofenac Potassium Alone Versus Diclofenac Potassium with Hyoscine-N-butyl Bromide (HBB) in Reduction of Pain in Women Undergoing Office Hysteroscopy: A Double Blind Randomized, Placebo-Controlled Trial.

Study Objective: To compare between oral diclofenac potassium alone versus a combination of it with hyoscine-N-butyl bromide (HBB) in reduction of pain in women undergoing office hysteroscopy. Design: Randomized, double-blind controlled trial. Setting: Kasralainy  hospital (a tertiary hospital). Intervention: Sixty-Four patients undergoing office hysteroscopy were randomly divided into 2 groups (study group and placebo group) in the ratio of 1:1. Group 1 (study group = 32 participants) received two oral HBB tablets and one tablet of diclofenac potassium and group 2 (placebo group = 32 participants) received two oral placebo tablet similar in size, structure and color to buscopan in addition to the diclofenac tablet. The patient was given the drugs 30-60 min before the procedure. Results: There was statistically significant difference between the two groups in the pain score immediately during entry (p value = 0.001) and after 30 min of the procedure (p value = < 0.001). And there was a statistically significant difference as regards the side effects (gastric irritation) of the medications (p value = 0.04) between the women participating in the two groups. Conclusion: The combination of diclofenac potassium and HBB helps a lot in decreasing the pain and discomfort during and after performing office hysteroscopy but with more gastric side effects.

Comparative study between two techniques for artificial shrinkage of blastocysts prior to vitrification: LASER pulse versus micro-needle technique in increasing chemical, clinical pregnancy and live birth rates after ICSI, a randomized controlled trial.

PURPOSE: This work investigates ICSI outcome between LASER Artificial Shrinkage (LAS) and Micro-Needle Artificial Shrinkage (MNAS) before vitrification. PATIENTS AND METHODS: Four hundred and nine women were included in the study; which were randomly divided into two groups according to the technique used for artificial shrinkage step of the blastocyst before vitrification: in the first group, Laser beam was used while in the second group the micro-needle was used. Ovarian stimulation was done before the ICSI procedure either by long, short or antagonist protocol. RESULTS: The statistical analysis of our study revealed that there was no statistically significant difference between the two groups regarding age, number of cases, AMH, Basal FSH, BMI, male factor, usage ovarian stimulation protocol, high quality blastocysts, the mean number of transferred embryos. While, there was a statistically significant difference between two groups after thawing with p-value < .001 in favor of the LAS method regarding the morphology of originally high quality blastocysts, blastocysts healthiness (not degenerated), pregnancy rate, the implantation rates. CONCLUSION: LASER artificial shrinkage of human blastocysts is a promising technology that could be implemented on a wider basis to improve ART practice, as our study revealed that the usage of LASER pulse for artificial shrinkage of blastocysts before vitrification has better implantation rate as well as better chemical and clinical pregnancy rate in comparison to the usage of micro-needle artificial shrinkage of blastocysts before vitrification. There is a statistically significant difference regarding live birth rate being more in the LASER group as compared to needle group, also the number of twins ether identical or non-identical are larger in laser group than in needle group but with no statistically significant difference. Clinical trials.gov ID: NCT04125017.

Castor oil for labor initiation in women with a previous cesarean section: a double-blind randomized study.

Objective: To evaluate the efficacy of castor oil in initiation of labor in women who had one previous cesarean section. This study was conducted as a trial to increase the rate of vaginal birth after cesarean (VBAC) and decrease the rate of elective repeated cesarean section (ERCS).Methods: A double-blinded randomized controlled study was conducted in an Egyptian University Hospital from July 2019 to July 2020. The participants were 70 pregnant women who had one previous cesarean section, singleton pregnancy in cephalic presentation, with a Bishop score ≤6 attempting to perform a trial of labor. Sixty mL castor oil was administered to group A and 60 mL sunflower oil was administered to group B (as a placebo) for initiation of labor at the start of week 39. Primary outcomes were the percentage of women entering the active phase of labor within 24 h after receiving castor oil or placebo and the number of successful VBAC deliveries.Results: Labor started in 16 patients (45.7%) within 24 h in the castor oil group and in 3 patients in the placebo group (8.5%), while the rate of successful VBAC was 65.7% (23 patients) in the castor oil group and 48.5% (17 patients) in the placebo group.Conclusion: Castor oil appears to be an effective, low-cost, and non-harmful method for the initiation of labor in patients with a previous cesarean section.

Pregnancy outcome of anti-HCV direct-acting antivirals: Real-life data from an Egyptian cohort.

We aimed to assess the pregnancy outcome in women with chronic HCV who had negative pregnancy test prior to the anti-HCV course and had unintended pregnancy while on HCV treatment. Hundred patients with a mean age of 30 ± 6.7 y were included and advised to withhold antivirals and continue follow-up in viral hepatitis and obstetrics centres till delivery. All patients received a 12-weeks regimen of anti-HCV [sofosbuvir plus daclatasvir (SOF/DCV): n = 95, SOF/DCV plus ribavirin: n = 3, and paritaprevir/ritonavir/ombitasvir plus ribavirin: n = 2]. Only nine patients completed the full antiviral course against medical advice, and 91 stopped between on-treatment weeks 4 and 8. Eighty-eight patients delivered full-term babies, eight had preterm babies and two had abortions. Of the nine patients who completed the full course of DAAs, seven (77.8%) delivered normal babies, attended their post-treatment week 12 visit, and all (100%) achieved sustained virological response. No major antiviral-related adverse events were reported.

Evaluating efficacy of intravenous carbetocin in reducing blood loss during abdominal myomectomy: a randomized controlled trial.

OBJECTIVE: To evaluate the efficacy of carbetocin versus placebo in decreasing intraoperative blood loss and the need for blood transfusion during abdominal myomectomy. DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Tertiary university hospital from September 2019 to February 2020. PATIENT(S): A total of 138 women with symptomatic leiomyoma who were candidates for abdominal myomectomy (n = 69 in each group). INTERVENTION(S): We randomized the study participants in a 1:1 ratio to carbetocin and placebo groups. Intravenous 100 µg carbetocin or placebo was administered slowly after induction of anesthesia. MAIN OUTCOME MEASURE(S): Intraoperative blood loss, need for blood transfusion, postoperative hemoglobin, operative time, length of hospitalization, and drug side-effects. RESULT(S): The baseline characteristics were similar among all groups. Carbetocin had significantly lower intraoperative blood loss compared with placebo (mean difference 184 mL). Hemoglobin level 24 hours after surgery was significantly lower in the placebo group than in the carbetocin group (9.1 ± 0.8 vs. 10.3 ± 0.6 g/dL). Eight women in the carbetocin group needed blood transfusion compared with 17 in placebo group. Operative time, length of hospitalization, and side-effects were similar in both groups. CONCLUSION(S): A single preoperative intravenous dose of 100 µg carbetocin is a simple, practical, and effective method of decreasing intraoperative blood loss and the need for blood transfusion during abdominal myomectomy, with tolerable, few, nonsignificant side-effects. CLINICAL TRIAL REGISTRATION NUMBER: NCT04083625.

Alalfy modified cervical inversion technique as a tamponade in controlling PPH in placenta previa, a multicentric double blind randomized controlled trial.

INTRODUCTION: Postpartum hemorrhage that occurs frequently with placenta previa is one of the causes of maternal mortality in 14% in developing countries. OBJECTIVE: To assess efficacy of cervical inversion as a tamponade in controlling bed of placenta in cases of placenta previa. PATIENTS AND METHOD: A prospective randomized controlled study was conducted among a total of 240 pregnant women with placenta previa (120 subjected to Alalfy modified cervical inversion technique plus hemostatic sutures and 120 was not subjected cervical inversion and only was subjected to hemostatic sutures in Obstetrics and Gynecology Department at Suez Canal University hospital, Helwan University and Algezeerah hospital for a planned cesarean section). RESULTS: The mean intraoperative blood loss, the intraoperative time, and the postoperative hemoglobin show a statistically significant difference between cases with placenta previa who were exposed to cervical inversion in comparison to cases that had no cervical inversion with a p-value <.001. CONCLUSION: Modified cervical inversion (Alalfy technique) as a tamponade when added to hemostatic sutures to the placental bed is an easy, rapid, and efficient procedure that can decrease the amount of blood loss, time needed to stop bleeding per bed, total operative time, also it can decrease the need for blood transfusion.

Routine cervical dilatation at caesarean section and its influence on postoperative pain and complications in obese women: a double blind randomized controlled trial.

INTRODUCTION: Numerous surgical techniques regarding cesarean section performance were assessed. The usefulness of cervical dilatation during cesarean section, are still based on restricted research obtained data. PURPOSE: To assess the impact of intraoperative digital dilatation of cervix on postoperative pain. MATERIAL AND METHODS: The current research study is a Prospective parallel group randomized controlled double blind research trial that was conducted in obstetrics and gynecology hospital, Faculty of Medicine, Cairo University and Algezeera Hospital, Egypt from the period May 2018 until February 2018. RESULTS: The visual analog scale scoring level was statistically significantly higher in noncervical dilatation research group at 8th, 30th, 48 hours and 7th day postoperative (p values <.001, .001, .001, and .001, respectively). On the other hand at the 4th day postoperative, there was no statistical significant difference concerning VAS scoring level. CONCLUSIONS: Manual cervical dilatation during cesarean section is an innovative procedure to reduce postoperative pain in obese women. We thought that according to the results of the present study, cervical dilatation leads to proper continuous adequate evacuation and drainage of the intracavitary contents that leads to decrease the uterine subinvolution, retained blood and so, decreased postoperative pain and postoperative blood loss. CLINICALTRIALS.GOV ID: NCT03513237.

Evaluation of the Cesarean Scar Niche In Women With Secondary Infertility Undergoing ICSI Using 2D Sonohysterography Versus 3D Sonohysterography and Setting a Standard Criteria; Alalfy Simple Rules for Scar Assessment by Ultrasound To Prevent Health Problems for Women.

BACKGROUND: Many expressions were used to define the defect that is seen by ultrasound after cesarean section (CS) namely scar defect, niche, isthmocele, uterine pouch or diverticula. OBJECTIVE: To compare the accuracy of 2 dimensional sonohysterography (2D SHG) to 3 dimensional sonohysterography (3D SHG) in evaluating cesarean section uterine scar depth (D), base width (BW), width (W) and residual myometrial thickness (RMT) in women with secondary infertility and establishment of a standard criteria; Alalfy simple rules for scar assessment. PATIENTS AND METHODS: This was an observational cross-sectional comparative study that was conducted on women who presented with secondary infertility and were candidates for intracytoplasmic sperm injection (ICSI) and giving a history of a previous cesarean section. Assessment of uterine scar in each woman was performed using 2D transvaginal ultrasound with sonohysterography (SHG) followed by 3D transvaginal with SHG with evaluation of niche depth, width, RMT, niche BW and RMT/depth ratio. The study was conducted at Algezeera hospital, Egypt. RESULTS: The present study revealed that 3D ultrasound with SHG is superior in evaluation of the RMT and niche width prior to ICSI providing better characterization of the scar niche. CONCLUSION: Scar niche should be assessed by a combined integrated 2D SHG and 3D SHG scan with the specific geometrical and anatomical considerations, Alalfy simple rules for scar niche assessment that involvemeasurement of niche depth, (Base width) BW, width, RMT and RMT/depth ratio in sagittal plane, RMT in coronal plane / niche width in coronal plane ratio (ratio less than 1 denotes scar weakness with more liability for dehiscence). TRIAL REGISTRATION: Clinical Trials.gov Id NCT04076904.

Efficacy and Safety of Intravenous Tramadol versus Intravenous Paracetamol for Relief of Acute Pain of Primary Dysmenorrhea: A Randomized Controlled Trial.

INTRODUCTION: Many pharmaceutical, surgical, and complementary medical interventions are used for primary dysmenorrhea treatment. However, no consensus has been reached about the most effective intervention. OBJECTIVE: To compare the efficacy and safety of IV tramadol versus IV paracetamol in relieving acute pain of primary dysmenorrhea. METHODS: This randomized controlled trial was conducted in a tertiary referral hospital and included 100 patients between 18 and 35 years old diagnosed with primary dysmenorrhea. Patients received either 1-g paracetamol or 100-mg tramadol in 100-mL normal saline as an IV infusion over 10 min. Pain intensity was measured by using a visual analog scale at 15, 30, 60 min, and 2 h. We recorded drug side effects and requirements for rescue analgesics. RESULTS: Pain scores were significantly lower in the tramadol group compared with the paracetamol group at 15, 30, 60 min, and 2 h (p < 0.001). Fewer patients in the tramadol group needed rescue analgesics compared with the paracetamol group (p = 0.04). No significant differences were reported in side effects between both groups. CONCLUSIONS: IV tramadol is superior to IV paracetamol in relieving acute pain of primary dysmenorrhea with a comparable side effect profile.

Comparative study regarding effect of pH on Misoprostol in induction of labor in full term primigravida pregnant women, a double blind randomized controlled trial.

OBJECTIVES: To evaluate the effect of altering vaginal pH on induction of labor in full-term pregnancies using Misoprostol. METHODS: This randomized controlled trial was conducted at Kasralainy Hospital, Cairo University, Egypt and Algezeera Hospital, Egypt. A total of 218 healthy term primigravida pregnant women who were scheduled for pregnancy termination were recruited in the study. The included patients were divided into three groups; Group A: Those who received normal saline vaginal wash (0.9% NaCl), Group B: those who received alkaline vaginal wash (5% sodium bicarbonate) and Group C: those who received acidic vaginal wash (5% acetic acid). Patients received 25 µg of Misoprostol E1 (Vagiprost® Adwia Pharmaceuticals, Egypt) every 6 h for a maximum of 24 h (total of four potential doses). RESULTS: The 'acid' group participants took a mean time of 20.46 h to reach active stage of labor, followed by the 'normal saline' group with 21.45 h and the 'alkaline' group with 22.59 h. The difference between the groups was statistically significant, with a p-value of 0.013. CONCLUSIONS: Douching the vagina with acidic solution seems to supplement the effect of Misoprostol on inducing labor in full-term pregnancies, as evidenced by having the shortest mean time needed to reach active stage of labor.

Strengths of community and health facilities based interventions in improving women and adolescents' care seeking behaviors as approaches for reducing maternal mortality and improving birth outcome among low income communities of Egypt.

BACKGROUND: Provision of emergency obstetric care is considered the key for maternal mortality reduction worldwide. This study evaluated the impact of community- and facility-based educational programs on provision of emergency obstetric care in Egypt. The study focused on evaluating utilization of the available health services and care seeking behaviors of mothers in the childbearing period. METHODS: We implemented a package of community- and facility-focused educational interventions in two of Egypt's lowest income governorates. At facility level, health professionals at rural health units from 21 villages over 5 years were trained. Mass media gathering, individual teaching at health facilities, printed materials and home-based care sessions were provided. Collectively, these interventions were designed to focusing on recognition of the early warning signs during pregnancy, delivery and postpartum period for timely referral to hospitals for 20,494 women and adolescents mothers. RESULTS: The impact of the interventions was highly reflected on the percent of mothers received care during their pregnancy period. Proper antenatal care at governmental or private health facilities was raised dramatically from 0.6 to 59.3% and those who utilized at least one family planning method from 61.4 to 74.4%. Accordingly, the rate of complications significantly reduced during pregnancy (38.1 to 15.1%), during delivery (24.1 to 13.1%) and during postpartum (81.7 to 7.0%). As an impact to the improvement, there was a marked reduction in adolescent pregnancy by 55% and better birth outcome with a reduction in the percent of stillbirth by 11.5%. CONCLUSION: It is important to provide a comprehensive package that works at both improving qualities of care as well as empowering women by knowledge to first aid measures at the community level. The cost-effective way to empower mothers to provide first aid measures as emergency obstetric care is to adopt the outreach approach which could be more influential than mass media campaigns for the at-risk and vulnerable and low-income communities.

Effect of Low-Level Laser Therapy versus Electroacupuncture on Postnatal Scanty Milk Secretion: A Randomized Controlled Trial.

OBJECTIVE: Postnatal scanty milk secretion is a common complaint. Some physical and medical interventions were advocated to help milk production. These interventions should be effective and safe for the mother and the infant. This study aimed to compare the effects of low-level laser therapy and electroacupuncture on postnatal scanty milk secretion. STUDY DESIGN: A randomized controlled study conducted on 60 healthy primiparous mothers with insufficient lactation. They were randomly divided into three equal groups: group A (control), group B (those who received low-power He-Ne laser beam on both breasts), and group C (those who received faradic current stimulation at Spleen 6, Liver 3, and Small Intestine 1 acupuncture points on both sides). All participants received 10 mg Domperidone three times a day and were given advice about lactation, nutrition, and fluid intake. Evaluation was done before and after the treatment program. RESULTS: The mean serum prolactin, infant weight, and visual analog scale (VAS) score were significantly increased in the three groups posttreatment when compared with their corresponding levels pretreatment. Posttreatment serum prolactin was significantly elevated in group C more than the other two groups (p = 0.001 and 0.012, respectively). Also, it was significantly elevated in group B more than in group A (p = 0.001). The mean value of infant weight was significantly elevated in group C when compared with its corresponding values in both groups A (p = 0.001) and B (p = 0.029). The VAS score was significantly increased in both groups B and C when compared with group A (p = 0.001). CONCLUSION: Electroacupuncture is more effective than low-level laser therapy in increasing postnatal scanty milk secretion. CLINICAL TRIAL REGISTRATION: NCT03806062.

Physical endometrial manipulation and its impact on success rate and live birth rate in ICSI in patients with unexplained infertility after recurrent ICSI failure, a double blinded randomized controlled trial.

Background: Unexplained infertility is a rising problem and endometrial manipulation could be one of the solutions for enhancing the pregnancy rate and live birth rate in such circumstances.Aims: To evaluate the influence of local endometrial physical manipulation with specializd method for endometrial and tubal hydration (Elgazzar and Alalfy technique) on ICSI outcome and in increasing chemical, clinical, and live birth rate in ICSI after previous recurrent ICSI failure in patients with unexplained infertility.Results: When comparing group 1 (hydrotubation group) and group 2 (the control group with no intervention) with regards to the biochemical, clinical, and live birth rate, the hydrotubation group revealed higher rates and a better ICSI outcome.Conclusion: Hydrotubation is useful in increasing biochemical, clinical, and live birth rates after recurrent failed ICSI trials with a specialized method for hydration of endometrium and tubes (Elgazzar and Alalfy technique).

The efficacy of intrauterine misoprostol during cesarean section in prevention of primary PPH, a randomized controlled trial.

Background: Postpartum hemorrhage is the leading cause of maternal mortality worldwide.Aim: To compare the incidence of postpartum hemorrhage in women eligible for elective cesarean section (CS) delivery when using intrauterine misoprostol added to oxytocin versus oxytocin alone.Design, Setting, Participants: This parallel randomized controlled trial study was conducted in two institutions in Egypt (Kasralainy and Aljazeerah hospital) 0.300 women eligible for elective CS delivery were enrolled in the study.Interventions: Before randomization, all women received the same preparations. After randomization; in the study group (N = 150), intrauterine misoprostol was used after placental delivery. In the control group (N = 150), the routine oxytocin alone was used.Results: Both groups were comparable (p-value >.05) with regard to the age, BMI, and gestational age as well as hemoglobin and hematocrit levels. The incidence of postpartum hemorrhage was significantly lower (p = .018) in the study group (1.33%) than the control group (6.67%). The absolute risk reduction was 5.3% (CI 95%: 0.8-10.6%) with a relative risk of 0.20 (CI 95%: 0.05-0.90) and number needed to treat (NNT) 19 (CI 95%: 125-9). Moreover, the needs for a blood transfusion, extra uterotonics or additional interventions were significantly lower in the study group than in the control group (p < .05). All the three parameters of blood loss ie the mean blood loss, and the mean reductions of hemoglobin and hematocrit levels were significantly (p-value <.05) lower in the study group (mean and SD) (442.59 and 151.33 mL,0.46 and 0.3 g/dL, and 0.84 and 0.56%), respectively than in the control group (591.01 and 287.97 mL,1.2 and 1.39 g/dL, and 3.47 and 3.52%), respectively. Adverse events were comparable between groups; these were fever, nausea, and vomiting and shivering.Conclusion: Intrauterine misoprostol (400 mg) when added to oxytocin is safe and effective in decreasing the incidence of postpartum hemorrhage (PPH) and reducing the amount of postpartum blood loss in case of elective CS delivery.

Effect of subcutaneous tissue closure technique in cesarean section on postoperative wound complications in obese Egyptian women.

Subcutaneous tissue closure technique is a wide area of interest for obstetricians who perform cesarean section especially on obese women while many observers studied in an extensive manner postoperative pain and wound cosmetic results. AIM OF THE WORK: The main goal of our work was to display the differences in wound outcome results as regard postoperative wound complications comparing the two widely implemented techniques in subcutaneous tissue closure (interrupted versus continuous methods). RESULTS: A comparative analysis between continuous and interrupted techniques regarding wound complications (gapping, seroma, erythema, and infection) showing statistical significant differences in all four wound complications presented with p values = .019, .011, .015, and .001, in consecutive order with odds ratio in wound gapping = 5.239, wound seroma OR = 9.429, wound erythema OR = 3.709, and wound infection OR = 6.136. CONCLUSIONS: Subcutaneous wound closure using interrupted technique of suturing in obese patients is superior to continuous technique as regard wound complications. Clinical trials.gov ID Identifier (NCT03354078).