Determining the Optimal Time Interval between Vaginal Dinoprostone Administration and Diagnostic Office Hysteroscopy in Nulliparous Women: A Randomized, Double-blind Trial.

STUDY OBJECTIVE: To determine the optimal timing of vaginal dinoprostone administration before office hysteroscopy (OH) in nulliparous women. DESIGN: Randomized, double-blind trial. SETTING: Tertiary referral hospital. PATIENTS: A total of 180 nulliparous women undergoing diagnostic OH. INTERVENTIONS: We randomly allocated the women to long-interval or short-interval dinoprostone groups: three mg dinoprostone was administered vaginally 12 hours before OH in the long-interval group and 3 hours before OH in the short-interval group. MEASUREMENTS AND MAIN RESULTS: The primary outcome was pain during OH measured using a 100-mm visual analog scale (0 = no pain; 100 = worst pain imaginable). The secondary outcomes were ease of hysteroscope passage, patient satisfaction score, and drug-related adverse effects. The patients in the long-interval dinoprostone group had lower pain scores during OH (p <.001). Contrarily, pain scores 30 minutes after the procedure were similar in both groups (p = .1). The patient satisfaction score was higher and clinicians found hysteroscope passage through the cervical canal easier and quicker in the long-interval dinoprostone group than in the short-interval group (p <.001, p = .003, and p <.001, respectively). Side effects were comparable in both study groups. CONCLUSION: Vaginal dinoprostone administered 12 hours before OH was more effective than that administered 3 hours before OH in reducing pain during OH in nulliparous women, with easier hysteroscope insertion, shorter procedure duration, and higher patient satisfaction score.

Misoprostol Prior to Diagnostic Office Hysteroscopy in the Subgroup of Patients with No Risk Factors for Cervical Stenosis: A Randomized Double Blind Placebo-Controlled Trial.

AIMS: To assess the effectiveness of vaginal misoprostol in minimizing the pain perceived by patients with no risk factors for cervical stenosis (i.e., parous women of reproductive age who have no history of cesarean section or cervical surgery) during diagnostic office hysteroscopy. METHODS: A total of 100 patients with no risk factors for cervical stenosis were randomized to the misoprostol group (n = 50) or the placebo group (n = 50). In the misoprostol group, 2 misoprostol tablets (400 µg) were administered vaginally 12 h before office hysteroscopy. In the placebo group, 2 placebo tablets were administered. The patients rated the intensity of pain perceived during the procedure and at 30 min after the procedure with the use of a 100 mm visual analog scale (VAS). The hysteroscopists also scored the difficulty of hysteroscope insertion into the uterine cavity with the use of a 100 mm VAS. RESULTS: There were no significant differences between both groups in the VAS pain scores during or at 30 min after the procedure (28.3 ± 13.58 vs. 30.42 ± 15.13 and 11.1 ± 10.23 vs. 13.32 ± 11.12, respectively). The difficulty of hysteroscope insertion into the uterine cavity was comparable between both groups. CONCLUSION: Misoprostol administration prior to diagnostic office hysteroscopy appears to have no beneficial role in the subgroup of patients with no risk factors for cervical stenosis.

Accuracy of Hysteroscopic Endomyometrial Biopsy in Diagnosis of Adenomyosis.

OBJECTIVES: To investigate the diagnostic accuracy of endomyometrial biopsy obtained via office hysteroscopy for the diagnosis of adenomyosis. STUDY DESIGN: Cross-sectional study. SETTING: Cairo University Teaching Hospital, Cairo, Egypt. PATIENTS: A total of 404 premenopausal women with symptoms clinically suggestive of having adenomyosis. INTERVENTIONS: All patients were subjected to 2-dimensional transvaginal sonography (TVS) in-office hysteroscopy examination with endomyometrial biopsy. Patients who subsequently underwent hysterectomy were included in the final analysis. MAIN MEASUREMENTS AND RESULTS: Accuracy of diagnostic modalities was represented using the terms sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy. A total of 292 patients were eligible for final analysis. Of these, 162 (55.47%) were diagnosed with adenomyosis based on hysterectomy specimens. TVS had a high sensitivity (83.95%) and a moderate specificity (60%). In contrast, endomyometrial biopsy was more specific (78.46%) than sensitive (54.32%). Hysteroscopic appearance of the endometrial cavity had low sensitivity (40.74%) and specificity (44.62%). Adding endomyometrial biopsy to TVS improved specificity (89.23%). CONCLUSION: Endomyometrial biopsy obtained via office hysteroscopy can diagnose adenomyosis with a high specificity and is recommended after TVS.

Hysteroscopic Myomectomy of Large Submucous Myomas in a 1-Step Procedure Using Multiple Slicing Sessions Technique.

OBJECTIVE: To evaluate the feasibility and efficacy of our technique for resectoscopic removal of large symptomatic submucous myomas. DESIGN: Prospective study (Canadian Task Force classification II-3). SETTING: A university teaching hospital and a private hospital. PATIENTS: Forty-nine patients with submucous myomas ≥ 4 cm in diameter complaining of abnormal uterine bleeding. Seventeen patients were also complaining of infertility. INTERVENTIONS: The intrauterine portion of submucous myomas was resected using the slicing technique. Slicing started at the site of the maximum bulge of the myoma and was continued down to the level of the endometrial surface. Each slicing session lasted for 5 to 10 minutes. After each slicing session, saline infusion was discontinued and restarted alternatively several times to induce rapid changes in the intrauterine pressure (hydromassage) to stimulate uterine contractions. The resectoscope was removed, and ovum forceps was used to extract the myoma fragments. Bimanual massage of the uterus was performed to induce extrusion of the intramural portion of the myoma into the uterine cavity. The same steps (slicing session lasting for 5-10 minutes to excise the portion of the myoma extruded into the uterine cavity, hydromassage, and uterine massage) were repeated several times until complete removal of the myoma. MEASUREMENTS AND MAIN RESULTS: The mean diameter of the principle myomas was 51.94 ± 5.58 mm. The rate of 1-step complete resection of myomas was 91.84% (45/49). Improvement of bleeding symptoms was observed in all patients with complete resection of myomas. Nine of the 17 infertile women conceived after hysteroscopic myomectomy. One-step complete resection of myomas was more frequent in patients with myomas < 6 cm (43/44 [97.73%] vs 2/5 [40%], risk ratio [RR] = 2.44, p = .002), single myomas (39/40 [97.5%] vs 6/9 [66.67%], RR = 1.46, p = .016), principle myomas with a Lasmar score < 7 (32/32 [100%] vs 13/17 [76.47%], RR = 1.31, p = .011), and myomas with less than 50% extension into the myometrium (26/26 [100%] vs 19/23 [82.61%], RR = 1.21, p = .042). The rate of 1-step complete removal of myomas was 95% (19/20) for type II myomas < 6 cm and 0% (0/3) for type II myomas ≥ 6 cm. CONCLUSION: Our technique of hysteroscopic myomectomy is a safe and effective management for submucous myomas up to 6 cm in diameter.

Comparative efficacy of lidocaine-prilocaine cream and vaginal misoprostol in reducing pain during levonorgestrel intrauterine device insertion in women delivered only by cesarean delivery: A randomized controlled trial.

OBJECTIVE: To compare efficacy of lidocaine-prilocaine (LP) cream versus misoprostol versus placebo before levonorgestrel-releasing intrauterine device (LNG-IUD) insertion. METHODS: This randomized controlled trial (RCT) was conducted in a tertiary referral hospital from April 30, 2020 to March 1, 2021 on 210 parous women willing to receive LNG-IUD and delivered only by elective cesarean delivery (CD). Participants received 200 µg vaginal misoprostol or 5 ml of LP cream 5% or placebo 3 h before LNG-IUS insertion. Primary outcome was pain during LNG-IUD insertion, while secondary outcomes were pain 10 min post-procedure, ease of insertion, patient satisfaction, insertion time, and drug side effects. RESULTS: Pain during LNG-IUS insertion was reduced in LP group and misoprostol group compared to placebo group (2.1 ± 1.0 vs 3.7 ± 1.6; p <0.001) and (2.3 ± 1.3 vs 3.7 ± 1.6; p <0.001), respectively. Ease of procedure and patient satisfaction were significantly higher in LP and misoprostol groups than placebo (P <0.001). Need for additional analgesia was significantly higher in placebo group than in the other two groups (P = 0.009). Adverse events were not significantly different between the three groups except vomiting and abdominal cramps, which were higher with misoprostol. CONCLUSION: LP cream and 200 µg of vaginal misoprostol administration before LNG-IUD insertion in women delivered only by elective CD effectively reduced pain during insertion and 10 min post-procedure with easier insertions, high patient satisfaction, and tolerable side effects. Pain reduction with LP cream was clinically significant.

Barbed sutures versus conventional sutures for uterine closure at cesarean section; a randomized controlled trial.

INTRODUCTION: The aim of this randomized control trial was to compare the operative data and the early postoperative outcomes of cesarean sections in which the uterine incision was closed with a barbed suture (STRATAFIX™ Spiral PDO Knotless Tissue Control Device, SXPD2B405, Ethicon Inc.) with those of cesarean sections in which the uterine incision was closed with a conventional smooth suture (VICRYL™; Ethicon Inc.). MATERIALS AND METHODS: One hundred pregnant patients were randomized in a 1:1 ratio to the Stratafix group or the Vicryl group. The uterine incision was closed by two layers of sutures in both groups. In the Vicryl group, the first layer was continuous and the second layer was interrupted. In the Stratafix group, both layers were continuous. RESULTS: The uterine closure time was significantly lower in the Stratafix group (224 ± 46 versus 343 ± 75 s, p < .001). Operative time was comparable between both groups. Twelve patients in the Vicryl group and two patients in the Stratafix group required additional sutures to achieve hemostasis (p value = .009). The mean blood loss during closure of uterine incision and mean hospital stay were lower in the Stratafix group but these differences failed to reach statistical significance. CONCLUSION: The use of barbed suture for uterine incision closure at cesarean section is associated with shorter uterine closure time and similar early perioperative complications compared with conventional smooth suture. The difference between both groups in the technique of suturing the second layer of the uterine incision may be the cause of the reduction in the uterine closure time and the need for additional sutures to achieve hemostasis during suturing the uterine incision with a barbed suture. Further, well designed randomized controlled trials should be conducted to investigate the association between the type of suture (barbed or conventional smooth) and remote complications of cesarean section (infertility, pelvic pain, abnormal placentation and rupture uterus).

Uroflowmetric changes, success rate and complications following Tension-free Vaginal Tape Obturator (TVT-O) operation in obese females.

OBJECTIVE: The goal of this study was to evaluate the outcome of Tension-free Vaginal Tape Obturator (TVT-O) operation in the treatment of urodynamic stress incontinence (USI) in obese females, with respect to uroflowmetric changes, success rate and postoperative complications. METHODS: This prospective observational study included 26 patients with USI at the Obstetrics & Gynecology department-Cairo University hospital during the year 2015. The participants had body mass index (BMI)≥30. Patients underwent TVT-O operation. Follow up of the patients was performed by cough test and uroflowmetry after one week, one month, three months and six months. Postoperative complications such as groin pain, sense of incomplete emptying, need to strain to complete micturition and urinary tract infection were recorded. Comparisons between groups were done using Chi square, Phi-Cramer test for categorical variables. RESULTS: The mean age for the subjects was 43.58±9.01years. The mean BMI was 33.4±2.1. The success rate of TVT-O operation was 21 out of 26 patients (≈81%). Normal maximum flow rate was in 88% of patients at week one and was normal in 100% of patients at months three and six (p=0.101 & 0.101). Postoperative groin pain was the main complaint during the first week after operation and decreased significantly from week one to the 1st month postoperative (84.62% & 65.38%, P=0.041). CONCLUSION: TVT-O operation showed a high success rate in treatment of USI in obese patients without affecting the voiding function of the bladder as proven by the uroflowmetry. The main postoperative complaint was the groin pain which significantly improved after one month.

Intralipid supplementation in women with recurrent spontaneous abortion and elevated levels of natural killer cells.

OBJECTIVE: To investigate the efficacy of intralipid supplementation in women with recurrent spontaneous abortion (RSA) and elevated natural killer cell activity undergoing in vitro fertilization/intracytoplasmic sperm injection. METHODS: Between February 10, 2013, and April 30, 2015, a double-blind randomized controlled study was conducted at a center in Egypt. Women with unexplained secondary infertility, RSA, and elevated levels of natural killer cells (>12%) were enrolled and randomly assigned to receive intralipid (2mL diluted at 20% in 250mL saline) or saline (250mL) infusion on the day of oocyte retrieval using random numbers and sealed envelopes. Patients and attending physicians were masked to group assignment. The infusions were repeated within 1week of a positive pregnancy test and then every 2weeks until the end of the first trimester. The primary outcome was chemical pregnancy 14days after embryo transfer. Analyses were by intention-to-treat. RESULTS: Overall, 296 women were enrolled. Chemical pregnancy was recorded for 84 (58.3%) of 144 women in the intralipid group and 76 (50.0%) of 152 in the control group (P=0.129). CONCLUSION: Intralipid supplementation did not increase frequency of chemical pregnancy. However, findings related to ongoing pregnancy and live birth should be investigated further. ClinicalTrials.gov:NCT01788540.

Delayed Start Versus Conventional GnRH Antagonist Protocol in Poor Responders Pretreated With Estradiol in Luteal Phase: A Randomized Controlled Trial.

OBJECTIVE: To compare the new delayed start protocol against the conventional gonadotropin (Gn)-releasing hormone antagonist protocol in poor responders (PORs). STUDY DESIGN: A total of 160 women with poor response to previous in vitro fertilization (IVF) cycle were randomized either to start Gn then Cetrotide 0.25 subcutaneously (sc) added when leading follicle (DF) reach >12 mm or Cetrotide 0.25 mg sc started first from day 2 to day 8 then Gn therapy was added and Cetrotide restarted when DF reach >12 mm. RESULTS: There was a statistically significant difference between conventional and delayed start protocols regarding the needed dose of Gn for stimulation (4368 ± 643 and 3798 ± 515), level of estradiol (E2; 778 ± 371 and 1076 ± 453), and endometrial thickness at human chorionic gonadotropin triggering (8.6 ± 1.8 and 9.8 ± 1.9), the number of DF (3.4 ± 1.5 and 4.9 ± 2.1), the number of retrieved follicles (2.4 ± 2.1 and 4.3 ± 2.5), and successful embryo transfer (13 vs 16), respectively (P < .05). There was a highly statistically significant difference between the 2 study groups regarding the number of oocytes fertilized (1.2 ± 2.0 vs 3.3 ± 1.4), metaphase II oocytes (0.9 ± 1.0 vs 2.7 + 1.6), and grade I embryos (0.7 ± 0.9 vs 2.1 + 1.1; P < .001). The chemical pregnancy, clinical pregnancy, and abortion rate showed a statistically significant difference between the 2 study groups (P value .003 and .006, respectively). CONCLUSION: Delayed start protocol significantly improved clinical pregnancy rate and IVF cycle parameters in PORs.

Role of fetal echocardiography in the evaluation of structure and function of fetal heart in diabetic pregnancies.

OBJECTIVE: To detect the structural and functional changes of fetal hearts in diabetic pregnancies by using Doppler echocardiography. METHODS: This prospective study included 119 pregnant women divided into three groups. Group 1 included 47 pregnant patients with pre-existing diabetes mellitus (DM), group 2 included 40 patients with gestational diabetes and group 3 included 32 non-diabetic pregnant women. M-mode echocardiography was used to measure the thickness of the fetal ventricular walls and interventricular septum. The mitral and tricuspid early (E) and late (A) diastolic velocities and the ventricular shortening fraction were measured. RESULTS: HbA1c % was significantly lower in gestational diabetes group compared with the pre-existing diabetes group. The interventricular septum was significantly thicker in the pre-existing diabetes group compared with other groups. Tricuspid and mitral E/A ratios were significantly lower in the pre-existing diabetes group compared with gestational diabetes and control groups. Moreover, there were no significant differences in the tricuspid and mitral E/A ratios between gestational diabetes group and the control group. The right and left ventricular shortening fractions were similar in the three groups. CONCLUSION: Fetuses of women with well-controlled gestational diabetes lack the diastolic dysfunction that is present in fetuses of women with pre-existing diabetes.