Vaginal Dinoprostone in Reducing Pain Perception During Diagnostic Office Hysteroscopy in Postmenopausal Women: A Randomized, Double-Blind, Placebo-Controlled Trial.

STUDY OBJECTIVE: To evaluate the efficacy of vaginal dinoprostone in reducing pain perception during diagnostic office hysteroscopy (OH) in postmenopausal women. DESIGN: Randomized, double-blind controlled trial. SETTING: Tertiary university hospital. PARTICIPANTS: Postmenopausal patients scheduled for OH. INTERVENTIONS: Eligible participants were randomized in a 1:1 ratio to the dinoprostone and placebo groups. The severity of pain was assessed with a visual analog scale (VAS) ranging from 0, no pain to 10, worst pain during OH and 30 minutes after OH. MEASUREMENTS AND MAIN RESULTS: The difference in the intensity of pain using the VAS score during the procedure. One hundred women (50 in each arm) were included in the study. The mean VAS score during OH was significantly lower in the dinoprostone group compared with the placebo group (3.9 ± 0.8 vs 5.6 ± 0.7; p <.001). The passage of the hysteroscope through the cervical canal was easier in the dinoprostone group (62.4 ± 9.5 vs 42.8 ± 10.8; p <.001). The 2 groups were comparable in terms of the duration of the procedure (p = .91) and the rate of adverse effects. CONCLUSION: Vaginal dinoprostone is effective in relieving pain during diagnostic OH in postmenopausal women with few adverse effects.

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.

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.

Role of maternal serum ferritin in prediction of preterm labour.

The aim of this study was to evaluate the value of measurement of serum ferritin level in pregnant women to predict preterm labour. The study included 236 women whose haemoglobin (Hb) levels were ≥10.5 gm/dl and gestational age (GA) was less than 30 weeks. Serum ferritin levels were measured at 30 weeks of gestational age. At the end of the study, 23 women delivered with preterm premature rupture of membrane (PPROM) and 17 women delivered before 37 weeks but without PROM (study group). The rest of the pregnant women (196 women) delivered between 37 and 40 weeks (control group). We found a significant difference between the two groups with respect to serum ferritin level. The cut off value of serum ferritin between the two groups was 31 ng/ml with sensitivity 92.8%, specificity 99.4%, positive predictive value 97.5%, negative predictive value 98.4% and accuracy 98.3%. Impact statement What is already known on this subject: maternal serum ferritin has been found to be elevated in women who delivered preterm. What the results of this study add: In this study, we have shown that serum ferritin 31 ng/ml is the optimal cut-point between preterm and full-term women. What the implications are of these findings for clinical practice and/or further research: Serum ferritin 31 ng/ml could be proposed as a potential helpful marker to predict preterm labour.

Comparing delayed cord clamping and umbilical cord milking during elective cesarean section for the neonatal outcome.

Objectives: to compare between immediate cord clamping, delayed cord clamping, and umbilical cord milking and their effects on hemoglobin and bilirubin level in term infants in cesarean section. Study design: A randomized clinical trial was conducted from November 2021 to June 2022, including 162 full term pregnant women undergoing elective cesarean section at EL-Shatby Maternity University Hospital. They were randomly assigned (1:1:1 ratio) either to immediate cord clamping just after delivery (Group 1) or delayed cord clamping for 30 s (Group 2) or umbilical cord milking 10 times for 10-15 s (Group 3). The primary outcome measures included hemoglobin and hematocrit levels of the newborn at birth and the secondary outcome was bilirubin level measurement at 72 h of life. Results: one hundred sixty- two newborns were randomized into 3 groups, fifty-four cases in each, and were investigated on hemoglobin and hematocrit levels; five were lost to follow-up and one hundred fifty-seven were tested for bilirubin. Participants among groups had no significant difference regarding demographic and clinical characteristics, regarding the hemoglobin at birth it was significant higher in the umbilical cord milking group (Group 3) through all groups (14.91 ± 0.91 g/dl vs15.38 ± 0.74 g/dl vs 16.56 ± 1.03 g/dl, p value <0.001), regarding hematocrit level at birth it was significant in the umbilical cord milking group (Group 3) through all groups (44.71 ± 2.94 vs 46.48 ± 2.61 vs 49.74 ± 3.26, p value <0.001). On the other hand, bilirubin level after 72 h had no significant different through the 3 groups (8.80(IQR 4.50-17.20), vs 9.70(IQR3.50-14.70), vs 8.50(IQR 3.20-19.50), respectively p value= 0.348). Conclusion: this study showed that umbilical cord milking 10 times for 10-15 s is more effective than delayed cord clamping for 30 s in enhancing hemoglobin and hematocrit levels in newborn delivered by cesarean section with no significant difference on bilirubin level in the newborn.

Retraction notice to "Comparing delayed cord clamping and umbilical cord milking during elective cesarean section for the neonatal outcome" [Eur. J. Obstet. Gynecol. Reprod. Biol. X 18 (2023) 100200].

[This retracts the article DOI: 10.1016/j.eurox.2023.100200.].

Efficacy of Milrinone Plus Sildenafil in the Treatment of Neonates with Persistent Pulmonary Hypertension in Resource-Limited Settings: Results of a Randomized, Double-Blind Trial.

BACKGROUND: The management of severe persistent pulmonary hypertension (PPHN) can be very challenging in many resource-limited centers without access to inhaled nitric oxide or extracorporeal membrane oxygenation. OBJECTIVES: The current study aimed to investigate the efficacy of oral sildenafil and intravenous milrinone infusion and compare the effects of these drugs in combination versus as monotherapy in neonates with PPHN. METHODS: A double-blind randomized controlled trial was conducted in which neonates with PPHN were divided into three groups of 20 patients each: group 1 received oral sildenafil starting at 0.5 mg/kg every 6 h to a target maintenance dose of 2 mg/kg every 6 h; group 2 received intravenous milrinone 0.5 µg/kg/min as a continuous infusion; and group 3 received both oral sildenafil and intravenous milrinone. RESULTS: Post-treatment pulmonary artery systolic pressure was significantly lower in group 3 than in groups 1 and 2, which both received monotherapy (p = 0.031). The oxygenation index also decreased significantly in the dual-therapy group (p = 0.002) compared with the monotherapy groups. Combined use of both drugs demonstrated a beneficial synergistic effect with better outcomes and reduced mortality. CONCLUSION: Dual therapy using sildenafil and milrinone was superior to monotherapy with either drug in neonates with severe PPHN and is recommended for use in resource-constrained settings. REGISTRATION: Pan African Clinical Trial Registry identifier number PACTR201902691230243.

A randomized controlled trial of the safety and efficacy of preoperative rectal misoprostol for prevention of intraoperative and postoperative blood loss at elective cesarean delivery.

OBJECTIVE: To assess the safety and efficacy of preoperative rectal misoprostol for the prevention of intraoperative and postoperative blood loss in women undergoing elective cesarean delivery. METHODS: A single-blind randomized controlled trial of 200 full-term pregnant women scheduled for elective cesarean delivery. Computer-generated randomization allocated women to receive 400 µg rectal misoprostol at urinary catheter insertion plus 400 µg rectally after abdominal closure (preoperative group, n=100) or 800 µg of rectal misoprostol after abdominal closure (postoperative group, n=100). Primary outcome was intraoperative blood loss. RESULTS: Intraoperative blood loss was significantly lower in the preoperative misoprostol group compared with the postoperative group (528.7 ± 114.8 mL vs 788.6 ± 165.8 mL; P<0.001). Blood loss during the first 24 hours after delivery was also lower in the preoperative group (199.3 ± 84.5 mL vs 302.9 ± 125.6 mL; P<0.001). Fewer women in the preoperative group needed additional uterotonics (7 vs 21; P<0.001). After delivery, the decrease in both hemoglobin and hematocrit levels was significantly less in the preoperative group (-6.8 vs -12.8% and -6.05 vs -17.8%, respectively; P<0.001). CONCLUSION: Preoperative rectal administration of misoprostol significantly reduced intraoperative and postoperative blood loss during and after elective cesarean delivery. ClinicalTrial.gov ID: NCT03680339. Date of registration 9/2018.

GnRH antagonist rescue protocol combined with cabergoline versus cabergoline alone in the prevention of ovarian hyperstimulation syndrome: a randomized controlled trial.

BACKGROUND: The aim of this study was to compare the efficacy of antagonist rescue protocol (replacing GnRH agonist with GnRH antagonist and reducing the dose of gonadotropins) combined with cabergoline versus cabergoline alone in the prevention of ovarian hyperstimulation syndrome (OHSS) in patients pretreated with GnRH agonist long protocol who were at high risk for OHSS. METHODS: Two hundred and thirty six patients were randomized in a 1:1 ratio to the cabergoline group or the antagonist rescue combined with cabergoline group. Both groups received oral cabergoline (0.5 mg/day) for eight days beginning on the day of HCG administration. In the antagonist rescue combined with cabergoline group, when the leading follicle reached 16 mm, GnRH agonist (triptorelin) was replaced with GnRH antagonist (cetrorelix acetate) and the dose of HP-uFSH was reduced to 75 IU/day. HCG (5,000 IU/I.M) was administered when the serum estradiol level dropped below 3500 pg/ml. The study was open label and the outcome assessors (laboratory staff and the doctor who performed oocyte retrieval) were blind to treatment allocation. RESULTS: The incidence of moderate/severe OHSS was significantly lower in the antagonist rescue combined with cabergoline group [5.08 % Vs 13.56 %, P value =0.025, OR = 0.342, 95 % CI, 0.129-0.906]. Four cycles were cancelled in the cabergoline group. There were no significant differences between the groups with respect to the number of retrieved oocytes, metaphase II oocytes, high quality embryos and fertilization rate. Moreover, the implantation and pregnancy rates were comparable between both groups. CONCLUSION: GnRH antagonist rescue protocol combined with cabergoline is more effective than cabergoline alone in the prevention of OHSS. TRIAL REGISTRATION: Clinical trial.gov ( NCT02461875 ).