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.

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.

Effect of self-administered vaginal dinoprostone on pain perception during copper intrauterine device insertion in parous women: a randomized controlled trial.

OBJECTIVE(S): To assess efficacy and safety of self-administered 3 mg dinoprostone vaginally in reducing pain during copper intrauterine device (IUD) insertion in parous women. DESIGN: Randomized, double-blinded, placebo-controlled trial. SETTING: Family planning clinic in a tertiary referral hospital. PATIENT(S): Multiparous women who were attending a family planning clinic and requesting copper IUD insertion. INTERVENTIONS(S): We randomly assigned 160 participants into two groups: The dinoprostone group (n = 80) received 3 mg dinoprostone vaginally, and the placebo group (n = 80) received placebo vaginally. MAIN OUTCOME MEASURE(S): Our primary outcome was mean pain scores during IUD insertion. Our secondary outcomes were mean pain scores during tenaculum application, during uterine sounding, and 15 minutes after insertion, ease of insertion, satisfaction score, need for additional analgesics, and side-effects. RESULT(S): Both groups showed no significant difference in anticipated pain score (P=.41), pain during tenaculum placement (P=.22), and pain during sound insertion (P=.07). The dinoprostone group had significantly lower pain scores during IUD insertion (34.8 ± 10.1 vs. 57.8 ± 11.8) and 15 minutes after insertion (20.6 ± 6.4 vs. 29.6 ± 6.2), easier IUD insertion (43.6 ± 21.9 vs. 64.7 ± 18.1), and higher satisfaction (83.9 ± 11.6 vs. 63.0 ± 9.1) compared with the placebo group. Fewer patients required additional analgesics in the dinoprostone group compared with the placebo group (P=.01). Side-effects were similar between the groups. CONCLUSION(S): Self-administered 3 mg dinoprostone vaginally before copper IUD insertion in parous women reduces pain scores during IUD insertion, making insertion easier and increasing women's satisfaction, with tolerable side-effects. CLINICAL TRIAL REGISTRATION NUMBER: NCT04046302.

Benefits of Self-administered Vaginal Dinoprostone 12 Hours before Levonorgestrel-releasing Intrauterine Device Insertion in Nulliparous Adolescents and Young Women: A Randomized Controlled Trial.

STUDY OBJECTIVE: To assess safety and efficacy of self-administered vaginal dinoprostone 12 hours before a 52-mg levonorgestrel intrauterine device (LNG-IUD) insertion in adolescents and young nulliparous women. DESIGN: Randomized controlled trial. SETTING: Tertiary referral hospital. PARTICIPANTS: Nulliparous adolescents and young women aged 18-22 years. INTERVENTIONS: Participants were randomly assigned into 2 groups; the dinoprostone group (n = 65) received dinoprostone 3 mg vaginally, and the placebo group (n = 65) received placebo tablets vaginally. MAIN OUTCOME MEASURES: Primary outcome was pain scores during LNG-IUD insertion measured using a visual analogue scale. Secondary outcomes were pain scores during speculum insertion, tenaculum placement, uterine sounding, and 20 minutes postprocedure, ease of insertion, Women's satisfaction score, need for additional analgesics, and side effects. RESULTS: The dinoprostone group had significantly lower pain scores during LNG-IUD insertion (2.83 ± 1.08 vs 3.95 ± 1.63), tenaculum placement (2.97 ± 1.41 vs 4.55 ± 1.53) and sounding of uterus (3.55 ± 1.71 vs 5.12 ± 1.37) compared with the placebo group (P < .001). No significant differences were found between both groups regarding anticipated pain scores (P = .85), pain during speculum insertion and 20 minutes postinsertion and insertion duration (P = .53). Women's satisfaction, provider reported ease of insertion, and need for additional analgesia were significantly better among dinoprostone users (P < .001, < .001, and .02, respectively). Side effects and procedure complications were similar for the 2 groups. CONCLUSION: Self-administered dinoprostone 3 mg vaginally 12 hours before a 52-mg LNG-IUD insertion in nulliparous adolescent and young women effectively reduced pain during insertion and increased women's satisfaction and ease of insertion reported by clinicians.

Evaluation and ranking of different interventions for pain relief during outpatient hysteroscopy: A systematic review and network meta-analysis.

AIM: To identify the highest-ranked pharmacological and nonpharmacological interventions for pain relief during outpatient hysteroscopy. METHODS: We conducted an online bibliographic search in different databases from inception till July 2019. We included randomized controlled trials assessing effect of pharmacological and nonpharmacological interventions on pain relief during outpatient hysteroscopy. Our main outcomes were pain scores at different endpoints of the procedure. We applied this network meta-analysis based on the frequentist approach using statistical package 'netmeta' (version 1.0-1) in R. RESULTS: The review included 39 randomized controlled trials (Women n = 3964). Misoprostol plus intracervical block anesthesia (mean difference [MD] = -3.32, 95% confidence interval [CI] [-6.06, -0.59]), misoprostol (MD = -1.92, 95% CI [-3.04, -0.81]) and IV analgesia (MD = -2.01, 95% CI [-3.27, -0.25]) were effective in reducing pain during the procedure compared to placebo. Ranking probability showed that misoprostol plus intracervical block anesthesia was the highest ranked pharmacological treatment for pain relief during the procedure (P score = 0.92) followed by misoprostol alone (P score = 0.78), and IV analgesia (P score = 0.76). Regarding nonpharmacological treatments, transcutaneous electrical nerve stimulation (TENS) showed a significant pain reduction compared to placebo (MD = -1.80, 95% CI [-3.31, -0.29]). TENS ranked as the best nonpharmacological treatment (P score = 0.80) followed by CO2 distention (P score = 0.65) and bladder distention (P score = 0.60). CONCLUSION: Combination of misoprostol plus local anesthesia appears to be the most effective pharmacological approach for pain reduction during and after outpatient hysteroscopy. Nonpharmacological approaches as TENS and bladder distention showed considerable efficacy but should be further investigated.

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).

Association of biochemical markers with the severity of pre-eclampsia.

OBJECTIVE: To assess the association between pre-eclampsia severity and biochemical and ultrasonography markers. METHODS: A retrospective study was undertaken of women with severe pre-eclampsia (group 1, n=90), mild pre-eclampsia (group 2, n=90), or a normal pregnancy (group 3, n=90) who attended a hospital in Egypt in October 2013-April 2015. Associations between pre-eclampsia and biochemical, cardiotocography, and ultrasonography markers were investigated. RESULTS: There were significant differences between the groups in C-reactive protein (331.44±112.38, 251.43±59.05, and 23.81±16.19 nmol/L; P≤0.05 for all), platelet count (113.40±36.72, 172.93±57.60, and 212.68±70.00×109 /L; P≤0.05 for group 1 comparisons), alanine transaminase (52.24±14.83, 38.34±13.12, and 23.11±6.92 U/L; P≤0.05 for group 1 comparisons), and serum uric acid (600.80±117.19, 481.83±118.97, and 243.89±53.54 µmol/L; P=0.050 for group 3 comparisons). Cardiotocography score was worse among women with severe pre-eclampsia than among those in the other two groups (P=0.039 for both comparisons). Biophysical profile score and umbilical artery resistance index differed by group (P≤0.05 for all). Middle cerebral artery resistance index was lower among women with severe pre-eclampsia (P≤0.05). CONCLUSION: The levels of C-reactive protein, blood urea nitrogen, serum uric acid, and alanine transaminase, and the platelet count were linked with the presence and severity of pre-eclampsia.