Oral tramadol versus oral celecoxib for analgesia after mediolateral episiotomy repair in obese primigravidae: a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: A variety of pharmacological and non-pharmacological interventions have been investigated, with the goal of relieving pain after post-episiotomy repair. We aimed to compare the efficacy of tramadol versus celecoxib orally in reducing pain after mediolateral episiotomy repair in obese primigravidae undergoing spontaneous vaginal delivery. METHODS: We conducted a randomized double-blinded trial in Cairo University hospital, Cairo, Egypt, from October 2018 to December 2019. We randomly assigned 200 women into two groups: group A (n = 100) received one tramadol tablet 100 mg orally whereas group B (n = 100) received one celecoxib tablet 200 mg orally. Our primary outcome was pain score using a 10-cm visual analog scale at different time intervals. Our secondary outcomes were the overall satisfaction score and drug side effects. RESULTS: After mediolateral episiotomy repair, the pain scores at 1, 2, and 4 h were significantly lower in the tramadol group than in the celecoxib group (p < 0.001). However, there were no significantly differences in pain scores at 8 and 12 h between the two groups (p = 0.50 and 0.48 respectively). Women's satisfaction score was significantly higher in the tramadol group than in the celecoxib group (p < 0.001). Fewer participants in the tramadol group needed additional analgesics than in the celecoxib group; however, the difference was not significant (p = 0.17). Drug adverse effects were comparable in the two groups. CONCLUSIONS: Primigravid women who received tramadol 100 mg orally after mediolateral episiotomy repair had lower pain scores and were more satisfied than women who received celecoxib 200 mg orally. Both drugs were well tolerated, with few side effects.

Benefits of vaginal dinoprostone administration prior to levonorgestrel-releasing intrauterine system insertion in women delivered only by elective cesarean section: a randomized double-blinded clinical trial.

PURPOSE: This study aimed at investigating the efficacy and safety of dinoprostone 3 mg vaginally prior to levonorgestrel-releasing intrauterine system (LNG-IUS) insertion in women undergoing elective cesarean delivery (CD). METHODS: We conducted a prospective, randomized, double-blinded, placebo-controlled trial at family planning clinic of Cairo University hospitals from August 2019 to January 2020. We included 200 women aged ≥ 18 years who previously delivered by elective CD willing to receive LNG-IUS. Women were randomly assigned with a 1:1 allocation ratio to receive 3 mg vaginal dinoprostone or placebo tablets two hours before LNG-IUS insertion. Our main outcomes were patient-reported pain during insertion and 30 min post-procedure, ease of insertion, satisfaction, duration of insertion, and different side effects. RESULTS: Patient-perceived pain during LNG-IUS insertion was significantly reduced in dinoprostone compared to placebo (4.1 ± 1.7 vs 6.4 ± 1.3; p < 0.001). Dinoprostone reduced pain scores 30 min post-procedure compared to placebo, but the difference was not statistically significant (3.5 ± 1.1 vs 3.7 ± 1.6; p = 0.25). Satisfaction score was higher in dinoprostone compared to placebo (7.9 ± 1.0 vs 5.9 ± 0.8; p < 0.001). The insertion was significantly easier and shorter in dinoprostone than placebo (3.9 ± 1.1 vs 5.9 ± 1.1; p < 0.001) and (5.6 ± 0.9 vs 7.2 ± 0.8; p < 0.001), respectively. Adverse events were not significantly different between both groups. CONCLUSION: Dinoprostone administration 2 h before LNG-IUS insertion in women delivered by elective CD effectively reduced pain during insertion and 30 min post-procedure. Women received dinoprostone had easier and shorter insertion and were more satisfied with tolerable side effects.

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.

The effect of mechanical cervical dilatation during scheduled cesarean section on the blood loss: a randomized controlled trial.

Objective: This study evaluates the effects of mechanical cervical dilatation during scheduled cesarean section (CS) on intra- and postoperative blood loss.Methods: A single-center randomized double-blind controlled trial (NCT03444792) conducted at a tertiary University Hospital in the period between 1 April 2017 and 31 March 2018 included all women scheduled for scheduled CS under spinal anesthesia if they met our inclusion criteria. Eligible participants were randomized to one of two groups. Group (I): Women with intraoperative cervical dilatation and Group (II): women with no intraoperative cervical dilatation. The primary outcome of this study was the mean volume of total blood loss during CS. The secondary outcomes included the mean reduction in the hemoglobin and hematocrit, the rate of primary postpartum hemorrhage, the duration of surgery, the duration of hospital stay, the rate of wound infection and endometritis.Results: No statistical significant difference between both study groups regarding the baseline characteristics. No significant difference in the intraoperative blood loss between both groups (p = .21); however, there was significantly more postoperative blood loss in group II (p = .001). The total blood loss was significantly higher in group II (912.6 ± 242.1 versus 845.8 ± 188.9 mL) in group I (p = .029). There were significantly lower postoperative hemoglobin and hematocrit levels in group II (p = .014 and .033 respectively). The mean duration of CS was significantly shorter in the cervical dilatation group (p = .002). No difference between both groups regarding the rate of postpartum hemorrhage (PPH) (p = .21), the duration of hospital stay (p = .17), the rate of wound infection (p = .32), the rate of endometritis (p = .82).Conclusions: Mechanical cervical dilatation during scheduled CS could be associated with lower postoperative blood loss, higher postoperative hemoglobin & hematocrit levels and shorter duration of CS.

Effect of clomiphene citrate on uterine hemodynamics in women with unexplained infertility.

PURPOSE: The aim of the study was to evaluate the effect of clomiphene citrate on uterine artery blood flow using pulsed Doppler and endometrial and subendometrial micro vascularization using 3D power Doppler in unexplained infertility. PATIENTS AND METHODS: In a prospective observational study at a university teaching hospital, the mid-luteal (peri-implantation) endometrial thickness and volume, uterine artery pulsatility index (PI) and resistance index (RI), endometrial and subendometrial vascularization index (VI), flow index (FI), and vascularization flow index (VFI), and serum estradiol and progesterone levels were compared between natural and clomiphene citrate stimulated cycles in the same group of 50 patients with unexplained infertility. Statistical analysis was done using paired t-test to compare different study variables. RESULTS: The primary outcome, which was the endometrial flow index, was significantly lower in the stimulated cycles (mean ± SD: 23.89±7.96 vs 27.49±8.73, mean difference (95% CI): -3.6 (-2, -5.9); P=0.03). The mean ± SD of endometrial thickness (10.92±3.04 vs 12.46±3.08 mm; P=0.01), volume (4.57±1.28 vs 5.26±1.32 cm3; P=0.009), endometrial VI (0.86±0.15 vs 0.95%±0.21%; P=0.02), VFI (0.25±0.08 vs 0.31±0.12; P=0.004), subendometrial VI (1.93±0.68 vs 2.26%±0.75%; P=0.02), FI (26.81±9.16 vs 30.73±9.87; P=0.04), and VFI (0.68±0.18 vs 0.79±0.21; P=0.006) were significantly lower in the stimulated cycles. However, there were no significant differences in the uterine artery PI (P=0.12) and RI (P=0.08) or serum estradiol (P=0.54) and progesterone (P=0.37) levels between natural and stimulated cycles. CONCLUSION: Peri-implantation endometrial perfusion is significantly lower in clomiphene citrate stimulated cycles when compared to natural ones in patients with unexplained infertility.