Sildenafil citrate as an adjuvant to clomiphene citrate for ovulation induction in polycystic ovary syndrome: crossover randomized controlled trial.

Introduction: To evaluate sildenafil citrate as an adjuvant to clomiphene citrate (CC) for ovulation induction (OI) in women with polycystic ovary syndrome (PCOS). Material and methods: A total of 595 infertile PCOS women were randomly assigned into either clomiphene/sildenafil (C/S) group or CC group. Transvaginal (TVS)-Doppler studies were done for participants when the dominant follicle reach 16 mm, to measure the resistance index, pulsatility index, and maximum velocity of sub-endometrial, uterine, and ovarian vessels. Participants were examined using TVS on the 21st day of the cycle to detect ovulation or, after a positive pregnancy test, for documentation of pregnancy. Participants with negative pregnancy tests were given 2 months' rest without OI, followed by crossover of OI medication between the 2 studied groups. The crossover results were assessed by TVS, TVS-Doppler, and pregnancy test. Results: The endometrial thickness was significantly higher among the C/S than the CC group during the first 3 months (9.6 ±1.2 vs. 8.7 ±1.0 mm, respectively, p = 0.003) and after crossover of OI (9.1 ±1.3 vs. 8.2 ±1.0 mm, respectively, p = 0.007).The chemical and clinical pregnancy rates were significantly higher among the C/S compared to the CC group (39.8% and 36.6% vs. 25% and 18.98%, respectively) (p = 0.01 and 0.001, respectively) during the first 3 months and after crossover of OI (36.6% and 33.1% vs. 23.8% and 20.6%, respectively) (p = 0.02 and 0.01, respectively). Conclusions: SC as an adjuvant to CC for OI in PCOS women increases the chemical and clinical pregnancy rates. It also improves the endometrial thickness and ovulation rate through improved endometrial and ovarian Doppler indices.

Uterine cavity evaluation after uterine preservation surgeries for morbidly adherent placenta.

Introduction: The morbidly adherent placenta (MAP) is usually associated with maternal morbidity and mortality. The objective of this study was to evaluate the uterine cavity after uterine preservation surgeries for MAP. Material and methods: The study group comprised women ≥ 28 weeks pregnant with confirmed MAP, with a desire for future fertility, and who agreed to uterine preservation surgery for MAP. The uterine preservation surgeries done for MAP include the following: uterine artery ligation, placental-myometrial en bloc excision, and/or internal iliac artery (IIA) ligation. Participants managed by uterine preservation surgeries for MAP were evaluated 3-6 months after the surgeries using office hysteroscopies to evaluate the uterine cavity after uterine preservation surgeries (primary outcome). The secondary outcome measures the pregnancy outcome after uterine preservation surgery. Results: The hysteroscopic examination of the uterine cavity after uterine preservation surgery for MAP showed normal uterine cavity in 36 participants (90%), while it showed abnormal uterine cavity in 4 participants (10%). The abnormal hysteroscopic findings were a single abnormal hysteroscopic finding (endometrial polyp) in 2 participants (5%) and 2 abnormal hysteroscopic findings (incompletely healed scar with unilateral tubal ostial occlusion) in 2 participants (5%). The incidence of pregnancy after uterine preservation surgeries for MAP was 7.5% (3/40). Conclusions: The uterine preservation surgeries for MAP in this study had no effect on menstrual pattern, uterine cavity, or future fertility. The effect of uterine preservation surgeries for MAP on menstrual pattern, uterine cavity, and future fertility should be evaluated in future larger studies.

Vaginal hysterectomy versus laparoscopically assisted vaginal hysterectomy for large uteri between 280 and 700 g: a randomized controlled trial.

OBJECTIVE: To compare surgical outcomes, postoperative complications and costs between vaginal hysterectomy and laparoscopically assisted vaginal hysterectomy in cases of large uteri. METHODS: Prospective randomized controlled trial done at Ain Shams University Maternity Hospital, where 50 patients were recruited and divided into two equal groups (each 25 patients). First group underwent vaginal hysterectomy, and the second underwent laparoscopically assisted vaginal hysterectomy. RESULTS: Patient characteristics were similar in both groups. As for surgical outcomes, estimated intraoperative blood loss (P = 0.90), operative time (P = 0.48), preoperative hemoglobin (P = 0.09), postoperative hemoglobin (P = 0.42), and operative complications (P = 1.0) did not differ between the two groups. The hospital costs (converted from Egyptian pound to U.S. dollars) were significantly higher in case of LAVH group [VH: $1060.86 ($180.09) versus LAVH: $1560.5 ($220.57), P value <0.001]. No significant difference exists in the duration of postoperative hospital stay between the two groups [VH: 49.92 h (28.50) versus LAVH: 58.56 (27.78), P = 0.28] or the actual uterine weight measured postoperatively [VH: 350.72 g (71.78) versus LAVH: 385.96 g (172.52), P = 0.35]. CONCLUSION: Both vaginal hysterectomy and laparoscopically assisted vaginal hysterectomy are safe procedures in cases of large uteri with no significant difference between them except in terms of costs as VH appears to be more cost effective. CLINICAL TRIALS.GOV: NCT02826304.

Randomized controlled trial comparing carbetocin, misoprostol, and oxytocin for the prevention of postpartum hemorrhage following an elective cesarean delivery.

OBJECTIVE: To compare the effectiveness and safety of carbetocin, misoprostol, and oxytocin for the prevention of postpartum hemorrhage following cesarean deliveries. METHODS: A double-blind randomized controlled trial enrolled patients with a singleton pregnancy scheduled for an elective cesarean delivery at a maternity hospital in Cairo, Egypt, between October 1, 2012 and June 30, 2013. Participants were randomized using a computer-generated sequence to receive treatment with carbetocin, misoprostol, or oxytocin. The primary outcome was the occurrence of uterine atony necessitating additional uterotonics. Per-protocol analyses were performed. Patients, investigators, and data analysts were masked to treatment assignments. RESULTS: The present study enrolled 263 patients; data were analyzed from 88 patients treated with carbetocin, 89 treated with misoprostol, and 86 women treated with oxytocin. Further uterotonics were needed for the treatment of 5 (6%) patients who were treated with carbetocin, 20 (22%) patients treated with misoprostol, and 11 (13%) patients treated with oxytocin. In the prevention of uterine atony, carbetocin was comparable with oxytocin (RR 0.41, 95%CI 0.14-1.25) and superior to misoprostol (RR 0.21, 95%CI 0.07-0.58). CONCLUSION: Additional uterotonics were needed less frequently by patients treated with carbetocin. Carbetocin was comparable to oxytocin and superior to misoprostol in the prevention of uterine atony following an elective cesarean delivery. ClinicalTrials.gov: NCT02053922.

Intravenous infusion of paracetamol for intrapartum analgesia.

AIM: To evaluate the efficacy and adverse effects of an i.v. infusion of paracetamol during the active phase of labor as compared with sterile water (placebo) as a method for intrapartum analgesia. METHODS: In a triple-blind, randomized, placebo-controlled trial, 120 low-risk primiparous women presenting in active labor at Ain Shams University Maternity Hospital, Cairo, Egypt, between August 2011 and October 2012, were allocated to receive either 1000 mg i.v. of paracetamol (n = 60) or sterile water (n = 60). The primary outcomes were the efficacy of the drug to supply adequate analgesia as measured by a change in the visual analog scale (VAS) pain intensity score at various time points after drug administration and the need for additional rescue analgesia. The secondary outcomes included the presence of adverse maternal or fetal events. RESULTS: Compared to controls, i.v. infusion of paracetamol was associated with significantly lower VAS score 15 and 30 min after the start of medication; also, there was a significantly lower incidence of need for rescue medication (8/57 [14%] vs 49/59 [83.1%], P < 0.001) at 60 min after the start of medication. There were no recorded maternal adverse effects in either group. There were no differences in occurrence of intrapartum fetal distress or neonatal Apgar scores between both groups. CONCLUSION: Paracetamol appears to be a safe and effective medicine that can be used during the intrapartum period.