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.

Endometrial Injury May Increase the Pregnancy Rate in Patients Undergoing Intrauterine Insemination: An Interventional Randomized Clinical Trial.

OBJECTIVE: This study aimed to investigate the effect of endometrial injury using Pipelle catheter in the follicular phase (cycle day 5, 6, or 7) of the stimulation cycle on pregnancy rates in patients undergoing intrauterine insemination. METHODS: This prospective randomized controlled study was carried out in the Assisted Reproductive Technology Unit of Ain Shams University Maternity Hospital, Cairo, Egypt, from July 1, 2013 to August 31, 2015. Three hundred sixty women, 20 to 35 years of age, with patent fallopian tubes, mild male factor infertility, or unexplained infertility were recruited. Participants were allocated randomly into 2 groups: experimental arm and control arm. Women in the experimental arm underwent endometrial biopsy using a Pipelle catheter on day 5, 6, or 7 of the stimulation cycle combined with intrauterine insemination. Women in the control group underwent intrauterine insemination with no endometrial biopsy done. The primary outcomes were the clinical and chemical pregnancy rates. RESULTS: Data of 344 participants were statistically analyzed. The chemical pregnancy rate was 23.66% in the experimental arm and 10.85% in the control arm (P = .002). The clinical pregnancy rate was 18.93% in the experimental arm and 7.42% in the control arm (P = .003). CONCLUSION: Endometrial injury using a Pipelle catheter in the stimulation cycle may improve pregnancy rates in women undergoing intrauterine insemination.

Clomiphene citrate before and after withdrawal bleeding for induction of ovulation in women with polycystic ovary syndrome: Randomized cross-over trial.

AIM: To compare the ovarian response to early versus late clomiphene citrate (CC) in women with polycystic ovary syndrome (PCOS). METHODS: This cross-over randomized controlled clinical trial included 90 infertile amenorrheic women with PCOS. After inducing withdrawal bleeding, patients were randomly divided into two equal groups to receive ovulation induction with CC 100 mg/day for 5 days. Group I started treatment the next day after finishing medroxyprogesterone acetate course for a menstrual cycle, and after a washout period of another menstrual cycle, the treatment was shifted to start on day 2 of withdrawal bleeding. Group II received a reversed protocol: late then early treatment. Women were followed up on transvaginal ultrasonography to monitor follicular growth, endometrial thickness and evidence of ovulation. Human chorionic gonadotropin 10 000 IU was given i.m. to trigger ovulation when at least one mature follicle measured ≥18 mm at day 14. RESULTS: In all cases, early induction protocol resulted in significantly higher proportion of ovulating patients, thicker endometrium and higher number of follicles 14-17 mm in diameter, ≥ 18 mm in diameter and total number of follicles (P < 0.001 for all comparisons). CONCLUSION: In women with PCOS, early initiation of CC before withdrawal bleeding or during the last days of the luteal phase can achieve a better ovulatory response.

Diathermy versus scalpel in transverse abdominal incision in women undergoing repeated cesarean section: A randomized controlled trial.

AIM: The aim of this study was to evaluate the volume of blood loss, wound incision time and wound complication according to use of scalpel or electrosurgery during the creation of transverse abdominal incisions during repeated cesarean section (CS). MATERIAL AND METHODS: A randomized controlled trial was carried out at Ain Shams University Maternity Hospital. We recruited 130 women with a history of one previous CS at the time of their planned lower-segment CS. Participants were randomized to anterior abdominal wall opening from subcutaneous tissue till the peritoneum by either the use of scalpel with disposable blade (No. 22) or diathermy using the standard diathermy pen electrode. The main outcome measures were the volume of blood loss from skin incision to the end of the peritoneal incision, the operative time and wound complication. RESULTS: We observed a highly significant difference between the two groups in blood loss (median [interquartile range], 11 [8-15.25] g for the diathermy group vs 20 [18-23] g for the scalpel group, P < 0.001) and skin-to-peritoneum incision time (median [interquartile range], 7 [5-7.25] min for the diathermy group vs 10 [7-11] min for the scalpel group, P < 0.001). The postoperative pain was less in the diathermy group but wound complications showed no statistical difference. CONCLUSION: The use of diathermy in the opening of anterior abdominal wall during CS decreases blood loss and operative time but has no impact on postoperative pain or wound complications.

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.

Intravenous infusion of paracetamol versus intravenous pethidine as an intrapartum analgesic in the first stage of labor.

OBJECTIVE: To evaluate the efficacy and adverse effects of an intravenous infusion of 1000 mg of paracetamol as compared with an intravenous injection of 50mg of pethidine hydrochloride for intrapartum analgesia. METHODS: In a randomized prospective study at Ain Shams University, Cairo, Egypt, between April and August 2010, 102 low-risk primiparous women in active labor were allocated to received either paracetamol (n=52) or pethidine hydrochloride (n=50). The primary outcome was 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 times after drug administration. The secondary outcomes included the need for additional rescue analgesia and the presence of adverse maternal or fetal events. RESULTS: As recorded by the VAS score, there was significant pain reduction at 15 minutes, and at 1 and 2 hours in both groups (P<0.001). The reduction in pain was significantly greater in the pethidine group only at 15 minutes (P=0.004). None of the women in the paracetamol group had adverse effects, as compared with 64% of the women receiving pethidine. CONCLUSION: The effectiveness of intravenous paracetamol was comparable to that of intravenous pethidine, but paracetamol had fewer maternal adverse effects.