The efficacy of the levonorgestrel intrauterine system versus oral megestrol acetate in treating atypical endometrial hyperplasia: a superior randomized controlled trial.

OBJECTIVE: To compare the efficacy of the levonorgestrel intrauterine system (LNG-IUS) versus megestrol acetate (MA) in inducing complete regression among women with atypical endometrial hyperplasia (AEH) who declined hysterectomy. METHODS: In this single-center, open-label randomized controlled trial, we included 148 women with AEH who declined hysterectomy. We randomized participants to receive either daily oral MA 160 mg (n=74) or apply LNG-IUS (n=74) and scheduled their follow-up by endometrial sampling at 3, 6, 9, 12, 18, and 24 months. The success rate and duration until complete regression were the primary outcomes. RESULTS: The mean duration until complete regression was 5.52 months (95% confidence interval [CI]=4.85-6.18) for the LNG-IUS group versus 6.87 months (95% CI=6.09-7.64) for the megestrol group (log-rank test p-value=0.011). The cumulative regression rate after 12 months was 91.9% with the LNG-IUS versus 77% with MA (p=0.026). Weight gain in the MA group vs LNG-IUS group after one year (4.7±4 kg vs. 2.7±2.6 kg, 95% CI=0.89-3.12; p=0.001) and after two years of therapy (7.8±5.1 kg vs. 4.1±2.9 kg, 95% CI=2.29-5.06; p<0.001). CONCLUSION: Compared to MA, the LNG-IUS was more efficacious in treating AEH in women who declined hysterectomy, especially those with moderate/severe obesity, with fewer adverse effects and less weight gain. Extending therapy to 12 months for persistent cases would improve regression rates with reasonable safety. Alternate hysteroscopic and office sampling seemed convenient for follow-up. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04385667.

The hematological impact of umbilical cord milking versus delayed cord clamping in premature neonates: a randomized controlled trial.

BACKGROUND: The hematological impact of umbilical cord milking (UCM) was compared to that of delayed cord clamping (DCC) as a faster placental transfusion technique for preterm neonates (between 24 and 34 + 6 weeks gestation). A comparison of important neonatal morbidities was also made. METHODS: This was an open-label randomized trial conducted from June 8, 2017, to April 22, 2019. Two hundred patients with preterm deliveries (24 and 34 + 6 weeks gestation) were assigned to the DCC or UCM group at random at a ratio of 1:1. The study power was 80% for a difference in the hematocrit value of 3% and Hb value of one gram, and an alpha error of 0.05. RESULTS: The following variables were analyzed in the comparison of UCM vs. DCC: first draw hemoglobin: 17.0 ± 1.9 vs. 16.8 ± 1.8 gm/dl (95% CI -0.75-0.29, P 0.383); first draw hematocrit: 55.6 ± 6.4 vs. 55.2 ± 6.4% (95% CI -2.18-1.38, P 0.659); peak hematocrit: 56.9 ± 6.4 vs. 56.3 ± 6.7% (95% CI -2.41-1.26, P 0.537); the need for respiratory assistance (47% vs. 30%, P 0.020), inotropes (16% vs. 6%, P 0.040), and blood transfusion (26% vs. 12%, P 0.018); and the occurrence of intraventricular hemorrhage (9% vs. 5%, P 0.407), necrotizing enterocolitis (6% vs. 2%, P 0.279), sepsis (25% vs. 15%, P 0.111), and neonatal death (13% vs. 4%, P 0.40). CONCLUSION: UCM facilitated a rapid transfer of placental blood equivalent to that of DCC for premature neonates. However, it resulted in increased rates of interventions and morbidities, especially in extremely preterm neonates. TRIAL REGISTRATION: The clinical trial was registered on May 10, 2017, with registration number (NCT03147846).

The effect of gum chewing on the return of bowel motility after planned cesarean delivery: a randomized controlled trial.

Objective: To endorse the impact of chewing gum on the intestinal functions' restoration, hospital stay and gastrointestinal complications after planned cesarean delivery (CD).Methods: Women aged between 20 and 35 years scheduled for planned CD; either first or repeated, with term, singleton, viable and healthy pregnancy at obstetrics and gynecology department, Armed Forces Hospital Southern Region, Khamis Mushayt, Saudi Arabia were invited to participate and randomized if eligible into three groups. The first group chewed sugar-free gum 2 h after recovery at least for half an hour and at 2-h interval during daytime. The second group received oral fluids 6 h postoperatively, while the third group was the control group. The primary outcome measure was the time to first passage of stool. The secondary outcomes included the time of the first passage of flatus, the first hearing of normal intestinal sounds, the duration of hospital stay the duration of parenteral therapy by intravenous fluids, the time of initiating breast-feeding and the cost of hospital stay. The study was prospectively registered at ClinicalTrials.gov (NCT02386748).Results: The study included 372 women randomized into three groups (124 women in each group). Chewing gum significantly improved intestinal recovery with faster onset of bowel movements, first audible intestinal sounds, passage of flatus and passage of stool (p = .0001). It was associated with significantly shorter duration of hospital stay and parenteral therapy duration (p = .0001). Abdominal distension, vomiting and ileus postoperatively were significantly higher in nonchewing gum groups. Neither paralytic ileus nor side effects were recorded with gum use.Conclusion: Chewing gum, within 2 h postoperatively, is a simple, safe and well-tolerated intervention that can boost rapid intestinal recovery and shorten hospital stay after planned cesarean deliveries.

How can methods of placental delivery in cesarean section affect perioperative blood loss? A randomized controlled trial of controlled cord traction versus manual removal of placenta.

AIM: Of the different described methods of placental delivery during cesarean section (CS), manual removal and cord traction are the most commonly used techniques. The ideal method of placental delivery during CS is still a conflicting issue as the data derived from the previous studies are widely heterogeneous and inconsistent. This study has investigated the effect of two different methods of placental delivery, controlled cord traction and manual removal, on perioperative blood loss. METHODS: This randomized controlled trial recruited 345 pregnant women scheduled for elective cesarean delivery at term. Eligible participants were randomly assigned to have their placentae delivered either by manual removal or cord traction. Perioperative blood loss was the study primary outcome measure. RESULTS: A total of 300 women were included in the final analysis. The longer placental delivery time in the cord traction group (n = 150) (60 s. [45-61.25] versus 45 s. [35-60] in the manual placental delivery group, P < 0.001) was associated with a statistically significant but clinically insignificant higher visually estimated blood loss (500 mL [interquartile range, 500-700] versus 500 mL [interquartile range, 400-500] in the manual removal group, P < 0.001). Although there were statistically significant differences in the hemoglobin levels, postoperatively, these differences were clinically insignificant and were not reflected in the corresponding deficits and percentages of deficit at 12- and 48-h postoperative intervals. CONCLUSIONS: Of the studied placental delivery techniques, there were no clinically significant differences in terms of the considered intraoperative and postoperative outcomes; hence, the practice of placental delivery can be left up to obstetrician's discretion and intraoperative scenario.

Knot positioning during McDonald cervical cerclage, does it make a difference? A cohort study.

Objective: To study the effect of McDonald cerclage knot position on the different maternal and neonatal outcomes. Methods: This historical cohort study included women with singleton pregnancy who had a prophylactic McDonald cervical cerclage between 1 May 2010 and 31 September 2017. Maternal and neonatal outcome parameters were compared between the anterior and posterior knot cerclage procedures. The primary outcome measure was the rate of term birth. Results: 550 Women had a prophylactic McDonald cervical cerclage, 306 with anterior knot (Group A) and 244 with posterior knot (Group B). There were no statistically significant differences regarding gestational age (GA) at delivery (36.3 ± 4.2 versus 35.8 ± 5.3 for groups A and B respectively), term birth rate, post-cerclage cervical length, symptomatic vaginitis, urinary tract infection, difficult cerclage removal and cervical lacerations. Similarly, there were no statistically significant differences as regards the studied neonatal outcomes including take home babies, neonatal intensive care admission, respiratory distress syndrome and neonatal sepsis. Survival analysis on GA at delivery demonstrated no statistically significant difference as regards the proportion of term deliveries in the anterior and posterior knot cerclage groups (log-rank test p-value = .478). Conclusions: Knot positioning during McDonald cervical cerclage, anteriorly or posteriorly, didn't significantly impact the studied maternal and neonatal outcomes.

Towards more accurate measurement of edge to os distance in low-lying placenta using three dimensional transvaginal ultrasound: an innovative technique.

BACKGROUND: Measurement of edge to os distance (EOD) is essential to differentiate low-lying from normal placenta, and to plan for delivery. Till now, measurement by 2D TVS is the gold standard, however, its accuracy is questioned. In this study, we introduced an innovative technique for measurement of EOD using 3D TVS. Our aim was to compare EOD measurements of the standard 2D technique, to those of our innovative 3D technique, and to correlate the difference, if any, with placental site and internal os width. METHODS: This study was conducted in the ultrasound unit of obstetrics and gynecology department, Zagazig University Hospitals, during the period from June 2014 to August 2017. Seventy six cases in whom the lower placental edge didn't reach the internal os (IO), and the EOD was less than 35 mm, were included in the study. Placental location was identified by 2D transabdominal sonography then 2D TVS was used to measure the EOD in all cases. Our new technique was then applied to measure EOD by 3D TVS following stepwise manipulations of the orthogonal planes in multiplanar view. Width of IO was measured also in all cases. RESULTS: The mean EOD measured by 3D TVS was significantly shorter than that measured using the 2D TVS. Anterolateral/posterolateral and lateral placentas were associated with high discrepancy in measurements between both methods, being the highest with lateral group. There was significant positive correlation between the IO width and the degree of difference between the EOD measured by both methods. CONCLUSIONS: Two dimensional TVS may not be accurate in EOD measurements in many cases of low-lying placentas, and 3D TVS may increase the accuracy of measurements in these cases. This new method is simple, precise and easily applied.

Mechanical induction of labor and ecbolic-less vaginal birth after cesarean section: A cohort study.

OBJECTIVE: During delivery counseling, some women with previous uncomplicated cesarean section (CS) wish mechanical induction of labor (IOL) but they are not accepting the added risk of using ecbolics to induce and/or augment labor. The objective of the study was to assess the safety and efficacy of the isolated use of transcervical Foley's catheter balloon as a mean of mechanical cervical ripening (CR)/IOL and successful ecbolic-less vaginal birth after cesarean section (VBAC). MATERIALS AND METHODS: A cohort study was conducted in two tertiary care maternity hospitals between October 2013 and July 2016 and recruited women with singleton pregnancy and cephalic presentation who had previous one uncomplicated CS and were scheduled for mechanical CR/IOL at term for routine obstetric indications. No ecbolics were used for induction or augmentation of labor as per patients' request. The primary outcome variable was the rate of successful VBAC. RESULTS: 108 Women had a completed trial of mechanical CR/IOL without ecbolics till delivery. Active labor started in 94 women (87%), however only 43 women (39.8%) had successful VBAC. No woman in the study cohort had uterine rupture, scar dehiscence, uterine tachysystole, postpartum hemorrhage and/or puerperal sepsis. No cases were admitted to intensive care units and there were no maternal mortalities. Prior successful VBAC and post-expulsion BS were the only independent predictors for successful VBAC and shorter duration of labor after balloon expulsion. CONCLUSION: Mechanical IOL with the mere use of transcervical Foley's catheter is a safe and effective method of VBAC in women refusing use of ecbolics.