Adeeb Khalifeh

Suture compared with staple skin closure after cesarean delivery: a randomized controlled trial.

OBJECTIVE: To compare the incidence of wound complications between suture and staple skin closure after cesarean delivery. METHODS: This prospective, randomized clinical trial conducted at three hospitals in the United States between 2010 and 2012 included women undergoing cesarean delivery at 23 weeks of gestation or greater through a low-transverse skin incision. Women were randomized to closure of the skin incision with suture or staples after stratifying by body mass index and primary compared with repeat cesarean delivery. The primary outcome was incidence of wound complications, predefined as a composite of infection, hematoma, seroma, separation of 1 cm or longer, or readmission for wound complications. Analysis was according to the intention-to-treat principle; results were stratified by randomization group and adjusted for hospital by including it as a covariate. RESULTS: A total of 746 women were randomized, 370 to suture and 376 to staple closure. The median gestational age was 39 weeks. Fifty-eight women (7.8%) had wound complications—4.9% in the suture group and 10.6% in the staple group (adjusted odds ratio [OR] 0.43, 95% confidence interval [CI] 0.23–0.78); this was largely the result of the decreased incidence of wound separation in the respective groups (1.6% compared with 7.4%; adjusted OR 0.20, 95% CI 0.07–0.51). CONCLUSIONS: Suture closure of the skin incision at cesarean delivery is associated with a 57% decrease in wound complications compared with staple closure. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT01211600. LEVEL OF EVIDENCE: I

Vaginal progesterone vs intramuscular 17α‐hydroxyprogesterone caproate for prevention of recurrent spontaneous preterm birth in singleton gestations: systematic review and meta‐analysis of randomized controlled trials

Randomized controlled trials (RCTs) have recently compared intramuscular 17α‐hydroxyprogesterone caproate (17‐OHPC) with vaginal progesterone for reducing the risk of spontaneous preterm birth (SPTB) in singleton gestations with prior SPTB. The aim of this systematic review and meta‐analysis was to evaluate the efficacy of vaginal progesterone compared with 17‐OHPC in prevention of SPTB in singleton gestations with prior SPTB.

Universal cervical length screening in singleton gestations without a previous preterm birth: ten reasons why it should be implemented

A short cervix is associated strongly with preterm birth. Pharmacologic intervention with vaginal progesterone in women with a singleton pregnancy and a short cervix in the second trimester decreases the incidence of preterm birth. We explore the evidence that universal cervical length screening in women with a singleton pregnancy meets the criteria for an effective screening test for preterm birth prevention, driving it towards becoming routinely offered in prenatal care.

Trends in Invasive Prenatal Diagnosis: Effect of Sequential Screening and Noninvasive Prenatal Testing

Objective: To examine trends in the incidence and method of invasive prenatal diagnosis due to the impact of sequential screening and noninvasive prenatal testing. Methods: This is a retrospective review of all pregnancies that have undergone invasive prenatal diagnostic testing between June 2002 and June 2014, divided in 3 periods: period 1 from June 2002 to October 2006, period 2 from November 2006 to December 2011, and period 3 from January 2012 to June 2014. The main outcome measures were trends in the incidence and method of each procedure. Results: There were 88,135 deliveries and 6,080 invasive procedures during the study period. In period 1, 2,755 (8.8%) procedures were carried out, in period 2 2,820 (7.3%), and in period 3 505 (2.5%; p < 0.01). In period 1, there were 1,990 (6.3%) cases of amniocentesis, 1,646 (4.3%) in period 2, and 254 (1.2%) in period 3 (p < 0.01). In addition, in 765 (2.5%) cases, chorionic villus sampling (CVS) was performed in period 1, compared to 1,174 (3.0%) cases in period 2 and 251 (1.3%) cases in period 3 (p < 0.01). Advanced maternal age as the sole indication for invasive procedures decreased significantly over time, while the indication of abnormal serum screening and abnormal ultrasound findings increased (p < 0.01). Conclusion: There was a significant decline in the incidence of invasive prenatal testing over the 12 years of the study. The decrease in amniocentesis was more marked than that in CVS.

Universal cervical length screening for preterm birth prevention in the United States (.)

Abstract Objective: To evaluate the incidence of implementation of universal cervical length (CL) screening for preterm birth (PTB) prevention among institutions with Maternal–Fetal Medicine (MFM) fellowship training in the United states. Methods: In January 2015, we conducted a national survey of institutions with MFM Fellowship Programs regarding implementation of universal CL screening, defined as CL screening of women with singleton gestations without a prior spontaneous PTB. We identified whether a transabdominal ultrasound (TAU) or transvaginal ultrasound (TVU) was used for screening. Results were compared by geographical regions. Results: We identified 78 MFM fellowship programs nationwide, of which 100% responded to the survey, provided by MFM fellows (86%) and MFM division directors (14%). In January 2015, 53 programs (68%) had implemented a CL screening program, with 25 programs (32%) using TVU while the rest (36%) used TAU for CL screening. The 16 programs in the Midwest had the highest percent of CL screening (15 programs, 94%), with the highest use of TVU (8 programs 50%). The 24 programs in the South had the lowest percent of CL screening (14 programs, 58%) (odds ratio [OR]: 0.52, 95% confidence interval [CI]: 0.19–1.46) and the lowest use of TVU (3 programs,12.5%) (OR: 0.22, 95% CI: 0.05–0.78) compared to rest of US). Conclusion: Universal CL screening has been implemented by over two-thirds of institutions with MFM Fellowship Programs, as of January 2015. Of these programs, about half screen by TAU and half by TVU.

Pain Associated With Cesarean Delivery Skin Closure: A Randomized Controlled Trial.

OBJECTIVE: To assess pain perception and pain medication use between women who underwent suture and those who underwent stapling for skin closure after cesarean delivery. METHODS: This was a secondary analysis of a prospective, multicenter, randomized clinical trial conducted from 2010 to 2012 at three hospitals in the United States. We evaluated pain outcomes associated with skin closure of a low transverse skin incision for cesarean delivery. Patient-reported pain and pain medication use during hospitalization and 6 weeks postpartum were evaluated as prespecified secondary outcomes of the trial. RESULTS: A total of 746 women were randomized to cesarean skin closure with sutures (n=370) or staples (n=376). There were no significant differences between the two groups with regard to pain perception during hospitalization (median average in-hospital pain score 3.9 in each group, P=.914), or at 4–8 weeks postsurgery (one in each group, P=.949). There were no significant differences in pain medication use during hospitalization (suture: 56 mg of intravenous morphine; staples: 54 mg, P=.545) or 4–8 weeks postpartum. CONCLUSION: We observed no differences in patient-reported pain or pain medication use among women who underwent skin closure with suture and those who underwent stapling after cesarean delivery. Taken in conjunction with the primary analysis that showed decreased wound morbidity with suture closure, the results of this study support the use of suture closure of the cesarean delivery skin incision. CLINCAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01211600. LEVEL OF EVIDENCE: I

Are women positive for the One Step but negative for the Two Step screening tests for gestational diabetes at higher risk for adverse outcomes

The aim of this study was to evaluate if women meeting criteria for gestational diabetes mellitus (GDM) by the One Step test as per International Association of the Diabetes and Pregnancy Study Groups (IADPSG) criteria but not by other less strict criteria have adverse pregnancy outcomes compared with GDM‐negative controls. The primary outcome was the incidence of macrosomia, defined as birthweight > 4000 g.

Current Implementation of Universal Cervical Length Screening for Preterm Birth Prevention in the United States [19].

INTRODUCTION: To evaluate the incidence of implementation of universal cervical length (CL) screening for preterm birth (PTB) prevention among institutions with Maternal-Fetal Medicine (MFM) fellowship training in the United States. METHODS: In January 2015, we conducted a national survey of institutions with MFM Fellowship Programs regarding implementation of universal CL screening, defined as CL screening of women with singleton gestations without a prior spontaneous PTB. We also identified whether a transabdominal ultrasound (TAU) or transvaginal ultrasound (TVU) was used for screening. Results were compared by geographical regions. We also assessed if a low obstetrical volume (annual deliveries<3000) affected implementation of TVU CL screening program. RESULTS: We identified 78 MFM fellowship programs, of which 100% responded to the survey. Fifty-three programs (68%) had implemented a CL screening program, with 25 programs (32%) using TVU while the rest (36%) used TAU for CL screening. The Midwest had the highest percent of CL screening (94%), with the highest use of TVU (50%). The South had the lowest percent of CL screening (58%) (OR 0.52 [0.19–1.46]) and the lowest use of TVU (12.5%) (OR 0.22 [0.05–0.78]) compared to rest of the United States. Lower annual obstetrical volume did not affect the likelihood of implementing a program using TVU (7.6%) compared to programs having higher obstetrical volume (24.3%) (OR 0.73 [0.24–2.17]). CONCLUSION/IMPLICATIONS: Universal CL screening has been implemented by over two thirds of institutions with MFM Fellowship Programs. Of these programs, approximately half screen by TAU and half by TVU.

One-step versus two-step diagnostic testing for gestational diabetes: a randomized controlled trial

Abstract Objective: To evaluate the incidence of gestational diabetes mellitus (GDM) using the one-step as compared with the two-step approach. Study design: This was a parallel group nonblinded randomized trial conducted at Thomas Jefferson University Hospital (TJUH) in Philadelphia, Pennsylvania from June 2016 to December 2016. The primary outcome was GDM incidence in the one-step compared to the two-approach. Pregnant women without a history of pregestational diabetes were offered screening for GDM at gestational age 24–28 weeks. Obese women, defined as having a BMI ≥30 kg/m2, as well as those with a history of a pregnancy complicated by GDM, a history of a macrosomic baby (>4000 g), or with polycystic ovarian syndrome (PCOS), were offered early screening at their initial prenatal visit, and screening was repeated at 24–28 weeks if initially normal. Women were excluded if they had pre-existing diabetes or had a history of bariatric surgery. Women who were eligible were randomized in a 1:1 ratio to either the one-step or two-step approaches. A sample size of 142 women was planned per group. Women randomized to the one-step approach, after an overnight fast, were given a 2-h glucose tolerance test, which consisted of a 75-g glucose load. Blood glucose levels were measured fasting, at 1 h and 2 h after the glucose load. Diagnostic cutoffs for GDM diagnosis were one value of either fasting ≥92 mg/dL, 1 h ≥180 mg/dL, or 2 h ≥153 mg/dL, respectively. Women randomized to the two-step approach were given a nonfasting 50-g glucose load, and the blood glucose level was measured an hour after the glucose load. If that value was ≥135 mg/dL, the patient had a 3-h glucose tolerance test consisting of a 100-g glucose load. Diagnostic cutoffs for GDM diagnosis for this 3-h test were ≥2 abnormal values of fasting ≥95 mg/dL, 1 h ≥180 mg/dL, 2 h ≥155 mg/dL and 3 h ≥140 mg/dL, respectively. All analyses were done using an intention-to-treat approach, evaluating women according to the treatment group to which they were randomly allocated. Results: Two hundred eighty-four women agreed to take part in the study and underwent randomization from June 2015 to December 2015. Of them, 249 completed the screening and were followed up for the primary endpoint. Out of the 249 women who completed the screening, 123 were assigned to the one-step group and 126 to the two-step group. GDM occurred in 10 women (8.1%) in the one-step group, and 7 women (5.6%) in the two-step group (p = .42). Preeclampsia, preterm birth (PTB), induction of labor, mode of delivery and incidence of gestational age (OASIS) were not significantly different. Perinatal outcomes were similar as well. Conclusions: Screening for GDM with one-step, compared with the two-step approach, resulted in a similar incidence of GDM.

Patient satisfaction and cosmetic outcome in a randomized study of cesarean skin closure

Abstract Objective: To evaluate patient satisfaction and patient and physician assessment of scar appearance after cesarean skin closure with suture versus staples. Methods: Women undergoing cesarean delivery (CD) at ≥23 weeks’ gestation via low-transverse skin incisions at three hospitals in the CROSS Consortium were randomized to receive skin closure using subcuticular absorbable suture or nonabsorbable metal staples. The primary outcome of this substudy, patient satisfaction, was assessed by surveys at the postpartum visit using a 10-point Likert scale. Scar outcomes according to patients and trained observers were assessed at the primary research site using the Patient and Observer Scar Assessment Scale (POSAS). The POSAS is comprised of a patient-completed assessment including subjective data such as pain and itchiness, and an observer-completed assessment about cosmetic criteria. Results: Between June 2010 and August 2012, 746 women were randomized; 370 received suture and 376 received staples. Satisfaction data were available for 606 (81%). Complete patient scar assessment data were available for 577 (77%) and complete observer scar assessment data were available for 275 (57% of the 480 planned for evaluation at the primary research site). Demographic data for women in the two groups were similar. Satisfaction with the closure method was higher (superior) among women who received suture closure: median 10 (interquartile range 9, 10) versus 9 (interquartile ranges (IQR) 6, 10); p < .01. The suture group also had higher satisfaction with the scar’s appearance at the postpartum visit: median nine (IQR 7, 10) versus 8 (IQR 6, 10); p = .02. Receiving one’s preferred closure method was associated with higher patient satisfaction, and wound complications were associated with lower satisfaction. POSAS scores were superior (lower) in the suture group. Patient Scar Assessment Scale scores were median 15 (IQR 10, 25) for sutures versus 20 (IQR 11, 28) for staples; p < .01. Observer Scar Assessment Scale scores were median 12 (IQR 9, 15) for sutures versus 13 (IQR 9, 16) for staples; p = .01. Conclusions: Satisfaction with the closure method, satisfaction with the scar’s appearance, and patient and physician assessments of scar cosmesis were all superior in those closed with suture. These results further support the use of sutures for cesarean skin closure.