scholarly journals Vaginal versus Intramuscular Progesterone for Prevention of Preterm Labour in Women with a Twin Pregnancy: a Randomized Controlled Trial

QJM ◽  
2020 ◽  
Vol 113 (Supplement_1) ◽  
Author(s):  
W H Tantawy ◽  
M M Ghaleb ◽  
M M A Elsayed
Keyword(s):  
Randomized Controlled Trial ◽  
Twin Pregnancy ◽  
Preterm Labour ◽  
Controlled Trial ◽  
Lower Percentage ◽  
Maternal Complications ◽  
Randomized Controlled ◽  
Vaginal Progesterone ◽  
Increased Risk ◽  
Twin Pregnancies

Abstract Background Twins constitute 2-4% of all births, and the rate of twining has increased by 76% between 1980 and 2009.Twin pregnancies, compared with singletons, are at increased risk for fetal anomalies, preterm births, aberrant fetal growth, cerebral palsy, and perinatal and infant mortality. Maternal complications associated with twin pregnancies include hypertensive disorders, gestational diabetes, cesarean delivery, postpartum hemorrhage, and maternal mortality. Aim of the Work This study aims to assess the efficacy of vaginal progesterone compared to intramuscular therapy in decreasing the rate of preterm birth in women with twin pregnancy. Patients and Methods Randomized Controlled Trial, women presented to Ain Shams University Maternity Hospital. The study was presented for approval from the ethical committee of the department of Obstetrics and Gynecology, faculty of medicine, Ain Shams University. Informed consent after explaining the study purpose and methods to the subjects. Data presentation will not be by the patient name but by diagnosis. Results There is no statistically significance between the two groups regarding number of neonatal RDS, NICU admission and neonatal death but lower percentage among vaginal progesterone group. Birth weight was significantly higher among vaginal group. NICU stay was significantly higher among intramuscular group. Conclusion Compared with intramuscular 17-OHPC, vaginal progesterone in women with twin pregnancy is associated with lower percentage of preterm labour, less recurrent SPTB, less adverse maternal side effects, fewer NICU admissions, better compliance.

A randomized controlled trial of two-doses of vaginal progesterone 400 vs. 200 mg for prevention of preterm labor in twin gestations

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Ahmed S. Abdel Wahab ◽  
Mostafa I. Abdelmonaem ◽  
Walaa M. Mahmoud ◽  
Ahmed E. Mansour
Keyword(s):  
Randomized Controlled Trial ◽  
Preterm Labor ◽  
Twin Pregnancy ◽  
Controlled Trial ◽  
Transvaginal Ultrasound ◽  
Statistical Significance ◽  
Average Weight ◽  
Randomized Controlled ◽  
Vaginal Progesterone ◽  
Second Twin

Abstract Objectives To compare between the effectiveness and safety of two different daily doses of vaginal progesterone (400 vs. 200 mg) in the prevention of preterm labor in twin pregnancy. Methods This is a prospective single-blinded randomized controlled trial conducted on 100 primi-gravida who had twin pregnancy and attended the antenatal clinic of a University hospital. They were equally and randomly allocated into two arms each containing 50 patients. Arm 1 received 400 mg and arm 2 received 200 mg vaginal progesterone daily at bed time starting from 14 weeks of pregnancy to 36 weeks. Transvaginal ultrasound was performed for assessment of the length of cervix at 14 and 22 weeks. Results Both arms of the current study were comparable regarding the cervical length at 14 and 22 weeks, mean gestational age at delivery, incidence of pre-term delivery, birth weight of the first twin. Second twin in addition to the average weight of both twins. No statistical significance differences between two arms regarding incidence of early neonatal death. NICU, mechanical ventilation, length of admission in NICU for the first twin. Second twin as well as both twins. Conclusions Vaginal progesterone treatment with different doses was tolerable, but wasn’t effective in the prevention of preterm labor in twin pregnancy.

Measuring Acceptability and Engagement of the Keep It Up! Internet-based HIV Prevention Randomized Controlled Trial for Young Men who have Sex with Men (Preprint)

2018 ◽  
Author(s):  
Krystal Madkins ◽  
David Moskowitz ◽  
Kevin Moran ◽  
Trey Dellucci ◽  
Brian Mustanski
Keyword(s):  
High School ◽  
Randomized Controlled Trial ◽  
Hiv Prevention ◽  
Controlled Trial ◽  
P Values ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Intervention Acceptability ◽  
Intervention Content ◽  
Sex With Men

BACKGROUND Since 2010, HIV diagnoses among men who have sex with men (MSM) have remained stably high while decreasing for heterosexual men and women. The burden of infection has disproportionately impacted younger MSM of color relative to other populations. Despite the increased risk, there are few HIV prevention programs targeted to diverse and young MSM. The Keep It Up! (KIU!) online intervention was created to address the HIV prevention needs of this population. OBJECTIVE The objective of this study was to examine the acceptability and engagement of KIU!, and explore any differences by demographics, within the context of a randomized controlled trial (RCT). METHODS Between May 2013 and December 2015, 445 participants were randomized into the intervention arm of the KIU! RCT. Data were taken from the baseline assessment, KIU! 2.0 intervention modules, and immediate post-test assessments of intervention acceptability and engagement. Outcomes of interests were qualitative and quantitative measures of intervention acceptability and engagement as well as process measures (i.e., star ratings of intervention content and paradata on time spent in intervention). RESULTS Participants were an average of 24 years old, 62.9% (280/445) identified as a racial or ethnic minority, 86.5% (385/445) identified as gay, and 84.3% (375/445) reported having at least some college education. Most participants rated the intervention content highly (4 out of 5 stars) and gave the intervention an average acceptability score of 3.5 out of 4. Compared to White participants, Black participants found the intervention more useful (p = .03), engaging (p < .001), and acceptable (p = .001); Latino participants found the intervention more engaging (p = .03); and “other” non-White participants found the intervention more engaging (p = .008) and acceptable (p = .02). Participants with high school or less education found the intervention more useful, engaging, and acceptable, and were more likely to give intervention content a five star rating than college educated participants (p-values = .047, <.001, .002, .01 respectively) or those with graduate degrees (p-values = .04, .001, < .001, .004 respectively). White participants showed the most variation between education levels and reporting positive attitudes towards the intervention. Among Black participants, graduate degree-earning participants spent significantly more time on the intervention than high-school or less educated participants (p = .02). CONCLUSIONS Overall, participants gave the intervention high acceptability and engagement ratings; but it was most acceptable and engaging to participants who were younger, identified as racial and ethnic minorities, had less education, and lived in the South. As these are all groups with greater burden of HIV infection, the KIU! intervention is promising as a primary HIV prevention tool. Future implementations of KIU! are needed to assess its acceptability outside of the highly controlled environment of an RCT. CLINICALTRIAL RCT# NCT01836445

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

scholarly journals The ACHIEVE Trial: Lessons Learned From Nesting a Randomized Controlled Trial Within an Observational Cohort Study

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 811-811
Author(s):  
Jennifer Deal ◽  
Nicholas Reed ◽  
David Couper ◽  
Kathleen Hayden ◽  
Thomas Mosley ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Observational Study ◽  
Cognitive Decline ◽  
Controlled Trial ◽  
Lessons Learned ◽  
Community Dwelling ◽  
Randomized Controlled ◽  
Study Staff ◽  
Increased Risk

Abstract Hearing impairment in older adults is linked to accelerated cognitive decline and a 94% increased risk of incident dementia in population-based observational studies. Whether hearing treatment can delay cognitive decline is unknown but could have substantial clinical and public health impact. The NIH-funded ACHIEVE randomized controlled trial of 977 older adults aged 70-84 years with untreated mild-to-moderate hearing loss, is testing the efficacy of hearing treatment versus health education on cognitive decline over 3 years in community-dwelling older adults (Clinicaltrials.gov Identifier: NCT03243422.) This presentation will describe lessons learned from ACHIEVE’s unique study design. ACHIEVE is nested within a large, well-characterized multicenter observational study, the Atherosclerosis Risk in Communities Study. Such nesting within an observational study maximizes both operational and scientific efficiency. With trial results expected in 2022, this presentation will focus on the benefits gained in design and recruitment/retention, including dedicated study staff, well-established protocols, and established study staff-participant relationships. Part of a symposium sponsored by Sensory Health Interest Group.

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