scholarly journals Effect of heat stable carbetocin vs oxytocin for preventing postpartum haemorrhage on post delivery hemoglobin–a randomized controlled trial.

2021 ◽  
pp. 1-8
Author(s):  
Sunil S. Vernekar ◽  
Swati S. Goudar ◽  
Mrityunjay Metgud ◽  
Yeshita V. Pujar ◽  
Manjunath S. Somannavar ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Postpartum Haemorrhage ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Heat Stable ◽  
Hemoglobin A

scholarly journals Effect of Heat stable Carbetocin vs Oxytocin for Preventing Postpartum Haemorrhage on Post Delivery Hemoglobin- A Randomized Controlled Trial

2021 ◽  
Author(s):  
Sunil S Vernekar ◽  
Swati S Goudar ◽  
Mrityunjay C Metgud ◽  
Yeshita V Pujar ◽  
Manjunath S Somannavar ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Postpartum Haemorrhage ◽  
Controlled Trial ◽  
Hemoglobin Level ◽  
Clinical Trial Registry ◽  
Middle Income ◽  
Randomized Controlled ◽  
Heat Stable ◽  
First Choice ◽  
The Difference

Abstract BackgroundPost-partum haemorrhage is one of the major causes of maternal mortality in low- and middle-income countries. Oxytocin is the first choice uterotonic for the PPH prevention but it requires cold storage. Heat stable carbetocin appears to be a promising agent for the prevention of PPH. The present study was an ancillary to the WHO CHAMPION Trial conducted to compare the effect of heat-stable carbetocin 100 µg IM versus oxytocin 10 IU IM on post-delivery hemoglobin level in one of the participating facilities in India.MethodsThis was a nested randomized controlled trial designed to compare the effect of heat-stable carbetocin 100 µg IM versus oxytocin 10 IU IM, administered within one minute of vaginal delivery of the baby for prevention of postpartum haemorrhage, on post-delivery 48–72 hours hemoglobin level, adjusted for pre-delivery hemoglobin level. 1,799 women from one hospital in India participated in this study.ResultsPre-delivery hemoglobin and postpartum blood loss were not significantly different between carbetocin and oxytocin. Post-delivery hemoglobin, unadjusted or adjusted for pre-delivery hemoglobin, was slightly lower for carbetocin compared to oxytocin. The drop in hemoglobin was slightly higher for carbetocin, although the difference was very small (1.2 g/dL for carbetocin, 1.1 g/dL for oxytocin). The proportion of participants with a drop in hemoglobin of 2 g/dL or more, adjusted for pre-delivery hemoglobin, was higher for carbetocin (RR = 1.29, 95% CI 1.02 to 1.63). From the regression coefficients it can be derived that post-delivery hemoglobin, adjusted for pre-delivery hemoglobin, decreases on average 0.12g/dL for each dL of blood lost, for the two treatments combined.ConclusionsThe present ancillary study showed that intramuscular administration of 100 µg of heat stable carbetocin can result in a slightly lower post-delivery hemoglobin, slightly higher drop and higher percentage of women having a drop of 2 g/dL or larger, compared to 10 IU of oxytocin, but these differences are not clinically relevant.Study registrationThe trial was registered with Clinical Trial Registry of India CTRI/2016/06/006996.

scholarly journals Pre-emptive treatment with fibrinogen concentrate for postpartum haemorrhage: randomized controlled trial †

2015 ◽  
Vol 114 (4) ◽  
pp. 623-633 ◽  
Author(s):  
A.J. Wikkelsø ◽  
H.M. Edwards ◽  
A. Afshari ◽  
J. Stensballe ◽  
J. Langhoff-Roos ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Postpartum Haemorrhage ◽  
Controlled Trial ◽  
Fibrinogen Concentrate ◽  
Randomized Controlled

scholarly journals One Drop App With an Activity Tracker for Adults With Type 1 Diabetes: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Chandra Y Osborn ◽  
Ashley Hirsch ◽  
Lindsay E Sears ◽  
Mark Heyman ◽  
Jennifer Raymond ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Type 1 Diabetes ◽  
Controlled Trial ◽  
Mobile App ◽  
Analysis Of Covariance ◽  
Activity Tracker ◽  
Randomized Controlled ◽  
Hemoglobin A ◽  
The One

BACKGROUND In 2017, mobile app support for managing diabetes was available to 64% of the global population of adults with diabetes. One Drop’s digital therapeutics solution includes an evidence-based mobile app with global reach, a Bluetooth-connected glucometer, and in-app coaching from Certified Diabetes Educators. Among people with type 1 diabetes and an estimated hemoglobin A<sub>1c</sub> level≥7.5%, using One Drop for 3 months has been associated with an improved estimated hemoglobin A<sub>1c</sub> level of 22.2 mg/dL (–0.80%). However, the added value of integrated activity trackers is unknown. OBJECTIVE We conducted a pragmatic, remotely administered randomized controlled trial to evaluate One Drop with a new-to-market activity tracker against One Drop only on the 3-month hemoglobin A<sub>1c</sub> level of adults with type 1 diabetes. METHODS Social media advertisements and online newsletters were used to recruit adults (≥18 years old) diagnosed (≥1 year) with T1D, naïve to One Drop’s full solution and the activity tracker, with a laboratory hemoglobin A<sub>1c</sub> level≥7%. Participants (N=99) were randomized to receive One Drop and the activity tracker or One Drop only at the start of the study. The One Drop only group received the activity tracker at the end of the study. Multiple imputation, performed separately by group, was used to correct for missing data. Analysis of covariance models, controlling for baseline hemoglobin A<sub>1c</sub>, were used to evaluate 3-month hemoglobin A<sub>1c</sub> differences in intent-to-treat (ITT) and per protocol (PP) analyses. RESULTS The enrolled sample (N=95) had a mean age of 41 (SD 11) years, was 73% female, 88% White, diagnosed for a mean of 20 (SD 11) years, and had a mean hemoglobin A<sub>1c</sub> level of 8.4% (SD 1.2%); 11% of the participants did not complete follow up. Analysis of covariance assumptions were met for the ITT and PP models. In ITT analysis, participants in the One Drop and activity tracker condition had a significantly lower 3-month hemoglobin A<sub>1c</sub> level (mean 7.9%, SD 0.60%, 95% CI 7.8-8.2) than that of the participants in the One Drop only condition (mean 8.4%, SD 0.62%, 95% CI 8.2-8.5). In PP analysis, participants in the One Drop and activity tracker condition also had a significantly lower 3-month hemoglobin A<sub>1c</sub> level (mean 7.9%, SD 0.59%, 95% CI 7.7-8.1) than that of participants in the One Drop only condition (mean 8.2%, SD 0.58%, 95% CI 8.0-8.4). CONCLUSIONS Participants exposed to One Drop and the activity tracker for the 3-month study period had a significantly lower 3-month hemoglobin A<sub>1c</sub> level compared to that of participants exposed to One Drop only during the same timeframe. One Drop and a tracker may work better together than alone in helping people with type 1 diabetes. CLINICALTRIAL ClinicalTrials.gov NCT03459573; https://clinicaltrials.gov/ct2/show/NCT03459573.

scholarly journals Misoprostol for treating postpartum haemorrhage: a randomized controlled trial [ISRCTN72263357]

2004 ◽  
Vol 4 (1) ◽  
Author(s):  
G Justus Hofmeyr ◽  
Sandra Ferreira ◽  
V Cheryl Nikodem ◽  
Lindeka Mangesi ◽  
Mandisa Singata ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Postpartum Haemorrhage ◽  
Controlled Trial ◽  
Randomized Controlled

scholarly journals A Randomized Controlled Trial of Misoprostol and Oxytocin in the Management of Third Stage of Labor

1970 ◽  
pp. 14-16
Author(s):  
Rokshana Ivy ◽  
Hasmot Ara ◽  
Kulsum Haq ◽  
Farid Uddin Ahmed
Keyword(s):  
Developing Countries ◽  
Randomized Controlled Trial ◽  
Postpartum Hemorrhage ◽  
Postpartum Haemorrhage ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Third Stage Of Labor ◽  
Oral Misoprostol ◽  
Third Stage ◽  
Misoprostol Group

The study was conducted to compare the effectiveness and safety of oral misoprostol with intramuscular oxytocin in the management of third stage of labor. One hundred patients were selected randomly who are expected to have vaginal delivery. Fifty patients received oral misoprostol 600 microgram and other fifty patients received oxytocin 10 IU intramuscularly after the birth of the baby. There were no significant differences between the prevalence of postpartum hemorrhage, duration of third stage of labor, additional oxytocin requirement, manual removal of placenta and blood transfusion. About the side-effects, shivering and fever were significantly higher in misoprostol group (p<0.001) and (p<0.003) respectively. But there were no significant differences in other sideeffects. Oral misoprostol can be used instead of intramuscular oxytocin in the management of third stage of labor, to prevent postpartum hemorrhage, in developing countries, especially as it is administered orally and thermo stable in tropical climate. Key words: Misoprostol; Oxytocin; Postpartum haemorrhage DOI: 10.3329/bjpp.v24i1.5732Bangladesh J Physiol Pharmacol 2008; 24(1&2) : 14-16

scholarly journals Effect of tranexamic acid on coagulation and fibrinolysis in women with postpartum haemorrhage (WOMAN-ETAC): protocol and statistical analysis plan for a randomized controlled trial

2016 ◽  
Vol 1 ◽  
pp. 31 ◽  
Author(s):  
Haleema Shakur ◽  
Bukola Fawole ◽  
Modupe Kuti ◽  
Oladapo O. Olayemi ◽  
Adenike Bello ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Statistical Analysis ◽  
Tranexamic Acid ◽  
Postpartum Haemorrhage ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Trial Protocol ◽  
Randomized Controlled ◽  
Link Type ◽  
Trial Participants

Background: Postpartum haemorrhage (PPH) is a leading cause of maternal death. Tranexamic acid has the potential to reduce bleeding and a large randomized controlled trial of its effect on maternal health outcomes in women with PPH (The WOMAN trial) is ongoing. We will examine the effect of tranexamic acid on fibrinolysis and coagulation in a subset of WOMAN trial participants. Methods: Adult women with clinically diagnosed primary PPH after vaginal or caesarean delivery are eligible for inclusion in the WOMAN trial. In a sub-group of trial participants, blood samples will be collected at baseline and 30 minutes after the first dose of tranexamic acid or matching placebo.  Our primary objective is to evaluate the effect of tranexamic acid on fibrinolysis. Fibrinolysis will be assessed by measuring D-dimers and by rotational thromboelastometry (ROTEM). Secondary outcomes are international normalized ratio (INR), prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, haemoglobin and platelets. We aim to include about 180 women from the University College Hospital, Ibadan in Nigeria. Discussion: This sub-study of WOMAN trial participants should provide information on the mechanism of action of tranexamic acid in women with postpartum haemorrhage. We present the trial protocol and statistical analysis plan. The trial protocol was registered prior to the start of patient recruitment. The statistical analysis plan was completed before un-blinding. Trial registration:The trial was registered:ClinicalTrials.gov, Identifier NCT00872469https://clinicaltrials.gov/ct2/show/NCT00872469; ISRCTN registry, Identifier ISRCTN76912190http://www.isrctn.com/ISRCTN76912190(Registration date: 22/03/2012).

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