scholarly journals Tranexamic Acid versus Placebo for Prevention of Primary Postpartum Haemorrhage among High Risk Women Undergoing Caesarean Section in Abakaliki: A Randomized Controlled Trial

2019 ◽  
Vol 09 (06) ◽  
pp. 914-922
Author(s):  
Nwafor Johnbosco Ifunanya ◽  
Ibo Chukwunenye Chukwu ◽  
Obi Chuka Nobert ◽  
Onwe Blessing ◽  
Ugoji Darlington-Peter Chibuzor ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
High Risk ◽  
Caesarean Section ◽  
Tranexamic Acid ◽  
Postpartum Haemorrhage ◽  
Controlled Trial ◽  
High Risk Women ◽  
Randomized Controlled ◽  
Acid Versus

Satisfaction with Team Midwifery Care for Low- and High-Risk Women: A Randomized Controlled Trial

Birth ◽  
2003 ◽  
Vol 30 (1) ◽  
pp. 1-10 ◽  
Author(s):  
Mary Anne Biró ◽  
Ulla Waldenström ◽  
Stephanie Brown ◽  
Jan H. Pannifex
Keyword(s):  
Randomized Controlled Trial ◽  
High Risk ◽  
Controlled Trial ◽  
Midwifery Care ◽  
High Risk Women ◽  
Randomized Controlled

Telephone Genetic Counseling for High-Risk Women Undergoing BRCA1 and BRCA2 Testing: Rationale and Development of a Randomized Controlled Trial

2008 ◽  
Vol 12 (1) ◽  
pp. 37-52 ◽  
Author(s):  
Beth N. Peshkin ◽  
Tiffani A. DeMarco ◽  
Kristi D. Graves ◽  
Karen Brown ◽  
Rachel H. Nusbaum ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Genetic Counseling ◽  
High Risk ◽  
Controlled Trial ◽  
Brca1 And Brca2 ◽  
High Risk Women ◽  
Randomized Controlled ◽  
Brca1 And Brca2 Testing

Telephone Genetic Counseling for High-Risk Women UndergoingBRCA1andBRCA2Testing: Rationale and Development of a Randomized Controlled Trial

2008 ◽  
Vol 0 (0) ◽  
pp. 080327164308306 ◽  
Author(s):  
Beth N. Peshkin ◽  
Tiffani A. DeMarco ◽  
Kristi D. Graves ◽  
Karen Brown ◽  
Rachel H. Nusbaum ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Genetic Counseling ◽  
High Risk ◽  
Controlled Trial ◽  
High Risk Women ◽  
Randomized Controlled

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).

scholarly journals A Patient-Controlled Intravenous Analgesia With Tramadol Ameliorates Postpartum Depression in High-Risk Woman After Cesarean Section: A Randomized Controlled Trial

2021 ◽  
Vol 8 ◽  
Author(s):  
Zhuoxi Wu ◽  
Peng Zhao ◽  
Jing Peng ◽  
Liang Fang ◽  
Jinping Ding ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
High Risk ◽  
Postpartum Depression ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Depression Scale ◽  
Clinical Trial Registration ◽  
High Risk Women ◽  
Randomized Controlled ◽  
Intravenous Analgesia

Background: Postpartum depression (PPD) is a severe psychiatric disorder. Its risk is associated with the cesarean section (CS). Currently, there are few early intervention strategies for these women with PPD who underwent CS.Methods: This was a parallel-group randomized controlled trial of singleton pregnant women who underwent elective CS in a tertiary referral hospital in China from October, 2017 to September, 2019. After operation, patients received randomly tramadol patient-controlled intravenous analgesia (PCIA; 4 mg/ml; TRA group), hydromorphone PCIA (0.04 mg/ml; HYD group), or ropivacaine patient-controlled epidural analgesia (PCEA; 1.5 mg/ml; ROP group) for 48 h in a 1:1:1 ratio. Total blinding during hospitalization was not feasible due to differences between the PCEA and PCIA treatments. All investigators who performed the follow-up were blinded to the group assignment.Outcomes: A total of 1,230 patients were enrolled for eligibility. Intention-to-treat analysis showed reduced incidence of PPD in the TRA group (n = 27 [6.6%]) than that in the HYD (10.2%, OR 1.62, 95% CI 0.98~2.68; p = 0.059) and ROP groups (10.5%, OR 1.66, 95% CI 1.01~2.75; p = 0.046) at 4 weeks post-operation, however, the difference was not statistically significant (Bonferroni corrected p = 0.118, p = 0.098, respectively). Subgroup analysis in high-risk women (preoperative Edinburgh Postpartum Depression Scale [EPDS] ≥10) showed a significantly lower incidence of PPD in the TRA group (16.5%) than in the HYD (32.6%) and ROP groups (30.9%) (Bonferroni corrected p = 0.022 and p = 0.038, respectively). The per-protocol analysis yielded similar results. Reported adverse events (AEs) were mostly mild. None of the women or infant discontinued treatment due to AEs.Conclusions: Tramadol PCIA after CS in high-risk women can help to reduce the risk of PPD at 4 weeks after elective CS.Clinical Trial Registration:https://clinicaltrials.gov/ct2/show/NCT03309163?term=ETPPD&draw=2&rank=1; ClinicalTrials.gov (NCT03309163).

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