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Postpartum Hemorrhage clinical trials

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NCT ID: NCT03326596 Withdrawn - Clinical trials for Postpartum Hemorrhage

Prevention of Postpartum Hemorrhage With TXA

TXA
Start date: April 20, 2018
Phase: Phase 4
Study type: Interventional

Hemorrhage remains the leading cause of maternal death worldwide. Tranexamic acid has been shown to reduce rates of hemorrhage when given prophylactically prior to cesarean delivery. It has also been shown to be an effective treatment in response to hemorrhage after a vaginal delivery. The aim of this study is to assess the impact of TXA on hemorrhage rates when given prophylactically prior to all deliveries.

NCT ID: NCT03303235 Withdrawn - Clinical trials for Postpartum Hemorrhage

Intravenous Versus Intramuscular Administration of Methylergonovine for Uterine Contraction in Cesarean Sections

Start date: July 2020
Phase: Early Phase 1
Study type: Interventional

Insufficient uterine tone resulting in atony can potentiate hemorrhage and adverse outcomes for the parturient. Oxytocin is the first pharmacologic agent used, followed by methylergonovine, carboprost, and misoprostol. The American Congress of Obstetricians and Gynecologists (ACOG) recommends the sequential use of oxytocin, followed by methylergonovine, carboprost, misoprostol, then surgical intervention for cases of refractory uterine atony. Many studies have examined the effect and dosage of intravenous uterotonics, including oxytocin. Although there are anecdotal reports of using intravenous bolus or rapid infusion of methylergonovine, no randomized trial has compared efficacy and side effects of these two routes of administration. Investigators hypothesize that intravenous methylergonovine reduces the time to adequate uterine tone (the tone at which the uterus is adequately contracted to prevent atony after delivery of neonate), decreases the total dose of methylergonovine to contract the uterus, and therefore produces fewer side effects of hypertension, nausea, and vomiting. Reducing the time to achieve adequate uterine tone is likely to decrease postpartum hemorrhage.

NCT ID: NCT02528708 Withdrawn - Clinical trials for Postpartum Hemorrhage

A Program to Evaluate Riastap® and FIBTEM® for the Early Control and Treatment of Postpartum Hemorrhage (PERFECT PPH)

PERFECT PPH
Start date: January 2021
Phase: Phase 1/Phase 2
Study type: Interventional

In this prospective, single-center, randomized, placebo-controlled, double-blind clinical trial, parturients with primary PPH are eligible for treatment with fibrinogen concentrate following both vaginal delivery and cesarean section complicated by an estimated blood loss (EBL) >1000 mL and an ongoing bleeding notwithstanding standard treatment measures (volume replacement, uterine massage, and uterotonic agents).

NCT ID: NCT02503319 Withdrawn - Clinical trials for Postpartum Hemorrhage

Clinical Study to Assess the Equivalence of Tranexamic Acid vs Oxytocin in Reducing the PPH (TRANOXY2015)

TRANOXY2015
Start date: January 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate that the tranexamic acid (TXA)Intravenous and oral, is equivalent oxytocin (OXY),intramuscularly, in reducing the blood loss in post partum period (mL) in patients at the end of pregnancy ( 37-42 w ) at low risk of post partum hemorrhage (PPH). The PPH means a blood loss equal to or greater than 500 ml after a vaginal delivery ( the bleeding is defined severe if it exceeds 1000 mL). PPH is called "primary" when blood loss arose within 24 hours after birth. This is a open-trial randomized, longitudinal, controlled that including 486 subjects .

NCT ID: NCT02410655 Withdrawn - Clinical trials for Postpartum Hemorrhage

An Evidence Based Protocol for Oxytocin Administration in Vaginal Delivery

Start date: November 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study will be to evaluate a standardized, evidence-based protocol versus a conventional approach for the dosing of oxytocin in vaginal delivery.

NCT ID: NCT01910675 Withdrawn - Clinical trials for Postpartum Haemorrhage

PCC and Fibrinogen Compared With FFP in PPH

Start date: July 2013
Phase: Phase 4
Study type: Interventional

The purpose of the study is to find out if the regimen of prothrombin complex concentrate (PCC) together with fibrinogen concentrate is as efficient as fresh frozen plasma (FFP) (plus fibrinogen if needed) during the early stages of the transfusion therapy in postpartum haemorrhage (PPH). The original protocol included the use of HES and the recruitment of patients was postponed while waiting the final decision by EMA. All HES solutions were abandoned at our institution in September and an amendment was made to change the protocol. HES solution are replaced by the use of hyperoncotic (20%) albumin.

NCT ID: NCT01710566 Withdrawn - Clinical trials for Postpartum Hemorrhage

Misoprostol and Oxytocin in Uniject® for Postpartum Hemorrhage Prevention in Communities

Start date: July 2013
Phase: Phase 3
Study type: Interventional

This community-based cluster Randomised Control Trial will assess the feasibility, cost, risks and benefits of use of oral Misoprostol and parenteral Oxytocin in Uniject® as prophylaxis for postpartum hemorrhage (PPH) in community settings. The study will be conducted in Jamnagar district in Gujarat state in India. The hypothesis is that a program to deliver oral misoprostol and one to deliver oxytocin via Uniject® will both be effective in preventing PPH when introduced in community-based settings.

NCT ID: NCT01487278 Withdrawn - Clinical trials for Postpartum Hemorrhage

Comparing Misoprostol and Oxytocin in UnijectTM for Postpartum Hemorrhage (PPH) Prevention in Mali

Start date: n/a
Phase: N/A
Study type: Interventional

This is a large, community-based, cluster-randomized trial to compare routine prophylactic use of 600 mcg oral misoprostol and 10 IU oxytocin delivered by UnijectTM intramuscularly during the third stage of labor.

NCT ID: NCT01252342 Withdrawn - Clinical trials for Postpartum Hemorrhage

Does Intramyometrial Oxytocin Improve Outcome in Elective Cesarean Delivery?

Start date: August 2011
Phase: Phase 4
Study type: Interventional

Oxytocin use has become routine practice in elective cesarean delivery to promote uterine contraction and reduce blood loss. However, there is a lack of consensus regarding the best dose of oxytocin and the most effective route of administration. Most dosage and delivery systems have been empirically derived. It is currently our practice at the Royal University Hospital to start an oxytocin infusion (20U/L) once the baby has been delivered. Some anesthesiologists use bolus intravenous oxytocin and it is occasionally requested by the obstetrician. A few obstetricians also choose to inject bolus oxytocin directly into the uterus (intramyometrial). The primary objectives of the study include: 1. Determine if our standard 'low dose' oxytocin infusion is adequate prophylaxis to prevent need for additional uterotonics, including additional oxytocin; 2. Determine if the addition of prophylactic intramyometrial oxytocin improves both the primary outcome (uterine tone) and secondary outcomes (estimated blood loss, preoperative to postoperative change in hematocrit, need for additional uterotonics, and need for blood pressure support); and 3. Act as a dose finding study to determine if the intramyometrial dose is sufficient to augment uterine contraction. The working hypothesis is that the use of intramyometrial oxytocin will not improve primary or secondary outcomes compared to the current practice of an oxytocin infusion alone.

NCT ID: NCT01108302 Withdrawn - Clinical trials for Postpartum Hemorrhage

Effectiveness, Safety and Feasibility of Auxiliary Nurse Midwives' (ANM) Use of Oxytocin in Uniject™ to Prevent Postpartum Hemorrhage in India

Start date: September 2011
Phase: N/A
Study type: Interventional

This cluster randomized community-based trial is designed to test the hypothesis that the intramuscular administration of 10 IU of oxytocin in Uniject™ during the third stage of labor by an Auxiliary Nurse Midwife (ANM) at births occurring in homes, Sub-Centers and Primary Health Centers in Bagalkot, India will reduce the risk of postpartum hemorrhage by 44% (from 9% to 5%) relative to home births attended by the same type of provider who does not provide the intervention drug. The study will also document correct use of oxytocin in Uniject, adverse maternal and fetal events associated with inappropriate use and a number of indicators reflecting the programmatic feasibility of implementing this intervention.