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Postpartum Hemorrhage clinical trials

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NCT ID: NCT00781066 Completed - Clinical trials for Postpartum Hemorrhage

Controlled Cord Traction During Third Stage of Labor

CCT
Start date: January 2007
Phase: Phase 3
Study type: Interventional

Of the estimated number of 529,000 maternal deaths for the year 2000, 132,000 (25%) were caused by postpartum hemorrhage (PPH); 99% of these deaths occurred in low-income countries. Where maternal mortality is high and resources are limited, the introduction of low-cost, evidence-based practices for primary prevention of PPH is an urgent need. Controlled cord traction (CCT) is actively promoted in combination with prophylactic uterotonics for the prevention of PPH. While the administration of uterotonics has been proven effective, there is no evidence of CCT being beneficial or safe. The investigators propose this study to evaluate two primary questions: 1. In women having term, single vaginal deliveries in hospital settings, in whom the third stage is managed with prophylactic oxytocin, does CCT produce a clinically significant reduction in the incidence of postpartum blood lose? 2. In these women, does CCT produce a clinically significant increase in the incidence of severe complications, including uterine inversion or the need for subsequent surgical evacuation of retained placental tissues and membranes (curettage or manual removal)? To answer these two questions we designed two arms randomized controlled trial.

NCT ID: NCT00499005 Completed - Clinical trials for Postpartum Haemorrhage

Carbetocin Versus Syntometrine for the Third Stage of Labour

Start date: November 2006
Phase: Phase 4
Study type: Interventional

Intramuscular carbetocin is as effective as intramuscular syntometrine for the prevention of postpartum haemorrhage

NCT ID: NCT00473707 Completed - Clinical trials for Postpartum Hemorrhage

Active Versus Expectant Management of the Third Stage of Labor

Start date: August 2002
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if giving oxytocin immediately after delivery causes less bleeding, transfusion needs and hastens delivery of placenta.

NCT ID: NCT00462839 Completed - Clinical trials for Postpartum Hemorrhage

Accuracy of Blood Loss Estimation After Vaginal Delivery

Start date: July 2006
Phase: N/A
Study type: Interventional

Post-partum hemorrhage (PPH) is defined as blood loss greater than 500 mL after vaginal delivery. Delayed diagnosis of PPH is a major cause of maternal morbidity and mortality. Obstetricians estimate blood loss at delivery by visual estimation of blood collected in the obstetric drapes. Blood is often mixed with urine and surgical sponges. The urine, blood, and sponges collect in a cone shaped plastic bag that is suspended from the perineum during delivery. Visual estimation of blood loss is insensitive in diagnosing PPH. In one study visual assessment of blood loss underestimated postpartum blood loss by 33% to 50% compared to an objective measurement of blood loss using photospectrometry. Other studies have shown that the magnitude of underestimation increases as the amount of blood loss is increased. A limitation of previous studies is that there is no "gold standard" for blood loss determination in the third stage of labor. Care providers (obstetricians, anesthesiologists, and labor & delivery nurses) need to be able to accurately estimate blood loss in order to better care for mothers and prevent morbidity and mortality. It is unknown whether provider type or experience (obstetric and anesthesiology resident, fellow, attending physicians, and nurses) influences the accuracy of blood loss estimation, or whether blood loss estimation can be improved by providing graduated markings on the vaginal delivery drape.

NCT ID: NCT00370877 Completed - Clinical trials for Postpartum Hemorrhage

rhuFVIIa in Post-partum Hemorrhage

Start date: April 2007
Phase: Phase 4
Study type: Interventional

The aim of this clinical research project is to evaluate the use of the recombinant human activated factor VII (rhFVIIa), given as a salvage therapy, in women with a dramatic postpartum hemorrhage still ongoing after all the currently available medical and surgical treatments. We are going to compare its early use, before elective surgery or arterial embolization, to its late use, after embolization or surgery, before salvage hysterectomy.

NCT ID: NCT00344929 Recruiting - Clinical trials for Post Partum Haemorrhage

Severe Post Partum Haemorrhage (PPH): A Randomized Trial on Transversal Intervention in 6 French Perinatal Networks

Start date: November 2005
Phase: N/A
Study type: Observational

Hypothesis A “multifaceted” intervention program aimed at increasing the responsiveness of care givers, the adequacy of care provided, and the efficacy of organisation of care, in presence of abnormal blood loss in the immediate post partum has more impact on the incidence of severe PPH and on the costs of care than the current methods of dissemination of clinical practice guidelines. Intervention Intervention group. The intervention includes three components: (1) outreach visits with local presentation of evidence-based clinical practice guidelines for management of PPH, and discussion of their applicability in the context of local organisation; (2) during these educational visits, reminders - check list, “PPH emergency case” containing appropriate materials – to be used in case of PPH, will be proposed; (3) finally, cases of severe PPH will be reviewed during peer review sessions organized in each participating unit, to help identifying weaknesses in care provided, and needs for improvement. Control group. The proposed guidelines for management of PPH will be disseminated through the participating perinatal networks; then each unit will be free to implement them at its own convenience. Randomisation procedure The trial follows a cluster randomised trial design. Randomisation of maternity units will be stratified by region, status (public versus private) and size (annual number of deliveries). The stratified design will guarantee the comparability of the two arms of the trial at baseline. Outcome measures The primary outcome is the incidence of severe PPH (number of severe PPH to number of deliveries). A severe PPH is defined as a PPH that was associated with one or more of the following: peripartum haemoglobin drop greater than 4g/dl, blood transfusion, arterial embolisation, surgical procedures such as hysterectomy or arterial ligation, transfer of the mother to intensive care unit, maternal death. Secondary outcomes include the cost of care and the cost/efficacy ratio, and the incidence of adverse effects of uterotonic drugs.

NCT ID: NCT00257803 Completed - Clinical trials for Postpartum Hemorrhage

Does the Rapid Intravenous Administration of Oxytocin After Delivery of the Baby Decrease the Bleeding During Cesarean Section in Women at Risk of Bleeding During Cesarean Section?

Start date: November 2005
Phase: N/A
Study type: Interventional

Oxytocin is normally given either rapidly into the vein (bolus) or put into an intravenous bag and administered more slowly, after delivery of the baby by cesarean section. Both of these methods are commonly used. To date there has been little research to demonstrate that one method of giving oxytocin is better than another in women who are more likely to bleed after delivery. The purpose of the study is to see whether a small bolus of oxytocin makes the uterus contract better to reduce bleeding and decreases the need to give additional oxytocin or more powerful drugs in women who are at risk for bleeding after delivery of their baby by cesarean section.

NCT ID: NCT00124540 Completed - Clinical trials for Postpartum Hemorrhage

Misoprostol for Preventing Postpartum Hemorrhage

Start date: August 2005
Phase: N/A
Study type: Interventional

This hospital-based, multicenter, randomized, placebo-controlled trial will assess the effects of misoprostol as part of active management of the third stage of labor on postpartum blood loss, complications, and side effects. Twelve hundred eligible women will receive routine oxytocics (oxytocin 5-10 IU) plus either 400 mcg sublingual misoprostol or placebo during or immediately after delivery. The primary outcome will be measured blood loss of =>500 mls within one hour after enrollment.

NCT ID: NCT00120237 Completed - Anemia Clinical Trials

Misoprostol for the Prevention of Postpartum Hemorrhage in Rural Pakistan

Start date: July 2005
Phase: N/A
Study type: Interventional

This community-based trial will study misoprostol for the prevention of postpartum hemorrhage in rural Pakistan. Traditional birth attendants assisting home deliveries will administer study tablets (600 mcg oral misoprostol or placebo) in the third stage of labor to women participating in the trial. Blood loss, hemoglobin levels, side effects, and other variables will be evaluated.

NCT ID: NCT00120042 Completed - Clinical trials for Postpartum Hemorrhage

Optimisation of the Management of Placental Delivery in Second Trimester Pregnancy Interruption

Start date: February 2005
Phase: N/A
Study type: Interventional

Interruption of a pregnancy after 14 weeks gestation may be required when the fetus is dead, severely malformed or in cases of maternal illness. This process is usually conducted medically in Australia, using the prostaglandin E1 analogue misoprostol. This prostaglandin, although not specifically licensed for use in pregnancy termination, is now a common abortifacient with a lot of accumulated experience both within Australia and internationally. Since 1996, misoprostol, a synthetic prostaglandin, has been used at King Edward Memorial Hospital as the principal agent for second trimester pregnancy termination. This agent is administered vaginally, and in its current form and dosage regimen results in 75-80% of women delivering within 24 hours. As experience with this agent has grown, it has been observed that in approximately 40% of women the placenta is either completely retained or incompletely delivered, necessitating operative removal and an increased potential for maternal blood loss. In this study, it is planned, in a randomized controlled clinical trial, to evaluate three regimens for the management of placental delivery in women undergoing second trimester pregnancy interruption. The primary intention of this study is to develop a third stage management protocol to reduce the incidence of placental retention in second trimester medical pregnancy termination. The secondary aim of this study is to assess the ultrasound appearance of the uterus and its cavity within 24 hours of second trimester pregnancy termination. The ultrasound appearances of the uterus following second trimester pregnancy loss have not been previously investigated in detail. Previous ultrasound studies of the term postpartum uterus have demonstrated a high incidence of echogenic material within the uterine cavity soon after an uncomplicated vaginal delivery. These findings have been of concern as the ultrasound appearances may erroneously imply a need for operative intervention. The investigators wish to ascertain if this high incidence of echogenic tissue presence is also true in the second trimester. Ultrasound is frequently used by clinicians to define placental completeness and the potential requirement for surgical curettage. The data from this single sonographic examination of the uterus will provide baseline data for a planned longitudinal study of uterine appearances following second trimester pregnancy loss and their correlation with clinical symptoms.