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Postpartum Hemorrhage clinical trials

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NCT ID: NCT02509312 Completed - Postoperative Pain Clinical Trials

Prospective Effect of Intravenous Ketorolac on Opioid Use, EBL and Complications Following Cesarean Delivery

Start date: May 2016
Phase: Phase 4
Study type: Interventional

In this randomized, double-blind control trial to evaluate the effect of ketorolac given at the time of cord clamp has on estimated blood loss and postcesarean pain control. Patients will be randomized to either placebo or ketorolac prior to surgery. Those randomized to ketorolac will receive ketorolac at cord clamp and three additional doses every 6 hours (total 4 doses/24 hours). Those in the placebo group will receive normal saline during those time periods. Our primary outcome is to assess whether intra-operative ketorolac increases the estimated blood loss during Cesarean delivery.

NCT ID: NCT02468310 Completed - Pre-eclampsia Clinical Trials

Evaluating the Effects of SMS Text Messaging Support System Among Frontline Health Workers in Ghana

Accelerate
Start date: August 10, 2015
Phase: N/A
Study type: Interventional

Introduction Maternal and neonatal mortality continue to be to be prominent public health issues in sub Saharan Africa including Ghana, with slow progress made towards attainment of Millennium Development Goals (MDG) 4 & 5. Studies have identified poor quality of maternal and child healthcare as a major challenge to the prevention of neonatal and maternal deaths. Effective interventions are required to make significant inroads in these areas. Objective To evaluate the effect of a SMS text messaging intervention to support clinical decision making by frontline health care professionals on neonatal and maternal mortality. Methods We propose to conduct a randomized controlled trial in the Eastern region of Ghana, involving 8 intervention and 8 control districts. The intervention consists of text messaging of standard protocols for maternal and neonatal care to front line health care providers in the region. A total of 17,040 pregnant women who are receiving care (including antenatal, delivery and post-natal) at any of the hospitals in the selected districts in the region will be monitored through monthly aggregate data on outcome measures such as neonatal and maternal deaths from eclampsia, postpartum haemorrhage, puerperal sepsis, birth asphyxia, low birth weight and neonatal sepsis. Cord sepsis will also be included as neonatal sepsis for this study. Also, a quality of care assessment in four sampled districts to measure adherence to the safe motherhood protocol will be conducted. Stata software package.55 and MLwiN software version 2.2456 will be employed in data analysis. Descriptive analysis will be carried out to explore baseline characteristics of study groups while logistic regression will be applied to evaluate the effect of the intervention. A two-tailed statistical significant level of 0.05 will be used. Expected outcome We hypothesize that the intervention will improve both maternal and neonatal service delivery and health outcomes in the intervention areas.

NCT ID: NCT02443610 Completed - Clinical trials for Venous Thromboembolism

Haemorrhages and Thromboembolic Venous Disease of the Postpartum

HEMOTHEPP
Start date: January 6, 2015
Phase:
Study type: Observational

The aim of this study is to evaluate the frequencey and the determinants of postpartum major complications (hemorrhage and thrombosis) up to 3 months after delivery in the maternity hospitals of Finistère (Bretagne - France)

NCT ID: NCT02430155 Completed - Clinical trials for Postpartum Hemorrhage

Balloon Tamponade for Atonic Primary Postpartum Hemorrhage

UBT
Start date: July 2014
Phase: N/A
Study type: Interventional

Postpartum hemorrhage (PPH) is responsible for around 25% of maternal mortality worldwide reaching as high as 60% in some countries.PPH can also be a cause of long-term severe morbidity, and approximately 12% of women who survive PPH will have severe anemia. Postpartum hemorrhage has been defined as blood loss in excess of 500 ml in a vaginal birth and in excess of 1 L in a cesarean delivery.For clinical purposes, any blood loss that has the potential to produce hemodynamic instability should be considered a PPH. However, clinical estimates of blood loss are often inaccurate. Primary (immediate) PPH occurs within the first 24 hours after delivery and approximately 70% of these cases are due to uterine atony. Furthermore, uterine tony is defined as the failure of the uterus to contract adequately after the child is born. Guidelines for the management of postpartum hemorrhage (PPH) involve a stepwise approach including the exclusion of retained products of conception and genital tract trauma. Uterine atony, which is the most common cause, the management of uterine atony is an established stepwise protocol that in many international guidelines. Uterine massage is recommended for the treatment of PPH. Initiate uterine massages soon as excessive bleeding/uterine atony is identified. Intravenous oxytocin alone still is the recommended uterotonic drug for the treatment of PPH. If intravenous oxytocin is unavailable or if the bleeding does not respond to oxytocin, intravenous ergometrine, oxytocin-ergometrine fixed dose or a prostaglandin drug (including sublingual misoprostol, 600 mcg) should be given. The use of intrauterine balloon tamponade is recommended for the treatment of primary PPH due to uterine atony in women who do not respond to uterotonics or if uterotonics are not available. Since 1983, when Goldrath published evidence that inserting a Foley catheter in the uterus and inflating it with water could achieve tamponade, case series and other studies have suggested that various uterine balloon tamponade(UBT) devices may be effective in treating PPH. The studies used various types of UBT devices, including a condom catheter, a Foley catheter, the Sengstaken-Blakemore Esophageal Tube, the Rusch Balloon, and the Bakri Uterine Balloon. In 2007, a systematic review of treatment options for PPH found that 84% success rate of UBT does not significantly vary from surgical treatment outcomes.The World Health Organization (WHO), the International Federation of Gynecology and Obstetrics (FIGO), the American College of Obstetricians and Gynecologists(ACOG), the Royal College of Obstetricians and Gynecologists(RCOG), and the International Confederation of Midwives (ICM) recognize balloon tamponade as a method that could significantly improve the management intractable PPH, especially in low-resource areas. In 2012, WHO updated the guidelines for the management of PPH and retained placenta to include: "The use of intrauterine balloon tamponade is recommended for the treatment of PPH due to uterine atony. This recommendation is now stronger than the previous guidelines. It can be used for women who do not respond to uterotonics or if uterotonics are not available. This procedure potentially can avoid surgery and is appropriate while awaiting transfer to a higher-level facility".Furthermore, FIGO included UBT as a recommended second-line intervention for the treatment of PPH in their updated guidelines issued in 2012. Bakri first published the concept of intrauterine balloon technology in the management of hemorrhage secondary to placenta praevia-accreta during caesarean section with or without bilateral hypo gastric arterial ligation.In 2006, the ACOG Practice Bulletin, published by the American College of Obstetricians and Gynecologists, made mention of the Bakri postpartum balloon for its specifically tailored design that enables conservative management of uterine bleeding in cases of uterine atony and other causes of PPH. The idea of using a condom as a balloon tamponade was first generated and evaluated in Bangladesh by Sayeba Akhter to fill a need and in response to the high cost of commercially available UBT devices.

NCT ID: NCT02411916 Completed - Clinical trials for Postpartum Hemorrhage

Effect of Adjunctive Misoprostol Treatment on Blood Loss at Vaginal Delivery

Start date: March 30, 2012
Phase: N/A
Study type: Interventional

This document defines the Clinical Investigation Protocol for a study designed to determine whether blood loss after spontaneous vaginal delivery is altered by the addition of misoprostol administration to the standard use of intravenous oxytocin after delivery. The protocol is an open-label randomized prospective trial to be carried out at Queens Hospital Center. Blood loss will be measured indirectly by comparing the maternal hemoglobin and hematocrit levels on admission in labor to those obtained within 24 hours after delivery.

NCT ID: NCT02409602 Completed - Clinical trials for Postpartum Hemorrhage

Influence of BIIAL Following PPH on Dorsal Clitoral Artery Blood Flow and FSFI

Start date: October 2014
Phase: N/A
Study type: Observational

Dorsal clitoral artery Doppler examinations in women with bilateral internal iliac artery ligation due to postpartum hemorrhage (study group) and age-matched healthy puerperal women were performed regularly in the postoperative period, in order to evaluate possible effects of BIIAL on clitoral blood flow.

NCT ID: NCT02396771 Completed - Clinical trials for Postpartum Hemorrhage

Effect of Uterine Massage Versus Sustained Uterine Compression on Blood Loss After Vaginal Delivery

Start date: January 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to compare trans-abdominal uterine massage to sustained uterine compression after vaginal delivery with respect to blood loss and maternal pain. It is a randomized controlled trial that will be conducted at the American University of Beirut Medical Center - Delivery Suite.

NCT ID: NCT02391636 Completed - Clinical trials for Postpartum Hemorrhage

Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage

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

Double blinded randomized controlled study

NCT ID: NCT02338089 Completed - Clinical trials for Postpartum Hemorrhage

Investigating the Effect of Pulsatile Administration of Oxytocin on the Desensitization of Human Myometrium In-vitro

Start date: January 2015
Phase: N/A
Study type: Interventional

Postpartum hemorrhage (PPH) is a leading cause of maternal morbidity and mortality worldwide and is caused most commonly by poor uterine muscle (myometrium) tone after delivery. The first line agent used in the prevention and treatment of PPH is oxytocin. Women who require augmentation of labor with intravenous oxytocin because of inadequate labor progression have been shown to be at increased risk of PPH. Typically, for augmentation of labor, oxytocin is used as a continuous infusion, with no consensus on the initial dose, its increments or maximal limit. High concentration continuous oxytocin infusions are not without theirs risks, which include hyperstimulation, fetal distress, as well as uterine rupture. Studies have shown the clinical benefits of pulsatile oxytocin delivery for labor induction and augmentation with regards to requirement of less total oxytocin, similar uterine contractility and similar rates of caesarean delivery when used for labor induction and augmentation. However, the rate of PPH as a primary outcome measure has not been investigated. Therefore we currently do not know the effect of pulsatile oxytocin delivery on the rate of PPH. The investigators hypothesize that the effect of myometrial desensitization following pulsatile oxytocin exposure would be lower when compared to continuous oxytocin exposure. These results will help in establishing whether myometrial contractility and sensitivity to oxytocin can be better preserved by delivery of pulsatile oxytocin, rather than continuous oxytocin for labor induction and augmentation, and thereby result in less PPH.

NCT ID: NCT02304055 Completed - Obstetrics Clinical Trials

Carbetocin Versus Oxytocin in the Management of Atonic Post Partum Haemorrhage (PPH) in Women Delivered Vaginally: A Randomised Controlled Trial

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

200 women will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will receive oxytocin 5IU (Syntocinon®, Novartis, Switzerland).