Active clinical trials for "Obstetric Labor Complications"

The duration of labor is decisive for maternal and fetal health. Poor progression often results in tired mothers, bad experience, delivery complications and a demand for cesarean section in next pregnancy. Proactive support of labor is a method originally from the Netherlands. The main idea is to define start of active labor earlier than the traditional "3-4 cm opening of the cervix and regular contractions" to be cervix < 0.5 cm in length, and 1 cm opening and painful contractions. From this point, it is expected to be a progress of 1cm/hour opening of cervix. If not, progress is supported by amniotomy or stimulation of contractions. This method is embraced by several clinics with great enthusiasm. However, there are no randomized controlled trials to prove that this method is better than others.

In this study the investigators want to assess complications associated to pregnancy and delivery, and interventions used during labor. Pregnancy and delivery related complications are a major health problem globally. Events during labor such as excessive bleeding, uterine rupture, emergency cesarean delivery; other instrumental deliveries and anesthesia problems are situations that potentially may lead to severe outcomes for the mother and child. Diabetes, anemia and hypertensive disorders may also complicate both the pregnancy and delivery. Between 60-80% of women delivering their first baby need suturing due to perineal tears (tears located to the area between the vagina and anus). Superficial perineal tears rarely cause long-term problems, but often lead to pain and discomfort immediately after birth. Deeper or severe perineal tears, involving the anal sphincter, may influence the woman's quality of life. This is mainly due to long-lasting pain, discomfort and sexual dysfunction, and the fact that obstetric anal sphincter tear is the main cause of anal incontinence. Recent clinical intervention studies have shown that the incidence of severe obstetric perineal tears may be reduced by 50-70% by introducing a bimanual support technique of the perineum. In these studies all midwives and gynecologists were trained in the bimanual support technique. When it comes to training in new medical techniques in general, some studies have shown that use of animated instructions on mobile phones may be a good alternative to the more traditional "hands-on" or "bedside" teaching methods. In a global perspective, it is important to study the efficacy of mobile units for transferring of new knowledge, especially for use in resource constrained settings.

The rate of postpartum hemorrhage (PPH) has risen dramatically in the developed world, along with a rise in blood transfusion rates. The rate of cesarean delivery has increased dramatically in the past decade and is well over 30% in the United States. With an increase in primary and repeat cesarean delivery, comes the added risk of abnormal placentation, which can contribute to maternal and fetal morbidity and mortality via placenta accreta, increta, and percreta. The incidence of accreta has increased 10-fold over the past 50 years, becoming the most common reason for cesarean hysterectomy in highly industrialized countries. These conditions have tremendous impact on maternal outcomes. Although whole blood (WB) contains all of the individual blood components, there are concerns for the use of WB due to the potential limitations such as the hemostatic efficacy of platelet after cold storage, the risk of hemolytic transfusion reaction following the transfusion of un-cross matched WB and the logistical issues in providing WB. Traditional obstetric transfusion protocols involve blood component therapy. Whole blood contains all components and could be more efficient for massive transfusion in obstetric hemorrhage. Trauma resuscitation protocols mimic whole blood in the 1:1:1 transfusion protocols of packed red blood cells to plasma to platelet ratio. It is difficult to compare trauma resuscitation to obstetric hemorrhage, but both can involve significant resuscitation and serious sequelae from unnecessary transfusion. The use of WB instead of component therapy may reduce the multiple organ dysfunction rates due to the rapid resolution of shock and coagulopathy. Additionally, the number of donor exposure is important factor for the transfusion-related allergic reactions including severe systemic reactions such as anaphylaxis. Use of WB may decrease number of donor exposure. The secondary aim is to compare the incidence of 3 common adverse outcomes associated with the transfusion of blood products in subjects who receive whole blood versus component therapy. Investigators hypothesize that the patients receiving WB will have fewer incidences of a) acute renal failure, b) acute heart failure and c) transfusion-related lung disease compared to those receiving component therapy.

The purpose of this study is to examine components of the coagulation system in women undergoing postpartum hysterectomy and to compare laboratory parameters of coagulation in these women to women at increased risk for a postpartum hysterectomy, but who do not have postpartum hemorrhage and a postpartum hysterectomy. During normal pregnancy, the hemostatic balance tips toward hypercoagulation. Non-obstetric surgical blood loss is associated with increased coagulation activity. We have observed that women undergoing a postpartum hysterectomy become hypocoagulable secondary to a consumptive coagulopathy and/or excessive fibrinolysis. This coagulopathy may lead to the administration of multiple blood products. Worldwide, postpartum hemorrhage is a leading cause of maternal death. Plasma levels of tissue plasminogen activator, urokinase plasminogen activator and their inhibitors increase during pregnancy. During labor and delivery activation of coagulation occurs with consumption of platelets, coagulation factors and inhibitors. Obstetric complications during delivery can excessively activate the coagulation system and disseminated intravascular coagulation may ensue. Current treatment for postpartum coagulopathy is non-specific and primarily consists of replacing blood components. If specific causes or markers of abnormal coagulation can be identified in women at risk, then it might be possible to target (with specific medications) specific abnormalities early in the process and decrease hemorrhage and the need for blood transfusions.

Quasi-experimental study to evaluate whether clinical care offered to clients was more appropriate and in line with WHO recommendations for care in normally progressing labor and in labor with complications, among providers using the novel intervention, ePartogram (an electronic version of the WHO paper partograph) vs. providers who offered care using the standard paper partograph, and whether fetal/newborn outcomes were improved among cases where partograph was used.

Preterm birth (PTB) is the major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors. Few prognostic tests are available to predict PTB. A short transvaginal ultrasound cervical length (TVU CL) has been shown to be a good predictor of PTB. Other strategies have been adopted for prevention of PTB. The evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix. However, the predictive value of the research has recently been questioned, as the threat rate from preterms in the low-risk population has not decreased over time. Numerous clinical studies have been conducted to improve and identify effective prevention strategies in the threat of preterm birth. Among the parameters studied, in addition to the measurement of the uterine cervix and its complaints during the three trimesters of pregnancy, an evaluation of the cervical consistency index (CCI) was also proposed, i.e. an ultrasound evaluation of cervical softness.

Retrospective observational study to determine the efficacy of remifentanil during the delivery. Authors will search the data in period between 2010 and 2014 in cohort of 100 parturients and obtain data of analgesic efficacy (VAS score after remifentanil analgesia induction) and parturients satisfaction with the method.

This study will randomise low-risk women to compare the effectiveness of trans-cervical balloon catheter for pre-induction cervical ripening for out-patient induction of labour with current practice (Propess). Women will be randomised to two treatment groups. The investigators wish to explore if such a trial is feasible, acceptable to women and what data collection is required for a future trial. Since no data exist, the investigators propose a study with approximately 60 women in each arm across two recruiting sites.

Midwives and Obstetricians when assisting women during labour do not follow the clinical guidelines on labour process care,in many cases oxytocin is used routinely without medical indication, and ends in the erroneous use of oxytocin, and risk of labour dystocia arise. In Spain, according to the National Health System the rate of oxytocin use during labour is 53.3%, in pregnant women with spontaneous onset of labour, which is high and is far from the expected standard (expected standard of 5 to 10%, as an indicator of good practice). The partogram is one of the conventional obstetric tools used in labour wards, specially the World Health Organization partogram with the four-hours action line, which is widely used and it serves to give a graphic content and a global vision of the evolution and medication given in a concrete women in labour, although a routine use of partogram is not recommended, and new studies are needed to stablish the effectiveness of the partograph. There are frequent professional errors using conventional partogram and this justify the need for a tool different from the usual ones. The algorithm of care in normal and in disrupted labour recommended by The National Institute for Health and Clinical Excellence (NICE) guidelines is complex. The tool the investigators have designed is A-BIRTHPERFORM digital tool for professionals and consists in helping applying the Intrapartum Care´s NICE Guidelines algorithms to help decision-making. Objective: The aim of the study will be to analyze if the use of A-BIRTHPERFORM contributes to improve perinatal results by reducing instrumental deliveries and caesarean sections. Methods: Design: randomized controlled trial. Participants: The study will be conducted in 4 maternity hospitals of different autonomous communities of Spanish. Participants will be women from 18 to 41 years of age, pregnant at term between 37 and 41 weeks gestation, with spontaneous onset of labour or induced labour and with low or medium obstetric risk. Participants will be randomized to receive professional care during delivery using A-BIRTHPERFORM or assigned to conventional partogram care. The control group will be subject to traditional care through the use of conventional partogram used in each hospital following the labour care guidelines of each participant hospital. The experimental group will be cared by professionals using A-BIRTHPERFORM during the whole labour process. Discussion: A-BIRTHPERFORM could help improve the use of NICE Guidelines on Intrapartum Care, and could help reducing the use of oxytocin, decreasing instrumented deliveries and severe perineal lacerations. The digital tool aims to provide standardization and systematization to childbirth care and to serve as a communication tool between team members. This tool could allow the professional to freely access it from any digital device, not necessarily located at the counter or reception of the maternal unit, which facilitates personal reflection on labour progress and with the team, in order to improve health results for women and their families.

We want to investigate the association between fundal pressure in the second stage and the risk of levator ani muscle (LAM) injury.