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Labor Complication clinical trials

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NCT ID: NCT05910359 Not yet recruiting - Labor Complication Clinical Trials

Ultrasound Prediction of POPP in Active Labor

(POPP-UP)
Start date: June 15, 2023
Phase: N/A
Study type: Interventional

Persistent occiput posterior position (POPP) represents a relevant risk factor for various adverse outcomes: prolonged labor, higher incidence of operative delivery and/or cesarean section for non-reassuring fetal conditions, higher incidence of high-grade perineal tears (OASIS). For such reasons, labor with POPP needs particular and non-routinary attention. Hence, it is important to diagnose in advance fetuses who present POPP to assure more adequate assistance in labor. Furthermore, digital examination shows a lower detection rate for such condition if compared to ultrasound in labor. This multicenter prospective cross-sectional interventional study aims to evaluate the occiput position and the descent of the fetal head at the beginning of active labor to predict POPP at delivery. All the participants will be subjected to transabdominal and transperineal ultrasound at the beginning of active labor (between 3 and 8 cm of cervical dilatation) to evaluate the position of the fetal head and its descent. At the delivery, the position of the fetal head and the features of the second stage of the labor will be recorded.

NCT ID: NCT05881629 Not yet recruiting - Labor Complication Clinical Trials

Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery

Start date: April 28, 2024
Phase: N/A
Study type: Interventional

The goal of this randomized trial is to test if changing a person's position in labor can increase the chances of delivering their baby vaginally. Specifically, it aims to answer the questions: - In fetuses who are facing upwards (occiput posterior, OP) or sideways (occiput transverse, OT) during labor, does changing the patient's position during active labor to a side-lying posture with a peanut ball increase the chances of them having a successful, spontaneous vaginal delivery? - Does changing the patient's position in active labor affect the position of the baby at the time of delivery? - Do intentional position changes in labor impact patient-perceived autonomy during their labor and delivery experience? Participants will: - Receive an ultrasound during labor to determine the position of their baby - Be asked to adopt a specific position in labor (side-lying with peanut ball) if they are randomized to the study group - Receive additional ultrasounds during labor to assess their baby's position - Fill out a questionnaire about their labor experience following the delivery of their baby

NCT ID: NCT05791630 Not yet recruiting - Clinical trials for Cesarean Section Complications

The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL)

NORWEL
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Appropriate and timely care during birth is critical to the survival and health of women and their babies. In 2020, the World Health Organization (WHO) presented the Labour Care Guide (LCG) as the new recommended tool for monitoring birth and assessing progression, replacing the WHO partograph. This evidence-based guide was designed to ensure improved quality and safety of care, and to avoid unnecessary interventions during birth. The LCG was developed to be used in all settings globally, but it has only been tested in health facilities in South America, Asia and Africa, while it has not been tested in high-income settings. Implementing a new guideline for monitoring birth is a comprehensive operation that will affect both the national economy, health systems, and individual patients; therefore, further research on the possible advantages is needed before national enrolment. Hence, the trial proposed in this application is crucial to form the required foundation of knowledge. The trial will be conducted in labour wards at ten hospitals, covering all health regions in Norway, and the established Norwegian Research Network for Clinical Studies in Obstetrics (NORBIRTH), with dedicated local principal investigators, will provide a robust research environment. This trial will test the effect of the LCG. Results from this trial will provide knowledge needed to determine a future implementation of the LCG in Norway.

NCT ID: NCT05302401 Not yet recruiting - Stress Clinical Trials

Effect of Intrapartum Continuous Midwife Support on Maternal and Neonatal Stress Level

Start date: April 2022
Phase: N/A
Study type: Interventional

This study aims to provide strong A-level evidence to the literature by supporting the maternal and fetal results of continuous midwife support together with saliva cortisol level measurements. As a result of this study, it is expected that women who receive intrapartum continuous midwife support and their babies have lower saliva cortisol levels than women in the control group, women who receive intrapartum continuous midwife support experience less fear, and women who receive intrapartum uninterrupted midwife support are expected to have lower intervention rates in their births. If the existing hypotheses are accepted, it is aimed to expand the practice of intrapartum continuous midwife support. Although pregnancy, childbirth and postpartum period are a physiological process, it is an important source of stress brought on by physical and hormonal changes for women's life. Uninterrupted midwife support in women who will give birth is associated with more vaginal births and fewer negative birth experiences. Uninterrupted midwife care also has higher female satisfaction, less intervention and lower maintenance costs. Therefore, evidence-based practices are needed to reduce the stress level of the woman during the intraparty period. In the study, the pregnancy diagnosis form will be applied by the researcher to the pregnant women in the experimental and control group between the 28th and 36th weeks of the outpatient clinic. Visual Analog Scale will be applied to determine the Wijma Birth Expectation/Experience (W-DEQ A) Scale and birth fear in order to determine the birth fears of pregnant women in the 28th-36th week. During outpatient checks, the first saliva cortisol samples will be taken by the scholar Meserret Aslan between 8:30 and 09:00 in the morning. By Bursiyer Meserret Aslan, six hours of online pregnancy training will be given to the pregnant women in the experimental group and uninterrupted midwife support will be provided during the intrapartum period. After birth, mother and newborn saliva cortisol samples will be repeated by the scholar Meserret Aslan within the first half hour of the postpartum from the experimental and control groups. Before postpartum discharge procedures take place between 24th and 72nd hours, a sample of mother and newborn saliva cortisol will be taken and stored under appropriate conditions (Refrigerator (2-8 °C) 4 Days) by Meserret Aslan, a scholar from the experimental and control groups. The Birth Experience Scale and the wijma birth expectancy/birth experience (W-DEQ B) scale will also be applied before discharge. The world health organization's maximum acceptable cesarean section rate is 53.1%. Turkey has the highest cesarean section rate among OECD countries. There are studies that show that continuous midwife support in childbirth is useful in reducing the rate of cesarean sections. In addition, it is foreseen that reducing the stress levels of women and their babies who are offered uninterrupted midwife support will contribute to the prevention of mental illness in the postpartum period, which is one of the most fragile periods for women's mental health. Intrapartum continuous midwife support, which will facilitate adaptation to the role of mother in the postpartum period, will also contribute to the mother and baby bonding that form the basis of mental health in the future life of the baby. This study is expected to contribute to improving maternal and infant health, as well as improving public mental health. Evidence-based information will be provided to investigate saliva cortisol levels and to demonstrate the importance of intrapartum continuous midwife support in reducing stress levels of women and their babies.

NCT ID: NCT05077540 Not yet recruiting - Labor Complication Clinical Trials

Oxytocin Versus, Sublingual Misoprostol in the Secondary Prevention of Postpartum Hemorrhage After Vaginal Delivery

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Researchers sought to see how oxytocin versus, sublingual misoprostol affected estimated and measured blood loss during vaginal delivery in women who had blood loss >300 ml .

NCT ID: NCT04009993 Not yet recruiting - Labor Complication Clinical Trials

A-BIRTHPERFORM Versus Conventional Partogram in the Improvement of Birth Results

A-BRTHPRFORM
Start date: June 2020
Phase: N/A
Study type: Interventional

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.