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Dystocia clinical trials

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NCT ID: NCT06283277 Not yet recruiting - Macrosomia, Fetal Clinical Trials

Fetal Clavicular Measurement to Predict Fetal Macrosomia

Start date: May 1, 2024
Phase:
Study type: Observational

Macrosomia is associated with increased risks for both the mother and the baby, including complications during delivery, injuries, and even death. The accurate diagnosis of macrosomia is often difficult before birth. There are a number of factors that can increase the risk of macrosomia, such as maternal obesity, diabetes, and excessive weight gain during pregnancy. There are also a number of different techniques that can be used to try to predict macrosomia, but none of them are perfect. The aim of this study is to evaluate sensitivity of measuring fetal clavicle length in third trimester compared with biacromial diameter and Hadlock formula IV for prediction of fetal macrosomia.

NCT ID: NCT06249061 Not yet recruiting - Labour Dystocia Clinical Trials

Oral Sodium Bicarbonate for the Prevention of Labour Dystocia

Labour-Aide
Start date: June 2024
Phase: N/A
Study type: Interventional

Sodium bicarbonate is often used by athletes to improve their muscle's ability to contract and power their activity. It works by decreasing the risk of lactic acid build-up, which causes cramping and fatigue. Some research suggests that using sodium bicarbonate in labour could help to improve the ability of the uterus to contract, helping to prevent labour dystocia (stalled or slow progress in labour). This could ultimately increase the chance of spontaneous vaginal delivery. This research is being done to investigate whether drinking sodium bicarbonate (commonly known as baking soda) dissolved in water as a hydration drink could benefit women in labour and increase the chance of a vaginal birth. In order to answer this question, pregnant people from London, Markham and Mississauga midwifery practices are being recruited to participate in this study. Participants will be randomly assigned to one of two groups when they are admitted to hospital in labour. One group will be asked to drink normal fluids of their choice while they are in labour (usual care). The second group will be asked to consume a drink made of baking soda and water, as well as normal fluids of their choice. Mode of birth and the use of birth interventions will be compared between the two groups. Infant outcomes will be compared to ensure that the use this drink in labour is safe. A risk of consuming sodium bicarbonate is gastrointestinal disturbance. The number of people who reported gastrointestinal upset will also be compared between the two groups. If this study shows that those who drank sodium bicarbonate in labour had an increased chance of vaginal birth and that it is safe, this low-cost, low-risk treatment has the potential to reduce birth interventions for pregnant people and their babies.

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: NCT05533996 Not yet recruiting - Clinical trials for Gestational Diabetes

Body Fat Index for Obstetric Risk Stratification

BFIors
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

Primary Outcome:- GDM Diagnosis Secondary Outcomes:- Pre-eclampsia diagnosis. Cesarean section delivery due to labor dystocia defined as protracted or arrested progress of labor using labor partogram.

NCT ID: NCT05510518 Not yet recruiting - Obesity Clinical Trials

Late Gestational Diabetes Mellitus Diagnosis in Obese Women

Start date: August 2022
Phase:
Study type: Observational

In the current work, we aim to perform a prospective study that will investigate the relationship between maternal obesity (BMI >30 kg/m2) and morbid obesity (BMI >35 kg/m2) with a late GDM diagnosis (>32 weeks), with an emphasis on obstetric and neonatal outcomes.

NCT ID: NCT05468658 Not yet recruiting - Birth Disorder Clinical Trials

The Effect of Feng Shui Delivery Room Design on Maternal and Infant Health

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

The aim of the study is to compare the births that took place in the Feng Shui Birth unit and those that took place in the standard delivery unit in terms of mother-infant health outcomes. The study will be carried out in a private clinic in Istanbul, between July and December 2022. In the study, which is planned as a controlled experimental study, 50 women who applied first and met the inclusion criteria of the study will be selected as the Control Group (B), and it is planned that these women will give birth using the normal routine delivery unit of the clinic. It is planned that the next 50 women will form the Experimental Group (A): and give birth in the birth environment designed according to the Feng Shui Philosophy.

NCT ID: NCT05341076 Not yet recruiting - Dystocia Clinical Trials

Labor Scale Versus WHO Partograph for Management of Labor (ScaLP)

ScaLP
Start date: August 1, 2022
Phase: N/A
Study type: Interventional

The current study aims at evaluating the impact of the implementation of the labor scale, in comparison to the standard WHO partograph, in the management of primiparous women, including CD rate, maternal and neonatal outcomes of labor.

NCT ID: NCT04546594 Not yet recruiting - Pain Clinical Trials

Epidemiological Data on Pain

ALGOBASES
Start date: October 2020
Phase:
Study type: Observational

The ALGOBASES project is an observational epidemiological study of pain through the collection of pain evaluation questionnaires and information with the aim of creating a descriptive "pain" evaluation in all patients who need to benefit from orthopedic, thoracic or gynecological surgery. The painful symptomatology will thus be evaluated in all its dimensions (demographic data, physical, psychological, socio-cultural components) and linked to the pathology justifying the specialized care. It is planned to collect the same data at each subsequent event in order to allow the determination of predictive factors, pain trajectories according to the type of surgery, and the profile of subjects at risk of acute or chronic postoperative pain.

NCT ID: NCT03650972 Not yet recruiting - Labour Dystocia Clinical Trials

Implementation of AFL Monitoring in Clinical Use

Start date: September 15, 2018
Phase: N/A
Study type: Interventional

The overall objective of this randomized controlled trial is to develop a clinical standard procedure for measuring lactate in amniotic fluid (amniotic fluid lactate = = AFL) during childbirth before oxytocin stimulation is started. The aim is to reduce the need for emergency caesarean section during dysfunctional labour. The aim is also to study how different substances (oxytocin and Samarin®) affect uterine metabolic status during labour. Labour dystocia, i.e. prolonged labour, occurs in up to 30% in primipara deliveries and in about 20% of all the deliveries. In 2016, in Finland oxytocin stimulation was used in 42% of all the deliveries. The uterus, myometrium, is one of the largest muscles in the human body and consists mainly of smooth muscle cells. During the contractions the myometrial vessels also contract, causing momentary hypoxia and activation of anaerobic metabolism: O2 and pH levels of the muscle cell decreases and the lactate concentration increases. After the contraction, the blood circulation is restored and the anaerobic metabolites gradually dissolve. Myometrium requires a sufficiently long break between the contractions to recover. In dysfunctional labour the anaerobic metabolites accumulate in the myometrium. Accumulation of lactate has proved significantly to reduce the spontaneous contractions of myometrium and hinder myometrium calcium metabolism, which in turn reduces the strength of the contractions. Amniotic fluid lactate is known to reflect the metabolic state of the uterus during the labour. Prolonged labour can in many aspects be compared to the athlete's tired muscles. Many of today's athletes try to control the accumulation of lactic acid in their muscles during training by drinking baking soda (bicarbonate) dissolved in water one hour before their physical activity. Bicarbonate is known to function as a lactic acid buffer. Bicarbonate is considered as food and is sold in grocery stores as baking soda and for example as Samarin®. Samarin® is safe to use during pregnancy because as a bicarbonate it does not pass through placenta and does not affect the fetus. The trial aims to research if high AFL values (AFL > 12 mmol/L) in women with labour arrest are best treated by: A) treating the labour according to the hospital's current guidelines during labour arrest, i.e. starting the stimulation with oxytocin and measuring the AFL again after one hour B) administering bicarbonate (Samarin®) dissolved in water one hour before starting the stimulation with oxytocin