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Obstetric Labor Complications clinical trials

View clinical trials related to Obstetric Labor Complications.

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NCT ID: NCT06261710 Recruiting - Labor Complication Clinical Trials

Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations

SOFIE
Start date: February 27, 2024
Phase: N/A
Study type: Interventional

This is a prospective, randomized trial to determine whether the use of sonographic parameters during labor results in less intrapartum infection compared to traditional invasive examination. Other secondary outcomes include maternal satisfaction and overall birth outcomes.

NCT ID: NCT06131684 Not yet recruiting - Clinical trials for Obstetric Labor Complications

Amniotic Fluid Analysis

Start date: November 2023
Phase: Early Phase 1
Study type: Interventional

This is a prospective study that will aid in ensuring the feasibility of timely and correct aspiration of amniotic fluid by study research team that include the clinical team taking care of the patient during her labor, timely transport and interpretation of specimens. It will also assist in providing information for the computation of necessary statistical measures (e.g. sample size, power analysis, etc.) for the study cohorts that lack the needed data in the medical literature.

NCT ID: NCT06049784 Not yet recruiting - Clinical trials for Obstetric Labor Complications

Prelabor Visual Biofeedback by a Self-operated Ultrasound Device

Start date: September 2023
Phase: N/A
Study type: Interventional

A substantial number of women report fear of childbirth and negative birth experiences. Our objective is to assess the efficacy of visual biofeedback before labor by self-operated home ultrasound for maternal pushing training, which is expected to reduce fear of childbirth, increase perceived control during birth, prevent prolonged labor and the ensuing maternal and neonatal negative adverse outcomes, and prevent maternal post-traumatic stress symptoms. Intrapartum visual biofeedback provided by obstetricians during the second stage of labor has been shown to increase pushing efficiency and improve maternal obstetric and psychological outcomes. Visual biofeedback has been performed only in an in-hospital setting and, with one exception we are aware of, only during labor. A Mobile Self-Operated Home Ultrasound System was reported as a feasible and reliable tool for obstetrical ultrasound. A randomized controlled trial will be conducted with three study groups of pregnant women (37-39 weeks of gestation): (1) Obstetrical ultrasound+visual biofeedback in-hospital and at home using self-operated ultrasound; (1) Obstetrical ultrasound+visual biofeedback in-hospital; (3) Obstetrical ultrasound only. Visual biofeedback by ultrasound will be performed by transperineal ultrasound, enabling the future mother to visualize the descent of the fetal head within the birth canal in response to her pushing effort. Follow-up will be conducted two weeks later and at six weeks postpartum. Positive results following the application of biofeedback by self-operated home ultrasound may change the paradigm for pre-labour sonographic education. Self-operated home ultrasound will also enable more comprehensive pre-labor ultrasound-based education and hopefully reduce adverse physical and psychological outcomes following childbirth.

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: December 1, 2023
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: NCT05837559 Recruiting - Labor Complication Clinical Trials

Traditional WHO Partograph and Korle-Bu Modified WHO Partograph for Uncomplicated Labour

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

Brief Background: The partograph is a graphical representation of the events in the first stage of labour. It is an instrument used in monitoring the well being of both the pregnant woman and her fetus (es) as they go through the first stage of labour. Most studies found the completion of a partograph in a client's record as the exception rather than the norm. Even at urban maternity wards as low as 5% completion rates of partograph have been recorded and in more than 60% of deliveries the partographs were completed after the deliveries, indicating it was being utilized only as a record-keeping procedure, not as a monitoring tool. The correct and effective use of the partograph is in itself labour intensive even with the requisite skills, making it unfriendly to use in situations where the delivery rates are high with few skilled attendants General Aim: To determine whether the use of a Korle-Bu modified WHO partograph will result in similar or improved patronization and leading to consistent monitoring of first stage labour and better outcomes compared to the traditional WHO partograph. Methods: This will be a randomized study of women presenting in labour with uncomplicated pregnancies to the Korle-Bu Teaching and La General hospitals in Accra. 500 labouring women will be monitored with the traditional WHO partograph in one arm and 500 labouring women will be monitored with the Korle-Bu modified WHO partograph. Computer generated cluster randomization with concealment will be used in patient selection and same research assistants ( Residents and Nurses) will be trained to stick to patient specific protocols for labout monitoring. Variables to be collected besides sociodemographic and obstetric data will include duration of labour, any interventions and neonatal and maternal outcome. Expected outcome (Expected results/what you hope to achieve from the study): It is expected that the Korlebu Teaching Hospital (KBTH) modified WHO partograph will be more user friendly, making it easier for service providers to use as a labor management tool than the traditional WHO partograph as intended, to reduce perinatal complication.

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: NCT05763043 Not yet recruiting - Clinical trials for Obstetric Labor Complications

Monoferric for Prenatal Iron Deficiency

Start date: November 2023
Phase: Early Phase 1
Study type: Interventional

A prospective observational study of pregnant women with iron deficiency anemia and oral iron intolerance or advanced gestational age.

NCT ID: NCT05719467 Recruiting - Pregnancy Related Clinical Trials

SAINT: Safe Induction of Labor Trial

SAINT
Start date: January 3, 2023
Phase: Phase 3
Study type: Interventional

Over the past years, the rates of labor induction have increased steadily, and at present more than one in four births occurs after induced labor in Norway. There is evidence that several groups of women benefit from labor induction, including those with preeclampsia (1), postdate pregnancy, diabetes, a large-for-gestational-age fetus, gestational diabetes, prelabor rupture of membranes at term, preterm prelabor rupture of membranes, twin pregnancy and intrahepatic cholestasis of pregnancy. At the same time, induction of labor is an independent risk factor for adverse obstetric outcomes, including cesarean section, operative vaginal delivery, chorioamnionitis, labor dystocia, prolonged labor, uterine rupture, and neonatal pH < 7.10. A recent Norwegian nationwide clinical practice pilot evaluation demonstrated that the rate of intervention was high, and that as many as 44% of women with labor induction experienced operative delivery. Given that induction of labor is a common procedure (15 000 women per year in Norway) and increases risk of several major obstetric complications, interventions that may reduce operative births and facilitate safe deliveries are highly warranted. Bicarbonate and butylscopolamine bromide have been used in smaller studies in order to shorten labor. The medications seem to be safe with a low frequency of adverse events. The rationale of the present study is therefore to assess the efficacy of oral bicarbonate and intravenous butylscopolamine bromide on facilitating spontaneous (non-operative) delivery in pregnant female participants with induction of labor.

NCT ID: NCT05674838 Enrolling by invitation - Hypotension Clinical Trials

Leg Elevation to Prevent Hypotension During Labor

Start date: October 29, 2022
Phase: N/A
Study type: Interventional

When hypotension is related to epidural placement, this can occur within 15-60 minutes after placement. The purpose of this study is to build upon this preliminary work and to use a randomized controlled trial to examine the effectiveness of leg elevation in preventing hypotension among a larger sample of laboring women who receive an epidural analgesia. This study will use a randomized, non-blinded, controlled design with two arms: Arm 1: Patient will be put in a left tilt position with her hip on a wedge and both legs elevated on a peanut ball. She'll remain in this position for approximately 40 minutes. Arm 2: Patient will be put in a left tilt position with her hip on a wedge and no leg elevation. She'll remain in this position for approximately 40 minutes.