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Preterm Labor clinical trials

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NCT ID: NCT05828966 Completed - Preterm Labor Clinical Trials

HUMAN CHORIONIC GONADOTROPIN (HcG) VS MAGNESIUM SULPHATE (MgSo4) AS A TOCOLYTIC AGENT- A RANDOMIZED CONTROLLED TRIAL

Start date: February 15, 2023
Phase: N/A
Study type: Interventional

Preterm labor is defined as regular contractions of the uterus resulting in changes in the cervix (effacement and dilatation) that start before 37 weeks of pregnancy. (1) Although preterm labor constitutes only 10% of total labors, yet 70% of infant's mortality is related to prematurity. It is therefore one of the international indices in assessment of health condition worldwide. Human Chorionic Gonadotropin (H.C.G.) is a heterodimeric glycoprotein produced primarily in the placenta and has multiple endocrines, paracrine and immunoregulatory actions. (3) The importance of H.C.G. in maintenance of early pregnancy has been widely accepted, reports have highlighted a potential role of H.C.G. in maintaining uterine quiescence in the third trimester. H.C.G. exerts a potent concentration dependent inhibitory effect on human myometrial contractions. (4) Recent data suggests that H.C.G. might have a role as an endogenous tocolytic agent in normal pregnancy. A significant decrease in serum H.C.G. level was found 2-3 weeks before the spontaneous onset of labour. This might contribute to increasing the contractility in the uterine muscle and gradually initiating the onset of labour. (5)

NCT ID: NCT05698966 Recruiting - Preterm Labor Clinical Trials

Low Dose Antenatal Corticosteroids for Late Preterm Delivery

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

This is a study proposal for a clinical trial to evaluate the effectiveness of a reduced dose of antenatal betamethasone (a steroid medication) in preventing respiratory problems in late preterm infants (born between 34 and 36 weeks of gestation). The study will be conducted in medical centers in Israel and will involve women who are at high risk for delivering a late preterm infant. The participants will be randomly assigned to receive either a full dose (12 mg) or a quarter dose (3 mg) of betamethasone, administered 24 hours apart. The main outcome measure of the study will be the incidence of respiratory problems or neonatal death within 72 hours of delivery in the two groups. The study is designed to determine if the reduced dose of betamethasone is non-inferior (i.e., not significantly worse) than the full dose in preventing respiratory problems in late preterm infants.

NCT ID: NCT05688007 Completed - Preterm Labor Clinical Trials

The Association Between Parathyroid Hormone and Preterm Labor

Start date: April 1, 2021
Phase:
Study type: Observational

This observational study aims to test the level of parathyroid hormone in pregnant women. The main question it aims to answer is: n Pregnant women, are the levels of serum PTH, calcium, magnesium, phosphorus & albumin similar in both preterm and term births?

NCT ID: NCT05632003 Completed - Preterm Labor Clinical Trials

Uterocervical Angle in Prediction of Preterm Labor

Preterm labor
Start date: January 1, 2022
Phase:
Study type: Observational

Preterm delivery occurs in about 5-18% of pregnancies before 37 weeks' gestation all over the world.It is associated with a high prevalence of neurological deficits, developmental disabilities and is a leading cause of infant and neonatal mortality. Many of the methods used for predicting preterm birth has not been proven efficacy and is not currently recommended for use.The length of the cervix has been one of the most useful methods in predicting the risk of premature delivery. Detection rates may be improved if combined with other parameters such as the uterocervical angle as a new predictor of spontaneous preterm birth. In this study we will compare between using the uterocervical angle and cervical length in the prediction of preterm labour.

NCT ID: NCT05612984 Withdrawn - Preterm Labor Clinical Trials

Calcium Aspirin Multiple Micronutrients (CAMMS) to Reduce Preterm Birth

CAMMS
Start date: April 1, 2024
Phase: Phase 3
Study type: Interventional

This trial will evaluate the impact of an integrated intervention of daily maternal calcium, aspirin, and multiple micronutrients (CAMMS) compared to iron-folic acid (IFA) during pregnancy on preterm birth and other adverse birth outcomes. Both interventions will be delivered through existing antenatal service platforms using context-specific strategies informed by formative research incorporating human-centered design processes to achieve high acceptability and high adherence, in three low-income countries with diverse contexts: Burkina Faso, Pakistan, and Zimbabwe.

NCT ID: NCT05586334 Recruiting - Preterm Labor Clinical Trials

Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth (PrediMAP)

PrediMAP
Start date: June 8, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to clinically validate the predictive performance (sensitivity and specificity) of the PrediMAP in-vitro diagnostic medical device to predict delivery within 7 days in the target population of women consulting obstetric emergencies for preterm labor (PTL).

NCT ID: NCT05430321 Completed - Preterm Labor Clinical Trials

The Effect of Facilitated Tucking After Vaginal Delivery on Late Preterm Stress, Comfort and Physiological Parameters

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Objective: It is aimed to examine the effect of facilitated tucking after vaginal delivery on late preterm stress, comfort and physiological parameters. Design: The study was designed randomized controlled study. Setting: The study was conducted spontaneous vaginal delivery of late preterm at State Hospital between January-June 2020. Participants: In order to determine the sample size of the study, power analysis was performed using the G*Power (v3.1, 7) program, and a total of 60 preterm were sampled, facilitated tucking (n=30) and control group (n=30). Methods: In the study, Newborn Information and Registration Form, Neonatal Comfort Behavior Scale (NCBS) and Newborn Stress Scale (NSS) were used. As for physiological parameters, for the temperature is used private digital thermometer, for the saturation and heart rate is used device preferred in hospital routine and lastly the respirator rate is clocked by nurses.

NCT ID: NCT05355649 Recruiting - Preterm Birth Clinical Trials

Aspiration Technique-based Device for Preterm Labor

PREGNOLIA
Start date: April 8, 2022
Phase: N/A
Study type: Interventional

Premature birth (PTB, birth before 37 weeks of pregnancy) is a global, yet unsolved, problem. With a global amount of approximately 15 M babies born prematurely, PTB is the leading cause of perinatal morbidity and mortality in many countries. Furthermore, premature babies often have complicated medical problems, especially those born very early. Some women spontaneously deliver prematurely without any symptom or sign of the imminent labor, whereas others present with symptoms of preterm labor (PTL). In the latter case, clinicians can intervene and treat the woman with tocolytics and antenatal corticosteroids in order to accelerate fetal lung maturation and reduce the risk of respiratory distress syndrome. However, one of the major challenges in the management of women presenting with symptoms of PTL is to distinguish between true and false PTL with the existing clinical methods (digital examination or transvaginal cervical length assessment). In fact, over 50% of the women presenting with PTL symptoms do not deliver prematurely and are still unnecessarily hospitalized and treated with corticosteroids as well as tocolytics, and only less than 10% of women give birth within 7 days of presentation. Unnecessary treatments and hospitalizations also result in increased health costs. Thus, there is a need for more accurate methods and tools to evaluate the cervical maturation status as indication of imminent labor in order to avoid unnecessary hospital admissions and therapy. Recently, cervical stiffness has been evaluated as more reliable tool for prediction of spontaneous preterm birth. Cervical stiffness can be evaluated using ultrasound by cervical elastography , but also by an aspiration technique-based method with a novel CE-marked device, the Pregnolia System. Thus, the aims of this study are to evaluate: - if the cervical stiffness measured with the Pregnolia System can differentiate between women with true PTL and those with false PTL, - if the knowledge of cervical stiffness improves the detection of women at true risk of spontaneous preterm birth in combination or over state of the art (e.g. cervical length on TVUS).

NCT ID: NCT05211297 Completed - Preterm Labor Clinical Trials

Impact of Suspected Preterm Labour on Cardiometabolic Profile and Neurodevelopment

SKs
Start date: March 1, 2021
Phase:
Study type: Observational

Suspected preterm labour (SPL), define as the presence of regular and painful uterine contractions and cervical shortening, constitute a prenatal insult with potential long-term consequences. However, despite recent evidence demonstrating a suboptimal neurodevelopment at 2 years in this population, it remains under-recognized as a significant risk factor for neurodevelopmental disorders or other chronic diseases. The objective of this study is to assess the impact of suspected preterm labour during pregnancy on cardiometabolic profile and neurodevelopment during childhood (6-8 years). Prospective cohort study including children whose mothers suffered a suspected preterm labor during pregnancy and paired controls. A neurodevelopment, cardiovascular and metabolic assessment at 6-8 years of age will be performed. A trained psychologist will carry out the neurodevelopment assessment. Body composition and physical fitness assessment will be performed by one trained pediatrician and nurse. Finally, cardiovascular assessment, including echocardiography and blood pressure, will be performed by two pediatric cardiologists. Data regarding perinatal and postnatal characteristics, diet, lifestyle and weekly screen time of the child will be obtained from clinical histories and direct interviews with the families. Primary outcome measures will include body mass index and adiposity, percentage of fat mass and total and regional lean mass, bone mineral content and density, cardio-respiratory resistance, isometric muscle strength, dynamic lower body strength, systolic and diastolic blood pressure, left ventricle (LV) systolic and diastolic function, general intelligence index, visuospatial working memory span, visual development test, visual acuity, index of emotional and behavioral problems.

NCT ID: NCT05110599 Terminated - Anxiety Clinical Trials

Bryophyllum Pinnatum Treatment of Anxiety Related to Signs of Preterm Birth

Start date: July 12, 2022
Phase: Phase 2
Study type: Interventional

The present IIT (Investigator-Initiated Trial) study is a prospective, randomised, placebo-controlled, double blind trial. Women hospitalised with signs of preterm birth can be recruited for the study. Participants will take study medication for 2 weeks (or until birth) and fill out a questionnaire at 3 time points (at baseline, after 1 week and after 2 weeks) to assess state of anxiety and sleep quality. Furthermore, information regarding adverse events and the further course of the pregnancy are recorded.