Currently there is a great need for an accurately and rapid assessment of patients suspected for Covid-19. Like CT, Lung Ultrasound (LUS) examination can potentially help with the initial triage of patients but also help track the evolution of the disease. LUS can be used in every setting, including settings with limited infrastructure, allowing the reduction of disparities in trials participation. LUS is also a practical approach that can be used by obstetricians/gynecologists, who are the primary care givers in the labour and delivery room. The International Lung UltraSound Analysis (ILUSA) Study is an international multicenter prospective explorative observational study to assess the predictive value of LUS in Covid-19 suspected and diagnosed pregnant patients.

NCT04353141

Conditions

1. COVID
2. Pregnancy Complications, Infectious
3. Pregnancy Related
4. Pregnancy, High Risk
5. Pregnancy Disease
6. Pneumonia
7. Pneumonia, Viral
8. Diagnoses Disease

Interventions

1. Diagnostic Test: standardized Lung Ultrasound (LUS) examination

MeSH:Pregnancy Complications, Infectious Pneumonia, Viral Pneumonia Pregnancy Complications

HPO:Pneumonia

The purpose of this study is to assess the health and wellbeing of pregnant and recently pregnant women during the COVID-19 pandemic using an online survey.

NCT04385238

Conditions

1. COVID-19
2. Pregnancy Complications
3. Mental Health Wellness 1
4. Anxiety
5. Depression
6. Ptsd
7. Coronavirus

Interventions

1. Other: This is an online survey with no intervention.

MeSH:Pregnancy Complications

This is a multicenter prospective study that aims to investigate the clinical impact of SARS-CoV-2 infection in pregnant women, pregnancy outcomes and perinatal transmission.

NCT04416373

Conditions

1. Coronavirus Infection
2. Pregnancy Complications
3. Vertical Transmission of Infectious Disease
4. Breastfeeding
5. Neonatal Infection

Interventions

1. Diagnostic Test: RT PCR SARS-CoV-2

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pregnancy Complications

The aim of this study is to capture data, laboratory markers, and clinical outcomes of obstetric and neonatal outcomes in cases of COVID-19 during pregnancy in Cuyahoga County.

NCT04418557

Conditions

1. COVID
2. Pregnancy Complications

Interventions

1. Diagnostic Test: RT-PCR and antibody testing

MeSH:Pregnancy Complications

Purpose: The emergence of a new coronavirus, coronavirus 2 (SARS-CoV-2) causing a novel infection in the human race resulting in a world-spanning pandemic came as a surprise and at a tremendous cost both for individual human lives as well as for the society and for the health care sector. The knowledge on how this new infection affects both the mother and the unborn child as well as the outcomes for the mother and the child in the long run are unknown. What is known is based on case-reports and small case-series solely. Both the coronaviruses causing Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS) can cause a threat to pregnant women and their offspring, which leads to the question whether this could be the case also for SARS-CoV-2. Aims: To establish a biobank of biological material from infected as well as non-infected pregnant women and their offspring. To combine this biobank with Swedish quality and health care registers, computerized patient charts and questionnaire data, enabling both short-term follow up, such as obstetric outcomes, as well as long-term outcomes both for mother and child. To study how the pandemic situation affects both the mother and her partner in their experience of pregnancy, childbirth, and early parenthood. Design: A national Swedish multicentre study. Women are included when they have a positive test for SARS-CoV-2 or a clinical suspicion of coronavirus disease 2019 (COVID-19) (COVID-19 group). Pregnant women without COVID-19 symptoms will be included at their routine visits (Screening group). Blood samples and other biological material will be collected at different time-points. Additional predictors and outcomes are collected from the Swedish Pregnancy Register as well as obligatory Swedish health registers. The biobank and its linkage to health registers through the Swedish personal identification number will enable future research. Child development will be followed during the first year of life by questionnaires to the parents. Womens' and their partners' experience of childbirth and parenthood will be studied in form of questionnaires based on validated instruments as well as in form of interviews. Sweden is one of few countries with prerequisites enabling a nearly population-based follow-up, even under the pandemic condition with considerable strains for the health care system. Conclusion: This project will help obstetricians and neonatologists in better recognizing the clinical manifestations of the virus, identify possible risk factors during pregnancy and tailor therapies along with providing the right level of surveillance and management during pregnancy, delivery, and child health care. The project will also enable sharing important unusual outcome data with other research collaborators, e.g. outcome for pregnant women with diabetes.

NCT04433364

Conditions

1. Sars-CoV2
2. Covid-19
3. Pregnancy Complications
4. Pregnancy Preterm
5. Pregnancy in Diabetic
6. Neonatal Infection

Interventions

1. Other: biological samples, questionnaires and interviews

MeSH:Pregnancy Complications Pregnancy in Diabetics

The purpose of this study is to characterize the incidence and clinical features of the maternal COVID 19 infection, as well as the associated morbidity of the mother and the child, in the French context

NCT04463758

Conditions

1. covid19 Infection
2. Pregnancy Complications
3. Neonatal Complications

Interventions

1. Other: An auto-questionnaire comprising three psychometric scales

MeSH:Pregnancy Complications

A cohort study of women who deliver at select sites on randomly selected days in 2019 and 2020, and all confirmed COVID-19 infections among pregnant or immediately postpartum women in 2020. The study population includes approximately 24,400 deliveries on randomly selected days in 2019 and 2020, and an additional 1000-2100 confirmed COVID-19 infections among pregnant women or immediately postpartum.

NCT04519502

Conditions

1. COVID-19
2. Pregnancy Complications

MeSH:Pregnancy Complications

Study title Spanish Registry of Pregnant Women with COVID-19 Protocol number and version Number 55/20. Version V8. Sponsors This registry is a project promoted by Dr. Oscar Martínez Pérez of the Obstetrics and Gynaecology department of the Puerta de Hierro University Hospital. Principal investigator of the registry National coordinator: Dr. Óscar Martínez Pérez. Obstetrics and Gynaecology Department. Puerta de Hierro University Hospital. Majadahonda. Epidemiologist: Maria Luisa de la Cruz Conti Researchers for each site: 100 sites from 32 Spanish provinces are included (Appendix 1) Funding Neither the hospitals nor the participating investigators will receive any financial compensation for their collaboration. A bank account has been opened at the hospital's Biomedical Research Foundation to receive donations: COV20/00021 - SARS-COV-2 and the COVID-19 disease Call financed by the Carlos III Institute of Health and co-financed with ERDF funds. Abstract Rationale: Knowledge about the impact of the SARS-CoV-2 virus on pregnancy is still scarce and all current recommendations are based on less than 100 cases published in the literature. To identify moderate effects (such as vertical transmission, obstetric morbidity, foetal death, maternal or neonatal death) and to allow accurate risk estimates, larger sample sizes than those currently available are required. Methods: Prospective observational study of pregnant women in whom SARS-CoV-2 infection is suspected at any time during pregnancy with positive test results for SARS-CoV-2, in order to create a registry of baseline characteristics of the pregnant woman, aspects related to the course of pregnancy and delivery, and related to the new-born, with an observation period of up to 14 days after delivery. Subsequently, several phased studies will be conducted to help establish and monitor the set of measures to improve the care of pregnant women. Discussion: The national registry for COVID-19 in pregnancy described here is a tool for sharing and centralizing data related to exposures to SARS-CoV-2 during pregnancy in a structured way. It should speed up the process of prospectively obtaining a large unbiased data set and will collect information at national level.

NCT04558996

Conditions

1. Covid19
2. Pregnancy Complications
3. Premature Rupture of Membrane
4. Abruptio Placentae
5. Prelabor Rupture of Membranes
6. Stillbirth

MeSH:Pregnancy Complications Fetal Membranes, Premature Rupture Stillbirth Abruptio Placentae Rupture

HPO:Placental abruption Premature rupture of membranes Stillbirth

Historically and traditionally, the recommendations related to physical exercise during pregnancy have been based more on moral or cultural issues than on scientific evidence. During some phases of history, pregnancy has meant a period of seclusion for women (not only physical). One of the adverse consequences has been the common recommendation of rest as a general rule for pregnant women. Scientific evidence from recent years has achieved a better understanding of the process of pregnancy and childbirth as well as maternal and fetal responses to exercise. Currently, both from a scientific and clinical/obstetric point of view, there is no doubt about the benefits of an active pregnancy for entire body of pregnant woman, and even her child. In fact, risks of a sedentary lifestyle are applicable to the pregnancy situation, even more with important associated complications during pregnancy and postpartum period. Unfortunately, the impact of COVID-19 has caused an unprecedented global crisis, in this sense the necessary measures taken by the different administrations, especially in terms of confinement causes (from now on) a large number of complications affecting different populations. In summary a complex situation without established prevention strategies exists. The pregnant population is, due to the nature of the gestation and delivery process, one of the population groups with the highest risk of adverse outcomes and associated complications and whose consequences include the mother, fetus, newborn and even children. According to an important body of scientific literature and based on an epigenetic effect, the intrauterine environment can be a determining factor for the future human being to evolve regardless of complications and pathologies (cardiovascular, metabolic, psychic, emotional). This is demonstrated by numerous recent scientific evidences that confirm the unfortunate association between an adverse intrauterine environment (due to various factors) and observable postnatal pathologies in infants. In addition, current publications report the large number and variety of alterations that the COVID-19 situation causes in pregnant women and that includes the entire female organism. This complex situation does not only affect aspects of a physical or physiological nature, but also psychic and emotional factors. In summary, a new state of confinement or similar situations in the near future (impossibility of groupings, distance between people), avoid during the daily life of pregnant women one of the important and recent recommendations made by the international scientific community: a pregnancy physically active. This is especially relevant, due to the dangerous association between complications of a psychological or emotional nature during pregnancy with pre, peri and postnatal disorders (low birth weights, perinatal complications, altered and prolonged deliveries, etc.), which affect not only to the mother and can determine the health of the future human being. According to the scientific literature and based on an epigenetic effect, the intrauterine environment can be a determining aspect in the health of the future human being and the prevention of complications and pathologies (cardiovascular, metabolic, psychic, emotional). This is demonstrated by numerous and recent scientific evidences that confirm the unfortunate association between an adverse intrauterine environment (due to various factors) and different pathologies during and after pregnancy. It is evident the change that COVID-19 and its effects will generate in the lifestyle of the pregnant population and the increased probability of suffering associated pathologies in the next 24-36 months. No preventive actions have yet been planned in Spain and its public hospitals against the impact of COVID-19 on the quality of life of pregnant women. It is urgent to design and perform an adequate strategy of intervention for its possible prevention. From the scientific point of view, the recommendations are clear and concrete, an aerobic exercise program, designed and supervised by professionals from the Sciences of Physical Activity and Sports, is the best option for pregnant women. In this sense, in the last 30 years, physical exercise has proven to have many benefits for pregnant women, without causing risks or adverse effects on maternal-fetal well-being. This is confirmed by an important body of scientific literature on gestational physical exercise and its effects on pregnancy outcomes.

NCT04563065

Conditions

1. Pregnancy Complications
2. Pregnancy, High Risk
3. Pregnancy Induced Hypertension
4. Newborn Morbidity
5. Fetal Growth Retardation
6. Fetus Disorder
7. Weight Gain, Maternal
8. Maternal-Fetal Relations

Interventions

1. Other: Exercise program
2. Other: Healthy lifestyle advise

MeSH:Pregnancy Complications Fetal Growth Retardation Hypertension, Pregnancy-Induced Weight Gain Gestational Weight Gain

HPO:Increased body weight Intrauterine growth retardation

Hypertensive disorders of pregnancy (HDP) are increasingly recognized sex-specific risk factors for premature cardiovascular disease (CVD) in women. HDP, including preeclampsia and gestational hypertension, confer a 2- to 3-fold increase in the risk of chronic hypertension and ischemic heart disease 10-15 years after delivery. Observational data suggest that breastfeeding can lower maternal blood pressure (BP), risk of metabolic syndrome, and other markers of cardiovascular risk in the short term and long term, possibly by helping to re-set the metabolic changes of pregnancy. We recently demonstrated an 11% reduction in the risk of metabolic syndrome among postpartum women with a variety of complications in pregnancy, including HDP, who breastfed for > 6 months, compared to those who did not breastfeed and those who breastfed for shorter durations. An analysis of 622 postpartum women at Kingston General Hospital showed that breastfeeding women had nearly a 6-mmHg lower systolic BP than women who did not breastfeed with an apparent dose-response effect of breastfeeding duration. Women with pregnancy complications including HDP are vulnerable to early weaning. Interactive, multi-modal approaches targeting a mother's breastfeeding self-efficacy (i.e., confidence about breastfeeding) have been effective in healthy postpartum women. However, breastfeeding support interventions have not yet been tested specifically in HDP women, who stand to derive substantial benefit from breastfeeding. This is an important area to study since nurse-led breastfeeding supportive interventions can be widely applied to the postpartum care of women with HDP and can be integrated into comprehensive CVD risk reduction programs for these women. Our primary outcome is postpartum BP, since hypertension is a key mediating factor in women's heart health. We conducted a feasibility study of a breastfeeding self-efficacy intervention to enhance breastfeeding outcomes among women with HDP showing feasibility (achieving pre-defined targets of a recruitment rate of >50% , attrition rates of < 30%), and > 70% participant satisfaction with the intervention, measured at the 6-month time point. Additionally, data showed trends in both systolic and diastolic BP favoring the intervention group. We are now conducting a multi-site open-label randomized trial to assess for a difference in blood pressure and breastfeeding between groups, and to serve as a cohort of HDP women for longitudinal follow-up.

NCT04580927

Conditions

1. Hypertensive Disorder of Pregnancy
2. Pregnancy Complications
3. Pre-Eclampsia
4. Hypertension, Pregnancy-Induced
5. Breastfeeding

Interventions

1. Behavioral: Breastfeeding self-efficacy (BSE)

MeSH:Toxemia Eclampsia Pre-Eclampsia Pregnancy Complications Hypertension, Pregnancy-Induced Hypertension

HPO:Eclampsia Hypertension Preeclampsia Toxemia of pregnancy