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19 active trials for Pregnant Women

CALM Pregnancy: Feasibility of Calm for Pregnant Women

The purpose of this study is to determine the feasibility of using a consumer-based mindfulness app, Calm, to reduce stress during pregnancy. Women will be randomly assigned to an intervention group (i.e., Calm) or standard care group and asked to participate in at least 10 minutes of daily meditation for the duration of their pregnancy (i.e., 12-weeks' gestation up to date of birth). Aim #1: Determine the feasibility (acceptability and demand) of using the Calm app at least 10-minutes per day for the duration of pregnancy (i.e., 12-weeks' gestation up to date of birth). Acceptability will be measured with an investigator-developed satisfaction survey. Demand will be measured using time spent in meditation and meditations used (tracked by Calm). For the intervention group, the benchmarks will be as follows: Acceptability (i.e., satisfaction) 70% (n=34) of participants will report a 75% satisfaction, Demand (i.e., time spent in meditation and meditations used,) 70% (n=34) of participants will adhere to ?75% of prescribed meditation using Calm. Aim #2: Determine the preliminary effects of using Calm at least 10-minutes per day for the duration of pregnancy (i.e., 12-16 weeks' gestation to date of birth) on stress. Stress will be measured using the Perceived Stress Scale (PSS) at baseline (i.e., 12-16-weeks' gestation) and every four weeks for the duration of the intervention using Ecological Momentary Assessment (i.e., text message). Stress will also be measured using cortisol serum at baseline (i.e., 12-16-weeks' gestation), and 32 weeks' gestation. Exploratory Aim #3: The investigators will explore the preliminary effects of using Calm at least 10-minutes per day for the duration of pregnancy (i.e., 12-16 weeks' gestation to date of birth) on gestational age of birth, fetal weight, APGAR scores (i.e., health score), and neonatal complications with time spent in neonatal intensive unit (if applicable).

Start: November 2019

Ultrasound Assessment of Gastric Content in Fasted Pregnant Women

Pulmonary aspiration of gastric content is one of the most feared perioperative complication of general anesthesia. Pregnant women are usually considered as high risk of pulmonary aspiration but there is no epidemiological study evaluating gastric content in pregnant women during the entire gestation periode. The main objective is evaluating prevalency of "full stomach" in differents stages of pregnancy in fasted pregnant women.

Start: March 2020

The Effect of Education Given to Primiparous Pregnant Women on Parental Self-Efficacy and Mother-Infant Attachment

This research will be carried out in a quasi-experimental design to determine the effect of maternity care and neonatal care training given to primiparous pregnant women on parental self-efficacy and mother-infant attachment in the postpartum period. Research Hypotheses: H0: There is no difference in parental self-efficacy and mother-infant attachment in the postpartum period between pregnant women who received training during pregnancy and did not. H1: There is a difference in parental self-efficacy and mother-infant attachment in the postpartum period between pregnant women who received and did not receive education during pregnancy.

Start: May 2021

Adapted Physical Activity to Promote Quality of Life, Well-being and Physical Activity Levels in Pregnant Women (WELL-DONE!Study)

The aim of the WELL-DONE! Study is to co-design, using different professional figures (midwives, psychologists, master's degree in motor science) but also taking into consideration the pregnant women's point of view, an intervention of adapted physical activity for pregnant women, included in the birth accompaniment courses and conducted by midwives, and to evaluate its effectiveness in terms of quality of life, well-being, levels of physical activity and satisfaction with respect to the proposed intervention.

Start: February 2021

Maternal Non-Stress Testing

Percent agreement of vital signs monitoring between the experimental sensor and standard of care monitoring

Start: April 2018

Using Teach Back to Improve Postpartum Maternal-infant Health Among Women With Limited Maternal Health Literacy

Study design This is a randomized controlled trial study with two arms -teach-back group vs. controlled group. Education for Teach-back group and Control group During the trial, women from Teach Back group and controlled group will receive three education sessions arranged by trained nursing supervisors who played the educator role (Table 1). The first education session is arranged at the day or the following day of admission before delivery, with a group meeting involving three women and one educator. The main purpose of the first session is to help women understand and prepare for the labor. The topics discussed at the first session includ delivery mode, labor process and pain relief, newborn health and care (common health issues and care skills), perinatal die and excises, and perinatal psychological health. On the day of discharge after delivery, women will receive the second group education session hosted by an educator. The main purpose of the second session is to help women understand postpartum health issues, get to know the practice of postpartum recovery and learn newborn care skills. The topics discussed at the second session includ postpartum recovery, postpartum maternal health, perineum care (diet, oral care, perineal care, and hygiene), breastfeeding, postpartum blue and depression, neonatal care, neonatal screening tests, newborn vaccination and early child development. At two-week postpartum, a short online meeting will be arranged between one woman and one educator. During the meeting, the educator answer questions raised by the woman and give advices on the challenges and difficulties in postpartum recover and caring newborn faced by the woman. Teach-back group and Control group share same education content and communication methods, e.g. power-point presentation, educational video clips, live demonstration, information booklet, group discussion, and Q&A, expect that before the end of each education session, women in Teach-back group will be asked to use their own words to restate what was just learned and the educator assesses the patient's understanding of the subject, identifies misunderstandings, corrects the mistaken, and provides additional information if required until women can correctly restate what they were expected to learn.

Start: May 2021

Effects of Chinese Medicine on Early Pregnant Women

From April 2021 to December 2021, 50 pregnant women who received intro fertilization (IVF) will be recuited. Among them, 25 of them would like to take Chinese fetal protection medicine from the fourth week of pregnancy (experimental group), while the remaining 25 will not (control group). Blood and feces will be collected in the early morning of the 6th week after successful transplantation to detect 16S DNA in feces, plasma metabonomics, and whole blood transcriptomics.

Start: April 2021

The Effect of the E-Mobile Health Application on Postpartum Adaptation

The purpose of this research is to determine the effect of the e-mobile health application on postpartum adaptation. The study will consist of two groups: Experimental group and control group.

Start: March 2021

Physical Exercise Cardiovascular Adaptation Monitoring in Pregnancy (PE-CAMP Study)

The main theme of this study focuses on providing evidence of the impact of antenatal physical activity on maternal/foetal cardiovascular changes during pregnancy and maternal cardiovascular adaptations during the early postpartum period.

Start: April 2018

Effect of Health Information Package Program (HIPP) on Knowledge and Compliance Among Saudi Pregnant Women With Anemia

Problem description: low compliance with iron supplementation of Saudi pregnant women with anemia is a serious public health concern. Objectives of the study are to determine the effectiveness of the Health Information Package Program (HIPP) in Saudi anemic pregnant women on their compliance with iron supplementation, knowledge about anemia, and level of hemoglobin. Methodology: Randomized Controlled Trial will be conducted on 196 Saudi anemic pregnant women attending the Maternity and Children Hospital in Sakakah- Al-Jouf region, their gestational age between 14 and less than 20 weeks. All participants will receive iron supplementation and they will learn how to take tablets. They will randomly assign to two intervention and control groups (98 each) using a computer-generated table of random numbers. The intervention group will receive a video presentation of the Health Information Package Program (HIPP) that will be narrated by the principal investigator, combined with PowerPoint slides to educate women about anemia in pregnancy and send it to them via WhatsApp application while the control group will receive usual care. The participants will be informed about the nature and aim of the study with assuring confidentiality and anonymity. Expected outcome: Health Information Package Program (HIPP) will be effective in terms of increasing women's knowledge regarding anemia during pregnancy, increase compliance with iron supplementation, and hemoglobin level.

Start: February 2021

The Effect of Labor Dance on Labor Pain, Anxiety, Birth Time and Maternal Satisfaction

Pregnant women who are in the process of labor need physical and emotional support of health professionals in issues such as coping with labor pain, relieving fear and anxiety, and experiencing positive birth. The fact that labor dance includes components such as upright posture, pelvic movement, touch, massage provides both physical and emotional support to the pregnant woman. The aim of the study is to examine the effect of labor dance applied to pregnant women in the first stage of birth on labor pain, anxiety, birth time and maternal satisfaction at birth.

Start: December 2020

Using Community Health Nurses and Workers for Home Visits to Improve Maternal and New Born Health in Ghana

Title: Using Community Health Workers (CHWs) and Nurses (CHNs) to increase Skilled Attendant at Birth (SAB) and improve Maternal and Neonatal Health in Rural Ghana Background: SAB is a key strategy for improving maternal and new born health since most of the complications occurring at childbirth could be better managed when the delivery is supervised by a doctor, midwife or nurse. The effect of home visits to pregnant women by a CHW/CHN partnership on SAB is yet to be evaluated in a trial in Ghana. This trial will determine the effectiveness of a CHW/CHN home visit intervention to pregnant women on increasing SAB and improving birth outcomes for mothers and their neonates. Methods: Following ethical approval, we will train CHWs and CHNs to provide a package of health education and support for delivery during three home visits to each pregnant woman. This partnership will be evaluated through a cluster randomized controlled trial in 20 electoral areas in Ellembelle district of Ghana: 10 will be randomized to receive the CHW/CHN partnership intervention and 10 to the control arm (usual care), with a target recruitment of 46-50 women per cluster. The CHWs and CHNs will receive technical and financial support throughout the study. Data on SAB, maternal utilization of safe practices during pregnancy, breast feeding initiation, exclusive breastfeeding, immunization coverage for mother and new born, maternal deaths and neonatal death rates will be collected. The impact of the CHW/CHN intervention on these indicators will be reported. Keywords: Community Health Nurse, Community Health Worker, Maternal, New born, Supervised delivery, Post-natal, Effectiveness

Start: April 2019

Pregnancy Registry in West China

With the Healthy China 2030 Plan for further reducing maternal mortality ratio (MMR), and increasing number of high-risk pregnancies in China, we aimed to develop a registry of pregnant women based on hospital-based Electronic Medical Records (EMR) data in West China, through integrating information technology and medical knowledge, by linking multi-resource data covering information regarding the whole cycle from pregnancy registration till delivery, and process of diagnosis, treatment and pregnancy outcomes, in order to provide reliable, valuable and efficient data resources for researches about high-risk pregnancy safety and MMR reduction in southwestern China. From January 29, 2014 to November 29, 2019, 64,468 pregnancies of 62,690 women were registered around gestational 13th weeks in the hospital, collecting over 47 million records (including repeated measurement data) from Health Information System (HIS), Laboratory Information System (LIS), and Picture Archiving and Communication System (PACS). After excluding 3476 pregnancies lost to follow-up and 7325 newly-pregnancies with expected date of delivery out of the study time, a total of 53,667 pregnancies about 51,964 women were finally included in the registry, who had been followed up till the occurrence of at least one outcome, including any pregnancy complication, abortion, stillbirth, induced labor, and live birth between January 1, 2015 and November 30, 2019. Till now, through data linkage, data collection, cleaning and recoding, we have generated more than 2100 structured variables regarding pre-pregnancy conditions, prenatal visit records, hospitalized diagnosis, treatment and discharge outcomes. The diagnoses of pregnancy complications, maternal and fetal outcomes, recorded by ICD-10 coding or free terms in original fields, were uniformly encoded by the Classification and Codes of Diseases released by Chinese National Standards Institute (GB/T14396-2016) and National Health Standard Criteria for Birth Defects (WS 377.6-2013).

Start: January 2014

Placental Transfer of Tenofovir

The purposes of this study are to determine whether transporters expression levels and drug interaction between TDF and FTC could contribute to modulate the placental transfer of this drug or. To test this hypothesis, an ex vivo model known as "the perfused ex vivo cotyledon model" allows to reproduce the conditions of the third trimester of pregnancy

Start: February 2013

Exploring Aromatherapy Intervention in Acute Care

This study aims to explore how the use of inhaled essential oils impacts the experience of a laboring and postoperative surgical patient. It is expected that the aromatherapy intervention will decrease levels of nausea, anxiety, and improve the perception of being cared for in laboring mothers and patients recovering from surgery. By learning more about aromatherapy, the investigators may be able to expand the aromatherapy intervention to more patients in other Massachusetts General Hospital departments. 20 laboring patients will be recruited on admission to the labor and delivery inpatient unit. They will be invited to participate in this study by nurses caring for them. 20 postoperative surgical patients will be recruited on admission to the surgical inpatient unit. They will be invited to participate in this study by nurses caring for them

Start: September 2020

Obstetric and Perinatal Outcomes of Women With COVID-19

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is currently spreading rapidly around the globe, causing a major public health issue. There is currently very few data about the impact of COVID-19 on pregnancy, and potential in utero infection. This is a prospective observational study of COVID-19 diagnosed pregnant patients. This objective is to examine the impact of COVID-19 during pregnancy on the rates of obstetric and perinatal complications.

Start: April 2020

Pregnant Obese Women and Fetal Ultrasound Quality.

Ultrasound (US) image construction uses equations that contain the value of the propagation velocity of sound waves; this velocity is assumed conventionally to be constant and equal to 1540 m/s in the human body. Since 1977, all manufacturers of US scanners have used this value, which was first established in 1950. In fatty tissue, however, the actual propagation velocity is only in the order of 1450 m/s. US velocity in fat tissue is slower than in other soft tissues (ie:1450 m/s vs 1540 m/s) therefore the intrinsic image quality in terms of sharpness and precision is improved when considering this parameter for image construction The main objective of this study is to evaluate the impact of ultrasound propagation velocity setting on completeness of ultrasound exams and images quality during the second and third trimester fetal ultrasound examination in obese patients.

Start: December 2019

Xiamen Registry of Pregnant Women and Offspring (REPRESENT)

To improve the health of women and children under the background of Healthy China 2030, the investigators developed REPRESENT by establishing a pregnancy registry in Xiamen, a sub-provincial city of over four million residents in east China, based on the Maternal and Child Health Management Platform, and then linking to three other platforms, i.e. Residents Healthcare Management Platform, Primary Healthcare Management Platform, and Electronic Healthcare Records (EHR) Platform, which had been developed since 2006. The registry documented information and events about pregnant women from registration at their first trimester to postpartum, and includes the childhood follow up records. The registry not only enables longitudinal follow up of pregnant women and their offspring, but also expands the scope of database from pre-pregnancy exposures to long-term outcomes by data linkage. During the past 11 years (January 2008 to March 2019), the REPRESENT has accumulated data concerning more than 700 thousands pregnancies. The data volume is substantial with over 800 variables being documented, and most variables are designed as structured fields. The disease categories and codes are standardized according to the International Classification of Diseases 10th Revision (ICD-10). The whole process of data access, data extraction, data processing and data analysis was conducted through an internal-only accessible server at Xiamen Health and Medical Big Data Center. All investigators cannot access sensitive information, are required to sign data confidentiality agreement and should obtain approval by the Xiamen Health and Medical Big Data Center and the Chinese Evidence-based Medicine Center.

Start: January 2008

The Maternal Cellular Immune System and Cytomegalovirus Intrauterine Infection

The purpose of this study is to find a correlation between function of cytomegalovirus -specific T cells and the probability for intrauterine transmission.

Start: February 2014