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20 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).

Phoenix, ArizonaStart: October 2019
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.

Hefei, AnhuiStart: May 2021
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

Esiama, Western RegionStart: 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
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