UniSA BackOff! Study: Adelaide PrenaBelt Trial
StillbirthInfant9 moreStillbirth (SB) is a devastating complication of pregnancy and contributes to over 2 million deaths globally every year. Over 20 million infants are born every year with low birth weight (LBW), which is associated with a twenty times increased risk of death in the first year of life and high rates of short- and long-term illnesses. Sleeping on one's back during pregnancy has recently emerged as a potential risk factor for LBW and SB in the medical literature. In high-income countries, SB rates have mostly remained the same in the past two decades and targeting modifiable risk factors could help reduce the number of SB and LBW in the population. When a pregnant woman sleeps on her back, her body position compresses underlying blood vessels and reduces blood flow to the developing baby. This body position could cause unpleasant symptoms for the mother and result in LBW or SB of her baby. Lying on her side or with a slight lateral tilt helps relieve this compression. One way to keep people off their back while sleeping is by using positional therapy (PT). It is a simple, safe, inexpensive and effective intervention for preventing people who snore or people who's breathing pauses during sleep from sleeping on their back. Reducing the amount of time pregnant women sleep on their back could help reduce SB and LBW rates. The investigators developed a PT device (PrenaBelt) and tested it in three clinical trials, which demonstrated that it significantly decreases the number of time women spend sleeping on their back. Using feedback from our previous research, the investigators developed five additional devices that will be tested in this study. The purpose of this study is to evaluate the new PrenaBelt (PB2) prototypes' ability to reduce the amount of time pregnant women sleep on their backs in the third trimester of pregnancy, validate the Ajuvia Sleep Monitor, and collect feedback on the devices. Demonstrating that the sleeping position of pregnant women can be modified through the use of a simple, inexpensive PT intervention may be one of the keys to achieving significant reductions in LBW and late SB rates in Australia and worldwide.
The PartoMa Project: For Improving Monitoring, Action and Triage During Labour
Obstetric Labor ComplicationsStillbirth1 moreOVERALL OBJECTIVE In an East African referral hospital, to develop and analyze the effect of locally agreed and achievable guidelines and a continual in-house training program for strengthening partogram-based monitoring-to-action during labour. INTERVENTION Paper partograms (WHO), locally developed labour management guidelines (the PartoMa guidelines) and continual in-house education. OVERALL DESIGN A quasi-experimental pre-post-study (The PartoMa study). SETTING Department of Obstetrics and Gynaecology, Mnazi Mmoja Hospital, Zanzibar. POPULATION Labouring women delivering at the study site from October 2014 to January 2016 and their offspring, as well as health providers. Women and their offspring will be enrolled at/after unset of labour and followed until discharge. ENDPOINTS The primary composite endpoint is stillbirths and birth asphyxia. For further description and secondary outcomes, please see below. STUDY TIME Data collection from October 2014 to January 2016, supplemented by a post-exit collection of case file data from October 2016 - January 2017.
Ghana PrenaBelt Trial: A Positional Therapy Device to Reduce Still-Birth
SleepPregnancy9 moreEvery day in Ghana, 47 babies are stillborn (SB) and 232 babies are born with low birth-weight (LBW) - many of whom will die in infancy or suffer lifelong consequences. Sleeping on the back during pregnancy has recently emerged in scientific literature as a potential risk factor for SB and LBW. In fact, one of the earliest studies to demonstrate this link was conducted in Ghana by investigators on this protocol. When a woman in mid-to-late-pregnancy lies on her back, her large uterus compresses one of the major veins that delivers blood back to her heart and may completely obstruct it. This may result in less blood being returned to her heart and less blood being pumped to her developing fetus. Such changes may negatively impact the growth of her fetus and, along with some other risk factors, may contribute to the death of her baby. The investigators have developed a device, 'PrenaBelt', to significantly reduce the amount of time a pregnant woman spends sleeping on her back. The PrenaBelt functions via a simple, safe, effective, and well-established modality called positional therapy. The purpose of this study is to determine the effect of the PrenaBelt on birth-weight and assess the feasibility of introducing it to Ghanaian third-trimester pregnant women in their home setting via an antenatal care clinic and local health-care staff. Data from this study will be used in effect size calculations for the design of a large-scale, epidemiological study targeted at reducing LBW and SB in Ghana and globally.
Misoprostol for Second Trimester Pregnancy Termination
Intra Uterine Fetal DeathThe majority of second-trimester pregnancy termination performed in the United States are performed surgically by dilation and evacuation. The frequency of induction of abortion increases as gestational age advances. In the late second trimester and early third trimester, induction is the primary method of termination in cases of fetal abnormalities. In many other countries, however, induction is the primary method of abortion throughout the second trimester
COVID-19-associated Anxiety of Pregnant Women for Anomalies, Stillbirth and Preterm Labor-2
Anxiety StateCapture of anxiety for anomalies, stillbirth and preterm labor of pregnant women during COVID-19 pandemia
Group Interpersonal Psychotherapy for Treatment of Major Depressive Disorder Following Perinatal...
Major Depressive DisorderMiscarriage2 moreThe purpose of this study is to conduct a randomized pilot trial in a sample of 60 women who meet criteria for Major Depressive Disorder (MDD) 1-18 months after a perinatal loss to demonstrate the feasibility of the proposed recruitment methods and research design, of the therapist training methods, and of delivering the adapted Interpersonal Psychotherapy group treatment. The investigators would like to examine preliminary evidence for the following hypotheses: Perinatal-loss specific IPT-G will be more acceptable to women who experience MDD following perinatal loss than will Coping with Depression (CWD). Perinatal-loss specific IPT-G will result in reduced time to remission from MDD and reduced depressive symptoms relative to CWD. Perinatal-loss specific IPT-G will result in increased social support and social functioning, reduced couple distress, and reduced grief relative to CWD.
Linking Facility-based Mortality Audits With Community Engagement in Gilgit-Baltistan, Pakistan...
External Causes of Morbidity and MortalityStillbirth1 morePakistan is one of the countries in South Asia where neonatal mortality rates remain stagnant. Babies born in Pakistan encounter the highest risk of dying; of every 1,000 babies born, 46 die before the end of their first month (UNICEF, 2018). Some of the highest perinatal and neonatal mortality rates in Pakistan are found in districts of Pakistan's mountainous northern region (Bhutta ZA, 2013), where geography, climate and security risks make it challenging for women in remote communities to reach health services in a timely manner. According to 2013 PDHS, the neonatal and perinatal mortality rate in the northern area of Gilgit Baltistan was 39/1,000 and 37/1,000, respectively. In the rural area of Khyber Pakhtunkhwa, the neonatal and perinatal mortality rate was 42/1,000 and 63/1,000, respectively. Implementation of a health facility mortality audit cycle has proved successful in reducing perinatal mortality by upto 30% in other LMICs. Meanwhile evidence suggests that the most common factors contributing to high mortality rates are due to phase-one delays (delay in the decision to seek care). This study will attempt to operationalize linkages between the community and facility to not only improve facility-based quality of care, but to bring change in the community through community-feedback meetings to mitigate phase one and two delays and improve maternal, perinatal and neonatal outcomes. Data from this study will inform MoH policy decisions about standardized mortality audits with community feedback. Given the geographical location of Gilgit-Baltistan (GB) and accompanying constraints such as terrain and security, this study will attempt to operationalize linkages between the community and facility to not only improve facility-based quality of care, but to bring change in the community through community-feedback meetings to mitigate phase one and two delays and improve maternal, perinatal and neonatal outcomes. Data from this study will inform MoH policy decisions about standardized mortality audits with community feedback.
Effects of a Health Workforce Capacity Building and Quality Improvement Intervention in Kinshasa...
Maternal DeathInfant Death1 moreThe aim of the study is to evaluate a health workforce capacity building and quality improvement intervention focused on integrated day-of-birth and post-pregnancy care at 16 hospitals in Kinshasa, Democratic Republic of Congo. The intervention package consists of a low-dose, high-frequency (LDHF) training of health workers, support for quality improvement teams, and provision of critical equipment, supplies and drugs within a quality improvement (QI) framework.
Introducing Fetal Scalp Stimulation as an Adjunct to Intermittent Auscultation in Low-Resource Settings....
Fetal DistressStillbirth2 moreThis study is a pilot study taking place in Moshi, Tanzania at the Kilimanjaro Christian Medical Centre (KCMC). The study aims to introduce fetal scalp stimulation into the intermittent auscultation protocols at KCMC, and to validate whether or not a handheld Doppler device can perform the fetal scalp stimulation test accurately.
Halifax PrenaBelt Trial
SleepPregnancy9 moreBack and right-sided sleeping position in pregnant women has recently emerged as a potential risk factor for low birthweight (LBW) and stillbirth (SB) in the medical literature. Assuming that sleep position in pregnant women is modifiable, the same literature has indicated that this risk factor is modifiable; however, there is no evidence that this risk factor is truly modifiable. The proposed link between back and right-sided sleeping position in a pregnant woman and LBW and SB of her baby is multifactorial; however, it ultimately implicates the woman's body position in causing compression of one of the large veins that brings blood back to her heart. This compression, along with other factors relating to the woman, her placenta, and her developing fetus, may result in decreased blood flow (nutrition and oxygen) to her developing baby, which, depending on the extent and duration, could result in LBW or SB of her baby. If the back sleeping position during pregnancy has a causative role in LBW and subsequently SB, the literature indicates that up to 17% of LBW and consequently 26% of SB could potentially be prevented by changing position to avoid back sleep. Note that 20 million LBW and 2.6 million SB occur each year worldwide. Positional therapy (PT) is a safe and effective intervention for preventing people who snore or people who's breathing pauses during sleep from sleeping on their back - a position that makes their condition worse. The most basic form of PT modifies a person's sleeping position by either: Preventing them from sleeping on their back through restricting their movement, or Rather than restricting movement, significantly reducing the amount of time they spend sleeping on their back by applying pressure points to their body while they are on their back, which eventually causes them to shift into a different position and avoid lying on their back. The purpose of this study is to evaluate the ability of a PT intervention to modify the position of pregnant women from their back and right side to their left side while they sleep in late pregnancy. This study will help determine whether this potential risk factor is modifiable by way of a PT intervention, and whether it is feasible to intervene to reduce or prevent back and right-sided position sleep in late pregnancy. Demonstrating that the sleeping position of pregnant women can be modified through use of a simple, inexpensive PT intervention may be one of the keys to achieving significant reductions in LBW and late SB rates in Canada and worldwide.