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The New England Journal of Medicine Mar 2023The use of azithromycin reduces maternal infection in women during unplanned cesarean delivery, but its effect on those with planned vaginal delivery is unknown. Data... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
The use of azithromycin reduces maternal infection in women during unplanned cesarean delivery, but its effect on those with planned vaginal delivery is unknown. Data are needed on whether an intrapartum oral dose of azithromycin would reduce maternal and offspring sepsis or death.
METHODS
In this multicountry, placebo-controlled, randomized trial, we assigned women who were in labor at 28 weeks' gestation or more and who were planning a vaginal delivery to receive a single 2-g oral dose of azithromycin or placebo. The two primary outcomes were a composite of maternal sepsis or death and a composite of stillbirth or neonatal death or sepsis. During an interim analysis, the data and safety monitoring committee recommended stopping the trial for maternal benefit.
RESULTS
A total of 29,278 women underwent randomization. The incidence of maternal sepsis or death was lower in the azithromycin group than in the placebo group (1.6% vs. 2.4%), with a relative risk of 0.67 (95% confidence interval [CI], 0.56 to 0.79; P<0.001), but the incidence of stillbirth or neonatal death or sepsis was similar (10.5% vs. 10.3%), with a relative risk of 1.02 (95% CI, 0.95 to 1.09; P = 0.56). The difference in the maternal primary outcome appeared to be driven mainly by the incidence of sepsis (1.5% in the azithromycin group and 2.3% in the placebo group), with a relative risk of 0.65 (95% CI, 0.55 to 0.77); the incidence of death from any cause was 0.1% in the two groups (relative risk, 1.23; 95% CI, 0.51 to 2.97). Neonatal sepsis occurred in 9.8% and 9.6% of the infants, respectively (relative risk, 1.03; 95% CI, 0.96 to 1.10). The incidence of stillbirth was 0.4% in the two groups (relative risk, 1.06; 95% CI, 0.74 to 1.53); neonatal death within 4 weeks after birth occurred in 1.5% in both groups (relative risk, 1.03; 95% CI, 0.86 to 1.24). Azithromycin was not associated with a higher incidence in adverse events.
CONCLUSIONS
Among women planning a vaginal delivery, a single oral dose of azithromycin resulted in a significantly lower risk of maternal sepsis or death than placebo but had little effect on newborn sepsis or death. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others; A-PLUS ClinicalTrials.gov number, NCT03871491.).
Topics: Female; Humans; Infant, Newborn; Pregnancy; Azithromycin; Perinatal Death; Pregnancy Complications, Infectious; Sepsis; Stillbirth; Anti-Bacterial Agents; Delivery, Obstetric; Neonatal Sepsis; Administration, Oral; Pregnancy Outcome; United States
PubMed: 36757318
DOI: 10.1056/NEJMoa2212111 -
BMJ (Clinical Research Ed.) Sep 2016To determine the risks of stillbirth and neonatal complications by gestational age in uncomplicated monochorionic and dichorionic twin pregnancies. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To determine the risks of stillbirth and neonatal complications by gestational age in uncomplicated monochorionic and dichorionic twin pregnancies.
DESIGN
Systematic review and meta-analysis.
DATA SOURCES
Medline, Embase, and Cochrane databases (until December 2015).
REVIEW METHODS
Databases were searched without language restrictions for studies of women with uncomplicated twin pregnancies that reported rates of stillbirth and neonatal outcomes at various gestational ages. Pregnancies with unclear chorionicity, monoamnionicity, and twin to twin transfusion syndrome were excluded. Meta-analyses of observational studies and cohorts nested within randomised studies were undertaken. Prospective risk of stillbirth was computed for each study at a given week of gestation and compared with the risk of neonatal death among deliveries in the same week. Gestational age specific differences in risk were estimated for stillbirths and neonatal deaths in monochorionic and dichorionic twin pregnancies after 34 weeks' gestation.
RESULTS
32 studies (29 685 dichorionic, 5486 monochorionic pregnancies) were included. In dichorionic twin pregnancies beyond 34 weeks (15 studies, 17 830 pregnancies), the prospective weekly risk of stillbirths from expectant management and the risk of neonatal death from delivery were balanced at 37 weeks' gestation (risk difference 1.2/1000, 95% confidence interval -1.3 to 3.6; I(2)=0%). Delay in delivery by a week (to 38 weeks) led to an additional 8.8 perinatal deaths per 1000 pregnancies (95% confidence interval 3.6 to 14.0/1000; I(2)=0%) compared with the previous week. In monochorionic pregnancies beyond 34 weeks (13 studies, 2149 pregnancies), there was a trend towards an increase in stillbirths compared with neonatal deaths after 36 weeks, with an additional 2.5 per 1000 perinatal deaths, which was not significant (-12.4 to 17.4/1000; I(2)=0%). The rates of neonatal morbidity showed a consistent reduction with increasing gestational age in monochorionic and dichorionic pregnancies, and admission to the neonatal intensive care unit was the commonest neonatal complication. The actual risk of stillbirth near term might be higher than reported estimates because of the policy of planned delivery in twin pregnancies.
CONCLUSIONS
To minimise perinatal deaths, in uncomplicated dichorionic twin pregnancies delivery should be considered at 37 weeks' gestation; in monochorionic pregnancies delivery should be considered at 36 weeks.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42014007538.
Topics: Female; Gestational Age; Humans; Infant, Newborn; Infant, Newborn, Diseases; Intensive Care, Neonatal; Perinatal Death; Pregnancy; Pregnancy, Twin; Prospective Studies; Risk Factors; Stillbirth; Twins, Dizygotic; Twins, Monozygotic
PubMed: 27599496
DOI: 10.1136/bmj.i4353 -
Nursing Interventions to Facilitate the Grieving Process after Perinatal Death: A Systematic Review.International Journal of Environmental... May 2021Perinatal death is the death of a baby that occurs between the 22nd week of pregnancy (or when the baby weighs more than 500 g) and 7 days after birth. After perinatal... (Review)
Review
Perinatal death is the death of a baby that occurs between the 22nd week of pregnancy (or when the baby weighs more than 500 g) and 7 days after birth. After perinatal death, parents experience the process of perinatal grief. Midwives and nurses can develop interventions to improve the perinatal grief process. The aim of this review was to determine the efficacy of nursing interventions to facilitate the process of grief as a result of perinatal death. A systematic review of the literature was carried out. Studies that met the selection criteria underwent a quality assessment using the Joanna Briggs Institute critical appraisal tool. Four articles were selected out of the 640 found. Two are quasi-experimental studies, and two are randomized controlled clinical studies. The interventions that were analyzed positively improve psychological self-concept and role functions, as well as mutual commitment, depression, post-traumatic stress and symptoms of grief. These interventions are effective if they are carried out both before perinatal loss and after it has occurred. The support of health professionals for affected parents, their participation in the loss, expressing feelings and emotions, using distraction methods, group sessions, social support, physical activity, and family education are some of the effective interventions.
Topics: Emotions; Female; Grief; Humans; Parturition; Perinatal Death; Pregnancy; Social Support
PubMed: 34073728
DOI: 10.3390/ijerph18115587 -
International Journal of Environmental... May 2020Perinatal death (PD) is a painful experience, with physical, psychological and social consequences in families. Each year, there are 2.7 million perinatal deaths in the...
BACKGROUND
Perinatal death (PD) is a painful experience, with physical, psychological and social consequences in families. Each year, there are 2.7 million perinatal deaths in the world and about 2000 in Spain. The aim of this study was to explore, describe and understand the impact of perinatal death on parents' social and family life.
METHODS
A qualitative study based on Gadamer's hermeneutic phenomenology was used. In-depth interviews were conducted with 13 mothers and eight fathers who had suffered a perinatal death. Inductive analysis was used to find themes based on the data.
RESULTS
Seven sub-themes emerged, and they were grouped into two main themes: 1) perinatal death affects family dynamics, and 2) the social environment of the parents is severely affected after perinatal death.
CONCLUSIONS
PD impacts the family dynamics of the parents and their family, social and work environments. Parents perceive that society trivializes their loss and disallows or delegitimizes their grief.
IMPLICATIONS
Social care, health and education providers should pay attention to all family members who have suffered a PD. The recognition of the loss within the social and family environment would help the families to cope with their grief.
Topics: Adaptation, Psychological; Adult; Fathers; Female; Grief; Humans; Male; Mothers; Perinatal Death; Pregnancy; Social Support; Spain
PubMed: 32422977
DOI: 10.3390/ijerph17103421 -
Midwifery Jun 2023Pregnancy following perinatal loss has a profound effect on parents and may contribute to intense psychological distress including grief, post-traumatic stress disorder,... (Review)
Review
BACKGROUND
Pregnancy following perinatal loss has a profound effect on parents and may contribute to intense psychological distress including grief, post-traumatic stress disorder, anxiety and depression. The subsequent pregnancy may also be perceived as more stressful due to the fear of recurrent loss. Midwives and other health care professionals need to be sensitive and empathetic to the needs of these parents when providing care in a pregnancy subsequent to a loss.
METHODOLOGY
The aim of this integrated literature review was to explore parents' experiences of pregnancy following a previous perinatal loss using a systematic approach. This is presented in a five-stage process that includes problem identification, literature search, data extraction and evaluation, data analysis and presentation of results. A systematic search of seven electronic databases was conducted (Jan 2009 -Jan 2023) to identify relevant primary research which addressed parents' experiences of pregnancy following a previous perinatal loss. Seven papers met the eligibility criteria and were assessed for quality using Crowe's Critical Appraisal Tool (CCAT). Thematic analysis identified two themes.
FINDINGS
The key themes identified from the literature were; the psychosocial needs and challenges faced by previously bereaved parents in subsequent pregnancies; and the need for specialist care and support in a subsequent pregnancy. Psychological needs and challenges included continued grief, depression, anxiety, and disparities in the grief process between men and women. The importance of specialist care with an increased level of support from competent, confident and compassionate health care providers was highlighted.
CONCLUSION
The experience of pregnancy following a perinatal loss can be a complex emotional experience for parents. The review identifies the need for post pregnancy loss debriefing and counselling and care pathways specific to caring for women and their partners in a pregnancy subsequent to a perinatal loss. Care in pregnancy subsequent to loss should be provided by empathetic, competent health care providers and include additional antenatal clinic appointments, pregnancy monitoring and psychological support in order to meet the needs of these expectant parents.
Topics: Male; Humans; Female; Pregnancy; Grief; Parents; Abortion, Spontaneous; Emotions; Anxiety; Stillbirth; Perinatal Death
PubMed: 37037073
DOI: 10.1016/j.midw.2023.103673 -
The Cochrane Database of Systematic... Mar 2023Mechanical methods were the first methods developed to ripen the cervix and induce labour. During recent decades they have been substituted by pharmacological methods.... (Review)
Review
BACKGROUND
Mechanical methods were the first methods developed to ripen the cervix and induce labour. During recent decades they have been substituted by pharmacological methods. Potential advantages of mechanical methods, compared with pharmacological methods may include reduction in side effects that could improve neonatal outcomes. This is an update of a review first published in 2001, last updated in 2012.
OBJECTIVES
To determine the effectiveness and safety of mechanical methods for third trimester (> 24 weeks' gestation) induction of labour in comparison with prostaglandin E2 (PGE2) (vaginal and intracervical), low-dose misoprostol (oral and vaginal), amniotomy or oxytocin.
SEARCH METHODS
For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP), and reference lists of retrieved studies (9 January 2018). We updated the search in March 2019 and added the search results to the awaiting classification section of the review.
SELECTION CRITERIA
Clinical trials comparing mechanical methods used for third trimester cervical ripening or labour induction with pharmacological methods. Mechanical methods include: (1) the introduction of a catheter through the cervix into the extra-amniotic space with balloon insufflation; (2) introduction of laminaria tents, or their synthetic equivalent (Dilapan), into the cervical canal; (3) use of a catheter to inject fluid into the extra-amniotic space (EASI). This review includes the following comparisons: (1) specific mechanical methods (balloon catheter, laminaria tents or EASI) compared with prostaglandins (different types, different routes) or with oxytocin; (2) single balloon compared to a double balloon; (3) addition of prostaglandins or oxytocin to mechanical methods compared with prostaglandins or oxytocin alone.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion and assessed risk of bias. Two review authors independently extracted data and assessed the quality of the evidence using the GRADE approach.
MAIN RESULTS
This review includes a total of 112 trials, with 104 studies contributing data (22,055 women; 21 comparisons). Risk of bias of trials varied. Overall, the evidence was graded from very-low to moderate quality. All evidence was downgraded for lack of blinding and, for many comparisons, the effect estimates were too imprecise to make a valid judgement. Balloon versus vaginal PGE2: there may be little or no difference in vaginal deliveries not achieved within 24 hours (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.82 to 1.26; 7 studies; 1685 women; low-quality evidence) and there probably is little or no difference in caesarean sections (RR 1.00, 95% CI 0.92 to 1.09; 28 studies; 6619 women; moderate-quality evidence) between induction of labour with a balloon catheter and vaginal PGE2. A balloon catheter probably reduces the risk of uterine hyperstimulation with fetal heart rate (FHR) changes (RR 0.35, 95% CI 0.18 to 0.67; 6 studies; 1966 women; moderate-quality evidence), serious neonatal morbidity or perinatal death (RR 0.48, 95% CI 0.25 to 0.93; 8 studies; 2757 women; moderate-quality evidence) and may slightly reduce the risk of aneonatal intensive care unit (NICU) admission (RR 0.82, 95% CI 0.65 to 1.04; 3647 women; 12 studies; low-quality evidence). It is uncertain whether there is a difference in serious maternal morbidity or death (RR 0.20, 95% CI 0.01 to 4.12; 4 studies; 1481 women) or five-minute Apgar score < 7 (RR 0.74, 95% CI 0.49 to 1.14; 4271 women; 14 studies) because the quality of the evidence was found to be very low and low, respectively. Balloon versus low-dose vaginal misoprostol: it is uncertain whether there is a difference in vaginal deliveries not achieved within 24 hours between induction of labour with a balloon catheter and vaginal misoprostol (RR 1.09, 95% CI 0.85 to 1.39; 340 women; 2 studies; low-quality evidence). A balloon catheter probably reduces the risk of uterine hyperstimulation with FHR changes (RR 0.39, 95% CI 0.18 to 0.85; 1322 women; 8 studies; moderate-quality evidence) but may increase the risk of a caesarean section (RR 1.28, 95% CI 1.02 to 1.60; 1756 women; 12 studies; low-quality evidence). It is uncertain whether there is a difference in serious neonatal morbidity or perinatal death (RR 0.58, 95% CI 0.12 to 2.66; 381 women; 3 studies), serious maternal morbidity or death (no events; 4 studies, 464 women), both very low-quality evidence, and five-minute Apgar score < 7 (RR 1.00, 95% CI 0.50 to 1.97; 941 women; 7 studies) and NICU admissions (RR 1.00, 95% CI 0.61 to 1.63; 1302 women; 9 studies) both low-quality evidence. Balloon versus low-dose oral misoprostol: a balloon catheter probably increases the risk of a vaginal delivery not achieved within 24 hours (RR 1.28, 95% CI 1.13 to 1.46; 782 women, 2 studies, and probably slightly increases the risk of a caesarean section (RR 1.17, 95% CI 1.04 to 1.32; 3178 women; 7 studies; both moderate-quality evidence) when compared to oral misoprostol. It is uncertain whether there is a difference in uterine hyperstimulation with FHR changes (RR 0.81, 95% CI 0.48 to 1.38; 2033 women; 2 studies), serious neonatal morbidity or perinatal death (RR 1.11, 95% CI 0.60 to 2.06; 2627 women; 3 studies), both low-quality evidence, serious maternal morbidity or death (RR 0.50, 95% CI 0.05 to 5.52; 2627 women; 3 studies), very low-quality evidence, five-minute Apgar scores < 7 (RR 0.71, 95% CI 0.38 to 1.32; 2693 women; 4 studies) and NICU admissions (RR 0.82, 95% CI 0.58 to 1.17; 2873 women; 5 studies) both low-quality evidence.
AUTHORS' CONCLUSIONS
Low- to moderate-quality evidence shows mechanical induction with a balloon is probably as effective as induction of labour with vaginal PGE2. However, a balloon seems to have a more favourable safety profile. More research on this comparison does not seem warranted. Moderate-quality evidence shows a balloon catheter may be slightly less effective as oral misoprostol, but it remains unclear if there is a difference in safety outcomes for the neonate. When compared to low-dose vaginal misoprostol, low-quality evidence shows a balloon may be less effective, but probably has a better safety profile. Future research could be focused more on safety aspects for the neonate and maternal satisfaction.
Topics: Female; Humans; Infant, Newborn; Pregnancy; Cesarean Section; Dinoprostone; Labor, Induced; Misoprostol; Oxytocin; Perinatal Death
PubMed: 36996264
DOI: 10.1002/14651858.CD001233.pub4 -
Reproductive Health Jan 2021For most parents, getting pregnant means having a child. Generally, the couple outlines plans and has expectations regarding the baby. When these plans are interrupted...
The perinatal bereavement project: development and evaluation of supportive guidelines for families experiencing stillbirth and neonatal death in Southeast Brazil-a quasi-experimental before-and-after study.
BACKGROUND
For most parents, getting pregnant means having a child. Generally, the couple outlines plans and has expectations regarding the baby. When these plans are interrupted because of a perinatal loss, it turns out to be a traumatic experience for the family. Validating the grief of these losses has been a challenge to Brazilian society, which is evident considering the childbirth care offered to bereaved families in maternity wards. Positively assessed care that brings physical and emotional memories about the baby has a positive impact on the bereavement process that family undergoes. Therefore, this study aims to assess the effects supportive guidelines have on mental health. They were designed to assist grieving parents and their families while undergoing perinatal loss in public maternities in Ribeirão Preto, São Paulo state, Brazil.
METHOD
A mixed-methods (qualitative/quantitative), quasi-experimental (before/after) study. The intervention is the implementation of bereavement supportive guidelines for women who experienced a stillbirth or a neonatal death. A total of forty women will be included. Twenty participants will be assessed before and twenty will be assessed after the implementation of the guidelines. A semi-structured questionnaire and three scales will be used to assess the effects of the guidelines. Health care professionals and managers of all childbirth facilities will be invited to participate in focus group. Data will be analyzed using statistical tests, as well as thematic analysis approach.
DISCUSSION
The Perinatal Bereavement guidelines are a local adaptation of the Canadian and British corresponding guidelines. These guidelines have been developed based on the families' needs of baby memories during the bereavement process and include the following aspects: (1) Organization of care into periods, considering their respective needs along the process; (2) Creation of the Bereavement Professional figure in maternity wards; (3) Adequacy of the institutional environment; (4) Communication of the guidance; (5) Creation of baby memories. We expect that the current project generates additional evidence for improving the mental health of women and families that experience a perinatal loss. Trial registration RBR-3cpthr For many couples, getting pregnant does not only mean carrying a baby, but also having a child. Most of the time, the couple has already made many plans and has expectations towards the child. When these plans are interrupted because of a perinatal loss, it turns out to be a traumatic experience for the family. In Brazilian culture, validating this traumatic grief is very difficult, especially when it happens too soon. The barriers can be noticed not only by the way society deals with the parents' grief, but also when we see the care the grieving families receive from the health care establishment. Creating physical and emotional memories might bring the parents satisfaction regarding the care they receive when a baby dies. These memories can be built when there is good communication throughout the care received; shared decisions; the chance to see and hold the baby, as well as collect memories; privacy and continuous care during the whole process, including when there is a new pregnancy, childbirth and postnatal period. With this in mind, among the most important factors are the training of health staff and other professionals, the preparation of the maternity ward to support bereaved families and the continuous support to the professionals involved in the bereavement. This article proposes guidelines to support the families who are experiencing stillbirth and neonatal death. It may be followed by childbirth professionals (nurses, midwives, obstetricians and employees of a maternity ward), managers, researchers, policymakers or those interested in developing specific protocols for their maternity wards.
Topics: Bereavement; Brazil; Child; Female; Grief; Humans; Infant, Newborn; Parents; Perinatal Care; Perinatal Death; Postnatal Care; Practice Guidelines as Topic; Pregnancy; Professional-Patient Relations; Social Support; Stillbirth
PubMed: 33407643
DOI: 10.1186/s12978-020-01040-4 -
Nature Medicine Jan 2023Pregnancy loss and perinatal death are devastating events for families. We assessed 'genomic autopsy' as an adjunct to standard autopsy for 200 families who had...
Pregnancy loss and perinatal death are devastating events for families. We assessed 'genomic autopsy' as an adjunct to standard autopsy for 200 families who had experienced fetal or newborn death, providing a definitive or candidate genetic diagnosis in 105 families. Our cohort provides evidence of severe atypical in utero presentations of known genetic disorders and identifies novel phenotypes and disease genes. Inheritance of 42% of definitive diagnoses were either autosomal recessive (30.8%), X-linked recessive (3.8%) or autosomal dominant (excluding de novos, 7.7%), with risk of recurrence in future pregnancies. We report that at least ten families (5%) used their diagnosis for preimplantation (5) or prenatal diagnosis (5) of 12 pregnancies. We emphasize the clinical importance of genomic investigations of pregnancy loss and perinatal death, with short turnaround times for diagnostic reporting and followed by systematic research follow-up investigations. This approach has the potential to enable accurate counseling for future pregnancies.
Topics: Pregnancy; Humans; Female; Perinatal Death; Autopsy; Abortion, Spontaneous; Prenatal Diagnosis; Genomics
PubMed: 36658419
DOI: 10.1038/s41591-022-02142-1 -
The Turkish Journal of Pediatrics 2019Yuan SM, Lin H. Fetal intrapericardial teratomas. Turk J Pediatr 2019; 61: 153-158. Fetal intrapericardial teratomas are rare and benign. However, they can be... (Review)
Review
Yuan SM, Lin H. Fetal intrapericardial teratomas. Turk J Pediatr 2019; 61: 153-158. Fetal intrapericardial teratomas are rare and benign. However, they can be life-threatening owing to the complicated massive pericardial effusions, tamponade, or cardiorespiratory distress. The purpose of this review is to give an overview on clinical features, management and prognoses of fetal intrapericardial teratomas. The materials of this study were based on a comprehensive literature retrieval of fetal intrapericardial teratomas published in the past two decades. It was noteworthy that fetal pericardial/pleural effusions or ascites were detected since 19-week gestation, and tumors could be found since 21-week gestation. A growing trend of tumors was observed in more than half of the cases. Prenatal centesis and postnatal tumor resection were required in most of the cases. Fetoneonatal deaths (including fetal demise, termination of pregnancy and neonatal death) occurred in one-third of the cases. The neonatal survival rate was 59.4%. Symptomatic fetuses usually required perinatal maneuvers, such as pericardiocentesis, or thoraco-/ pericardio-amniotic shunt in order to improve fetal hemodynamic status and prolong the pregnancy for lung maturity. Open fetal surgery and ex utero intrapartum treatment (EXIT) procedure can be considered, however, impact of EXIT procedure on later delivery remains uncertain. Postnatal operation is a curative and symptom-relieving method for those cases with prenatally diagnosed intrapericardial teratomas. As a result, the fetoneonatal outcomes are somewhat promising.
Topics: Abortion, Induced; Female; Fetal Death; Fetal Heart; Heart Neoplasms; Humans; Hydrops Fetalis; Infant, Newborn; Paracentesis; Pericardial Effusion; Perinatal Death; Pregnancy; Prenatal Diagnosis; Teratoma
PubMed: 31951327
DOI: 10.24953/turkjped.2019.02.001 -
The Cochrane Database of Systematic... Dec 2020Stillbirth is generally defined as a death prior to birth at or after 22 weeks' gestation. It remains a major public health concern globally. Antenatal interventions may... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Stillbirth is generally defined as a death prior to birth at or after 22 weeks' gestation. It remains a major public health concern globally. Antenatal interventions may reduce stillbirths and improve maternal and neonatal outcomes in settings with high rates of stillbirth. There are several key antenatal strategies that aim to prevent stillbirth including nutrition, and prevention and management of infections.
OBJECTIVES
To summarise the evidence from Cochrane systematic reviews on the effects of antenatal interventions for preventing stillbirth for low risk or unselected populations of women.
METHODS
We collaborated with Cochrane Pregnancy and Childbirth's Information Specialist to identify all their published reviews that specified or reported stillbirth; and we searched the Cochrane Database of Systematic Reviews (search date: 29 Feburary 2020) to identify reviews published within other Cochrane groups. The primary outcome measure was stillbirth but in the absence of stillbirth data, we used perinatal mortality (both stillbirth and death in the first week of life), fetal loss or fetal death as outcomes. Two review authors independently evaluated reviews for inclusion, extracted data and assessed quality of evidence using AMSTAR (A Measurement Tool to Assess Reviews) and GRADE tools. We assigned interventions to categories with graphic icons to classify the effectiveness of interventions as: clear evidence of benefit or harm; clear evidence of no effect or equivalence; possible benefit or harm; or unknown benefit or harm or no effect or equivalence.
MAIN RESULTS
We identified 43 Cochrane Reviews that included interventions in pregnant women with the potential for preventing stillbirth; all of the included reviews reported our primary outcome 'stillbirth' or in the absence of stillbirth, 'perinatal death' or 'fetal loss/fetal death'. AMSTAR quality was high in 40 reviews with scores ranging from 8 to 11 and moderate in three reviews with a score of 7. Nutrition interventions Clear evidence of benefit: balanced energy/protein supplementation versus no supplementation suggests a probable reduction in stillbirth (risk ratio (RR) 0.60, 95% confidence interval (CI) 0.39 to 0.94, 5 randomised controlled trials (RCTs), 3408 women; moderate-certainty evidence). Clear evidence of no effect or equivalence for stillbirth or perinatal death: vitamin A alone versus placebo or no treatment; and multiple micronutrients with iron and folic acid versus iron with or without folic acid. Unknown benefit or harm or no effect or equivalence: for all other nutrition interventions examined the effects were uncertain. Prevention and management of infections Possible benefit for fetal loss or death: insecticide-treated anti-malarial nets versus no nets (RR 0.67, 95% CI 0.47 to 0.97, 4 RCTs; low-certainty). Unknown evidence of no effect or equivalence: drugs for preventing malaria (stillbirth RR 1.02, 95% CI 0.76 to 1.36, 5 RCTs, 7130 women, moderate certainty in women of all parity; perinatal death RR 1.24, 95% CI 0.94 to 1.63, 4 RCTs, 5216 women, moderate-certainty in women of all parity). Prevention, detection and management of other morbidities Clear evidence of benefit: the following interventions suggest a reduction: midwife-led models of care in settings where the midwife is the primary healthcare provider particularly for low-risk pregnant women (overall fetal loss/neonatal death reduction RR 0.84, 95% CI 0.71 to 0.99, 13 RCTs, 17,561 women; high-certainty), training versus not training traditional birth attendants in rural populations of low- and middle-income countries (stillbirth reduction odds ratio (OR) 0.69, 95% CI 0.57 to 0.83, 1 RCT, 18,699 women, moderate-certainty; perinatal death reduction OR 0.70, 95% CI 0.59 to 0.83, 1 RCT, 18,699 women, moderate-certainty). Clear evidence of harm: a reduced number of antenatal care visits probably results in an increase in perinatal death (RR 1.14 95% CI 1.00 to 1.31, 5 RCTs, 56,431 women; moderate-certainty evidence). Clear evidence of no effect or equivalence: there was evidence of no effect in the risk of stillbirth/fetal loss or perinatal death for the following interventions and comparisons: psychosocial interventions; and providing case notes to women. Possible benefit: community-based intervention packages (including community support groups/women's groups, community mobilisation and home visitation, or training traditional birth attendants who made home visits) may result in a reduction of stillbirth (RR 0.81, 95% CI 0.73 to 0.91, 15 RCTs, 201,181 women; low-certainty) and perinatal death (RR 0.78, 95% CI 0.70 to 0.86, 17 RCTs, 282,327 women; low-certainty). Unknown benefit or harm or no effect or equivalence: the effects were uncertain for other interventions examined. Screening and management of fetal growth and well-being Clear evidence of benefit: computerised antenatal cardiotocography for assessing infant's well-being in utero compared with traditional antenatal cardiotocography (perinatal mortality reduction RR 0.20, 95% CI 0.04 to 0.88, 2 RCTs, 469 women; moderate-certainty). Unknown benefit or harm or no effect or equivalence: the effects were uncertain for other interventions examined.
AUTHORS' CONCLUSIONS
While most interventions were unable to demonstrate a clear effect in reducing stillbirth or perinatal death, several interventions suggested a clear benefit, such as balanced energy/protein supplements, midwife-led models of care, training versus not training traditional birth attendants, and antenatal cardiotocography. Possible benefits were also observed for insecticide-treated anti-malarial nets and community-based intervention packages, whereas a reduced number of antenatal care visits were shown to be harmful. However, there was variation in the effectiveness of interventions across different settings, indicating the need to carefully understand the context in which these interventions were tested. Further high-quality RCTs are needed to evaluate the effects of antenatal preventive interventions and which approaches are most effective to reduce the risk of stillbirth. Stillbirth (or fetal death), perinatal and neonatal death need to be reported separately in future RCTs of antenatal interventions to allow assessment of different interventions on these rare but important outcomes and they need to clearly define the target populations of women where the intervention is most likely to be of benefit. As the high burden of stillbirths occurs in low- and middle-income countries, further high-quality trials need to be conducted in these settings as a priority.
Topics: Cardiotocography; Female; Fetal Death; Fetal Development; Humans; Infant, Newborn; Insecticide-Treated Bednets; Midwifery; Nutrition Assessment; Perinatal Death; Pregnancy; Prenatal Care; Randomized Controlled Trials as Topic; Stillbirth; Systematic Reviews as Topic
PubMed: 33336827
DOI: 10.1002/14651858.CD009599.pub2