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1.
Pharmacoepidemiol Drug Saf ; 2022 Apr 14.
Article in English | MEDLINE | ID: covidwho-1797776

ABSTRACT

PURPOSE: Women infected with SARS-CoV-2 during pregnancy are at increased risk of developing severe illness and experience a higher rate of preterm births than pregnant women who are not infected. The use of innovative or repurposed therapies to treat COVID-19 patients is widespread; however, there are very limited data regarding the patterns of use and safety profile of most of these therapeutics in pregnant women. We assessed the patterns of use of COVID-19 therapeutics during pregnancy using data from the International Registry of Coronavirus in Pregnancy (IRCEP). METHODS: The IRCEP is an international observational cohort study intended to assess the risk of major obstetric and neonatal outcomes among pregnant women with COVID-19. Women enrolled while pregnant or within 6 months after end of pregnancy. Follow-up for women enrolled while pregnant includes monthly online questionnaires throughout the pregnancy and, for live births, through the infant's first 90 days of life. Participants provide information on demographic characteristics, health history, COVID-19 tests and symptoms, medications, and obstetric and neonatal outcomes. RESULTS: A total of 5780 women with COVID-19 during pregnancy were identified from the IRCEP. Severity of COVID-19 was classified in 372 of them as severe, 3053 moderate, and 2355 mild. The most frequently reported COVID-19 therapies, other than analgesics, included azithromycin (12.8%), steroids (3.5%), interferon (2.4%), oseltamivir (2.1%), chloroquine/hydroxychloroquine (1.7%), anticoagulants (2.0%), antibodies (0.9%), and remdesivir (0.3%). Most drugs were preferentially used for severe cases. Patterns of use varied by country. CONCLUSIONS: IRCEP participants reported use of therapeutics for COVID-19 during pregnancy for which there is little safety information. Findings on COVID-19 pharmacotherapy utilization patterns can guide future studies examining the safety of COVID-19 therapies during pregnancy.

2.
Am J Epidemiol ; 2022 Mar 08.
Article in English | MEDLINE | ID: covidwho-1730633

ABSTRACT

Limited data are available about the potential health effects of infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on pregnant women and their developing offspring. We developed the International Registry of Coronavirus Exposure in Pregnancy (IRCEP) to provide data on the risk of major adverse obstetric and neonatal outcomes among women with varying degrees of severity and timing of COVID-19 exposure during pregnancy. We describe here the cohort and share the lessons learned. The IRCEP enrolls women tested for SARS-CoV-2 or with a clinical diagnosis of COVID-19 during pregnancy and obtains information using an online data collection system. By March 2021, 17,532 participants from 77 countries had enrolled; 54% enrolled during pregnancy and 46% afterwards. Among women with symptomatic COVID-19 with a positive SARS-CoV-2 test (N=4,934), symptoms were mild in 41%, moderate in 52% and severe in 7%; 7.7% were hospitalized for COVID-19 and 1.7% were admitted to an intensive care unit. The biggest challenges were retention of participants enrolled during pregnancy, and the potential bias introduced when participants enroll after pregnancy outcomes are known. Multiple biases need to be considered and addressed when estimating and interpreting the effects of COVID-19 in pregnancy in these types of cohorts.

3.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-324199

ABSTRACT

Background: Pregnant and postpartum women face unique challenges and concerns during the COVID-19 pandemic. Thus far, no studies have explored the factors associated with increased levels of worry in this population globally. The current study sought to assess the frequency and sources of worry during the COVID-19 pandemic in an international sample of pregnant and postpartum women. Methods: We conducted an anonymous, online, cross-sectional survey in 64 countries between May and June 2020. The survey was available in 12 languages and hosted on the Pregistry platform for COVID-19 studies. Participants were sought mainly on social media platforms and online parenting forums. The survey included questions related to demographics, level of worry, support, stress, COVID-19 exposure, frequency of media usage, and mental health indicators. Results: The study included 7,561 participants. Eighty-three percent of all participants indicated that they were either ‘somewhat’ or ‘very’ worried. Women 13-28 weeks pregnant were significantly more likely to indicate that they were ‘very worried’ compared to those who were postpartum or at other stages of pregnancy. When compared with women living in Europe, those in Africa, Asia and Pacific, North America and South/Latin America were more likely to have increased levels of worry, as were those who more frequently interacted with social media. Different forms of support and stress also had an impact upon level of worry, while indicators of stress and anxiety were positively associated with worry level. Conclusion: Pregnant and postpartum women are vulnerable to the changes in societal norms brought about by the COVID-19 pandemic. Understanding the factors associated with levels of worry within this population will enable society to address potential unmet needs and improve the current and future mental health of parents and children.

4.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-321746

ABSTRACT

Background: With the development of multiple effective vaccines, reducing the global morbidity and mortality of COVID-19 will depend on the distribution, and ultimately acceptance, of COVID-19 vaccination. Estimates of global vaccine acceptance among pregnant women and mothers of young children are yet unknown. An understanding of the challenges and correlates to vaccine acceptance will aid the acceleration of vaccine administration within these key populations.Methods: Acceptance of COVID-19 vaccination among pregnant women and mothers of children younger than 18-year-old, as well as potential predictors, were assessed through an online survey. This survey was administered by Pregistry on several online platforms between October 28 and November 18, 2020.Findings: 17,871 total survey responses from 16 countries were obtained. Given a 90% COVID-19 vaccine efficacy, 52·0% of pregnant women (n=2747/5282) and 73·4% of non-pregnant women (n=9214/12562) indicated an intention to receive the vaccine. 69·2% of mothers (n=11800/17054), both pregnant and non-pregnant, indicated an intention to vaccinate their young children. Vaccine acceptance was generally highest in India, the Philippines, and all sampled countries in Latin America;it was lowest in Russia, the United States, and Australia. The strongest predictors of vaccine acceptance included confidence in vaccine safety or effectiveness, worrying about COVID-19, belief in the importance of vaccines to their own country, compliance to mask guidelines, trust of public health agencies, monitoring news media coverage of COVID-19 as well as general vaccine attitude.Interpretations: COVID-19 vaccine acceptance and its predictors among women vary globally. Current acceptance levels of a COVID-19 vaccine among women from the high-income countries included in this study are insufficient to meet the requirements for community immunity. Perceived risk of the virus and the disease, and public trust play key roles shaping the vaccine acceptance and confidence on top of the existing pre-COVID 19 vaccine attitudes.Funding Statement: Human Immunomics Initiative at the Harvard TH Chan School of Public Health;Pregistry, LLCDeclaration of Interests: The authors disclose no potential conflicts of interest.Ethics Approval Statement: The study was classified exempt by the Harvard Longwood Campus Institutional Review Board (HLC IRB) per the regulations found at 45 CFR 46.104(d)(2) on the basis that it poses no greater than minimal risk and that the recorded information cannot readily identify the subject (directly or indirectly). The study protocol was reviewed and approved by the ethical review committee of Harvard Longwood Campus.

5.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-306206

ABSTRACT

Background: As mass vaccination campaigns against COVID-19 accelerate worldwide, there remains only limited evidence regarding vaccine effectiveness (VE) among pregnant women. Pregnant women have been shown to be at risk for severe COVID-19, resulting in adverse obstetrics outcomes, and their immune system is known to undergo alterations during pregnancy. Phase III clinical trials of the approved mRNA COVID-19 vaccines excluded pregnant women, yet current guidelines encourage offering the vaccine to pregnant women. In this study, we examine data from Israel’s largest healthcare organization to evaluate the effectiveness of the BNT162b2 mRNA vaccine among pregnant women. Methods: : We conducted an observational cohort study of pregnant women 16 years or older, with no history of SARS-CoV-2, who were vaccinated between December 20, 2020 and June 3, 2021. Vaccinated subjects were matched to unvaccinated controls according to a set of demographic and clinical characteristics. Study outcomes included documented infection with SARS-CoV-2, symptomatic COVID-19, COVID-19-related hospitalization, severe illness and death. For each outcome, VE was estimated at several periods following vaccination as one minus the risk ratio using the Kaplan–Meier estimator. Results: : 10,861 vaccinated women were matched to an identical number of unvaccinated controls. Estimated VE from 7 through 28 days after the second dose was 97% (95% CI 91%-100%) for any documented infection, 96% (86-100%) for infections with documented symptoms, and 85% (32%-100%) for COVID-19-related hospitalization. Only one event of severe illness was observed in the unvaccinated group, and no deaths were observed in either group -- insufficient incidence for estimating VE for these outcomes. Discussion: The BNT162b2 mRNA vaccine was found to have high VE among pregnant women. Since high VE has been reported as one of the strongest predictors of COVID-19 vaccine acceptance among pregnant women, the high VE estimates found in this study have the potential to increase vaccine acceptance in this group. In addition, the present VE estimates are similar to those reported in the general population for the same variants, suggesting that it may be possible to infer the VE for pregnant women from studies in the general population for both current and future variants.

7.
BMC Pregnancy Childbirth ; 21(1): 768, 2021 Nov 12.
Article in English | MEDLINE | ID: covidwho-1528682

ABSTRACT

BACKGROUND: Pregnant and postpartum women face unique challenges and concerns during the COVID-19 pandemic. Thus far, no studies have explored the factors associated with increased levels of worry in this population globally. The current study sought to assess the frequency and sources of worry during the COVID-19 pandemic in an international sample of pregnant and postpartum women. METHODS: We conducted an anonymous, online, cross-sectional survey in 64 countries between May and June 2020. The survey was available in 12 languages and hosted on the Pregistry platform for COVID-19 studies. Participants were sought mainly on social media platforms and online parenting forums. The survey included questions related to demographics, level of worry, support, stress, COVID-19 exposure, frequency of media usage, and mental health indicators. RESULTS: The study included 7561 participants. Eighty-three percent of all participants indicated that they were either 'somewhat' or 'very' worried. Women 13-28 weeks pregnant were significantly more likely to indicate that they were 'very worried' compared to those who were postpartum or at other stages of pregnancy. When compared with women living in Europe, those in Africa, Asia and Pacific, North America and South/Latin America were more likely to have increased levels of worry, as were those who more frequently interacted with social media. Different forms of support and stress also had an impact upon level of worry, while indicators of stress and anxiety were positively associated with worry level. CONCLUSION: Pregnant and postpartum women are vulnerable to the changes in societal norms brought about by the COVID-19 pandemic. Understanding the factors associated with levels of worry within this population will enable society to address potential unmet needs and improve the current and future mental health of parents and children.


Subject(s)
Anxiety/etiology , COVID-19/psychology , Pregnancy Complications/etiology , Adolescent , Adult , Anxiety/epidemiology , Anxiety/psychology , Cross-Sectional Studies , Female , Global Health/statistics & numerical data , Health Surveys , Humans , Logistic Models , Odds Ratio , Postpartum Period/psychology , Pregnancy , Pregnancy Complications/epidemiology , Pregnancy Complications/psychology , Risk Factors , Stress, Psychological/epidemiology , Stress, Psychological/etiology , Stress, Psychological/psychology , Young Adult
8.
Nat Med ; 27(10): 1693-1695, 2021 10.
Article in English | MEDLINE | ID: covidwho-1526092

ABSTRACT

To evaluate the effectiveness of the BNT162b2 messenger RNA vaccine in pregnant women, we conducted an observational cohort study of pregnant women aged 16 years or older, with no history of SARS-CoV-2, who were vaccinated between 20 December 2020 and 3 June 2021. A total of 10,861 vaccinated pregnant women were matched to 10,861 unvaccinated pregnant controls using demographic and clinical characteristics. Study outcomes included documented infection with SARS-CoV-2, symptomatic COVID-19, COVID-19-related hospitalization, severe illness and death. Estimated vaccine effectiveness from 7 through to 56 d after the second dose was 96% (95% confidence interval 89-100%) for any documented infection, 97% (91-100%) for infections with documented symptoms and 89% (43-100%) for COVID-19-related hospitalization. Only one event of severe illness was observed in the unvaccinated group and no deaths were observed in either group. In summary, the BNT162b2 mRNA vaccine was estimated to have high vaccine effectiveness in pregnant women, which is similar to the effectiveness estimated in the general population.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , Pregnancy Complications, Infectious/prevention & control , Adolescent , Adult , COVID-19/epidemiology , COVID-19/virology , COVID-19 Vaccines/administration & dosage , Cohort Studies , Female , Humans , Incidence , Pregnancy , SARS-CoV-2/isolation & purification , Young Adult
9.
Am J Epidemiol ; 190(11): 2339-2349, 2021 11 02.
Article in English | MEDLINE | ID: covidwho-1493666

ABSTRACT

We assessed the teratogenicity of tenofovir, a human immunodeficiency virus (HIV) drug similar to remdesivir that is currently being evaluated for the treatment of coronavirus disease 2019 (COVID-19). Using US Medicaid Analytic eXtract (MAX) claims data (2000-2014), we identified a population-based pregnancy cohort of women with HIV who filled at least 1 prescription for antiretroviral therapies (ART) during the first trimester. Women on tenofovir disoproxil fumarate (TDF) were compared with women receiving ART without TDF. Major malformations were identified by International Classification of Diseases, Ninth Revision, codes using validated algorithms. Relative risks and 95% confidence intervals were estimated using propensity score stratification to control for potential confounders. We incorporated the results into prior knowledge by conducting a systematic literature review and a meta-analysis. Major congenital malformations were diagnosed in 37 out of 866 (4.27%) infants exposed to TDF and 38 out of 1,020 (3.73%) infants exposed to ART other than TDF; the adjusted relative risk was 1.21 (95% confidence interval: 0.77, 1.90). Estimates for specific malformations were imprecise. The pooled relative risk from the meta-analysis with 6 prior studies was 0.88 (95% confidence interval: 0.75, 1.03). Based on evidence accumulated in patients with HIV, first-trimester TDF use does not increase the risk of major congenital malformations overall in the newborn compared with other ART.


Subject(s)
Antiviral Agents/adverse effects , Pregnancy Complications, Infectious/drug therapy , Tenofovir/adverse effects , Adult , Anti-HIV Agents/therapeutic use , Antiviral Agents/therapeutic use , COVID-19/drug therapy , COVID-19/epidemiology , Cohort Studies , Female , HIV Infections/drug therapy , Humans , Pandemics , Pregnancy , Pregnancy Outcome , Pregnant Women , Reverse Transcriptase Inhibitors/adverse effects , Reverse Transcriptase Inhibitors/therapeutic use , SARS-CoV-2 , Tenofovir/therapeutic use
11.
J Matern Fetal Neonatal Med ; : 1-9, 2021 Jun 22.
Article in English | MEDLINE | ID: covidwho-1279993

ABSTRACT

BACKGROUND: Stress is a complex condition that can have a profound effect on an individual's sense of wellbeing and their ability to live a happy and healthy life. COVID-19 and its associated stressors have the potential to disrupt numerous facets of our everyday lives. Pregnant and postpartum women are especially vulnerable to changes in the availability of routine health and social care services and of their support networks. The current study sought to explore stress levels and their influencers among an international cohort of pregnant and postpartum women during the COVID-19 pandemic. METHODS: We conducted an anonymous, online, cross-sectional survey in 64 countries between May and June 2020. The survey was hosted on the Pregistry platform and made available in 12 languages, with respondents sought through a variety of social media platforms and parenting forums. In addition to levels of stress, we collected data related to demographics, COVID-19 exposure and worries, lifestyle changes, traditional and social media use, precautionary measures related to COVID-19, and mental health. RESULTS: In total, 7185 women were included in our sample. We found statistically significant (p-value <0.05) reductions in stress score among older women (≥35 years of age), those either living with a partner or married, those who had graduated from college, and those with medical coverage. Higher stress scores were found among women who resided in Africa, Asia and the Pacific, the Middle East, and North America compared with those in Europe. When race and ethnicity were included in the model, black women were found to have higher stress compared to white women. Level of family and community support was inversely associated with level of stress. CONCLUSION: Our study is one of the first to explore stress levels among pregnant and postpartum women during the COVID-19 pandemic. We found statistically significant differences in stress levels by age, education, marital status, region of residence, race/ethnicity and level of support. Understanding stress during the COVID-19 pandemic, and exploring ways to address it, will be key to contributing to the mental and physical health of expectant and new mothers, as well as their children, in both the short and long term.

12.
PLoS One ; 16(4): e0249780, 2021.
Article in English | MEDLINE | ID: covidwho-1197377

ABSTRACT

Pregnant and postpartum women face unique challenges during the COVID-19 pandemic that may put them at elevated risk of mental health problems. However, few large-scale and no cross-national studies have been conducted to date that investigate modifiable pandemic-related behavioral or cognitive factors that may influence mental health in this vulnerable group. This international study sought to identify and measure the associations between pandemic-related information seeking, worries, and prevention behaviors on perinatal mental health during the COVID-19 pandemic. An anonymous, online, cross-sectional survey of pregnant and postpartum women was conducted in 64 countries between May 26, 2020 and June 13, 2020. The survey, available in twelve languages, was hosted on the Pregistry platform for COVID-19 studies (https://corona.pregistry.com) and advertised in social media channels and online parenting forums. Participants completed measures on demographics, COVID-19 exposure and worries, information seeking, COVID-19 prevention behaviors, and mental health symptoms including posttraumatic stress via the IES-6, anxiety/depression via the PHQ-4, and loneliness via the UCLA-3. Of the 6,894 participants, substantial proportions of women scored at or above the cut-offs for elevated posttraumatic stress (2,979 [43%]), anxiety/depression (2,138 [31%], and loneliness (3,691 [53%]). Information seeking from any source (e.g., social media, news, talking to others) five or more times per day was associated with more than twice the odds of elevated posttraumatic stress and anxiety/depression, in adjusted models. A majority of women (86%) reported being somewhat or very worried about COVID-19. The most commonly reported worries were related to pregnancy and delivery, including family being unable to visit after delivery (59%), the baby contracting COVID-19 (59%), lack of a support person during delivery (55%), and COVID-19 causing changes to the delivery plan (41%). Greater worries related to children (i.e., inadequate childcare, their infection risk) and missing medical appointments were associated with significantly higher odds of posttraumatic stress, anxiety/depression and loneliness. Engaging in hygiene-related COVID-19 prevention behaviors (face mask-wearing, washing hands, disinfecting surfaces) were not related to mental health symptoms or loneliness. Elevated posttraumatic stress, anxiety/depression, and loneliness are highly prevalent in pregnant and postpartum women across 64 countries during the COVID-19 pandemic. Excessive information seeking and worries related to children and medical care are associated with elevated symptoms, whereas engaging in hygiene-related preventive measures were not. In addition to screening and monitoring mental health symptoms, addressing excessive information seeking and women's worries about access to medical care and their children's well-being, and developing strategies to target loneliness (e.g., online support groups) should be part of intervention efforts for perinatal women. Public health campaigns and medical care systems need to explicitly address the impact of COVID-19 related stressors on mental health in perinatal women, as prevention of viral exposure itself does not mitigate the pandemic's mental health impact.


Subject(s)
COVID-19/epidemiology , COVID-19/psychology , Mental Disorders/epidemiology , Mental Health , Pregnancy/psychology , Adult , Anxiety/epidemiology , Anxiety/psychology , Cross-Sectional Studies , Depression/epidemiology , Depression/psychology , Female , Humans , Loneliness/psychology , Middle Aged , Pandemics , Parturition/psychology , Perinatal Care , Postpartum Period/psychology , SARS-CoV-2/isolation & purification , Stress, Psychological/epidemiology , Stress, Psychological/etiology , Surveys and Questionnaires , Women's Health
13.
Am J Epidemiol ; 190(11): 2339-2349, 2021 11 02.
Article in English | MEDLINE | ID: covidwho-1180572

ABSTRACT

We assessed the teratogenicity of tenofovir, a human immunodeficiency virus (HIV) drug similar to remdesivir that is currently being evaluated for the treatment of coronavirus disease 2019 (COVID-19). Using US Medicaid Analytic eXtract (MAX) claims data (2000-2014), we identified a population-based pregnancy cohort of women with HIV who filled at least 1 prescription for antiretroviral therapies (ART) during the first trimester. Women on tenofovir disoproxil fumarate (TDF) were compared with women receiving ART without TDF. Major malformations were identified by International Classification of Diseases, Ninth Revision, codes using validated algorithms. Relative risks and 95% confidence intervals were estimated using propensity score stratification to control for potential confounders. We incorporated the results into prior knowledge by conducting a systematic literature review and a meta-analysis. Major congenital malformations were diagnosed in 37 out of 866 (4.27%) infants exposed to TDF and 38 out of 1,020 (3.73%) infants exposed to ART other than TDF; the adjusted relative risk was 1.21 (95% confidence interval: 0.77, 1.90). Estimates for specific malformations were imprecise. The pooled relative risk from the meta-analysis with 6 prior studies was 0.88 (95% confidence interval: 0.75, 1.03). Based on evidence accumulated in patients with HIV, first-trimester TDF use does not increase the risk of major congenital malformations overall in the newborn compared with other ART.


Subject(s)
Antiviral Agents/adverse effects , Pregnancy Complications, Infectious/drug therapy , Tenofovir/adverse effects , Adult , Anti-HIV Agents/therapeutic use , Antiviral Agents/therapeutic use , COVID-19/drug therapy , COVID-19/epidemiology , Cohort Studies , Female , HIV Infections/drug therapy , Humans , Pandemics , Pregnancy , Pregnancy Outcome , Pregnant Women , Reverse Transcriptase Inhibitors/adverse effects , Reverse Transcriptase Inhibitors/therapeutic use , SARS-CoV-2 , Tenofovir/therapeutic use
14.
Eur J Epidemiol ; 36(2): 197-211, 2021 Feb.
Article in English | MEDLINE | ID: covidwho-1111293

ABSTRACT

With the development of multiple effective vaccines, reducing the global morbidity and mortality of COVID-19 will depend on the distribution and acceptance of COVID-19 vaccination. Estimates of global vaccine acceptance among pregnant women and mothers of young children are yet unknown. An understanding of the challenges and correlates to vaccine acceptance will aid the acceleration of vaccine administration within these populations. Acceptance of COVID-19 vaccination among pregnant women and mothers of children younger than 18-years-old, as well as potential predictors, were assessed through an online survey, administered by Pregistry between October 28 and November 18, 2020. 17,871 total survey responses from 16 countries were obtained. Given a 90% COVID-19 vaccine efficacy, 52.0% of pregnant women (n = 2747/5282) and 73.4% of non-pregnant women (n = 9214/12,562) indicated an intention to receive the vaccine. 69.2% of women (n = 11,800/17,054), both pregnant and non-pregnant, indicated an intention to vaccinate their children. Vaccine acceptance was generally highest in India, the Philippines, and all sampled countries in Latin America; it was lowest in Russia, the United States and Australia. The strongest predictors of vaccine acceptance included confidence in vaccine safety or effectiveness, worrying about COVID-19, belief in the importance of vaccines to their own country, compliance to mask guidelines, trust of public health agencies/health science, as well as attitudes towards routine vaccines. COVID-19 vaccine acceptance and its predictors among women vary globally. Vaccination campaigns for women and children should be specific for each country in order to attain the largest impact.


Subject(s)
COVID-19 Vaccines/therapeutic use , COVID-19/prevention & control , Health Knowledge, Attitudes, Practice , Patient Acceptance of Health Care/psychology , Patient Acceptance of Health Care/statistics & numerical data , Pregnancy Complications, Infectious/prevention & control , Adolescent , Adult , Aged , Child , Child, Preschool , Female , Humans , Intention , Internationality , Middle Aged , Mothers/psychology , Mothers/statistics & numerical data , Pregnancy , Pregnant Women/psychology , SARS-CoV-2 , Young Adult
15.
Am J Obstet Gynecol ; 224(3): 290.e1-290.e22, 2021 03.
Article in English | MEDLINE | ID: covidwho-778326

ABSTRACT

BACKGROUND: Hydroxychloroquine is generally considered safe in pregnancy for the treatment of rheumatic conditions, but studies have been too small to evaluate teratogenicity. Quantifying the risk of congenital malformations associated with early pregnancy exposure to hydroxychloroquine is important in both the context of its ongoing use for rheumatological disorders and its potential future use for coronavirus disease 2019 prophylaxis, for which a number of clinical trials are ongoing despite initial trials for coronavirus disease 2019 treatment having been negative. OBJECTIVE: The study objective was to evaluate the risk of major congenital malformations associated with exposure to hydroxychloroquine during the first trimester of pregnancy, the period of organogenesis. STUDY DESIGN: We performed a population-based cohort study nested in the Medicaid Analytic eXtract (MAX, 2000-2014) and IBM MarketScan Research Database (MarketScan, 2003-2015). The source cohort included 2045 hydroxychloroquine-exposed pregnancies and 3,198,589 pregnancies not exposed to hydroxychloroquine continuously enrolled in their respective insurance program for 3 months before the last menstrual period through at least 1 month after delivery; infants were enrolled for at least 3 months after birth. We compared the risk of congenital malformations in women using hydroxychloroquine during the first trimester of pregnancy with that of those not using hydroxychloroquine, restricting the cohort to women with rheumatic disorders and using propensity score matching to control for indication, demographics, medical comorbidities, and concomitant medications (1867 hydroxychloroquine-exposed pregnancies and 19,080 pregnancies not exposed to hydroxychloroquine). The outcomes considered included major congenital malformations diagnosed during the first 90 days after delivery and specific malformation types for which there were at least 5 exposed events: oral cleft, cardiac, respiratory, gastrointestinal, genital, urinary, musculoskeletal, and limb defects. RESULTS: Overall, 54.8 per 1000 infants exposed to hydroxychloroquine were born with a major congenital malformation versus 35.3 per 1000 unexposed infants, corresponding to an unadjusted relative risk of 1.51 (95% confidence interval, 1.27-1.81). Patient characteristics were balanced in the restricted, propensity score-matched cohort. The adjusted relative risk was 1.26 (95% confidence interval, 1.04-1.54); it was 1.33 (95% confidence interval, 1.08-1.65) for a daily dose of ≥400 mg and 0.95 (95% confidence interval, 0.60-1.50) for a daily dose of <400 mg. Among the different malformation groups considered, more substantial increases in the risk of oral clefts, respiratory anomalies, and urinary defects were observed, although estimates were imprecise. No pattern of malformation was identified. CONCLUSION: Our findings suggest a small increase in the risk of malformations associated with first-trimester hydroxychloroquine use. For most patients with autoimmune rheumatic disorders, the benefits of treatment during pregnancy will likely outweigh this risk. If hydroxychloroquine were shown to be effective for coronavirus disease 2019 prophylaxis in ongoing trials, the risk of malformations would need to be balanced against such benefits.


Subject(s)
Abnormalities, Drug-Induced/etiology , Hydroxychloroquine/adverse effects , Pregnancy Complications/drug therapy , Adult , COVID-19/prevention & control , Female , Humans , Pregnancy , SARS-CoV-2
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