Monitoring for Adverse Pregnancy Outcomes Related to Drug Exposure during Pregnancy

1990 ◽  
pp. 99-99
Author(s):  
E. Andrews ◽  
P. Tennis
Keyword(s):  
Pregnancy Outcomes ◽  
Drug Exposure ◽  
Adverse Pregnancy Outcomes ◽  
Exposure During Pregnancy ◽  
Adverse Pregnancy

scholarly journals Protocol of a prospective and multicentre China Teratology Birth Cohort (CTBC): association of maternal drug exposure during pregnancy with adverse pregnancy outcomes

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yangwen Zhou ◽  
Jing Tao ◽  
Ke Wang ◽  
Kui Deng ◽  
Yanping Wang ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Birth Cohort ◽  
Birth Defects ◽  
Gestational Age ◽  
Pregnancy Outcomes ◽  
Drug Exposure ◽  
Adverse Pregnancy Outcomes ◽  
Link Type ◽  
Exposure During Pregnancy ◽  
Adverse Pregnancy

Abstract Background As reported, 27-93 % of pregnant women take at least one drug during pregnancy. However, drug exposure during pregnancy still lacks sufficient foetal safety evidence of human origin. It is urgent to fill the knowledge gap about medication safety during pregnancy for optimization of maternal disease treatment and pregnancy drug consultation. Methods and analysis The China Teratology Birth Cohort (CTBC) was established in 2019 and is a hospital-based open-ended prospective cohort study with the aim of assessing drug safety during pregnancy. Pregnant women who set up the pregnancy health records in the first trimester or who seek drug consultation regardless of gestational age in the member hospitals are recruited. Enrolled pregnant women need to be investigated four times, namely, 6–14 and 24–28 weeks of gestational age, before discharge after hospital delivery, and 28–42 days after birth. Maternal medication exposure during pregnancy is the focus of the CTBC. For drugs, information on the type, name, and route of medication; start and end time of medication; single dose; frequency of medication; dosage form; manufacturer; and reason for medication is collected. The adverse pregnancy outcomes collected in the study include birth defects, stillbirth, spontaneous abortion, preterm birth, post-term birth, low birth weight, macrosomia, small for gestational age, large for gestational age and low Apgar score. CTBC uses an electronic questionnaire for data collection and a cloud system for data management. Biological samples are collected if informed consents are obtained. Multi-level logistic regression, mixed-effect negative binomial distribution regression and spline function regression are used to explore the effect of drugs on the occurrence of birth defects. Discussion The findings of the study will assist in further understanding the risk of birth defects and other adverse pregnancy outcomes associated with maternal drug exposure and developing the optimal treatment plans and drug counselling for pregnant women. Trial registration This study was approved by the Research Ethics Committee of the West China Second Hospital of Sichuan University and registered at the Chinese Clinical Trial Registry (http://www.chictr.org.cn/index.aspx, registration number ChiCTR1900022569).

Evaluating the Risks of Systemic Maternal Ivermectin Exposure During Pregnancy in Human and Vertebrate Animals: a Scoping Review

2020 ◽  
Vol 15 ◽  
Author(s):  
Camille S. Westlake ◽  
David M. Aronoff
Keyword(s):  
Pregnant Women ◽  
Scoping Review ◽  
Pregnancy Outcomes ◽  
Animal Studies ◽  
The United States ◽  
Adverse Pregnancy Outcomes ◽  
Human Studies ◽  
Maternal Child Health ◽  
Exposure During Pregnancy ◽  
Adverse Pregnancy

Background: Ivermectin is widely used for the treatment of neglected tropical diseases associated with adverse maternal and fetal outcomes when infection complicates pregnancy. However, the United States FDA classification and current distribution protocols limit ivermectin treatment in pregnant women because antepartum safety has not been well-established. Objective: We conducted a scoping review to address the question of what is known from both human and vertebrate animal studies about the safety of systemic ivermectin exposure during pregnancy. Method: We searched PubMed for adverse outcomes related to systemic ivermectin exposure in human and vertebrate animal pregnancies, including English-language primary articles from 1900 – 2019. Results: We identified 23 primary articles for evaluation, including 10 human studies and 13 vertebrate animal studies of interest. One prospective randomized, controlled trial investigating the safety of systemic ivermectin exposure during pregnancy and four retrospective human studies did not identify a significant association with adverse birth outcome metrics. Of the three human case reports, two reported uncomplicated prenatal courses and one reported stillbirth and maternal death. A retrospective cross-sectional study concluded a positive association between onchocerciasis and spontaneous abortion, mitigated by ivermectin mass drug administration. While adverse pregnancy outcomes were observed at high doses in mice, rats, and rabbits, there was overall a lack of evidence to support concerns that therapeutic doses of ivermectin (0.2 mg/kg) cause adverse pregnancy outcomes. Conclusion: Further research is warranted to address safety concerns regarding the use of ivermectin in pregnant women in treating and preventing neglected helminth infections that threaten maternal-child health.

ADVERSE PREGNANCY OUTCOMES AND CORRELATION OF \r\nPREGNANCY GINGIVITIS WITH SUSPECTED \r\nPERIODONTOPATHOGENS

2017 ◽  
Vol 73 (11) ◽  
Author(s):  
Gülden EreÅŸ ◽  
Esra Zor ◽  
Cengiz Han Açıkel
Keyword(s):  
Pregnancy Outcomes ◽  
Adverse Pregnancy Outcomes ◽  
Adverse Pregnancy
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