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Drug safety during pregnancy has always been a hot topic of discussion, and there have been many medical accidents caused by drug exposure during pregnancy, such as the response shutdown incident in the United States, which has triggered "seal limb deformities" incidents that have spread around the world.
Drug exposure during pregnancy is also serious in mainland China, because pregnancy is a special period, and many drugs cannot be tested on pregnant women due to ethical requirements.
On June 1 this year, a study by Chinese scholars that lasted six years and estimated the number of 150,000 pregnant women to be recruited was published in the world's top journal Nature communications.
What are the main drug exposures of pregnant women during pregnancy in our country? How do these drugs affect pregnancy? What are the effects on the fetus? Let's read this latest literature with Sister Quan!
01 A study cohort of 150,000 pregnant women over a period of 6 years
This is a prospective, longitudinal, multicenter cohort study in China, which was launched in August 2018 and is expected to enroll 150,000 pregnant women, with a total of 112,986 pregnant women enrolled in the study.
All participants received five follow-up visits, respectively:
To assess the association between drug use during pregnancy, mainly within 14 weeks, and adverse pregnancy outcomes (including: miscarriage, stillbirth, preterm birth, low birth weight, and serious birth defects).
Drug exposure and birth cohorts (DEBC) in this study were achieved
In addition to clinical and epidemiological data, and at the forefront of cohort studies in China.
Biological specimens for DEBC include maternal peripheral blood, urine, umbilical cord blood, and tissue samples.
With these high-quality, well-annotated human biospecimens and a wealth of clinical and epidemiological data, not only that:
02 Baseline characteristics of the study cohort
As of December 31, 2021, DEBC had recruited 150,577 participants, and a total of 112,986 pregnant women were included in the database after excluding pregnant women who had lost follow-up, had not been quality audited, or had reached the pregnancy outcome stage or had multiple pregnancies.
Among the pregnant women recruited, 11.42% were of advanced maternal age (≥ 35 years old), 66.74% had a university degree or higher education level, 94.35% had natural conception, and 59.03% had planned pregnancy.
Regarding lifestyle factors, 43.23% of pregnant women and/or their husbands smoke at least one cigarette a day, 14.50% drink alcohol at least once during the perinatal period (from the first 3 months of pregnancy to 3 months of pregnancy), and 88.96% take folic acid or multivitamins containing folic acid during pregnancy.
The biobank of this analysis cohort holds approximately 580,000 processed biological samples, including approximately 467,600 processed blood samples (plasma, serum, and fur), and approximately 79,000 urine samples from pregnant women.
In addition, about 7,400 processed cord blood samples (plasma, serum, and chorion), amniotic fluid (supernatant and amniotic cells), placenta samples (maternal and fetal surface tissues), and other tissues were collected from cases of adverse pregnancy outcomes.
Approximately 26,000 processed biological samples from adverse pregnancy controls (normal pregnancies) are also stored in the biobank.
Of the 150,577 participants initially recruited, about 83%, 22%, and 4% of pregnant women provided blood samples in the first trimester, second trimester, and trimester, respectively.
About 43%, 4% and 4% of pregnant women provided urine samples in the first trimester, the second trimester and the trimester, respectively.
aHistogram of maternal samples collected during pregnancy. b Histogram of biospecimen collected by participants with adverse pregnancy outcomes. c Number of maternal samples collected during pregnancy.
03 Drug exposure in the Chinese cohort
This should be what everyone is most looking forward to seeing, to sum up, approximately
Pregnant women who took drugs in the first trimester tended to be older, more educated, use assisted reproductive technologies, plan to become pregnant, take folic acid supplements, and do not smoke or drink alcohol compared to those who did not take any drugs in the first trimester.
A survey of 112,986 pregnant women included in this analysis showed that
The main drugs are:
The above are the drugs that are always used most frequently,
The mean duration of drug exposure ranged from 4.1 days (cephalosporin) to 58.9 days (progesterone).
There were also significant drug exposures in proprietary Chinese medicines, including Fuzheng Formula, Cold Ling Granules, Wenbu Kidney Yang Fang and Banlangen Granules.
04 Adverse pregnancy outcomes in the Chinese cohort
This set of queues, where.
Maternal age, education level, and fertilization method were all significantly associated with the occurrence of adverse pregnancy outcomes, with those with adverse pregnancy outcomes tending to be older, less educated (high school or below), and using assisted reproductive technology than those without adverse outcomes.
The main adverse pregnancy outcomes were as follows:
Among these drugs, dydrogesterone exposure in the first trimester of pregnancy is associated with stillbirth, preterm birth, low birth weight, and birth defects,
In progesterone-exposed pregnant women in the first trimester,.
The following table details the significant associations between all drug exposures and adverse pregnancy outcomes:
05Please look at this study objectively
First of all, especially in patients with chronic diseases and recurrent miscarriages.
About 90% of women in the United States take at least one medication during pregnancy, and 70% take at least one prescription medication.
In France, 93% of pregnant women receive prescriptions and dispensing of medicines, using an average of 7.4±5.5 different medicines.
A large sample-size study conducted in Italy showed that 73% of pregnant women in this cohort were prescribed at least one drug during pregnancy.
This cohort study is the first time in China that the drug exposure rate in the first trimester of Chinese pregnant women was 30.70%, with significant differences in drug exposure rates among pregnant women with different demographics.
It is worth noting that.
Secondly, we can see that such as dydrogesterone, progesterone, aspirin, heparin, levothyroxine and some traditional Chinese patent medicines and so on.
Faced with the relationship between drug exposure and adverse pregnancy outcomes, it may be difficult for many of us to achieve a live birth without the use of these drugs.
Taking dydrogesterone as an example, this study found that dydrogesterone reduced the miscarriage rate, but also led to an increase in preterm birth, stillbirth, low birth weight, and birth defects.
In a word, we can't conclude from this study that dydrogesterone is associated with adverse pregnancy, and we also need to see a reduction in the miscarriage rate caused by dydrogesterone.
But we can rest assured that this study confirms
In China, the use of traditional Chinese medicine is common in pregnant women, and there is no precise evidence of the effect of these drugs on pregnancy outcomes, but this study gives some recommendations.
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It is important to note that TCM supplements are composed of a variety of herbs from different suppliers, and quantitative testing of their active ingredients is still difficult, suggesting that we need to further evaluate the safety of TCM for tocolyscopy.
Overall, this is the first very large pregnancy drug exposure study in China, and it is a milestone in the collection of real data on pregnancy outcomes and maternal drug exposure during pregnancy in China.
At the same time, this large cohort includes TCM in the scope of research, thus filling an important gap in evidence-based research on the use of TCM in pregnant women in China.
However, we should also note that due to the limitations of cohort studies, although the relationship between drugs and adverse pregnancy was involved in the study, it was not possible to draw causal conclusions for the time being because sufficient interference or confounding factors were not excluded.
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——THE END——
bibliography
Li L, Wang K, Wang M, Tao J, Li X, Liu Z, Li N, Qiu X, Wei H, Lin Y, He Y, Deng Y, Kang H, Li Y, Yu P, Wang Y, Zhu J, Liu H. The maternal drug exposure birth cohort (DEBC) in China. Nat Commun. 2024 Jun 21; 15(1):5312. doi: 10.1038/s41467-024-49623-0.