Abstract
Objective: During December 2020, a massive vaccination program was introduced in our country. The Pfizer-BioNTech, BNT162b2 vaccine was first offered exclusively to high-risk population, such as medical personnel (including pregnant women). In this study we compare short term outcomes in vaccinated vs. non-vaccinated pregnant women.
Methods: In this prospective observational cohort study, vaccinated and non-vaccinated pregnant women were recruited using an online Google forms questionnaire targeting medical groups on Facebook and WhatsApp. A second questionnaire was sent one month after the first one for interim analysis. Our primary outcome was composite complications in vaccinated and non-vaccinated groups, considered any of the following: vaginal bleeding, pregnancy loss, hypertension, gestational diabetes, and preterm birth. Secondary outcomes included: vaccine side effects, diagnosis of COVID-19 since the last questionnaire, prevalence of vaccinated participants, and reasons for refusal to be vaccinated.
Results: Overall, 432 women answered the first questionnaire, of which 326 responses were received to the second questionnaire. Vaccination rate increased from 25.5% to 62% within a month. Maternal age, gestational age at enrollment, nulliparity and number of children were similar in both groups. The rate of composite pregnancy complications was similar between vaccinated and non-vaccinated group (15.8% vs 20.1%, p = 0.37), respectively. The risk for COVID-19 infection was significantly lower in the vaccinated group (1.5% vs 6.5%, p = 0.024, Odds Ratio: 4.5, 95% confidence interval 1.19-17.6).
Conclusions: mRNA vaccine during pregnancy does not seem to increase the rate of pregnancy complications and is effective in prevention of COVID-19 infection.
Keywords: Covid-19 vaccine; Pregnancy vaccination; mRNA vaccine.
【저자키워드】 COVID-19 vaccine, mRNA vaccine, pregnancy vaccination, 【초록키워드】 Vaccine, BNT162b2 vaccine, vaccination, mRNA vaccine, children, Infection, risk, outcome, hypertension, pregnant women, Prevalence, Maternal, Pregnancy, Preterm birth, COVID-19 infection, response, bleeding, Complication, age, women, Side effects, group, questionnaire, Pfizer-BioNTech, Gestational diabetes, high-risk population, Facebook, Participants, Enrollment, Primary outcome, 95% confidence interval, interim analysis, significantly lower, refusal, WhatsApp, country, effective, secondary, prevention of COVID-19, recruited, introduced, groups, diagnosis of COVID-19, Google form, in both groups, nulliparity, offered, prospective observational cohort, 【제목키워드】 prospective observational study, COVID-19 vaccination, Effectiveness,