Methods:
This cross-sectional study was conducted in a maternity hospital in King Saud Medical City (KSMC) from February 2022 to June 2022 after being approved by the KSMC’s institutional review board, with reference number H1RI-06-Feb22-01. The questionnaire was developed and validated by experts. A pilot study was conducted before the official study to test the validity of the questionnaire, and the pilot study participants were excluded from this study. All participants gave their written informed consent before they were included in the study. Each participant’s vaccination status was checked using the Tawakkalna mobile application, which showed the vaccination status (number of doses, dates, and type of vaccines). This application is mandatory for all citizens, whether Saudi or nonSaudi. In this study, all women admitted to the postpartum ward who were more than 18 years old and had received the COVID-19 vaccine (Pfizer-BioNTech, Moderna, or Oxford-AstraZeneca) either before or during pregnancy were included as one arm and compared to nonvaccinated women as a second arm. We excluded women who either did not have proof of their vaccination status or refused to complete the questionnaire.
The questionnaire had two parts; the first part included demographic data, including the patient’s age, past obstetrical history, and vaccination status (number of doses, time of each dose, and type of vaccine). The second part included the gestational age at delivery and the newborn’s birth weight, Apgar score, and neonatal intensive care unit (NICU) admission. The participants were divided into two groups, the vaccinated and nonvaccinated women. The primary outcome was the effect of the COVID-19 vaccine on gestational age and birth weight. The secondary outcomes included the development of polyhydramnios, oligohydramnios, mode of delivery, Apgar score, postpartum hemorrhage, and NICU admission. The mother and the newborn were followed up till the time of discharge from the hospital. Data were collected, cleaned, and verified in an excel sheet, after which they were coded and analyzed using SPSS (version 26). The chi-square and ANOVA tests were used to compare variables to each other.