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.