Effect of COVID-19 Infection on Obstertric Complications and Maternal Outcomes

Completed

• Conditions: Obstetric Complication; Maternal Outcomes; COVID-19; Infection
• Interventions: Other: Data collection

• Registration Number: NCT06557694
• Lead Sponsor: Tanta University

Brief Summary

This study aimed to evaluate the effect of COVID-19 infection on obstetric complications and maternal outcomes.

Detailed Description

During the SARS-CoV-2 pandemic, pregnant women were reported to have a higher susceptibility to COVID-19 infection. Pregnant women who tested positive for SARS-CoV-2 are at higher risk of a severe form of COVID-19, associated with higher rates of intensive care unit (ICU) admission and increased needs for respiratory support, compared to the age-matched non-pregnant population.

Women infected during pregnancy also have an increased risk of adverse pregnancy outcomes including preterm-birth, with a significant proportion secondary to iatrogenic preterm birth due to maternal illness. Infection with SARS-CoV-2 during pregnancy has also been reported to be associated with a higher risk of stillbirth directly or indirectly caused by the virus.

Infected pregnant patients tended to present asymptomatically with pre-Delta and Omicron variants, and symptomatically with Delta variant. A previous systematic review suggested that people who are pregnant did not have an increased risk of SARS-CoV-2 infection or symptomatic COVID-19, but they were at risk of severe COVID-19 compared with those who were not pregnant.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-15
• Study First Submitted QC: 2024-08-15
• Last Update Submitted: 2024-08-15
• Study First Posted: 2024-08-16
• Last Update Posted: 2024-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 260

Inclusion Criteria

• Age from 18 to 40 years.
• Pregnant women with COVID-19 infection diagnosed either by PCR or rapid test.

Exclusion Criteria

• Patients vaccinated for COVID-19 before or during the current pregnancy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Data collection	Data collection	Data collected included maternal demographics, medication during pregnancy, the gestational week when COVID-19 was diagnosed, antenatal diseases occurring after COVID-19 detection during pregnancy, intrauterine growth retardation (IUGR), small for gestational age (SGA), fetal distress, intrauterine fetal demise (IUFD), intrapartum complications, gestational age (GA) at delivery, mode of delivery, postpartum hemorrhage (PPH), admission to the maternal ICU, birth weight, admission to the NICU, and the indication for NICU hospitalization

Primary Outcome Measures

Name	Time	Method
Pregnancy related complications	For one month	Pregnancy related complications as preterm birth, preeclampsia, intrauterine fetal demise (IUFD), increased cesarean section rate, postpartum hemorrhagic gastroenteritis (HGE) were collected

Secondary Outcome Measures

Name	Time	Method
Intensive care unit admission rate	For one month	Intensive care unit admission rate was collected.
Apgar score	For 5 minutes post-intervention	Apgar score is a quick test performed on a baby at 1 and 5 minutes after birth. The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.
Use of mechanical ventilation	For one year	Use of mechanical ventilation was collected.
Incidence of death	For one month	Incidence of death was collected.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt