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Completed

NCT Number: NCT06557694

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

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

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infection Infections Lung Diseases Maternal Outcomes Nidovirales Infections Obstetric Complication Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data Collection

Other

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 Pregnancy outcomes included mode of delivery, gestational age at delivery, pre-eclampsia, and postpartum hemorrhage (defined as an estimated blood loss of 1,000 mL or greater).

Primary outcomes

  1. Pregnancy related complications

    Time frame: 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 outcomes

  1. Intensive care unit admission rate

    Time frame: For one month

    Intensive care unit admission rate was collected.

  2. Use of mechanical ventilation

    Time frame: For one year

    Use of mechanical ventilation was collected.

  3. Incidence of death

    Time frame: For one month

    Incidence of death was collected.

  4. Apgar score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 16, 2024
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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