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

NCT06557694 | Completed

• 1 other identifier: 36264PR750/7/24
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19; Infection; Obstetric Complication; Maternal Outcomes

Outcome Measures

Primary Outcomes (1)

• Pregnancy related complications

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

  For one month

Secondary Outcomes (4)

• Intensive care unit admission rate

  For one month

• Use of mechanical ventilation

  For one year

• Incidence of death

  For one month

• Apgar score

  For 5 minutes post-intervention

Study Arms (1)

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

Other: Data collection

Interventions

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).

Data collection

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This retrospective study was carried out on 260 pregnant women with COVID-19 infection who presented in Tanta University Hospitals in the period from January 2021 to December 2022 with approval from the institutional ethical committee.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

COVID-19; Infections

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 16, 2024
• Study Start: January 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)