Perinatal Outcomes and Hematologic Parameters in COVID-19 Pregnancies

NCT04515108 | Completed

• 1 other identifier: E1-20-672
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Complete blood count parameters are routinely evaluated cost-effective markers in diagnosis and clinical follow-up of infectious diseases.There is increasing number of studies to report the course of COVID-19 in pregnancy. The current study aimed to elucidate the changes in hematologic parameters in response to SARS-CoV-2 infection and whether there was an increase in adverse perinatal outcomes such as increased neonatal intensive care unit admission and lower APGAR scores in pregnancies with COVID-19.

Conditions

Pregnancy, Infections in; Covid19

Keywords

COVID-19; Pregnancy; Complete blood count; Perinatal outcome; Monocyte/lymphocyte ratio (MLR)

Outcome Measures

Primary Outcomes (1)

• complete blood count parameters (including the number of lymphocytes, Leukocytes, monocytes, platelets and red blood cells).

  cell count per mm3.

  first 1 hour of hospitalization.

Secondary Outcomes (4)

• APGAR score

  5 minutes

• maternal and newborn length

  5 minutes

• maternal and newborn weight

  2 minutes

• body temperature

  2 minutes

Study Arms (2)

Group 1 (Pregnants with COVID-19)

Study group included pregnant women with clinically confirmed COVID-19.

Other: Clinical assessment

Group 2 (Pregnants without COVID-19)

Control group consisted of healthy pregnant women in the same number and same gestational week with the Study group.

Other: Clinical assessment

Interventions

Clinical assessment OTHER

Perinatal outcomes and diagnostic value of hematologic parameters were compared between pregnancies with and without COVID-19.

Group 1 (Pregnants with COVID-19); Group 2 (Pregnants without COVID-19)

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The current study included 39 pregnant women with clinical diagnosis of COVID-19 on the obstetric isolation unite and 69 pregnant women without COVID-19.

You may qualify if:

• Spontaneous pregnancy,
• Singleton pregnancy,
• Clinically diagnosed COVID-19 (SARS-CoV-2 positivity in real time-polymerase chain reaction)

You may not qualify if:

• Chronic maternal diseases (rheumatological diseases, renal failure, vascular malformations, hypertension, cardiac disease, diabetes mellitus, obesity, hypo-hyperthyroidism, congenital hematological disorders),
• Acute inflammatory conditions (acute pancreatitis, acute appendicitis),
• Pregnancy complications (gestational diabetes, PPROM, preeclampsia),
• Multiple pregnancies,
• Anticoagulant medication.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (4)

• Cheng B, Jiang T, Zhang L, Hu R, Tian J, Jiang Y, Huang B, Li J, Wei M, Yang J, Ren S, Wang G. Clinical Characteristics of Pregnant Women With Coronavirus Disease 2019 in Wuhan, China. Open Forum Infect Dis. 2020 Jul 11;7(8):ofaa294. doi: 10.1093/ofid/ofaa294. eCollection 2020 Aug.

  PMID: 32760752 RESULT

• Peng J, Qi D, Yuan G, Deng X, Mei Y, Feng L, Wang D. Diagnostic value of peripheral hematologic markers for coronavirus disease 2019 (COVID-19): A multicenter, cross-sectional study. J Clin Lab Anal. 2020 Oct;34(10):e23475. doi: 10.1002/jcla.23475. Epub 2020 Jul 17.

  PMID: 32681559 RESULT

• Sun S, Cai X, Wang H, He G, Lin Y, Lu B, Chen C, Pan Y, Hu X. Abnormalities of peripheral blood system in patients with COVID-19 in Wenzhou, China. Clin Chim Acta. 2020 Aug;507:174-180. doi: 10.1016/j.cca.2020.04.024. Epub 2020 Apr 24.

  PMID: 32339487 RESULT

• Dashraath P, Wong JLJ, Lim MXK, Lim LM, Li S, Biswas A, Choolani M, Mattar C, Su LL. Coronavirus disease 2019 (COVID-19) pandemic and pregnancy. Am J Obstet Gynecol. 2020 Jun;222(6):521-531. doi: 10.1016/j.ajog.2020.03.021. Epub 2020 Mar 23.

  PMID: 32217113 RESULT

MeSH Terms

Conditions

Pregnancy Complications, Infectious; COVID-19

Condition Hierarchy (Ancestors)

Infections; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Esin Merve Erol Koç, MD

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 17, 2020
• Study Start: March 10, 2020
• Primary Completion: August 5, 2020
• Study Completion: August 10, 2020
• Last Updated: August 17, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)