Perinatal Outcomes and Hematologic Parameters in COVID-19 Pregnancies

Sponsor
Ankara City Hospital Bilkent (Other)
Overall Status
Completed
CT.gov ID
NCT04515108
Collaborator
(none)
108
1
5
21.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Clinical assessment

Detailed Description

The objective of this study is to evaluate the relationship between Coronavirus Disease 2019 (COVID-19) in pregnancy and adverse perinatal outcomes. The secondary aim is to analyze the diagnostic value of hematologic parameters in COVID-19 complicated pregnancies.The current study is conducted in a high volume tertiary obstetrics center burdened by COVID-19 pandemics, in Turkey, between March 20 and July 25, 2020. The study included a pregnant women cohort who had been regularly followed up and delivered in our clinics. The cohort was divided into two groups to reveal the impact of COVID-19 on the complete blood count cell indices and unfavorable obstetric and early neonatal outcomes in pregnant women. The clinically confirmed diagnosis of COVID-19 cases were included in Study Group (n=39) the healthy pregnant women without COVID-19 were included in Control Group (n=69). The study achieved a power of 0.89 and 0.98 with a 5% level of significance.

Study Design

Study Type:
Observational
Actual Enrollment :
108 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Comparison of Hematological Parameters and Perinatal Outcomes in COVID-19 Pregnancies and Healthy Pregnancy Cohort
Actual Study Start Date :
Mar 10, 2020
Actual Primary Completion Date :
Aug 5, 2020
Actual Study Completion Date :
Aug 10, 2020

Arms and Interventions

Arm Intervention/Treatment
Group 1 (Pregnants with COVID-19)

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

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

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

Outcome Measures

Primary Outcome Measures

  1. complete blood count parameters (including the number of lymphocytes, Leukocytes, monocytes, platelets and red blood cells). [first 1 hour of hospitalization.]

    cell count per mm3.

Secondary Outcome Measures

  1. APGAR score [5 minutes]

    1st and 5th minute newborn assessment

  2. maternal and newborn length [5 minutes]

    centimeters

  3. maternal and newborn weight [2 minutes]

    kilograms

  4. body temperature [2 minutes]

    Celsius degree

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 42 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Spontaneous pregnancy,

  • Singleton pregnancy,

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

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ankara City Hospital Ankara Turkey 06100

Sponsors and Collaborators

  • Ankara City Hospital Bilkent

Investigators

  • Principal Investigator: Esin Merve Erol Koç, MD, Ankara City Hospital Bilkent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Esin Merve Erol Koç, Medical Doctor, Ankara City Hospital Bilkent
ClinicalTrials.gov Identifier:
NCT04515108
Other Study ID Numbers:
  • E1-20-672
First Posted:
Aug 17, 2020
Last Update Posted:
Aug 17, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Esin Merve Erol Koç, Medical Doctor, Ankara City Hospital Bilkent
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 17, 2020