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Association Between Prolactin Levels in Pregnant Women in COVID-19. Gether With Rates of Breastfeeding and the Covid-19 Virus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05506280
Recruitment Status : Completed
First Posted : August 18, 2022
Last Update Posted : December 20, 2022
Sponsor:
Information provided by (Responsible Party):
JORGE VELAZQUEZ SAORNIL, Universidad Católica de Ávila

Study Description
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Brief Summary:
Background: Currently in the world, 41% of children under 6 months are exclusively breastfed. The Covid-19 pandemic has had a major impact on breastfeeding.; Methods: A statistical analysis of linear regression, prolactin analysis in the 3rd trimester of pregnancy and 15 days 15 after delivery was performed in women with Covid- 19 infection and healthy, finally the rates of 16 breastfeeding were evaluated. The sample was made up of 680 pregnant women from the Valladolid 17 Health Area, central region of Spain.

Condition or disease Intervention/treatment
Breastfeeding COVID-19 Infection Procedure: blood prolactin levels

Study Design
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Study Type : Observational
Actual Enrollment : 720 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Association Between Prolactin Levels in Pregnant Women to- 2 Gether With Rates of Breastfeeding and the COVID-19 Virus. A 3 Randomised Trial
Actual Study Start Date : April 13, 2022
Actual Primary Completion Date : April 30, 2022
Actual Study Completion Date : May 22, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Prolactin

Groups and Cohorts
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Group/Cohort Intervention/treatment
Pregnant women
pregnant women infected by Covid-19
 Procedure: blood prolactin levels
The extraction technique was performed by venipuncture in 110 veins located in the antecubital area with a 21G butterfly nut with a Vacutainer Safety 111 Lok@ adapter, a 2.5x45cm latex venous compressor and a tube with separating gel 112 (yellow cap)


Outcome Measures
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Primary Outcome Measures :
  1. Prolactin value [ Time Frame: 15 days ]
    ng/ml. 0 mimimun, 100 maximum


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
pregnant women under the coding of the clinical process of normal pregnancy or diagnosis of Covid-19 infection
Criteria

Inclusion Criteria:

  • pregnant women under the coding of the clinical process of normal pregnancy or diagnosis of Covid-19 infection

Exclusion Criteria:

  • No informed consent.
  • No pregnant women.
  • Older than 50 years old.
  • Younger than 16 years old.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05506280


Locations
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Spain
Universidad Católica de Ávila
Ávila, Spain, 05005
Sponsors and Collaborators
Universidad Católica de Ávila
More Information
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Publications of Results:

Other Publications:

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Responsible Party: JORGE VELAZQUEZ SAORNIL, Principal Investigator, Universidad Católica de Ávila
ClinicalTrials.gov Identifier: NCT05506280    
Other Study ID Numbers: 16/08/22
First Posted: August 18, 2022    Key Record Dates
Last Update Posted: December 20, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by JORGE VELAZQUEZ SAORNIL, Universidad Católica de Ávila:
Covid-19 infection
Pregnant women
Prolactin levels
Breastfeeeding
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases