Association Between Prolactin Levels in Pregnant Women to- 2 Gether With Rates of Breastfeeding and the Covid-19 Virus

Sponsor

Universidad Católica de Ávila (Other)

Overall Status

Completed

CT.gov ID

NCT05506280

Collaborator

(none)

720

Enrollment

Location

1.3

Actual Duration (Months)

561.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

(1) Background: Currently in the world, 41% of children under 6 months are exclusively 13 breastfed. The Covid-19 pandemic has had a major impact on breastfeeding.; (2) Methods: A statis- 14 tical 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	Phase
Breastfeeding COVID-19 Infection	Procedure: blood prolactin levels

Study Design

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 :

Apr 13, 2022

Actual Primary Completion Date :

Apr 30, 2022

Actual Study Completion Date :

May 22, 2022

Arms and Interventions

Arm	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)

Arm

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

Primary Outcome Measures

higher average value of prolactin [15 days]
ng/ml. 0 mimimun, 100 maximum

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Universidad Católica de Ávila	Ávila		Spain	05005

Sponsors and Collaborators

Universidad Católica de Ávila

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Humbwavali JB, Giugliani C, Silva ICMD, Duncan BB. Temporal trends in the nutritional status of women and children under five years of age in sub-Saharan African countries: ecological study. Sao Paulo Med J. 2018 Sep-Oct;136(5):454-463. doi: 10.1590/1516-3180.2017.0267261117.

Responsible Party:

JORGE VELAZQUEZ SAORNIL, Principal Investigator, Universidad Católica de Ávila

ClinicalTrials.gov Identifier:

NCT05506280

Other Study ID Numbers:

16/08/22

First Posted:

Aug 18, 2022

Last Update Posted:

Aug 18, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by JORGE VELAZQUEZ SAORNIL, Principal Investigator, Universidad Católica de Ávila

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Aug 18, 2022