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

NCT ID: NCT05506280

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

720 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-13

Study Completion Date

2022-05-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breastfeeding COVID-19 Infection

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Covid-19 infection Pregnant women Prolactin levels Breastfeeeding

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pregnant women

pregnant women infected by Covid-19

blood prolactin levels

Intervention Type PROCEDURE

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidad Católica de Ávila

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

JORGE VELAZQUEZ SAORNIL

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universidad Católica de Ávila

Ávila, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 30570097 (View on PubMed)

Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.

Reference Type RESULT
PMID: 26869575 (View on PubMed)

Black RE, Victora CG, Walker SP, Bhutta ZA, Christian P, de Onis M, Ezzati M, Grantham-McGregor S, Katz J, Martorell R, Uauy R; Maternal and Child Nutrition Study Group. Maternal and child undernutrition and overweight in low-income and middle-income countries. Lancet. 2013 Aug 3;382(9890):427-451. doi: 10.1016/S0140-6736(13)60937-X. Epub 2013 Jun 6.

Reference Type RESULT
PMID: 23746772 (View on PubMed)

Juan J, Gil MM, Rong Z, Zhang Y, Yang H, Poon LC. Effect of coronavirus disease 2019 (COVID-19) on maternal, perinatal and neonatal outcome: systematic review. Ultrasound Obstet Gynecol. 2020 Jul;56(1):15-27. doi: 10.1002/uog.22088.

Reference Type RESULT
PMID: 32430957 (View on PubMed)

Huntley BJF, Huntley ES, Di Mascio D, Chen T, Berghella V, Chauhan SP. Rates of Maternal and Perinatal Mortality and Vertical Transmission in Pregnancies Complicated by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Co-V-2) Infection: A Systematic Review. Obstet Gynecol. 2020 Aug;136(2):303-312. doi: 10.1097/AOG.0000000000004010.

Reference Type RESULT
PMID: 32516273 (View on PubMed)

Galang RR, Chang K, Strid P, Snead MC, Woodworth KR, House LD, Perez M, Barfield WD, Meaney-Delman D, Jamieson DJ, Shapiro-Mendoza CK, Ellington SR. Severe Coronavirus Infections in Pregnancy: A Systematic Review. Obstet Gynecol. 2020 Aug;136(2):262-272. doi: 10.1097/AOG.0000000000004011.

Reference Type RESULT
PMID: 32544146 (View on PubMed)

Rasmussen SA, Smulian JC, Lednicky JA, Wen TS, Jamieson DJ. Coronavirus Disease 2019 (COVID-19) and pregnancy: what obstetricians need to know. Am J Obstet Gynecol. 2020 May;222(5):415-426. doi: 10.1016/j.ajog.2020.02.017. Epub 2020 Feb 24.

Reference Type RESULT
PMID: 32105680 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

16/08/22

Identifier Type: -

Identifier Source: org_study_id