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

Breastfeeding Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05506280
• Other study ID #: 16/08/22
• Status: Completed
• Start date: April 13, 2022
• Est. completion date: May 22, 2022

Study information

• Verified date: December 2022
• Source: Universidad Católica de Ávila
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: May 22, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breastfeeding
• COVID-19
• COVID-19 Infection

Intervention

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)

Locations

Country	Name	City	State
Spain	Universidad Católica de Ávila	Ávila

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica de Ávila

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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 coun — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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):4 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prolactin value	ng/ml. 0 mimimun, 100 maximum	15 days