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

• ClinicalTrials.gov Identifier: NCT05506280
• Recruitment Status: Completed
• First Posted: August 18, 2022
• Last Update Posted: December 20, 2022
• Sponsor: Universidad Católica de Ávila
• Information provided by (Responsible Party): JORGE VELAZQUEZ SAORNIL, Universidad Católica de Ávila

Tracking Information

• First Submitted Date: August 15, 2022
• First Posted Date: August 18, 2022
• Last Update Posted Date: December 20, 2022
• Actual Study Start Date: April 13, 2022
• Actual Primary Completion Date: April 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 15, 2022)

Prolactin value [ Time Frame: 15 days ]

ng/ml. 0 mimimun, 100 maximum

Original Primary Outcome Measures (submitted: August 16, 2022)

higher average value of prolactin [ Time Frame: 15 days ]

ng/ml. 0 mimimun, 100 maximum

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Association Between Prolactin Levels in Pregnant Women in COVID-19. Gether With Rates of Breastfeeding and the Covid-19 Virus
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Other; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: pregnant women under the coding of the clinical process of normal pregnancy or diagnosis of Covid-19 infection

Condition

• Breastfeeding
• 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)

Study Groups/Cohorts

Pregnant women

pregnant women infected by Covid-19

Intervention: Procedure: blood prolactin levels

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.
• 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.
• 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. Erratum In: Lancet. 2013. 2013 Aug 3;382(9890):396.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 16, 2022): 720
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: May 22, 2022
• Actual Primary Completion Date: April 30, 2022 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Pregnant women

• Ages: 16 Years to 50 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT05506280
• Other Study ID Numbers: 16/08/22
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: JORGE VELAZQUEZ SAORNIL, Universidad Católica de Ávila
• Original Responsible Party: Same as current
• Current Study Sponsor: Universidad Católica de Ávila
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Universidad Católica de Ávila
• Verification Date: December 2022