NCT05506280

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
720

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2022

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
Last Updated

December 20, 2022

Status Verified

December 1, 2022

Enrollment Period

17 days

First QC Date

August 15, 2022

Last Update Submit

December 15, 2022

Conditions

BreastfeedingCOVID-19 Infection

Keywords

Covid-19 infectionPregnant womenProlactin levelsBreastfeeeding

Outcome Measures

Primary Outcomes (1)

  • Prolactin value

    ng/ml. 0 mimimun, 100 maximum

    15 days

Study Arms (1)

Pregnant women

pregnant women infected by Covid-19

Procedure: blood prolactin levels

Interventions

blood prolactin levelsPROCEDURE

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)

Pregnant women

Eligibility Criteria

Age16 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • No informed consent.
  • No pregnant women.
  • Older than 50 years old.
  • Younger than 16 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Católica de Ávila

Ávila, 05005, Spain

Location

Related Publications (7)

  • 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.

    PMID: 30570097BACKGROUND

  • 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.

    PMID: 26869575RESULT

  • 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.

    PMID: 23746772RESULT

  • 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.

    PMID: 32430957RESULT

  • 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.

    PMID: 32516273RESULT

  • 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.

    PMID: 32544146RESULT

  • 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.

    PMID: 32105680RESULT

MeSH Terms

Conditions

Breast FeedingCOVID-19

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 15, 2022

First Posted

August 18, 2022

Study Start

April 13, 2022

Primary Completion

April 30, 2022

Study Completion

May 22, 2022

Last Updated

December 20, 2022

Record last verified: 2022-12

Locations

ES(1)