Models for Evaluate the Proximity of the Moon on the Freq... | NCT02277873

Studies
Models for Evaluate the Proximity of the Moon on the Frequency of Births

NCT02277873

Sponsor

Christian Ramos Penafiel

Status

Completed

Last Update Posted

Oct 29, 2014Estimated

Enrollment

25,152Actual

Phase

Not provided

Conditions

Establish the Relationship Between Moon and Births

Interventions

pregnancy

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jun 2013Actual

Completion Date

Mar 2014Actual

First Submitted Date

Jul 17, 2014

First Submission Date that Met QC Criteria

Oct 28, 2014

First Posted Date

Oct 29, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2014

Last Update Posted Date

Oct 29, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christian Ramos Penafiel, MD, Hospital General de MexicoSponsor-Investigator

Lead Sponsor

Christian Ramos PenafielOTHER_GOV

Collaborators

Name	Class
Instituto de Salud del Estado de Mexico	UNKNOWN
Hospital General de Mexico	OTHER_GOV
Universidad Nacional Autonoma de Mexico	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to establish the relationship between moon and births through two analytic models.

Detailed Description

Retrospective, descriptive and observational study. Classical model performs comparisons of births among lunar periods, lineal, cubical and exponential estimation was performed in the SPSS software and the inflection point of the curve was estimated using the formula x=[In (1/ebx)]/ebx in the Geogebra model. The significance was establish by a p value of ≤ 0.05 (95% IC).

The second analysis was performed by the difference of media between all the stages of the moon cycle as in another trials. The difference was establish by the T-student test. The difference between groups was performed by the one way ANOVA test.

This study had the review and approval from the Ethics Committee of the institution and according with Mexican regulation, and in adherence to the Helsinki declaration and International Conference for Harmonisation

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25,152Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No Treatment		Defined population (pregnant women) compared on a environmental moon luminosity influence	Behavioral: pregnancy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pregnancy	Behavioral	Observational study in order to establish relationship between moon and births	No Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
First model of analysis (Classic model)	Initial association was tempted to be done based on previous analysis described. The "Gibada moon" phase showed a significant difference versus Full moon and new moon, due to average birth is increased in this phase	up to 12 months

Secondary Outcomes

Measure	Description	Time Frame
Second model of analysis. Luminosity - Births	For this analysis, the moon luminosity was estimated as percentage (%), as a measure of proximity between moon and the earth, and was correlated to number of births. More the percentage of light is, closest to the earth the moon is.	up to 34 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant women from January 2009 until June 2013

Exclusion Criteria:

Pregnant women from any other period of time

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Pregnant women from urban and rural regions from north part of Mexico city county area

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian Ramos, MD	Hospital General de Mexico	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital General de Cuautitlan		Cuautitlán	State of Mexico	54715	Mexico

Intervention Browse Module

MeSH Terms

ID	Term
D011247	Pregnancy

Ancestor Terms

ID	Term
D012098	Reproduction
D055703	Reproductive Physiological Phenomena
D012101	Reproductive and Urinary Physiological Phenomena

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Browse Branches

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