Perinatal Outcomes in Umbilical Cord Entanglement | NCT03504969

Studies
Perinatal Outcomes in Umbilical Cord Entanglement

NCT03504969

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Apr 20, 2018Actual

Enrollment

201Estimated

Phase

Not provided

Conditions

Umbilical Cord; Complications, Affecting Fetus

Interventions

Not provided

Countries

Not provided

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

Apr 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Estimated

Primary Completion Date

Jan 1, 2020Estimated

Completion Date

Jan 1, 2020Estimated

First Submitted Date

Mar 28, 2018

First Submission Date that Met QC Criteria

Apr 19, 2018

First Posted Date

Apr 20, 2018Actual

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

Apr 19, 2018

Last Update Posted Date

Apr 20, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Umbilical Cord Entanglement and Perinatal Outcomes.

Detailed Description

Umbilical Cord Entanglement and Perinatal Outcomes neonatal outcomes and the effect on mode of delivery

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

201Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
perinatal outcomes	number of neonates with bad Apgar score	one year

Secondary Outcomes

Measure	Description	Time Frame
delivery outcome	number of vaginal deliveries switch to S.C	one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all vaginal deliveries with or without Umbilical Cord Entanglement

Exclusion Criteria:

multible pregnancy

Accepts Healthy Volunteers

Yes

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

women in active vaginal delivery

Sampling Method

Probability Sample