The ADRB3 Receptor in Pregnancy | NCT02381106

Studies
The ADRB3 Receptor in Pregnancy

NCT02381106

Sponsor

Karolinska Institutet

Status

Suspended

Last Update Posted

May 17, 2023Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Pregnancy Complications

Interventions

Not provided

Countries

Sweden

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

May 2023

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

assay difficulties

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Dec 2028Estimated

Completion Date

Dec 2029Estimated

First Submitted Date

Nov 11, 2014

First Submission Date that Met QC Criteria

Mar 5, 2015

First Posted Date

Mar 6, 2015Estimated

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

May 15, 2023

Last Update Posted Date

May 17, 2023Actual

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 primary overall objective of this study is to characterize the levels of and compare levels of the ADRB3 receptor in human non-pregnant myometrium, pregnant myometrium at different time points in pregnancy, in normal and dysfunctional labor and also to measure levels and expression of these receptors in placental arteries at different maturation statuses of placenta and in pre-eclampsia/hypertension

Detailed Description

Not provided

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

Retention

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Women with preeclampsia		Women delivered by cesarian section and with preeclampsia
Women with dysfunctional labor		Women delivered with cesarian section due to dtsfunctional labor
Women with cesarian section due to maternal request		Women with cesarian section due to maternal request
Women with preamture labor		Women with pemature labor undergoing cesarian section

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
characterization of the levels of the ADRB3 receptor in human pregnant myometrium		1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women undergoing cesarian section

Exclusion Criteria:

Interkurrent diseases

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Pregant women undergoing cesarian section.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept of Obstetrics and Gynecology, Danderyd Hospital		Stockholm		18288	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D011248	Pregnancy Complications

Ancestor Terms

ID	Term
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

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Browse Branches

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