Maternal And Fetal Outcomes in Pregnant Women With Liver... | NCT06594237

Studies
Maternal And Fetal Outcomes in Pregnant Women With Liver Disease

NCT06594237

Sponsor

Muhammad Aamir Latif

Status

Completed

Last Update Posted

Sep 19, 2024Actual

Enrollment

195Actual

Phase

Not provided

Conditions

Fulminant Hepatic Failure

Interventions

Not provided

Countries

Pakistan

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

Sep 2024

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

Jul 1, 2023Actual

Primary Completion Date

Aug 31, 2024Actual

Completion Date

Aug 31, 2024Actual

First Submitted Date

Sep 10, 2024

First Submission Date that Met QC Criteria

Sep 10, 2024

First Posted Date

Sep 19, 2024Actual

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

Sep 10, 2024

Last Update Posted Date

Sep 19, 2024Actual

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

Liver disease complications during pregnancy can impact maternal and neonatal health, though not many studies are on view to investigate maternal and fetal outcomes in Pakistani pregnant women. So, this study was aimed to determine the maternal and fetal outcomes among pregnant females with liver disease.

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

No data available

No data is available for this block.

Enrollment

195Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maternal or Fetal survival or mortality.	Fetal and maternal outcomes in terms of survival or death were noted.	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant females with liver disease
With gestational age > 24 weeks
Any parity or gravidity status

Exclusion Criteria:

Pregnant females with renal disease or any kind of malignancy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Pregnant females with gestational age > 24 weeks, regardless of their parity or gravidity status, with liver disease were enrolled in this study. Those with renal disease or any kinds of malignancy were not part of the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mehnaz Khakwani, FCPS	Department of Obstetrics & Gynecology, Nishtar Hospital, Multan	Principal Investigator
Hajra Sultana, FCPS	Department of Obstetrics & Gynecology, Nishtar Hospital, Multan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nishtar Medical University		Multan	Punjab Province	66000	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Data can be shared with other researchers on a reasonable request.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017114	Liver Failure, Acute

Ancestor Terms

ID	Term
D017093	Liver Failure
D048550	Hepatic Insufficiency
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided