NCT06594237

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
195

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

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

July 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.2 years

First QC Date

September 10, 2024

Last Update Submit

September 10, 2024

Conditions

Fulminant Hepatic Failure

Outcome Measures

Primary Outcomes (1)

  • Maternal or Fetal survival or mortality.

    Fetal and maternal outcomes in terms of survival or death were noted.

    24 hours

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • Pregnant females with renal disease or any kind of malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nishtar Medical University

Multan, Punjab Province, 66000, Pakistan

Location

MeSH Terms

Conditions

Liver Failure, Acute

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Study Officials

  • Mehnaz Khakwani, FCPS

    Department of Obstetrics & Gynecology, Nishtar Hospital, Multan

    PRINCIPAL INVESTIGATOR

  • Hajra Sultana, FCPS

    Department of Obstetrics & Gynecology, Nishtar Hospital, Multan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Consultant

Study Record Dates

First Submitted

September 10, 2024

First Posted

September 19, 2024

Study Start

July 1, 2023

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

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

Locations

PA(1)