Fulminant Hepatic FailureNCT06594237
Maternal And Fetal Outcomes in Pregnant Women With Liver Disease
An observational study of Fulminant Hepatic Failure, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Fulminant Hepatic Failure
- How many people
- 195 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2023to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- 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.
Who may be able to join
- Pregnant females with liver disease
- With gestational age > 24 weeks
- Any parity or gravidity status
Who cannot join
- Pregnant females with renal disease or any kind of malignancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Fulminant Hepatic Failure
- Medical subject headings
- Liver Failure, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal or Fetal survival or mortality.
Fetal and maternal outcomes in terms of survival or death were noted.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jul 2023
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fulminant Hepatic FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Mehnaz Khakwani, FCPS, Principal investigator, Department of Obstetrics & Gynecology, Nishtar Hospital, MultanHajra Sultana, FCPS, Principal investigator, Department of Obstetrics & Gynecology, Nishtar Hospital, Multan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594237
- Sponsor's protocol ID
- NishterMultan-2
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared with other researchers on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal And Fetal Outcomes in Pregnant Women With Liver Disease
- ClinicalTrials.gov ID
- NCT06594237
- Acronym / sponsor ID
- NishterMultan-2
- Conditions
- Fulminant Hepatic Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- Pregnant females with liver disease
- With gestational age > 24 weeks
- Any parity or gravidity status
Key exclusion criteria (1 listed)
- Pregnant females with renal disease or any kind of malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maternal or Fetal survival or mortality.
Time frame: 24 hours
Fetal and maternal outcomes in terms of survival or death were noted.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. Data can be shared with other researchers on a reasonable request.
Related trials for Fulminant Hepatic Failure
Active, not recruitingPhase 2
TReatment for ImmUne Mediated PathopHysiology
Acute Liver Failure, Fulminant Hepatic Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehnaz Khakwani, FCPS principal investigator
Department of Obstetrics & Gynecology, Nishtar Hospital, Multan
Hajra Sultana, FCPS principal investigator
Department of Obstetrics & Gynecology, Nishtar Hospital, Multan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fulminant Hepatic Failure, run by Muhammad Aamir Latif at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal or Fetal survival or mortality. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.