Intrahepatic Cholestasis of PregnancyNCT04922580
Predictors of Adverse Neonatal Outcomes in Intrahepatic Cholestasis of Pregnancy
An observational study of Intrahepatic Cholestasis of Pregnancy, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
Many studies have attempted to find the predictors of adverse neonatal outcome in women with Intrahepatic Cholestasis of Pregnancy(ICP).Serum total bile acid level exceeding 40 µmol/L has been associated with increased risk of meconium staining, low Apgar scores, preterm delivery, and stillbirth.Other predictors such… Read more about this study
- Who is it for?
- Ages 1 minute to 28 days
- Conditions the study is for
- Intrahepatic Cholestasis of Pregnancy
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2012to 31 Dec 2020
- 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 1 minute to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: neonates
Who may be able to join
- Newborns were born in maternal and child health hospital of Yong Chuan District from January 2012 to December 2020;②all Newborns' mothers diagnosed intrahepatic cholestasis of pregnancy.
Who cannot join
- The newborns were born with severe congenital heart disease and deformities
Trial locations and contacts
1 site in 1 country.
China1 site
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing, Chongqing Municipality, 400042
About this study
Many studies have attempted to find the predictors of adverse neonatal outcome in women with Intrahepatic Cholestasis of Pregnancy(ICP).Serum total bile acid level exceeding 40 µmol/L has been associated with increased risk of meconium staining, low Apgar scores, preterm delivery, and stillbirth.Other predictors such as level of transaminases, history of cholelithiasis, and hepatitis virus infection have been studied but the results are inconclusive.A more comprehensive investigation involving multiple neonatal outcomes and a wide variety of outcome predictors is needed in order to establish guidelines for optimal timing of delivery in pregnancies complicated by ICP. The aim of our study was to evaluate wide variety of predictors of adverse neonatal outcomes in a large cohort of women with ICP .
Read the detailed description
We performed a retrospective cohort study of all women diagnosed with ICP. Pregnancy outcomes including delivery gestational age, spontaneous preterm delivery, iatrogenic preterm delivery, birth weight, mode of delivery, oligohydramnios, intrauterine growth restriction (IUGR), placental abruption, preterm premature rupture of membrane (PPROM), concerning fetal heart tracing, chorioamnionitis, endometritis, postpartum hemorrhage, transfusion, stillbirth, neonatal intensive care unit (NICU) admission, hyperbilirubinemia, meconium stained amniotic fluid, respiratory distress syndrome(RDS) or transient tachypnea of newborn(TTN) (transient tachypnea of the newborn), and composite neonatal outcome were ascertained. A composite adverse neonatal outcome was created and defined as any of the following: NICU admission, hypoglycemia, hyperbilirubinemia, RDS, TTN, mechanical ventilation use, oxygen by nasal cannula, pneumonia, and stillbirth. PPROM was defined by rupture of membrane before 37 weeks gestation. Concerning fetal heart tracing was defined as recurrent variable or late decelerations with moderate variability, prolonged decelerations, or category 3 tracing. Providers who were caring for the women reviewed and independently characterized fetal heart tracings. Since fetal heart tracings were not accessible to authors, authors accepted the providers' interpretation. For analysis of concerning fetal heart tracing, women with non-labor cesarean section were excluded. Hyperbilirubinemia was defined by neonatal hyperbilirubinemia that required phototherapy. Hypoglycemia was defined by neonatal hypoglycemia that required intravenous infusion. Diagnosis of RDS and TTN were made by the managing neonatologist and based on standard clinical guidelines.
- Conditions
- Intrahepatic Cholestasis of Pregnancy
- Medical subject headings
- Intrahepatic Cholestasis of Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalization group | Newborns of ICP mothers require hospitalization after birth | |
| without Hospitalization group | Newborns of ICP mothers don't require hospitalization after birth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemia
Hypoglycemia was defined by neonatal hypoglycemia that required intravenous infusion
Measured: up to 28 days
Hyperbilirubinemia
Hyperbilirubinemia was defined by neonatal hyperbilirubinemia that required phototherapy
Measured: up to 28 days
NICU admission
Newborns required hospitalization in the NICU after birth
Measured: up to 28 days
RDS
Newborns were diagnosed with respiratory distress syndrome
Measured: up to 28 days
TTN
Newborns were diagnosed with transient tachypnea of the newborn
Measured: up to 28 days
mechanical ventilation use
Newborns required mechanical ventilation
Measured: up to 28 days
oxygen by nasal cannula
Newborns required oxygen by nasal cannula
Measured: up to 28 days
pneumonia
Newborns were diagnosed with pneumonia
Measured: up to 28 days
stillbirth
newborns died after birth
Measured: up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start1 Jan 2012
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic Cholestasis of PregnancyStudies 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
- Retrospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- maternal and child health hospital of Yong Chuan District
- Responsible party
- Principal investigator, Chen Long,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922580
- Sponsor's protocol ID
- ICP
- Status last verified
- Aug 2021
- First submitted
- 5 Jun 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Adverse Neonatal Outcomes in Intrahepatic Cholestasis of Pregnancy
- ClinicalTrials.gov ID
- NCT04922580
- Acronym / sponsor ID
- ICP
- Conditions
- Intrahepatic Cholestasis of Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Collaborators
- maternal and child health hospital of Yong Chuan District
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 10 Jun 2021 (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.
Many studies have attempted to find the predictors of adverse neonatal outcome in women with Intrahepatic Cholestasis of Pregnancy(ICP).Serum total bile acid level exceeding 40 µmol/L has been associated with increased risk of meconium staining, low Apgar scores, preterm delivery, and stillbirth.Other predictors such as level of transaminases, history of cholelithiasis, and hepatitis virus infection have been studied but the results are inconclusive.A more comprehensive investigation involving multiple neonatal outcomes and a wide variety of outcome predictors is needed in order to establish guidelines for optimal timing of delivery in pregnancies complicated by ICP. The aim of our study was to evaluate wide variety of predictors of adverse neonatal outcomes in a large cohort of women with ICP .
Detailed description
We performed a retrospective cohort study of all women diagnosed with ICP. Pregnancy outcomes including delivery gestational age, spontaneous preterm delivery, iatrogenic preterm delivery, birth weight, mode of delivery, oligohydramnios, intrauterine growth restriction (IUGR), placental abruption, preterm premature rupture of membrane (PPROM), concerning fetal heart tracing, chorioamnionitis, endometritis, postpartum hemorrhage, transfusion, stillbirth, neonatal intensive care unit (NICU) admission, hyperbilirubinemia, meconium stained amniotic fluid, respiratory distress syndrome(RDS) or transient tachypnea of newborn(TTN) (transient tachypnea of the newborn), and composite neonatal outcome were ascertained. A composite adverse neonatal outcome was created and defined as any of the following: NICU admission, hypoglycemia, hyperbilirubinemia, RDS, TTN, mechanical ventilation use, oxygen by nasal cannula, pneumonia, and stillbirth. PPROM was defined by rupture of membrane before 37 weeks gestation. Concerning fetal heart tracing was defined as recurrent variable or late decelerations with moderate variability, prolonged decelerations, or category 3 tracing. Providers who were caring for the women reviewed and independently characterized fetal heart tracings. Since fetal heart tracings were not accessible to authors, authors accepted the providers' interpretation. For analysis of concerning fetal heart tracing, women with non-labor cesarean section were excluded. Hyperbilirubinemia was defined by neonatal hyperbilirubinemia that required phototherapy. Hypoglycemia was defined by neonatal hypoglycemia that required intravenous infusion. Diagnosis of RDS and TTN were made by the managing neonatologist and based on standard clinical guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospitalization group | – | –Newborns of ICP mothers require hospitalization after birth |
| without Hospitalization group | – | –Newborns of ICP mothers don't require hospitalization after birth |
Who may qualify
- Ages
- 1 minute to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- neonates
Key inclusion criteria (1 listed)
- Newborns were born in maternal and child health hospital of Yong Chuan District from January 2012 to December 2020;②all Newborns' mothers diagnosed intrahepatic cholestasis of pregnancy.
Key exclusion criteria (1 listed)
- The newborns were born with severe congenital heart disease and deformities
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
Hypoglycemia
Time frame: up to 28 days
Hypoglycemia was defined by neonatal hypoglycemia that required intravenous infusion
Hyperbilirubinemia
Time frame: up to 28 days
Hyperbilirubinemia was defined by neonatal hyperbilirubinemia that required phototherapy
NICU admission
Time frame: up to 28 days
Newborns required hospitalization in the NICU after birth
RDS
Time frame: up to 28 days
Newborns were diagnosed with respiratory distress syndrome
TTN
Time frame: up to 28 days
Newborns were diagnosed with transient tachypnea of the newborn
mechanical ventilation use
Time frame: up to 28 days
Newborns required mechanical ventilation
oxygen by nasal cannula
Time frame: up to 28 days
Newborns required oxygen by nasal cannula
pneumonia
Time frame: up to 28 days
Newborns were diagnosed with pneumonia
stillbirth
Time frame: up to 1 day
newborns died after birth
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 18 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Intrahepatic Cholestasis of Pregnancy, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
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 1 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 18 Aug 2021. 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 China. 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?
Hypoglycemia (time frame: up to 28 days). The study lists 9 primary outcomes in all. 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 18 Aug 2021.