Intrahepatic Cholestasis of PregnancyNCT05637151
Different Effects of Delayed Clamping on Neonatal Bilirubin Levels Between Pregnant Women With Intrahepatic Cholestasis of Pregnancy and Normal Pregnant Women
A study testing clamp time of umbilical in people with Intrahepatic Cholestasis of Pregnancy, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
Objective:The aim of this study was to investigate the relationship between delayed cord clamping and neonatal bilirubin levels in pregnant women with intrahepatic cholestasis of pregnancy. Method:This observational prospective cohort study included a total of 200 pregnant women at 37-40 gestational weeks. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrahepatic Cholestasis of Pregnancy
- What is being tested?
- clamp time of umbilical
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 1 Jun 2024
- Phase
- Interventional
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The pregnant woman is born at a gestational age of 37-40 weeks;
- The pregnant woman has a single child;
- Regular obstetric examination durinv pregnancy with complete obstetric examination data was diagnosed as intrahepatic cholestasis of pregnancy(ICP).
Who cannot join
- Pregnancy complicated with medical and surgical diseases, such as thyroiddysfunction and chronic hypertension;
- Insufficiency of vital organ function or complicated tumor;
- Pregnant women with other pregnancy complications besides ICP, such as preeclampsia, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027
ying hua, +8613676403165, wzfeyhy1015@126.com
About this study
Official title: Different Effects of Delayed Cord Clamping on Neonatal Bilirubin Levels Between Pregnant Women With Intrahepatic Cholestasis of Pregnancy and Normal Pregnant Women
Objective:The aim of this study was to investigate the relationship between delayed cord clamping and neonatal bilirubin levels in pregnant women with intrahepatic cholestasis of pregnancy.
Method:This observational prospective cohort study included a total of 200 pregnant women at 37-40 gestational weeks. Among them, 100 pregnant women with intrahepatic cholestasis of pregnancy were divided into 50 cases of immediate cord clamping group （ICC in pregnant women with ICP）and 50 cases of delayed cord clamping group（DCC in pregnant women with ICP）, and 100 normal pregnant women were also divided into 50 cases of immediate cord clamping group （ICC in normal pregnant women）and 50 cases of delayed cord clamping group（DCC in normal pregnant women）. The bilirubin levels of neonates in each group were compared.
- Conditions
- Intrahepatic Cholestasis of Pregnancy
- Being tested
- clamp time of umbilical
- Keywords
- Intrahepatic cholestasis during pregnancy, neonatal bilirubin, bilirubin, ICP, neonatal jaundice
- Medical subject headings
- Intrahepatic Cholestasis of Pregnancy, Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clamp time of umbilicalOther
The umbilical cord was clamped immediately or late for more than 30s
| Study group | Role | What they receive |
|---|---|---|
| ICC in pregnant women with ICP | Other | Immediate cord clamping group in pregnant women with intrahepatic cholestasis of pregnancy Receives: Other: clamp time of umbilical |
| DCC in pregnant women with ICP | Experimental | Delayed cord clamping group in pregnant women with intrahepatic cholestasis of pregnancy Receives: Other: clamp time of umbilical |
| ICC in normal pregnant women | Other | Immediate cord clamping group in normal pregnant women Receives: Other: clamp time of umbilical |
| DCC in normal pregnant women | Experimental | Delayed cord clamping group in normal pregnant women Receives: Other: clamp time of umbilical |
What is being measured
The primary outcome is the main question the study is designed to answer.
the neonatal bilirubin values
the neonatal bilirubin values
Measured: 2-4 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start1 Dec 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
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.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Hua, Study director, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637151
- Sponsor's protocol ID
- SAHoWMU-CR2022-07-206
- Status last verified
- Feb 2023
- First submitted
- 28 Nov 2022
- Last updated
- 22 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Effects of Delayed Cord Clamping on Neonatal Bilirubin Levels Between Pregnant Women With Intrahepatic Cholestasis of Pregnancy and Normal Pregnant Women
- ClinicalTrials.gov ID
- NCT05637151
- Acronym / sponsor ID
- SAHoWMU-CR2022-07-206
- Conditions
- Intrahepatic Cholestasis of Pregnancy
- Keywords
- Intrahepatic cholestasis during pregnancy, neonatal bilirubin, bilirubin, ICP, neonatal jaundice
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 5 Dec 2022 (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.
Objective:The aim of this study was to investigate the relationship between delayed cord clamping and neonatal bilirubin levels in pregnant women with intrahepatic cholestasis of pregnancy.
Method:This observational prospective cohort study included a total of 200 pregnant women at 37-40 gestational weeks. Among them, 100 pregnant women with intrahepatic cholestasis of pregnancy were divided into 50 cases of immediate cord clamping group （ICC in pregnant women with ICP）and 50 cases of delayed cord clamping group（DCC in pregnant women with ICP）, and 100 normal pregnant women were also divided into 50 cases of immediate cord clamping group （ICC in normal pregnant women）and 50 cases of delayed cord clamping group（DCC in normal pregnant women）. The bilirubin levels of neonates in each group were compared.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ICC in pregnant women with ICP | Other | Other: clamp time of umbilicalImmediate cord clamping group in pregnant women with intrahepatic cholestasis of pregnancy |
| DCC in pregnant women with ICP | Experimental | Other: clamp time of umbilicalDelayed cord clamping group in pregnant women with intrahepatic cholestasis of pregnancy |
| ICC in normal pregnant women | Other | Other: clamp time of umbilicalImmediate cord clamping group in normal pregnant women |
| DCC in normal pregnant women | Experimental | Other: clamp time of umbilicalDelayed cord clamping group in normal pregnant women |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The pregnant woman is born at a gestational age of 37-40 weeks;
- The pregnant woman has a single child;
- Regular obstetric examination durinv pregnancy with complete obstetric examination data was diagnosed as intrahepatic cholestasis of pregnancy(ICP).
Key exclusion criteria (3 listed)
- Pregnancy complicated with medical and surgical diseases, such as thyroiddysfunction and chronic hypertension;
- Insufficiency of vital organ function or complicated tumor;
- Pregnant women with other pregnancy complications besides ICP, such as preeclampsia, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clamp time of umbilicalThe umbilical cord was clamped immediately or late for more than 30s | Other | DCC in normal pregnant women, DCC in pregnant women with ICP, ICC in normal pregnant women, ICC in pregnant women with ICP |
Primary outcome
the neonatal bilirubin values
Time frame: 2-4 days after birth
the neonatal bilirubin values
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
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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.
Ying Hua study director
Second Affiliated Hospital of Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clamp time of umbilical in people with Intrahepatic Cholestasis of Pregnancy, run by Second Affiliated Hospital of Wenzhou 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 22 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Hua (+8613676403165 ext. +8613676403165, wzfeyhy1015@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the neonatal bilirubin values (time frame: 2-4 days after birth). 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 22 Feb 2023.