Recurrent Pregnancy LossNCT05186207
Establishment of Special Disease Cohort for RPLand Study of Impact Mechanism of Early Embryo Development
An observational study of Recurrent Pregnancy Loss, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
Trial summary
Recurrent pregnancy loss (RPL) is a refractory disease with diverse etiologies, complex pathogenesis and limited therapeutic options. Current tests and treatments lack uniform specifications. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Recurrent Pregnancy Loss
- What is being tested?
- abnormal pre-pregnancy test results that need clinical intervention
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2022to 31 Dec 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients who were treated in the outpatient department of Zhejiang University Women's Hospital from January 1, 2018 to December 31, 2020.
Who may be able to join
- (1) patients who were treated in the outpatient department of Zhejiang University Women's Hospital from January 1, 2018 to December 31, 2020;
- (2) With history of once spontaneous abortion;
- (3) Having fertility requirements but not yet pregnant;
- (4) Those who are willing to give birth again during the study period.
Who cannot join
- (1) Previous history of multiple spontaneous abortion, inevitable abortion or missed abortion;
- (2) Re pregnancy after abortion, now in pregnancy or delivered;
- (3) Patients who are participating in other clinical studies or those who refuse to participate in the study;
- (4) The researchers consider that she is not suitable to participate in this study for other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Women's Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
Qiong Luo, Doctor, 86-0571-87061501, luoq@zju.edu.cn
About this study
Official title: Women's Hospital School of Medicine Zhejiang University
Recurrent pregnancy loss (RPL) is a refractory disease with diverse etiologies, complex pathogenesis and limited therapeutic options. Current tests and treatments lack uniform specifications. This study is a prospective clinical cohort study which intends to screen out meaningful examination items and reliable and effective treatment. The study content includes (1) tracking the re-pregnancy information of patients with initial inevitable abortion, comparing the clinical data and examination test results between patients with single abortion and RPL, and (2) comprehensively and systematically screening the patients with initial inevitable abortion, taking those without obvious abnormalities and those with a re-pregnancy into the control group and taking those with a re-pregnancy after abnormal findings were treated into the study group, recording the pregnancy and perinatal conditions of the two groups, comparing the pregnancy outcomes of the two groups, and analyzing the risk factors for RPL. The results of this study will establish a model of maternal and newborn risk assessment for first trimester medication use and provide strong evidence-based evidence to clarify the diagnosis and treatment processes of RPL.
Read the detailed description
Objective: (1) to establish a prediction model of pregnancy outcome and apply it to clinical practice; (2) to standardize the diagnosis and treatment of RPL.
This study is an observational study. The investigators only collect the medical data of patients without any intervention in the diagnosis and treatment plan. The data collection is in the charge of specially-assigned members of the investigators. The investigators set a security password for the database. The data is collected from outpatient medical record system, inpatient medical record system and questionnaire. One investigator is responsible for inputting the data into the database, and another investigator is responsible for checking the Corrigendum.
- Before enrollment, the investigators would record the medical history of the couple in detail, including age, menstruation, marriage and reproductive history, family history, and the details of previous abortion.
- The following examinations should be completed before pregnancy: in addition to the routine pre-pregnancy examination items, the examination items related to recurrent spontaneous abortion were added, including uterine artery resistance ultrasound, couple's chromosome, reproductive hormone, OGTT test and some immune related indexes.
- According to the examination results, the experts of recurrent spontaneous abortion team would evaluate the patients and divided them into:
- Control group:those who needn't clinical intervention before or after pregnancy , pregnancy was prepared under the clinical and health care guidance provided by experts, and intrauterine pregnancy was confirmed within the study period.
- Observation group: those who need clinical intervention before or after pregnancy, the experts shall formulate a personalized treatment plan according to the international guidelines. Investigators wouldn't interfere with the expert diagnosis and treatment process. And they should be confirmed intrauterine pregnancy within the study period. (4) The investigators monitored and tracked the indicators during pregnancy and perinatal period of the two groups, including:
- The participants should complete the routine health care and necessary examination items on schedule, which is the same as that of normal pregnant women.
- Coagulation function and immune function related tests will be performed respectively in early pregnancy, middle pregnancy and late pregnancy respectively.
- Length of cervical canal will be check at least once in the second trimester of pregnancy. Uterine artery blood flow was monitored by ultrasound at least every 4 weeks from early pregnancy until 24 weeks of pregnancy. The fetal growth measurement ultrasound was performed respectively at 20 weeks, 28 weeks, 32 weeks and 36 weeks of gestation.
- Additional OGTT test at 12-16 weeks of gestation.
- Tests of glucose and lipid metabolism indexes of maternal blood and urine during early, middle and late pregnancy. (5) When the participant is hospitalized for delivery, the investigators will collect the following data: length of hospital stay, diagnosis, fetal position, number of pregnancies, weight gain before delivery, mode of delivery, postpartum hemorrhage, puerperal infection, neonatal birth weight, neonatal Apgar score and examination results during and after delivery. (6) The following analysis shall be made according to the obtained medical data:
- The statistical differences of various indexes between the two groups were compared.
- The abortion rate, preterm birth rate and other pregnancy outcomes were compared between the two groups.
- Multivariate analysis was used to analyze the independent risk factors of recurrent abortion.
- Conditions
- Recurrent Pregnancy Loss
- Being tested
- abnormal pre-pregnancy test results that need clinical intervention
- Keywords
- Recurrent Pregnancy Loss, Cohort Sutdy, Early Embryo Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abnormal pre-pregnancy test results that need clinical interventionOther
The patients who need clinical intervention before or after pregnancy were divided into observation group. Doctors will formulate a personalized treatment plan according to the international guidelines. Researchers wouldn't interfere with the expert diagnosis and treatment process.
| Study group | Role | What they receive |
|---|---|---|
| observation group | those who need clinical intervention before or after pregnancy, the experts shall formulate a personalized treatment plan according to the international guidelines. Researchers wouldn't interfere with the expert diagnosis and treatment process. And they should be confirmed intrauterine pregnancy within the study period. Receives: Other: abnormal pre-pregnancy test results that need clinical intervention | |
| control group | those who need not clinical intervention before or after pregnancy, pregnancy was prepared under the clinical and health care guidance provided by experts, and intrauterine pregnancy was confirmed within the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with different pregnant outcome
Number of participants with abortion, preterm birth, stillbirth, induced labor, flat birth or cesarean section
Measured: From date of enrollment until the date of termination of pregnancy, assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start12 Jan 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Pregnancy LossStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186207
- Sponsor's protocol ID
- IRB-20210298-R
- Status last verified
- Jan 2022
- First submitted
- 19 Nov 2021
- Last updated
- 21 Jan 2022
- 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 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's Hospital School of Medicine Zhejiang University
- ClinicalTrials.gov ID
- NCT05186207
- Acronym / sponsor ID
- IRB-20210298-R
- Conditions
- Recurrent Pregnancy Loss
- Keywords
- Recurrent Pregnancy Loss, Cohort Sutdy, Early Embryo Development
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- 12 Jan 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Jan 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.
Recurrent pregnancy loss (RPL) is a refractory disease with diverse etiologies, complex pathogenesis and limited therapeutic options. Current tests and treatments lack uniform specifications. This study is a prospective clinical cohort study which intends to screen out meaningful examination items and reliable and effective treatment. The study content includes (1) tracking the re-pregnancy information of patients with initial inevitable abortion, comparing the clinical data and examination test results between patients with single abortion and RPL, and (2) comprehensively and systematically screening the patients with initial inevitable abortion, taking those without obvious abnormalities and those with a re-pregnancy into the control group and taking those with a re-pregnancy after abnormal findings were treated into the study group, recording the pregnancy and perinatal conditions of the two groups, comparing the pregnancy outcomes of the two groups, and analyzing the risk factors for RPL. The results of this study will establish a model of maternal and newborn risk assessment for first trimester medication use and provide strong evidence-based evidence to clarify the diagnosis and treatment processes of RPL.
Detailed description
Objective: (1) to establish a prediction model of pregnancy outcome and apply it to clinical practice; (2) to standardize the diagnosis and treatment of RPL.
This study is an observational study. The investigators only collect the medical data of patients without any intervention in the diagnosis and treatment plan. The data collection is in the charge of specially-assigned members of the investigators. The investigators set a security password for the database. The data is collected from outpatient medical record system, inpatient medical record system and questionnaire. One investigator is responsible for inputting the data into the database, and another investigator is responsible for checking the Corrigendum.
- Before enrollment, the investigators would record the medical history of the couple in detail, including age, menstruation, marriage and reproductive history, family history, and the details of previous abortion.
- The following examinations should be completed before pregnancy: in addition to the routine pre-pregnancy examination items, the examination items related to recurrent spontaneous abortion were added, including uterine artery resistance ultrasound, couple's chromosome, reproductive hormone, OGTT test and some immune related indexes.
- According to the examination results, the experts of recurrent spontaneous abortion team would evaluate the patients and divided them into:
- Control group:those who needn't clinical intervention before or after pregnancy , pregnancy was prepared under the clinical and health care guidance provided by experts, and intrauterine pregnancy was confirmed within the study period.
- Observation group: those who need clinical intervention before or after pregnancy, the experts shall formulate a personalized treatment plan according to the international guidelines. Investigators wouldn't interfere with the expert diagnosis and treatment process. And they should be confirmed intrauterine pregnancy within the study period. (4) The investigators monitored and tracked the indicators during pregnancy and perinatal period of the two groups, including:
- The participants should complete the routine health care and necessary examination items on schedule, which is the same as that of normal pregnant women.
- Coagulation function and immune function related tests will be performed respectively in early pregnancy, middle pregnancy and late pregnancy respectively.
- Length of cervical canal will be check at least once in the second trimester of pregnancy. Uterine artery blood flow was monitored by ultrasound at least every 4 weeks from early pregnancy until 24 weeks of pregnancy. The fetal growth measurement ultrasound was performed respectively at 20 weeks, 28 weeks, 32 weeks and 36 weeks of gestation.
- Additional OGTT test at 12-16 weeks of gestation.
- Tests of glucose and lipid metabolism indexes of maternal blood and urine during early, middle and late pregnancy. (5) When the participant is hospitalized for delivery, the investigators will collect the following data: length of hospital stay, diagnosis, fetal position, number of pregnancies, weight gain before delivery, mode of delivery, postpartum hemorrhage, puerperal infection, neonatal birth weight, neonatal Apgar score and examination results during and after delivery. (6) The following analysis shall be made according to the obtained medical data:
- The statistical differences of various indexes between the two groups were compared.
- The abortion rate, preterm birth rate and other pregnancy outcomes were compared between the two groups.
- Multivariate analysis was used to analyze the independent risk factors of recurrent abortion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| observation group | – | Other: abnormal pre-pregnancy test results that need clinical interventionthose who need clinical intervention before or after pregnancy, the experts shall formulate a personalized treatment plan according to the international guidelines. Researchers wouldn't interfere with the expert diagnosis and treatment process. And they should be confirmed intrauterine pregnancy within the study period. |
| control group | – | –those who need not clinical intervention before or after pregnancy, pregnancy was prepared under the clinical and health care guidance provided by experts, and intrauterine pregnancy was confirmed within the study period. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who were treated in the outpatient department of Zhejiang University Women's Hospital from January 1, 2018 to December 31, 2020.
Key inclusion criteria (4 listed)
- (1) patients who were treated in the outpatient department of Zhejiang University Women's Hospital from January 1, 2018 to December 31, 2020;
- (2) With history of once spontaneous abortion;
- (3) Having fertility requirements but not yet pregnant;
- (4) Those who are willing to give birth again during the study period.
Key exclusion criteria (4 listed)
- (1) Previous history of multiple spontaneous abortion, inevitable abortion or missed abortion;
- (2) Re pregnancy after abortion, now in pregnancy or delivered;
- (3) Patients who are participating in other clinical studies or those who refuse to participate in the study;
- (4) The researchers consider that she is not suitable to participate in this study for other reasons.
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 |
|---|---|---|
| abnormal pre-pregnancy test results that need clinical interventionThe patients who need clinical intervention before or after pregnancy were divided into observation group. Doctors will formulate a personalized treatment plan according to the international guidelines. Researchers wouldn't interfere with the expert diagnosis and treatment process. | Other | observation group |
Primary outcome
Number of participants with different pregnant outcome
Time frame: From date of enrollment until the date of termination of pregnancy, assessed up to 24 months.
Number of participants with abortion, preterm birth, stillbirth, induced labor, flat birth or cesarean section
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
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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.
Women's Hospital, School of Medicine, Zhejiang University
Hangzhou, China
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 Recurrent Pregnancy Loss, run by Women's Hospital School Of Medicine Zhejiang 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 4 inclusion and 4 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 21 Jan 2022. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with different pregnant outcome (time frame: From date of enrollment until the date of termination of pregnancy, assessed up to 24 months.). 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 21 Jan 2022.