Establishment of Special Disease Cohort for RPLand Study of Impact Mechanism of Early Embryo Development

NCT05186207 | Unknown

• 1 other identifier: IRB-20210298-R
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Recurrent Pregnancy Loss

Keywords

Recurrent Pregnancy Loss; Cohort Sutdy; Early Embryo Development

Outcome Measures

Primary Outcomes (1)

• Number of participants with different pregnant outcome

  Number of participants with abortion, preterm birth, stillbirth, induced labor, flat birth or cesarean section

  From date of enrollment until the date of termination of pregnancy, assessed up to 24 months.

Study Arms (2)

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.

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.

Interventions

abnormal pre-pregnancy test results that need clinical intervention OTHER

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.

observation group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients who were treated in the outpatient department of Zhejiang University Women's Hospital from January 1, 2018 to December 31, 2020.

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead

Study Sites (1)

Women's Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: January 11, 2022
• Study Start: January 12, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: January 21, 2022

Record last verified: 2022-01

Locations

CN (1)