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Status unknownNCT02990390Updated Dec 14, 2016

The Epidemiology of Recurrent Spontaneous Abortion Associated With Thrombophilla

An observational study in Recurrent Pregnancy Loss, sponsored by Shanghai First Maternity and Infant Hospital. Status unknown at 1 site in China. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-14.

Sponsored by Shanghai First Maternity and Infant Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Enrollment
45,000
Ages
18 Years to 50 Years
Sex
Female
01

Study summary

RSA is a multifactorial disorder resulting from genetic factors, anatomic factors, autoimmune disorders, endocrine dysfunction, thrombophilia, life style factors, and maternal infections. However, the underlying causes remain undetermined in up to 50% of cases. In this clinical cohort study, we intended to get an epidemiological evidence for patients with recurrent spontaneous abortion associated with thrombophilla.

02

Conditions studied

  • Recurrent Pregnancy Loss
03

In context

Lead sponsor

Shanghai First Maternity and Infant Hospital is the lead sponsor of 48 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Woman who had their Second miscarriage before 12(th) week of gestation.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Woman who had 2 miscarriages before 12(th) week of gestation.Signed consent form.

Exclusion criteria

Exclusion Criteria:

  1. having experienced severe allergies, trauma history and/or operation history within 3 months;
  2. with a history of mental illness and/or family history of mental illness
  3. limb disabled
  4. taking medicine within one month
  5. suffering major events or having mood swings
  6. with a history of recurrent pregnancy loss
  7. having internal and surgical disease(after having variety of physical examination such as electrocardiogram/hepatic and renal function/blood routine and urine routine)
  8. chromosome aberrations in anyone of the couple.
05

Study design

Observational model
Cohort
Enrollment
45,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. D-Dimer

    Time frame: through study completion, an average of 3 year

Secondary outcomes

  1. BMI in kg/m^2

    Time frame: through study completion, an average of 3 year

  2. platelet aggregation time

    Time frame: through study completion, an average of 3 year

  3. anticardiolipin antibody

    Time frame: through study completion, an average of 3 year

07

Study locations

1 of 1 sites recruiting
  • Shanghai first Maternity and Infant health hospital, Tong Ji University
    Shanghai, 200051, China
    Recruiting
    • Shihua Bao, PhD · Contactbaoshihua@tongji.edu.cn · 86-21-20261430
    • Yan Yan, Master · Contactshtjyanyan@163.com · 86-21-20261430
    • Shihua Chen, PhD · Principal investigator
    • Yan Yan, master · Sub investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2016, a primary completion of Oct 2019 and a completion of Oct 2019. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 27, 2016
First posted
Dec 13, 2016
Start
Nov 2016
Primary completionEst.
Oct 2019
CompletionEst.
Oct 2019
Last update
Dec 14, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02990390
Lead sponsor
Shanghai First Maternity and Infant Hospital
Responsible party
Shihua Bao (Principal Investigator, Shanghai First Maternity and Infant Hospital) — Principal investigator
First posted
Dec 13, 2016
Start date
Nov 2016
Primary completion
Oct 2019 (estimated)
Completion
Oct 2019 (estimated)
Last update
Dec 14, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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