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Risk Assessment and Prevention of Spontaneous Abortion (RAPSA)

Primary Purpose

Spontaneous Abortion

Status
Unknown status
Phase
Not Applicable
Locations
Bulgaria
Study Type
Interventional
Intervention
sFlt-1 measurement & placental Doppler
Sponsored by
Orthogyn Medical Center, Bulgaria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spontaneous Abortion

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • visualized fetal structures in utero & heart pulsations until 8th week of gestation
  • normal THS/T4 levels
  • no uterine malformations
  • no submucous fibroids and/or endometrial polyps
  • BMI < 27

Exclusion Criteria:

  • fetal structures in utero & heart pulsations not visualized until 8th week of gestation
  • elevated THS/T4 levels
  • uterine malformations
  • submucous fibroids and/or endometrial polyps
  • BMI > 27

Sites / Locations

  • Orthogyn Medical and Dental CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control group

sFlt-1 & Doppler group

Arm Description

Outcomes

Primary Outcome Measures

Occurence of spontaneous abortion

Secondary Outcome Measures

Full Information

First Posted
June 25, 2020
Last Updated
June 29, 2020
Sponsor
Orthogyn Medical Center, Bulgaria
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1. Study Identification

Unique Protocol Identification Number
NCT04456660
Brief Title
Risk Assessment and Prevention of Spontaneous Abortion
Acronym
RAPSA
Official Title
Risk Assessment and Prevention of Spontaneous Abortion
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 20, 2020 (Actual)
Primary Completion Date
June 20, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Orthogyn Medical Center, Bulgaria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to determine the role of sFlt-1 and placental bloodflow evaluation in the detection of high risk for spontaneous abortion

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spontaneous Abortion

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Title
sFlt-1 & Doppler group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
sFlt-1 measurement & placental Doppler
Intervention Description
Measurement of sFlt-1 levels in maternal blood as a potential inflammation indicator. Investigating the levels of placental circulation.
Primary Outcome Measure Information:
Title
Occurence of spontaneous abortion
Time Frame
from 6th to 28th week of gestation

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: visualized fetal structures in utero & heart pulsations until 8th week of gestation normal THS/T4 levels no uterine malformations no submucous fibroids and/or endometrial polyps BMI < 27 Exclusion Criteria: fetal structures in utero & heart pulsations not visualized until 8th week of gestation elevated THS/T4 levels uterine malformations submucous fibroids and/or endometrial polyps BMI > 27
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Petar N Ignatov, PhD
Phone
0035988896318
Ext
00359
Email
ignatov@orthogyn.com
Facility Information:
Facility Name
Orthogyn Medical and Dental Center
City
Sofia
ZIP/Postal Code
1618
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petar D Ignatov, PhD
Phone
00359888963189
Ext
00359
Email
ignatov@orthogyn.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Risk Assessment and Prevention of Spontaneous Abortion

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