NCT05513768

Brief Summary

IT WAS AIMED TO EVALUATE IF MBPC CAN BE USED IN PREDICTION OF EARLY BIRTH. TAKING THE FIRST TRIMESTER FROM PREGNANCY WAS STORED UNTIL THE TIMING OF DELIVERY.THE PARTICIPANTS WERE SEPARATED INTO TWO GROUPS ACCORDING TO THE TIME OF BIRTH, EARLY AND TIMELY. SERUM MBPC LEVELS BETWEEN TWO GROUPS EVALUATED.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

November 23, 2022

Status Verified

November 1, 2022

Enrollment Period

10 months

First QC Date

August 22, 2022

Last Update Submit

November 18, 2022

Conditions

Keywords

PRETERM DELİVERY, MBPC,

Outcome Measures

Primary Outcomes (1)

  • detection of prediction value of serum mbpc levels in preterm delivery

    identifying prediction value of first trmester serum mbpc levels by comparing by serum levels of mbpc in groups

    10 mounths

Study Arms (2)

women who gave birth prematurely

women who had serum taken in the first trimester and gave birth earlier than 37 weeks according to the time of delivery

Diagnostic Test: level of myosin binding protein c in serum

those who gave birth on time

women who have had serum taken in the first trimester, stored and delivered on time

Diagnostic Test: level of myosin binding protein c in serum

Interventions

Serum samples will be taken from the participants in the first trimester, transferred to eppendorf tubes after appropriate procedures, and stored at -80 degrees until the time of deliveryParticipants will be divided into two groups according to the timing of birthThe first group is those who gave birth earlier than 37 weeks those who gave birth on time in the other group The mbpc levels will be looked at and compared.

those who gave birth on timewomen who gave birth prematurely

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Includes participants whose serum samples were collected in the first trimester, stored, and then divided into two according to timing of delivery fırst grup ıs preterm group, and second one ıs those who gave birth on time

You may qualify if:

  • being pregnant in the first trimester
  • be between 18-40 years old

You may not qualify if:

  • no history of preterm birth
  • being pregnant with assisted reproductive techniques
  • having a multiple pregnancy
  • have cervical insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa Training and Research Hospital

Istanbul, Gaziosmanpaşa, 32225, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • elif yıldız

    Gaziosmanpasa Research and Education Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MEDİCAL DOCTOR

Study Record Dates

First Submitted

August 22, 2022

First Posted

August 24, 2022

Study Start

January 1, 2022

Primary Completion

October 30, 2022

Study Completion

October 30, 2022

Last Updated

November 23, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations