NCT02686112

Brief Summary

The study aims to quantify the relations between first \& second trimester bleeding and maternal \& neonatal morbidity. Additionally, the study will help in assessing the risk for abortions in women with threatened abortions and the risk factors for threatened abortion.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

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, 2007

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 19, 2016

Completed
Last Updated

February 19, 2016

Status Verified

February 1, 2016

Enrollment Period

9 years

First QC Date

January 28, 2016

Last Update Submit

February 15, 2016

Conditions

Threatened Abortion

Outcome Measures

Primary Outcomes (1)

  • Maternal and neonatal outcome in pregnancies with 1st and 2nd trimester bleeding

    by using our data in the past 7 years we will examine retrospectively cases of patients from their first admission due to vaginal bleeding throgh their pregnancy and labor . the mesearment will include : Intra uterine growth retardation , Antepartum hemorrhage, premature rupture of membrane, Intra uterine fetal death , Preterm delivery, Apgar less than 7, Congenital malformation, Mode of delivery - vaginal delivery vs. cesarean section

    9 months

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women who attanded the Emergency department with vaginal bleeding and/or abdominal pain and were on their 20th week of pregnancy or less.

You may qualify if:

  • Women who attended the Emergency department with vaginal bleeding and/or abdominal pain and were on their 20th week of pregnancy or less.

You may not qualify if:

  • Women with any background that can explain vaginal bleeding or any other circumstance that can explain it.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Abortion, Threatened

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Eyal Levy, Resident

    Bnai Zion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

January 28, 2016

First Posted

February 19, 2016

Study Start

January 1, 2007

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

February 19, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share