Threatened AbortionPOTANCT02686112
Pregnancy Outcome in Woman With Threatened Abortion
An observational study of Threatened Abortion, run by Bnai Zion Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Threatened Abortion
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Women who attended the Emergency department with vaginal bleeding and/or abdominal pain and were on their 20th week of pregnancy or less.
Who cannot join
- Women with any background that can explain vaginal bleeding or any other circumstance that can explain it.
About this study
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.
Read the detailed description
the study is following woman retrospectively through their pregnancy from the first trimester troughout delivery .
we will measure the relation between first and/or second trimester bleeding ( threatend abortion ) and pregnancy outcome ( as written below ) - maternal and neonatal .
- Conditions
- Threatened Abortion
- Medical subject headings
- Abortion, Threatened
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study startJan 2007
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Threatened AbortionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eyal.levy, Bnai Zion Medical Center
- Investigators
- Eyal Levy, Resident, Principal investigator, Bnai Zion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686112
- Sponsor's protocol ID
- BNZ-0043-14
- Acronym
- POTA
- Status last verified
- Feb 2016
- First submitted
- 28 Jan 2016
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Outcome in Woman With Threatened Abortion
- ClinicalTrials.gov ID
- NCT02686112
- Acronym / sponsor ID
- POTA / BNZ-0043-14
- Conditions
- Threatened Abortion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Jan 2007
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 19 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
the study is following woman retrospectively through their pregnancy from the first trimester troughout delivery .
we will measure the relation between first and/or second trimester bleeding ( threatend abortion ) and pregnancy outcome ( as written below ) - maternal and neonatal .
Study design
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Women who attended the Emergency department with vaginal bleeding and/or abdominal pain and were on their 20th week of pregnancy or less.
Key exclusion criteria (1 listed)
- Women with any background that can explain vaginal bleeding or any other circumstance that can explain it.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maternal and neonatal outcome in pregnancies with 1st and 2nd trimester bleeding
Time frame: 9 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
- Individual participant dataSharing planned: No
Related trials for Threatened Abortion
Not yet recruitingObservational study
Serum Progesterone and Threatened Abortion During Lactation
Threatened Abortion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eyal Levy, Resident principal investigator
Bnai Zion
Questions about this trial
What is this clinical trial studying?
An observational study of Threatened Abortion, run by Bnai Zion Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal and neonatal outcome in pregnancies with 1st and 2nd trimester bleeding (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016.