Missed AbortionNCT01775917
The Role of Uterine Artery Doppler Parameters in the Management of Retained Products of Conception.
An observational study of Missed Abortion and Incomplete Abortion, run by Carmel Medical Center at 1 site in Israel.
Trial summary
During the recent decades the need for surgical evacuation of the uterus in early miscarriages and incomplete miscarriages has been questioned. It has been shown that an observational approach can be, in many cases, as good as an invasive one without increasing the incidence of uterine infections. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Missed Abortion, Incomplete Abortion, Uterine Gestational Residua
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to Jan 2015
- How long will I take part?
- 6 Weeks
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: women of age 20-45 with missed abortion up to 8 weeks of pregnancy or incomplete abortion treated with misoprostol in the emergency room
Who may be able to join
None listed.
Who cannot join
- known allergy to prostaglandins or NSAIDS
- heavy vaginal bleeding and hemodynamic instability
- multifetal gestation
- women with a clotting problems or treated with anticoagulant medications
- fever above 37.5 c
- anemia with hemoglobin < 9/5 gr%
- missed abortion with CRL larger than 8 weeks of pregnancy
- diseases that can be aggravated by prostaglandins : severe asthma, uncontrolled blood pressure, glaucoma, sickle cell anemia, mitral stenosis
Trial locations and contacts
1 site in 1 country.
About this study
During the recent decades the need for surgical evacuation of the uterus in early miscarriages and incomplete miscarriages has been questioned.
It has been shown that an observational approach can be, in many cases, as good as an invasive one without increasing the incidence of uterine infections.
Read more
it has been shown that misoprostol - prostaglandin E1 given for missed abortions is successful in emptying the uterus in 85% of cases without any need for surgical intervention. and during recent years many women prefer this approach than the surgical one .
Many have tried using sonographic signs such as endometrial thickness, the presence of a gestational sac, and color doppler to differ between blood clots and a gestational residua in uterus, and to decide according to these signs wether there is a need for surgical evacuation or an expectant management could be used. but none of these methods have been proven to be completely efficient as predictors.
In this study the investigators will examine whether the doppler indices in the uterine arteries can help to predict which gestational residua needs surgical evacuation of the uterus and which could be managed expectantly.
The study hypothesis is that the resistance in uterine artery doppler will be lower in cases with intrauterine residua as opposed to high resistance in cases without residua.
Read the detailed description
It's a prospective observational study that will take place in the gynecology department in Carmel medical center in Haifa, Israel.
The study population are women with the diagnosis of missed abortion matching 8 weeks of pregnancy or less, incomplete abortion or anembryonic pregnancy that are treated with misoprostol in the gynecologic emergency room according to the department's protocol.
our department's protocol for the treatment of missed abortion matching 8 weeks of pregnancy or less, anembryonic pregnancy or incomplete abortions . these women usually get a full explanation from the doctor in the emergency room about the possible treatments :
- surgical evacuation i.e. dilatation and curettage
- treatment with misoprostol 800 mcg given vaginally. both treatments are used routinely in our emergency room. If the woman chooses the treatment with misoprostol she will then also be told about the study and if she agrees to participate in the study she will sign an informed consent form.
After getting the first dose of misoprostol 800 mcg vaginally the woman is usually discharged home and then a sonographic follow up will be done on several preset occasions where an ultrasound is done vaginally and few sonographic indices are examined : the presence of gestational sac or gestational residua and its size, color doppler for the residua, the size of uterus... in addition to these indices routinely examined during the follow up according to the department protocol we will examine in this study the indices of uterine artery doppler (i.e. S/D ratio, resistance index, pulsatility index).
according to the department protocol day 3 will be the first day of follow up , if a gestational sac is still seen in the uterus, or an endometrial thickness above 30 mm, a second dose of misoprostol is given, and the women will be reexamined on day 10, then a surgical evacuation is performed if we still have the same findings (gestational sac or endometrium >30mm) otherwise the woman is discharged and the last follow up will be on day 4-5 of her next menstruation, that's when it will be decided if the abortion is complete and the uterus is completely empty. if a gestational residua is found after the menstruation then the woman will have to go through surgical evacuation .
In the end we will compare the uterine artery doppler indices of the women with complete abortions to those with failed misoprostol treatment who needed surgical evacuation .
No change in the treatment will be done during the study based on the uterine artery doppler indices , it's only an observational study .
- Medical subject headings
- Abortion, Missed, Abortion, Incomplete
What is being measured
The primary outcome is the main question the study is designed to answer.
uterine artery doppler parameters
comparison between uterine artery doppler parameters after complete abortion with misoprostol to doppler parameters in incomplete abortion with the need of surgical uterine evacuation. and in result to try and find a doppler value that could be used to predict the success of observational management in incomplete abortions or abortions with misoprostol.
Measured: 1 year
Secondary outcomes (1)
success rate of treatment of misoprostol in missed and incomplete abortions
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missed 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
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grace Younes, M.D, Principal investigator, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775917
- Sponsor's protocol ID
- CMC-12-0106-CTIL
- Status last verified
- Jun 2014
- First submitted
- 23 Jan 2013
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Uterine Artery Doppler Parameters in the Management of Retained Products of Conception.
- ClinicalTrials.gov ID
- NCT01775917
- Acronym / sponsor ID
- CMC-12-0106-CTIL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 25 Jan 2013 (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.
During the recent decades the need for surgical evacuation of the uterus in early miscarriages and incomplete miscarriages has been questioned.
It has been shown that an observational approach can be, in many cases, as good as an invasive one without increasing the incidence of uterine infections.
it has been shown that misoprostol - prostaglandin E1 given for missed abortions is successful in emptying the uterus in 85% of cases without any need for surgical intervention. and during recent years many women prefer this approach than the surgical one .
Many have tried using sonographic signs such as endometrial thickness, the presence of a gestational sac, and color doppler to differ between blood clots and a gestational residua in uterus, and to decide according to these signs wether there is a need for surgical evacuation or an expectant management could be used. but none of these methods have been proven to be completely efficient as predictors.
In this study the investigators will examine whether the doppler indices in the uterine arteries can help to predict which gestational residua needs surgical evacuation of the uterus and which could be managed expectantly.
The study hypothesis is that the resistance in uterine artery doppler will be lower in cases with intrauterine residua as opposed to high resistance in cases without residua.
Detailed description
It's a prospective observational study that will take place in the gynecology department in Carmel medical center in Haifa, Israel.
The study population are women with the diagnosis of missed abortion matching 8 weeks of pregnancy or less, incomplete abortion or anembryonic pregnancy that are treated with misoprostol in the gynecologic emergency room according to the department's protocol.
our department's protocol for the treatment of missed abortion matching 8 weeks of pregnancy or less, anembryonic pregnancy or incomplete abortions . these women usually get a full explanation from the doctor in the emergency room about the possible treatments :
- surgical evacuation i.e. dilatation and curettage
- treatment with misoprostol 800 mcg given vaginally. both treatments are used routinely in our emergency room. If the woman chooses the treatment with misoprostol she will then also be told about the study and if she agrees to participate in the study she will sign an informed consent form.
After getting the first dose of misoprostol 800 mcg vaginally the woman is usually discharged home and then a sonographic follow up will be done on several preset occasions where an ultrasound is done vaginally and few sonographic indices are examined : the presence of gestational sac or gestational residua and its size, color doppler for the residua, the size of uterus... in addition to these indices routinely examined during the follow up according to the department protocol we will examine in this study the indices of uterine artery doppler (i.e. S/D ratio, resistance index, pulsatility index).
according to the department protocol day 3 will be the first day of follow up , if a gestational sac is still seen in the uterus, or an endometrial thickness above 30 mm, a second dose of misoprostol is given, and the women will be reexamined on day 10, then a surgical evacuation is performed if we still have the same findings (gestational sac or endometrium >30mm) otherwise the woman is discharged and the last follow up will be on day 4-5 of her next menstruation, that's when it will be decided if the abortion is complete and the uterus is completely empty. if a gestational residua is found after the menstruation then the woman will have to go through surgical evacuation .
In the end we will compare the uterine artery doppler indices of the women with complete abortions to those with failed misoprostol treatment who needed surgical evacuation .
No change in the treatment will be done during the study based on the uterine artery doppler indices , it's only an observational study .
Study design
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- women of age 20-45 with missed abortion up to 8 weeks of pregnancy or incomplete abortion treated with misoprostol in the emergency room
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- known allergy to prostaglandins or NSAIDS
- heavy vaginal bleeding and hemodynamic instability
- multifetal gestation
- women with a clotting problems or treated with anticoagulant medications
- fever above 37.5 c
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
uterine artery doppler parameters
Time frame: 1 year
comparison between uterine artery doppler parameters after complete abortion with misoprostol to doppler parameters in incomplete abortion with the need of surgical uterine evacuation. and in result to try and find a doppler value that could be used to predict the success of observational management in incomplete abortions or abortions with misoprostol.
1 secondary outcome
success rate of treatment of misoprostol in missed and incomplete abortions
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2014.
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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.
Grace Younes, M.D principal investigator
Carmel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Missed Abortion and Incomplete Abortion, run by Carmel Medical Center at 1 site in Israel.
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 0 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 3 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact grace younes, MD (972508845924, graceyounes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
uterine artery doppler parameters (time frame: 1 year). 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 3 Jun 2014; AzTrials last refreshed its copy on 8 Nov 2026.