An observational study in Missed Abortion, Incomplete Abortion and Uterine Gestational Residua, sponsored by Carmel Medical Center. Status unknown at 1 site in Israel. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2014-06-03.
Sponsored by Carmel Medical Center · Observational
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.
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 :
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 .
48 studies on the registry are indexed under Abortion, Missed; 10 are open to participants now.
Browse Abortion, Missed studies →Carmel Medical Center is the lead sponsor of 119 studies on the registry; 7 are open to participants now.
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women of age 20-45 with missed abortion up to 8 weeks of pregnancy or incomplete abortion treated with misoprostol in the emergency room
Inclusion Criteria:1. women with missed abortion (embryo karger than 5 mm with no heart beat) or anembryonic pregnancy (empty gestational sac larger than 20 mm) 2. incomplete abortion 3. missed abortion with CRL (crown ump length) no larger than 8 weeks of pregnancy 4. women who got a clear explanation about all treatment options and they chose misoprostol as a treatment 5. women who read and signed an form
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 1 year
success rate of treatment of misoprostol in missed and incomplete abortions
Time frame: 1 year
This study is status unknown, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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