An interventional study of medical VS surgical evacuation of the uterus in Medical; Abortion, Fetus, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-26.
Sponsored by Tel-Aviv Sourasky Medical Center · Not applicable, Interventional, and Treatment
Study Objective: To compare the time to new pregnancy and pregnancy outcomes in women who received Misoprostol for uterus evacuation versus those treated surgically with dilatation and curettage.
Study Population: Women to be admitted to the Lis maternity department for first trimester failed pregnancy. Patients will choose between medical versus surgical management. Of this group, women interested and successful in achieving a new pregnancy without first engaging in birth control methods will be included in our study.
Inclusion Criteria: Women with first trimester failed pregnancy (up until week 12 according to LMP and up to CRL compatible with 11 gestational weeks) Exclusion Criteria: Women under the age of 18 or over the age of 45, women who conceived via fertility treatments, women with a molar pregnancy.
Study Type: prospective study. Study Description: Women who visit the emergency department or gynecology clinic with a first-trimester miscarriage will be questioned regarding their subsequent family planning. In the event that the woman is interested in another pregnancy, and is not planning to use birth control methods prior to conception, the use of folic acid will be recommended, and she will receive an explanation of the research process. Women who agree to participate in the study orally and who sign a written consent form will be included in the study.
Three to six months following uterine evacuation, study participants will receive a telephone call to assess whether they have conceived, and the case that they had not yet conceived, will receive a follow-up call after an additional three to six months.
Each woman who conceived, will receive a follow-up call to assess the details of the birth. In the event that she did not give birth in the Lis Maternity Hospital, she will be asked to fax a copy of the release letter she received from the hospital.
Type of Birth: Normal vaginal delivery, operative delivery, cesarean section. Birth details will be collected via the automated system in Lis in the event that the birth took These women will be included in the study and will be divided into two groups: surgical vs. medical management. The study will include roughly 200 women in each of the two groups.
It will be clarified that:
Study Parameters: 1 .Demographic Parameters of the two groups - age, gravity, parity, ethnicity, history of infertility.
Mechanism of Anonymity:
The primary researcher will be responsible for the removal of identifying data. After this data has been removed, in the event that it is still necessary to complete data on the participants, we will make contact with the participant and he will sign a telephone consent form regarding this data completion. In the event that no data is mission and/or after the data is completed through a telephone call, the identifying details will be removed in a way that it will be impossible to replace them. And the telephone consent forms will be saved in a cabinet that can be accessed only by the primary and secondary researchers.
320 studies on the registry are indexed under Abortion, Spontaneous; 53 are open to participants now.
This study's planned enrollment of 400 is above the median of 147 across 174 interventional studies indexed under Abortion, Spontaneous.
Browse Abortion, Spontaneous studies →Tel-Aviv Sourasky Medical Center is the lead sponsor of 541 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Misoprostol for uterine evacuation
Other: medical VS surgical evacuation of the uterus
dilatation and curettage for uterine evacuation
Other: medical VS surgical evacuation of the uterus
mentioned above
Time from evacuation of the uterus to new conception
Time frame: 2 years
pregnancy outcome
abortion/preterm labor/ term labor
Time frame: 2 years
No study locations are listed for this record.
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Tel-Aviv Sourasky Medical Center