Medical; Abortion, FetusNCT03570307
Fertility and Obstetric Outcomes After Medical Management Versus Surgical Treatment for First-trimester Miscarriage First-trimester Miscarriage
A study testing medical VS surgical evacuation of the uterus in people with Medical; Abortion, Fetus, run by Tel-Aviv Sourasky Medical Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Medical; Abortion, Fetus
- What is being tested?
- medical VS surgical evacuation of the uterus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Jun 2018to Jun 2020
- Phase
- Interventional
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Criteria: Women with first trimester failed pregnancy
Who cannot join
- Women under the age of 18 or over the age of 45, women who conceived via fertility treatments, women with a molar pregnancy
About this study
Official title: Fertility and Obstetric Outcomes After Medical Management Versus Surgical Treatment for First-trimester Miscarriage
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.
Read more
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:
- The researcher will confirm the identity of the participant at the outset of the telephone call.
- The researcher will request consent and introduce him or herself as a member of the research team from the Lis Hospital. In the event of refusal to participant, the research will apologize and terminate the telephone call.
Study Parameters: 1 .Demographic Parameters of the two groups - age, gravity, parity, ethnicity, history of infertility.
- Comparison of the success of the surgical treatment versus medical management - in this case, failure is defined as the need for subsequent surgical treatment. This will include data on the percentage of women who received multiple doses of Misoprostol.
- A comparison of the time (in months) until a new pregnancy is conceived (from the data of the dilatation and curettage or the first dose of the Misoprostol) 4. Pregnancy Outcomes - first trimester miscarriage, obstetric outcomes, early deliveries, pregnancy complications - IUGR, placental abruption, pre-eclampsia, cesarean sections, neonatal outcomes. This data will be collected in multiple telephone conversations - three months after conception and following the delivery date.
- Validation of details of pregnancies that ended in miscarriage - was the pregnancy desired? Mode of conception (if fertility treatments - which?), months until conception, gestational age at the time that a non-viable pregnancy was diagnosed, mode of pregnancy termination. The details will be validated in relation to details in our automated system.
- At what month did the woman resume menstruation? Was an ultrasound performed to assess uterine evacuation prior to a new pregnancy conception?
- Details on pregnancy following dilatation and curettage - time to conception from pregnancy termination, pregnancy outcomes, gestational age at birth (or miscarriage), birth weight, Apgar scores, pH (if available).
- Data on fertility, age, obstetric history, time to conception of new pregnancies, need for fertility treatments.
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.
- Conditions
- Medical; Abortion, Fetus
- Being tested
- medical VS surgical evacuation of the uterus
- Keywords
- MISCARRAGE, CURATTAGE MISOPROSTOL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical VS surgical evacuation of the uterusOther
mentioned above
| Study group | Role | What they receive |
|---|---|---|
| drug treatment | Other | Misoprostol for uterine evacuation Receives: Other: medical VS surgical evacuation of the uterus |
| surgical treatment | Other | dilatation and curettage for uterine evacuation Receives: Other: medical VS surgical evacuation of the uterus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from evacuation of the uterus to new conception
Measured: 2 years
Secondary outcomes (1)
pregnancy outcome
abortion/preterm labor/ term labor
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study startJun 2018 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical; Abortion, FetusStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, michal roll, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570307
- Sponsor's protocol ID
- 0360-17
- Status last verified
- Apr 2018
- First submitted
- 17 Jun 2018
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility and Obstetric Outcomes After Medical Management Versus Surgical Treatment for First-trimester Miscarriage
- ClinicalTrials.gov ID
- NCT03570307
- Acronym / sponsor ID
- 0360-17
- Conditions
- Medical; Abortion, Fetus
- Keywords
- MISCARRAGE, CURATTAGE MISOPROSTOL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jun 2018 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 26 Jun 2018 (actual)
- 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.
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:
- The researcher will confirm the identity of the participant at the outset of the telephone call.
- The researcher will request consent and introduce him or herself as a member of the research team from the Lis Hospital. In the event of refusal to participant, the research will apologize and terminate the telephone call.
Study Parameters: 1 .Demographic Parameters of the two groups - age, gravity, parity, ethnicity, history of infertility.
- Comparison of the success of the surgical treatment versus medical management - in this case, failure is defined as the need for subsequent surgical treatment. This will include data on the percentage of women who received multiple doses of Misoprostol.
- A comparison of the time (in months) until a new pregnancy is conceived (from the data of the dilatation and curettage or the first dose of the Misoprostol) 4. Pregnancy Outcomes - first trimester miscarriage, obstetric outcomes, early deliveries, pregnancy complications - IUGR, placental abruption, pre-eclampsia, cesarean sections, neonatal outcomes. This data will be collected in multiple telephone conversations - three months after conception and following the delivery date.
- Validation of details of pregnancies that ended in miscarriage - was the pregnancy desired? Mode of conception (if fertility treatments - which?), months until conception, gestational age at the time that a non-viable pregnancy was diagnosed, mode of pregnancy termination. The details will be validated in relation to details in our automated system.
- At what month did the woman resume menstruation? Was an ultrasound performed to assess uterine evacuation prior to a new pregnancy conception?
- Details on pregnancy following dilatation and curettage - time to conception from pregnancy termination, pregnancy outcomes, gestational age at birth (or miscarriage), birth weight, Apgar scores, pH (if available).
- Data on fertility, age, obstetric history, time to conception of new pregnancies, need for fertility treatments.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| drug treatment | Other | Other: medical VS surgical evacuation of the uterusMisoprostol for uterine evacuation |
| surgical treatment | Other | Other: medical VS surgical evacuation of the uterusdilatation and curettage for uterine evacuation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Criteria: Women with first trimester failed pregnancy
Key exclusion criteria (1 listed)
- Women under the age of 18 or over the age of 45, women who conceived via fertility treatments, women with a molar pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical VS surgical evacuation of the uterusmentioned above | Other | drug treatment, surgical treatment |
Primary outcome
Time from evacuation of the uterus to new conception
Time frame: 2 years
1 secondary outcome
pregnancy outcome
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing medical VS surgical evacuation of the uterus in people with Medical; Abortion, Fetus, run by Tel-Aviv Sourasky 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: status not confirmed, as of the sponsor's last update on 26 Jun 2018. 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?
Results are not available in the source record.
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?
Time from evacuation of the uterus to new conception (time frame: 2 years). 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 26 Jun 2018.