Pregnancies of Unknown Location (PUL)amalisNCT02581761
A Prospective Study of Misoprostol Administration in Asymptomatic Patients With Pregnancies of Unknown Location
A study testing CYTOTEC in people with Pregnancies of Unknown Location (PUL), run by Sheba Medical Center.
Trial summary
A randomized prospective double blind study of misoprostol administration in asymptomatic patients with pregnancies of unknown location. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancies of Unknown Location (PUL)
- What is being tested?
- CYTOTEC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Mar 2018
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- hemodynamically stable women >18 years old with a PUL with abnormal plateauing serum βHCG trend
Who cannot join
- Hemoglobin<10
About this study
Official title: A Randomized Prospective Double Blind Study of Misoprostol Administration in Asymptomatic Patients With Pregnancies of Unknown Location
A randomized prospective double blind study of misoprostol administration in asymptomatic patients with pregnancies of unknown location.
Read the detailed description
A randomized prospective double blind study of misoprostol administration in asymptomatic patients with pregnancies of unknown location.
The management of asymptomatic patients with pregnancies of unknown location (PUL) remains a challenge. Determining the location of the pregnancy is the first priority in the evaluation of these women. Some of these asymptomatic women present with inappropriate raising beta-human chorionic gonadotropin (βHCG), while others have assurance of pregnancy duration (e.g. IVF pregnancies) with no sonographic evidence of intra or extra uterine pregnancy. Most of the PULs are failed intra-uterine pregnancies.
The main concern regarding PUL is the late diagnosis of an ectopic pregnancy (EP). Some studies report that between 5 and 42% of women seen for US assessment with a positive pregnancy test have a PUL and only 6-20% will subsequently diagnosed with EP (1). Other studies report that 94% of PUL will resolve spontaneously, and out of the 6% that did not spontaneously resolve 68.9 % were finally diagnosed with failed IUP and only 5.6% were diagnosed with EP (2).
Women with PUL should be evaluated in minimum time, but also with minimal invasiveness. Management that will resolve such pregnancies in a rapid manner will save time and money and possibly avoid unnecessary administration of MTX or surgical intervention.
Several protocols have been investigated in order to fasten the diagnosis of PUL. For example, obtaining serial β-HCG, the first one in the initial presentation, two days later and seven days later (3). Another protocol suggested endometrial sampling by D\&C or aspiration of uterine continents with Karman cannula and checking the β-HCG after 24 hours (2).
Purpose: The aim of our study will be to prospectively assess the use of misoprostol in asymptomatic patients with pregnancies of unknown location(PUL).
The study group will contain hemodynamically stable women >18 years old with a PUL with abnormal plateauing serum β-HCG trend (increase<53%or decrease <15% in 2 days) < 1000 IU/l and a pelvic ultrasound unremarkable for an intrauterine pregnancy (IUP) or an ectopic pregnancy (EP).
Each participant will get Vaginal misoprostol 800 mcg or placebo. Main Outcome Measure(s): The primary outcome measure will be an uneventful decline of serum β-HCG to an undetectable level (<2 IU/l) by the initial intervention strategy. Secondary outcome measures will include additional treatment (e.g. methotrexate (MTX) administration or laparoscopy), side effects and serum β-HCG clearance time, features of the optimal candidates for treatment by cytotec.
- Conditions
- Pregnancies of Unknown Location (PUL)
- Being tested
- CYTOTEC, Placebo
- Keywords
- Hemodynamically stable women >18 years old, with abnormal plateauing serum βHCG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYTOTECDrug
Also called Misoprostol
synthetic prostaglandin E1
PlaceboOther
Also called Whitepsol H-15
no active material
| Study group | Role | What they receive |
|---|---|---|
| Cytotec treatment group | Experimental | patient with pregnancy of unkown location will receive cytotec 800 mcg per vaginal Receives: Drug: CYTOTEC |
| Placebo treatment group | Placebo comparator | patient with pregnancy of unkown location will receive suppository which contain Whitepsol H-15 with no active material (Cytotec). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be an uneventful decline of serum β-HCG to an undetectable level (<2 IU/l) by the initial intervention strategy
Measured: two weeks for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancies of Unknown Location (PUL)Studies of the same condition, open and under way.
- More trials run by Sheba 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Isa Amal, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581761
- Sponsor's protocol ID
- SHEBA-14-1327-IA-CTIL
- Acronym
- amalis
- Status last verified
- Oct 2015
- First submitted
- 27 Aug 2015
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Double Blind Study of Misoprostol Administration in Asymptomatic Patients With Pregnancies of Unknown Location
- ClinicalTrials.gov ID
- NCT02581761
- Acronym / sponsor ID
- amalis / SHEBA-14-1327-IA-CTIL
- Conditions
- Pregnancies of Unknown Location (PUL)
- Keywords
- Hemodynamically stable women >18 years old, with abnormal plateauing serum βHCG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Nov 2015
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 21 Oct 2015 (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.
A randomized prospective double blind study of misoprostol administration in asymptomatic patients with pregnancies of unknown location.
Detailed description
A randomized prospective double blind study of misoprostol administration in asymptomatic patients with pregnancies of unknown location.
The management of asymptomatic patients with pregnancies of unknown location (PUL) remains a challenge. Determining the location of the pregnancy is the first priority in the evaluation of these women. Some of these asymptomatic women present with inappropriate raising beta-human chorionic gonadotropin (βHCG), while others have assurance of pregnancy duration (e.g. IVF pregnancies) with no sonographic evidence of intra or extra uterine pregnancy. Most of the PULs are failed intra-uterine pregnancies.
The main concern regarding PUL is the late diagnosis of an ectopic pregnancy (EP). Some studies report that between 5 and 42% of women seen for US assessment with a positive pregnancy test have a PUL and only 6-20% will subsequently diagnosed with EP (1). Other studies report that 94% of PUL will resolve spontaneously, and out of the 6% that did not spontaneously resolve 68.9 % were finally diagnosed with failed IUP and only 5.6% were diagnosed with EP (2).
Women with PUL should be evaluated in minimum time, but also with minimal invasiveness. Management that will resolve such pregnancies in a rapid manner will save time and money and possibly avoid unnecessary administration of MTX or surgical intervention.
Several protocols have been investigated in order to fasten the diagnosis of PUL. For example, obtaining serial β-HCG, the first one in the initial presentation, two days later and seven days later (3). Another protocol suggested endometrial sampling by D\&C or aspiration of uterine continents with Karman cannula and checking the β-HCG after 24 hours (2).
Purpose: The aim of our study will be to prospectively assess the use of misoprostol in asymptomatic patients with pregnancies of unknown location(PUL).
The study group will contain hemodynamically stable women >18 years old with a PUL with abnormal plateauing serum β-HCG trend (increase<53%or decrease <15% in 2 days) < 1000 IU/l and a pelvic ultrasound unremarkable for an intrauterine pregnancy (IUP) or an ectopic pregnancy (EP).
Each participant will get Vaginal misoprostol 800 mcg or placebo. Main Outcome Measure(s): The primary outcome measure will be an uneventful decline of serum β-HCG to an undetectable level (<2 IU/l) by the initial intervention strategy. Secondary outcome measures will include additional treatment (e.g. methotrexate (MTX) administration or laparoscopy), side effects and serum β-HCG clearance time, features of the optimal candidates for treatment by cytotec.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cytotec treatment group | Experimental | Drug: CYTOTECpatient with pregnancy of unkown location will receive cytotec 800 mcg per vaginal |
| Placebo treatment group | Placebo comparator | Other: Placebopatient with pregnancy of unkown location will receive suppository which contain Whitepsol H-15 with no active material (Cytotec). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- hemodynamically stable women >18 years old with a PUL with abnormal plateauing serum βHCG trend
Key exclusion criteria (1 listed)
- Hemoglobin<10
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 |
|---|---|---|
| CYTOTECAlso: Misoprostolsynthetic prostaglandin E1 | Drug | Cytotec treatment group |
| PlaceboAlso: Whitepsol H-15no active material | Other | Placebo treatment group |
Primary outcome
The primary outcome measure will be an uneventful decline of serum β-HCG to an undetectable level (<2 IU/l) by the initial intervention strategy
Time frame: two weeks for each patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
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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.
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 CYTOTEC in people with Pregnancies of Unknown Location (PUL), run by Sheba 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 21 Oct 2015. 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. Some participants in this study may receive a placebo. 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?
The primary outcome measure will be an uneventful decline of serum β-HCG to an undetectable level (<2 IU/l) by the initial intervention strategy (time frame: two weeks for each patient). 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 21 Oct 2015.