Pregnancy, EctopicNCT03461835
Management of Pregnancies of Unknown Location (PUL)
A study testing Risk classification of PUL by M4 and Risk classification of PUL by NICE in people with Pregnancy, Ectopic and Pregnancy, High Risk, run by Göteborg University at 3 sites in Sweden.
Trial summary
In a randomized multicenter trial the investigators want to compare the ability of two hCG-based models in correctly classifying EPs as high risk among PULs and correctly classifying IUPs and failed PULs as low risk after two hCG measurements. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy, Ectopic, Pregnancy, High Risk, Pregnancy Early
- What is being tested?
- Risk classification of PUL by M4 and Risk classification of PUL by NICE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 609 participants
- Where
- 3 sitesSweden
- Study dates
- 22 Feb 2018to 30 Dec 2024
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with a PUL
- Patients with mild or no symptoms
- Patients willing to be randomized
- First hCG value <10,000 IU/L
- Patients with an interval between two hCG measurements of 44-56 h
Who cannot join
- Hemodynamically unstable patients
- Hemoperitoneum
- Patients not managed as outpatients during the course of the initial two hCG measurements
- Non-understanding of the oral or written study information
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Södra Älvsborgs Sjukhus
Borås, 501 82
Sahlgrenska University Hospital
Gothenburg, 413 45
Skaraborgs sjukhus Skövde
Skövde, 541 85
About this study
Official title: - a Randomized Control Trial of Two hCG- Based Decision Support Models
In a randomized multicenter trial the investigators want to compare the ability of two hCG-based models in correctly classifying EPs as high risk among PULs and correctly classifying IUPs and failed PULs as low risk after two hCG measurements.
After the classification of PULs into high or low risk of EP, the clinical management will be the same within each risk group (high and low) regardless of randomization group (which model classified the patients). The clinical management will be according to the management protocol published in a NICE guideline.
Read the detailed description
Pregnancy of unknown location (PUL) is a term used to describe a situation where there is no evidence of a gestation either intra-or extrauterine on transvaginal sonography (TVS) in women seeking medical attention for various reasons in early pregnancy. The principal tool in PUL management besides TVS is the interpretation of the change in serial serum human chorionic gonadotropin (hCG) levels. A recent meta-analysis concluded that there is not enough evidence to recommend a specific strategy using hCG when managing PULs. In a NICE (National Institute of health and care excellence) guideline however women with a PUL acceptable for outpatient surveillance, where the rate of change in rising hCG levels surpassing 63 % in 48 hours (h) highly likely represents an IUP and the patient is triaged to a TVS after one week. Those with a decline in hCG levels of more than 50 % are predicted to be failed PULs and a urinary pregnancy test (UPT) after two weeks is appropriate. If the rate of change in hCG levels fail to meet these cut-offs a re-visit within 24 h is warranted in order to possibly diagnose an EP and suitable treatment selected. In a previous study; an hCG based logistic regression model, M4 classified 70 % of all PULs as low risk of being an EP, hence qualifying for a reduced follow-up while correctly identifying 88 % of EPs. A study from Sahlgrenska University hospital (SU) evaluated the M4 model with similar results, where also the cut-offs by NICE similarly identified 86 % of EPs but to a lesser extent correctly classified low risk PULs. Another finding in the study was that EPs identified by M4 mainly depicted rising hCG levels opposed to the NICE model identifying mainly EPs with declining hCG levels which could have clinical consequences since EPs with rising hCG levels more often seem to necessitate laparoscopic surgery and maybe a postponed diagnosis could be deleterious in these cases. Hence, the M4 model potentially would be better than the NICE cut-offs for PUL management. None of these findings however have been evaluated in a randomized controlled trial (RCT). An updated version of M4 named M6 was first published 2016 and has not been externally validated. Neither has prior cut-offs of declining hCG levels currently used to define a failed PUL.
The handling of these women is often lengthy with a high level of uncertainty before a final diagnosis can be made. The psychological morbidity in this group is largely unknown, while well acknowledged in women following miscarriage, were up to 41% self-reporting clinically significant levels of anxiety and 36% reporting depression within 1 month. In a recent study 24 % (CI 21-28) and 11 % (8-14) respectively of women with either a miscarriage or ectopic pregnancy experienced moderate or severe anxiety and depression according to the Hospital Anxiety Depression Scale (HADS), compared to 13 % (7-21) and 2 % (1-8) in a control group without complications in early pregnancy. We aim to determine the presence and severity of psychological distress and quality of life among women with a pregnancy of unknown location.
A secondary objective is to test following hypothesis: Women with an early normal pregnancy starting as a pregnancy of unknown location have twice as high probability of having HADS-scores above or equal to eight on both subscales, than women with an early normal pregnancy.
We calculated that we would need 121 women in each group to reach a power of 80 % to detect an absolute difference of 15 percentage points after one week, with a 15 % incidence of HADS anxiety score ≥ 8 among control subjects and 30 % among IUP starting as a PUL at a two-sided alpha level of 0.05 (20). For protection against that 10 % of patients will be lost to follow-up a total of 130 women are included in each group. In a second calculation based on using HADS as a continuous scale, 94 women would need to be included in each group to detect an absolute two points difference on the anxiety subscale of the HADS assuming a mean score of 6.0 and a standard deviation of 3.4 in control subjects, at a significance level 0.05 and power 0.80. This minimally important difference is based on mean scores on the HADS anxiety subscale reported for women in early pregnancy in prior studies (20-22). We plan to include a total of 210 women with a 1:1 ratio to account for an expected 10 % loss to follow-up.
- Conditions
- Pregnancy, Ectopic, Pregnancy, High Risk, Pregnancy Early
- Being tested
- Risk classification of PUL by M4, Risk classification of PUL by NICE
- Medical subject headings
- Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk classification of PUL by M4Diagnostic test
High or low risk of being an ectopic pregnancy
Risk classification of PUL by NICEDiagnostic test
High or low risk of being an ectopic pregnancy
| Study group | Role | What they receive |
|---|---|---|
| M4 | Active comparator | High risk classification if the chance of the PUL being an EP ≥5 %; a calculation based on the average value of the two hCG and the ratio of these two hCG (0 h/48 h). Otherwise a low risk classification is made and a predicted outcome of either an IUP or failed PUL is presented. Receives: Diagnostic Test: Risk classification of PUL by M4; Diagnostic Test: Risk classification of PUL by NICE |
| NICE | Active comparator | High risk classification if the change in rising hCG levels ≤ 63 % or the change in declining hCG ≤ 50 %. If these cut-offs are exceeded the PUL is classified as low risk and predicted to be either an IUP or failed PUL depending on rising or declining hCG levels. Receives: Diagnostic Test: Risk classification of PUL by M4; Diagnostic Test: Risk classification of PUL by NICE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
EPs (percent) correctly classified as high risk of being an EP among PULs
Measured: 1 month
Specificity
IUPs and failed PULs (percent) correctly classified as low risk of being an EP among PULs
Measured: 1 month
Secondary outcomes (10)
HAD (Hospital and anxiety scale)
Scoring (Depression and anxiety):
0-7=Normal Borderline abnormal=8-10 11-21=Abnormal
Measured: 1 month
Follow up visits (efficacy)
Number of hCG and TVS performed overall and within each final outcome (EP, IUP, and failed PUL)
Measured: 1 month
Adverse events
Number of treatment related adverse events as assessed by EMA (European medicines agency)
Measured: 1 month
Deviation from PUL management protocol
Number of unplanned visits, initiated by the physician or the patient
Measured: 1 month
Treatment of ectopic pregnancy
Surgical (laparoscopic salpingotomy/salpingectomy), medical (MTX) or expectant management. Number of ruptured EPs.
Measured: 1 month
The Short Form (36) Health Survey
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: 1 month
Sensitivity (M6)
EPs (%) correctly classified as high risk of being an EP among PULs
Measured: 1 month
Specificity (M6)
IUPs and failed PULs (%) correctly classified as low risk of being an EP among PULs
Measured: 1 month
Specificity, optimal cut-off
Optimal cut-off in hCG decline (percent) between two measurements to correctly classify IUPs and failed PULs as low risk of being an EP among PULs with declining hCG levels.
Measured: 1 month
Sensitivity, optimal cut-off
Optimal cut-off in hCG decline (percent) between two measurements to correctly classify an EP as high risk among PULs with declining hCG levels.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start22 Feb 2018
- Primary completion30 Aug 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pregnancy, EctopicStudies 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
- 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
- 609 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annika Strandell, Ass.prof., Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461835
- Sponsor's protocol ID
- PUL study
- Status last verified
- Apr 2025
- First submitted
- 9 Feb 2018
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barnhart K, van Mello NM, Bourne T, Kirk E, Van Calster B, Bottomley C, Chung K, Condous G, Goldstein S, Hajenius PJ, Mol BW, Molinaro T, O'Flynn O'Brien KL, Husicka R, Sammel M, Timmerman D. Pregnancy of unknown location: a consensus statement of nomenclature, definitions, and outcome. Fertil Steril. 2011 Mar 1;95(3):857-66. doi: 10.1016/j.fertnstert.2010.09.006. Epub 2010 Oct 14.
PubMed 20947073van Mello NM, Mol F, Opmeer BC, Ankum WM, Barnhart K, Coomarasamy A, Mol BW, van der Veen F, Hajenius PJ. Diagnostic value of serum hCG on the outcome of pregnancy of unknown location: a systematic review and meta-analysis. Hum Reprod Update. 2012 Nov-Dec;18(6):603-17. doi: 10.1093/humupd/dms035. Epub 2012 Sep 6.
PubMed 22956411National Collaborating Centre for Women's and Children's Health (UK). Ectopic Pregnancy and Miscarriage: Diagnosis and Initial Management in Early Pregnancy of Ectopic Pregnancy and Miscarriage. London: RCOG Press; 2012 Dec. Available from http://www.ncbi.nlm.nih.gov/books/NBK132775/
PubMed 23638497Van Calster B, Abdallah Y, Guha S, Kirk E, Van Hoorde K, Condous G, Preisler J, Hoo W, Stalder C, Bottomley C, Timmerman D, Bourne T. Rationalizing the management of pregnancies of unknown location: temporal and external validation of a risk prediction model on 1962 pregnancies. Hum Reprod. 2013 Mar;28(3):609-16. doi: 10.1093/humrep/des440. Epub 2013 Jan 4.
PubMed 23293216Fistouris J, Bergh C, Strandell A. Classification of pregnancies of unknown location according to four different hCG-based protocols. Hum Reprod. 2016 Oct;31(10):2203-11. doi: 10.1093/humrep/dew202. Epub 2016 Aug 31.
PubMed 27580995Mavrelos D, Nicks H, Jamil A, Hoo W, Jauniaux E, Jurkovic D. Efficacy and safety of a clinical protocol for expectant management of selected women diagnosed with a tubal ectopic pregnancy. Ultrasound Obstet Gynecol. 2013 Jul;42(1):102-7. doi: 10.1002/uog.12401. Epub 2013 May 27.
PubMed 23303651Bobdiwala S, Guha S, Van Calster B, Ayim F, Mitchell-Jones N, Al-Memar M, Mitchell H, Stalder C, Bottomley C, Kothari A, Timmerman D, Bourne T. The clinical performance of the M4 decision support model to triage women with a pregnancy of unknown location as at low or high risk of complications. Hum Reprod. 2016 Jul;31(7):1425-35. doi: 10.1093/humrep/dew105. Epub 2016 May 10.
PubMed 27165655Fistouris J, Garbergs H, Bergman K, Bergh C, Strandell A. Managing Pregnancies of Unknown Location With the M4 Prediction Model or the NICE Algorithm: A Randomised Controlled Trial With Cross-Sectional Diagnostic Accuracy Data. BJOG. 2025 May;132(6):742-751. doi: 10.1111/1471-0528.18079. Epub 2025 Jan 22.
PubMed 39840550
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- - a Randomized Control Trial of Two hCG- Based Decision Support Models
- ClinicalTrials.gov ID
- NCT03461835
- Acronym / sponsor ID
- PUL study
- Conditions
- Pregnancy, Ectopic, Pregnancy, High Risk, Pregnancy Early
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 609 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 12 Mar 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.
In a randomized multicenter trial the investigators want to compare the ability of two hCG-based models in correctly classifying EPs as high risk among PULs and correctly classifying IUPs and failed PULs as low risk after two hCG measurements.
After the classification of PULs into high or low risk of EP, the clinical management will be the same within each risk group (high and low) regardless of randomization group (which model classified the patients). The clinical management will be according to the management protocol published in a NICE guideline.
Detailed description
Pregnancy of unknown location (PUL) is a term used to describe a situation where there is no evidence of a gestation either intra-or extrauterine on transvaginal sonography (TVS) in women seeking medical attention for various reasons in early pregnancy. The principal tool in PUL management besides TVS is the interpretation of the change in serial serum human chorionic gonadotropin (hCG) levels. A recent meta-analysis concluded that there is not enough evidence to recommend a specific strategy using hCG when managing PULs. In a NICE (National Institute of health and care excellence) guideline however women with a PUL acceptable for outpatient surveillance, where the rate of change in rising hCG levels surpassing 63 % in 48 hours (h) highly likely represents an IUP and the patient is triaged to a TVS after one week. Those with a decline in hCG levels of more than 50 % are predicted to be failed PULs and a urinary pregnancy test (UPT) after two weeks is appropriate. If the rate of change in hCG levels fail to meet these cut-offs a re-visit within 24 h is warranted in order to possibly diagnose an EP and suitable treatment selected. In a previous study; an hCG based logistic regression model, M4 classified 70 % of all PULs as low risk of being an EP, hence qualifying for a reduced follow-up while correctly identifying 88 % of EPs. A study from Sahlgrenska University hospital (SU) evaluated the M4 model with similar results, where also the cut-offs by NICE similarly identified 86 % of EPs but to a lesser extent correctly classified low risk PULs. Another finding in the study was that EPs identified by M4 mainly depicted rising hCG levels opposed to the NICE model identifying mainly EPs with declining hCG levels which could have clinical consequences since EPs with rising hCG levels more often seem to necessitate laparoscopic surgery and maybe a postponed diagnosis could be deleterious in these cases. Hence, the M4 model potentially would be better than the NICE cut-offs for PUL management. None of these findings however have been evaluated in a randomized controlled trial (RCT). An updated version of M4 named M6 was first published 2016 and has not been externally validated. Neither has prior cut-offs of declining hCG levels currently used to define a failed PUL.
The handling of these women is often lengthy with a high level of uncertainty before a final diagnosis can be made. The psychological morbidity in this group is largely unknown, while well acknowledged in women following miscarriage, were up to 41% self-reporting clinically significant levels of anxiety and 36% reporting depression within 1 month. In a recent study 24 % (CI 21-28) and 11 % (8-14) respectively of women with either a miscarriage or ectopic pregnancy experienced moderate or severe anxiety and depression according to the Hospital Anxiety Depression Scale (HADS), compared to 13 % (7-21) and 2 % (1-8) in a control group without complications in early pregnancy. We aim to determine the presence and severity of psychological distress and quality of life among women with a pregnancy of unknown location.
A secondary objective is to test following hypothesis: Women with an early normal pregnancy starting as a pregnancy of unknown location have twice as high probability of having HADS-scores above or equal to eight on both subscales, than women with an early normal pregnancy.
We calculated that we would need 121 women in each group to reach a power of 80 % to detect an absolute difference of 15 percentage points after one week, with a 15 % incidence of HADS anxiety score ≥ 8 among control subjects and 30 % among IUP starting as a PUL at a two-sided alpha level of 0.05 (20). For protection against that 10 % of patients will be lost to follow-up a total of 130 women are included in each group. In a second calculation based on using HADS as a continuous scale, 94 women would need to be included in each group to detect an absolute two points difference on the anxiety subscale of the HADS assuming a mean score of 6.0 and a standard deviation of 3.4 in control subjects, at a significance level 0.05 and power 0.80. This minimally important difference is based on mean scores on the HADS anxiety subscale reported for women in early pregnancy in prior studies (20-22). We plan to include a total of 210 women with a 1:1 ratio to account for an expected 10 % loss to follow-up.
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 |
|---|---|---|
| M4 | Active comparator | Diagnostic Test: Risk classification of PUL by M4, Diagnostic Test: Risk classification of PUL by NICEHigh risk classification if the chance of the PUL being an EP ≥5 %; a calculation based on the average value of the two hCG and the ratio of these two hCG (0 h/48 h). Otherwise a low risk classification is made and a predicted outcome of either an IUP or failed PUL is presented. |
| NICE | Active comparator | Diagnostic Test: Risk classification of PUL by M4, Diagnostic Test: Risk classification of PUL by NICEHigh risk classification if the change in rising hCG levels ≤ 63 % or the change in declining hCG ≤ 50 %. If these cut-offs are exceeded the PUL is classified as low risk and predicted to be either an IUP or failed PUL depending on rising or declining hCG levels. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with a PUL
- Patients with mild or no symptoms
- Patients willing to be randomized
- First hCG value <10,000 IU/L
- Patients with an interval between two hCG measurements of 44-56 h
Key exclusion criteria (4 listed)
- Hemodynamically unstable patients
- Hemoperitoneum
- Patients not managed as outpatients during the course of the initial two hCG measurements
- Non-understanding of the oral or written study information
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 |
|---|---|---|
| Risk classification of PUL by M4High or low risk of being an ectopic pregnancy | Diagnostic test | M4, NICE |
| Risk classification of PUL by NICEHigh or low risk of being an ectopic pregnancy | Diagnostic test | M4, NICE |
Primary outcome
Sensitivity
Time frame: 1 month
EPs (percent) correctly classified as high risk of being an EP among PULs
Specificity
Time frame: 1 month
IUPs and failed PULs (percent) correctly classified as low risk of being an EP among PULs
10 secondary outcomes
HAD (Hospital and anxiety scale)
Time frame: 1 month
Follow up visits (efficacy)
Time frame: 1 month
Adverse events
Time frame: 1 month
Deviation from PUL management protocol
Time frame: 1 month
Treatment of ectopic pregnancy
Time frame: 1 month
The Short Form (36) Health Survey
Time frame: 1 month
Sensitivity (M6)
Time frame: 1 month
Specificity (M6)
Time frame: 1 month
Specificity, optimal cut-off
Time frame: 1 month
Sensitivity, optimal cut-off
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Background: PubMed 20947073Barnhart K, van Mello NM, Bourne T, Kirk E, Van Calster B, Bottomley C, Chung K, Condous G, Goldstein S, Hajenius PJ, Mol BW, Molinaro T, O'Flynn O'Brien KL, Husicka R, Sammel M, Timmerman D. Pregnancy of unknown location: a consensus statement of nomenclature, definitions, and outcome. Fertil Steril. 2011 Mar 1;95(3):857-66. doi: 10.1016/j.fertnstert.2010.09.006. Epub 2010 Oct 14.
- Background: PubMed 22956411van Mello NM, Mol F, Opmeer BC, Ankum WM, Barnhart K, Coomarasamy A, Mol BW, van der Veen F, Hajenius PJ. Diagnostic value of serum hCG on the outcome of pregnancy of unknown location: a systematic review and meta-analysis. Hum Reprod Update. 2012 Nov-Dec;18(6):603-17. doi: 10.1093/humupd/dms035. Epub 2012 Sep 6.
- Background: PubMed 23638497National Collaborating Centre for Women's and Children's Health (UK). Ectopic Pregnancy and Miscarriage: Diagnosis and Initial Management in Early Pregnancy of Ectopic Pregnancy and Miscarriage. London: RCOG Press; 2012 Dec. Available from http://www.ncbi.nlm.nih.gov/books/NBK132775/
- Background: PubMed 23293216Van Calster B, Abdallah Y, Guha S, Kirk E, Van Hoorde K, Condous G, Preisler J, Hoo W, Stalder C, Bottomley C, Timmerman D, Bourne T. Rationalizing the management of pregnancies of unknown location: temporal and external validation of a risk prediction model on 1962 pregnancies. Hum Reprod. 2013 Mar;28(3):609-16. doi: 10.1093/humrep/des440. Epub 2013 Jan 4.
- Background: PubMed 27580995Fistouris J, Bergh C, Strandell A. Classification of pregnancies of unknown location according to four different hCG-based protocols. Hum Reprod. 2016 Oct;31(10):2203-11. doi: 10.1093/humrep/dew202. Epub 2016 Aug 31.
- Background: PubMed 23303651Mavrelos D, Nicks H, Jamil A, Hoo W, Jauniaux E, Jurkovic D. Efficacy and safety of a clinical protocol for expectant management of selected women diagnosed with a tubal ectopic pregnancy. Ultrasound Obstet Gynecol. 2013 Jul;42(1):102-7. doi: 10.1002/uog.12401. Epub 2013 May 27.
- Background: PubMed 27165655Bobdiwala S, Guha S, Van Calster B, Ayim F, Mitchell-Jones N, Al-Memar M, Mitchell H, Stalder C, Bottomley C, Kothari A, Timmerman D, Bourne T. The clinical performance of the M4 decision support model to triage women with a pregnancy of unknown location as at low or high risk of complications. Hum Reprod. 2016 Jul;31(7):1425-35. doi: 10.1093/humrep/dew105. Epub 2016 May 10.
- Derived from this study: PubMed 39840550Fistouris J, Garbergs H, Bergman K, Bergh C, Strandell A. Managing Pregnancies of Unknown Location With the M4 Prediction Model or the NICE Algorithm: A Randomised Controlled Trial With Cross-Sectional Diagnostic Accuracy Data. BJOG. 2025 May;132(6):742-751. doi: 10.1111/1471-0528.18079. Epub 2025 Jan 22.
- Individual participant dataSharing planned: No
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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.
Annika Strandell, Ass.prof. principal investigator
Göteborg University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk classification of PUL by M4 and Risk classification of PUL by NICE in people with Pregnancy, Ectopic and Pregnancy, High Risk, run by Göteborg University at 3 sites in Sweden.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03461835, which also lists 8 linked publications.
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 6 Apr 2025; AzTrials last refreshed its copy on 26 Oct 2026.