Pregnancy, High Risk Clinical Trial
Official title:
- a Randomized Control Trial of Two hCG- Based Decision Support Models
Verified date | April 2024 |
Source | Göteborg University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 609 |
Est. completion date | August 30, 2024 |
Est. primary completion date | August 30, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Patients with a PUL 2. Patients with mild or no symptoms 3. Patients willing to be randomized 4. First hCG value <10,000 IU/L 5. Patients with an interval between two hCG measurements of 44-56 h Exclusion Criteria: 1. Hemodynamically unstable patients 2. Hemoperitoneum 3. Patients not managed as outpatients during the course of the initial two hCG measurements 4. Non-understanding of the oral or written study information |
Country | Name | City | State |
---|---|---|---|
Sweden | Södra Älvsborgs Sjukhus | Borås | |
Sweden | Sahlgrenska University Hospital | Göteborg | |
Sweden | Skaraborgs sjukhus Skövde | Skövde |
Lead Sponsor | Collaborator |
---|---|
Göteborg University |
Sweden,
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. — View Citation
Bobdiwala 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. — View Citation
Fistouris 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. — View Citation
Mavrelos 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. — View Citation
National 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/ — View Citation
Van 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. — View Citation
van 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity | EPs (percent) correctly classified as high risk of being an EP among PULs | 1 month | |
Primary | Specificity | IUPs and failed PULs (percent) correctly classified as low risk of being an EP among PULs | 1 month | |
Secondary | HAD (Hospital and anxiety scale) | Scoring (Depression and anxiety):
0-7=Normal Borderline abnormal=8-10 11-21=Abnormal |
1 month | |
Secondary | Follow up visits (efficacy) | Number of hCG and TVS performed overall and within each final outcome (EP, IUP, and failed PUL) | 1 month | |
Secondary | Adverse events | Number of treatment related adverse events as assessed by EMA (European medicines agency) | 1 month | |
Secondary | Deviation from PUL management protocol | Number of unplanned visits, initiated by the physician or the patient | 1 month | |
Secondary | Treatment of ectopic pregnancy | Surgical (laparoscopic salpingotomy/salpingectomy), medical (MTX) or expectant management. Number of ruptured EPs. | 1 month | |
Secondary | 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. | 1 month | |
Secondary | Sensitivity (M6) | EPs (%) correctly classified as high risk of being an EP among PULs | 1 month | |
Secondary | Specificity (M6) | IUPs and failed PULs (%) correctly classified as low risk of being an EP among PULs | 1 month | |
Secondary | 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. | 1 month | |
Secondary | 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. | 1 month |
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