Prospective Validation of the ADNEX Model for Discrimination Between Benign and Malignant Adnexal Masses in Pregnancy: International Ovarian Tumour Analysis in Pregnancy Study (p-IOTA)

NCT05974618 | Recruiting

• 1 other identifier: S66455
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective Validation of the ADNEX Model for discrimination between benign and malignant adnexal masses in pregnancy: International Ovarian Tumour Analysis in pregnancy study (p-IOTA)

Conditions

Adnexal Mass; Adnexal Tumor; Adnexal Cyst; Pregnancy Related

Keywords

IOTA; ovarian mass; pregnancy; ultrasound; post-partum; benign; malignant

Outcome Measures

Primary Outcomes (1)

• - Estimation of the false discovery rate when the ADNEX Model is applied at 11-14 weeks.

  \- Estimation of the false discovery rate when the ADNEX Model is applied at 11-14 weeks.

  outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)

Secondary Outcomes (13)

• - Estimation of the false discovery rate when the 2-step strategy (i.e. Modified Benign Simple Descriptors followed by ADNEX) is applied at 11-14 weeks.

  outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)

• - Estimation of the false discovery rate when the ADNEX Model and the 2-step strategy (i.e. Modified Benign Simple Descriptors followed by ADNEX) are applied at any time point during pregnancy;

  outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)

• Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at 11-14 weeks gestation.

  outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)

• Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at 11-14 weeks gestation.

  outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)

• Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at 11-14 weeks gestation.

  outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)

Other Outcomes (3)

• Change in the ultrasound appearance of endometriomas during gestation;

  outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)

• - Occurrence of complications such as rupture, torsion, or malignancy during pregnancy in patients with conservatively treated masses (cumulative incidence illustrated by 'reverse' Kaplan-Meier curves).

  outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)

• - Comparison of the performance of ADNEX with CA125 and that of ADNEX without CA125.

  outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)

Study Arms (3)

First arm (primary objective):

First arm (primary objective): Adnexal mass scanned at 11-14 weeks. If the decision is to manage the adnexal mass conservatively, the patient is to be re-scanned once more: 0 - 90 days postpartum. In addition, the patient will be asked to enter into the third arm of the study (see below) knowing that she can opt out from that arm at any point. If she consents to participate in the third arm, she will participate in a series of longitudinal examinations as described for the third arm. All patients with a mass detected before 11 weeks will also be scanned at 11-14 weeks and can enter all three arms of the study. In this scenario, if more than one scan is performed during pregnancy before 11 weeks, only the first of several scans before 11 weeks will be included for the second and third arms of the study.

Diagnostic Test: Ultrasound

Second arm (secondary objective):

Second arm (secondary objective): Adnexal mass is seen for the first time during that pregnancy at any gestation. If the decision is to manage the adnexal mass conservatively, the patient is to be re-scanned once more: 0 - 90 days postpartum. For patients with a mass detected before 11 weeks, see also above (they will be re-scanned at both 11-14 weeks and at 0-90 days postpartum). In addition, the patient will be asked to enter into the third arm of the study knowing that she can opt out from that arm at any point. If she consents to this, she will participate in a series of longitudinal examinations as described for the third arm.

Diagnostic Test: Ultrasound

Third arm (secondary objective):

Third arm (secondary objective): Patients from the first and second arms who agree to enrol into the third arm i.e. longitudinal examination of an adnexal mass during pregnancy. For the purposes of the longitudinal evaluation, the time points for the ultrasound examination are: * initial presenting scan if \<11 weeks; * 11-14 weeks; * 16 week scan - endometriomas ONLY; * second trimester routine scan (18-22 weeks); * 30-34 weeks; * any additional scans during pregnancy which resulted in either conservative management with extra scans or surgical intervention (with reason for the extra scan or for surgery documented); * 0-90 days postpartum.

Diagnostic Test: Ultrasound

Interventions

Ultrasound DIAGNOSTIC_TEST

A standardised transvaginal (supplemented with transabdominal if transvaginal is not sufficient) examination is performed. When a colour Doppler ultrasound examination is performed, the pulse repetition frequency should be 0.3-0.6 KHz. The colour Doppler gain should be increased until colour Doppler artefacts appear and then lowered until just below the reappearance of colour Doppler artefacts. Ultrasound frequency and "priority" (grey scale or colour/Power Doppler) must also be optimised when using colour/power Doppler. Doppler ultrasound should be used with all masses included, irrespective of gestational age.

First arm (primary objective):; Second arm (secondary objective):; Third arm (secondary objective):

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Our sample population will come from Early Pregnancy Units and from Tertiary referral centres for ultrasound with or without an oncology department attached to it. The sample size estimation is based on data from Tertiary referral centres.

You may qualify if:

• Consecutive patients with non-physiological adnexal masses or physiological cysts measuring 5cm or more in largest dimension;
• In case of more than one mass seen, only most suspicious mass to be included OR in case of two similar masses, the one with the largest dimension or most easily accessible with ultrasound;
• Previously recruited patient presenting with a different mass in subsequent pregnancy;
• Age 18 years and above.

You may not qualify if:

• Cysts deemed to be clearly physiological WHEN smaller than 5 cm (largest diameter);
• The denial or withdrawal of written informed consent;
• Same cyst already recruited for p-IOTA in a previous pregnancy.
• Age \< 18 years

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Related Publications (47)

• Goh WA, Rincon M, Bohrer J, Tolosa JE, Sohaey R, Riano R, Davis J, Zalud I. Persistent ovarian masses and pregnancy outcomes. J Matern Fetal Neonatal Med. 2013 Jul;26(11):1090-3. doi: 10.3109/14767058.2013.768980. Epub 2013 Feb 21.

  PMID: 23356452 BACKGROUND

• Sherard GB 3rd, Hodson CA, Williams HJ, Semer DA, Hadi HA, Tait DL. Adnexal masses and pregnancy: a 12-year experience. Am J Obstet Gynecol. 2003 Aug;189(2):358-62; discussion 362-3. doi: 10.1067/s0002-9378(03)00731-2.

  PMID: 14520194 BACKGROUND

• Korenaga TK, Tewari KS. Gynecologic cancer in pregnancy. Gynecol Oncol. 2020 Jun;157(3):799-809. doi: 10.1016/j.ygyno.2020.03.015. Epub 2020 Apr 5.

  PMID: 32268951 BACKGROUND

• de Haan J, Verheecke M, Van Calsteren K, Van Calster B, Shmakov RG, Mhallem Gziri M, Halaska MJ, Fruscio R, Lok CAR, Boere IA, Zola P, Ottevanger PB, de Groot CJM, Peccatori FA, Dahl Steffensen K, Cardonick EH, Polushkina E, Rob L, Ceppi L, Sukhikh GT, Han SN, Amant F; International Network on Cancer and Infertility Pregnancy (INCIP). Oncological management and obstetric and neonatal outcomes for women diagnosed with cancer during pregnancy: a 20-year international cohort study of 1170 patients. Lancet Oncol. 2018 Mar;19(3):337-346. doi: 10.1016/S1470-2045(18)30059-7. Epub 2018 Jan 26.

  PMID: 29395867 BACKGROUND

• Leiserowitz GS, Xing G, Cress R, Brahmbhatt B, Dalrymple JL, Smith LH. Adnexal masses in pregnancy: how often are they malignant? Gynecol Oncol. 2006 May;101(2):315-21. doi: 10.1016/j.ygyno.2005.10.022. Epub 2005 Nov 28.

  PMID: 16310839 BACKGROUND

• Froyman W, Landolfo C, De Cock B, Wynants L, Sladkevicius P, Testa AC, Van Holsbeke C, Domali E, Fruscio R, Epstein E, Dos Santos Bernardo MJ, Franchi D, Kudla MJ, Chiappa V, Alcazar JL, Leone FPG, Buonomo F, Hochberg L, Coccia ME, Guerriero S, Deo N, Jokubkiene L, Kaijser J, Coosemans A, Vergote I, Verbakel JY, Bourne T, Van Calster B, Valentin L, Timmerman D. Risk of complications in patients with conservatively managed ovarian tumours (IOTA5): a 2-year interim analysis of a multicentre, prospective, cohort study. Lancet Oncol. 2019 Mar;20(3):448-458. doi: 10.1016/S1470-2045(18)30837-4. Epub 2019 Feb 5.

  PMID: 30737137 BACKGROUND

• Alcazar JL, Pascual MA, Graupera B, Auba M, Errasti T, Olartecoechea B, Ruiz-Zambrana A, Hereter L, Ajossa S, Guerriero S. External validation of IOTA simple descriptors and simple rules for classifying adnexal masses. Ultrasound Obstet Gynecol. 2016 Sep;48(3):397-402. doi: 10.1002/uog.15854.

  PMID: 26748432 BACKGROUND

• Sayasneh A, Kaijser J, Preisler J, Johnson S, Stalder C, Husicka R, Guha S, Naji O, Abdallah Y, Raslan F, Drought A, Smith AA, Fotopoulou C, Ghaem-Maghami S, Van Calster B, Timmerman D, Bourne T. A multicenter prospective external validation of the diagnostic performance of IOTA simple descriptors and rules to characterize ovarian masses. Gynecol Oncol. 2013 Jul;130(1):140-6. doi: 10.1016/j.ygyno.2013.04.003. Epub 2013 Apr 8.

  PMID: 23578539 BACKGROUND

• Sayasneh A, Ferrara L, De Cock B, Saso S, Al-Memar M, Johnson S, Kaijser J, Carvalho J, Husicka R, Smith A, Stalder C, Blanco MC, Ettore G, Van Calster B, Timmerman D, Bourne T. Evaluating the risk of ovarian cancer before surgery using the ADNEX model: a multicentre external validation study. Br J Cancer. 2016 Aug 23;115(5):542-8. doi: 10.1038/bjc.2016.227. Epub 2016 Aug 2.

  PMID: 27482647 BACKGROUND

• Timmerman D, Testa AC, Bourne T, Ferrazzi E, Ameye L, Konstantinovic ML, Van Calster B, Collins WP, Vergote I, Van Huffel S, Valentin L; International Ovarian Tumor Analysis Group. Logistic regression model to distinguish between the benign and malignant adnexal mass before surgery: a multicenter study by the International Ovarian Tumor Analysis Group. J Clin Oncol. 2005 Dec 1;23(34):8794-801. doi: 10.1200/JCO.2005.01.7632.

  PMID: 16314639 BACKGROUND

• Timmerman D, Van Calster B, Testa AC, Guerriero S, Fischerova D, Lissoni AA, Van Holsbeke C, Fruscio R, Czekierdowski A, Jurkovic D, Savelli L, Vergote I, Bourne T, Van Huffel S, Valentin L. Ovarian cancer prediction in adnexal masses using ultrasound-based logistic regression models: a temporal and external validation study by the IOTA group. Ultrasound Obstet Gynecol. 2010 Aug;36(2):226-34. doi: 10.1002/uog.7636.

  PMID: 20455203 BACKGROUND

• Timmerman D, Ameye L, Fischerova D, Epstein E, Melis GB, Guerriero S, Van Holsbeke C, Savelli L, Fruscio R, Lissoni AA, Testa AC, Veldman J, Vergote I, Van Huffel S, Bourne T, Valentin L. Simple ultrasound rules to distinguish between benign and malignant adnexal masses before surgery: prospective validation by IOTA group. BMJ. 2010 Dec 14;341:c6839. doi: 10.1136/bmj.c6839.

  PMID: 21156740 BACKGROUND

• Timmerman D, Van Calster B, Testa A, Savelli L, Fischerova D, Froyman W, Wynants L, Van Holsbeke C, Epstein E, Franchi D, Kaijser J, Czekierdowski A, Guerriero S, Fruscio R, Leone FPG, Rossi A, Landolfo C, Vergote I, Bourne T, Valentin L. Predicting the risk of malignancy in adnexal masses based on the Simple Rules from the International Ovarian Tumor Analysis group. Am J Obstet Gynecol. 2016 Apr;214(4):424-437. doi: 10.1016/j.ajog.2016.01.007. Epub 2016 Jan 19.

  PMID: 26800772 BACKGROUND

• Van Calster B, Van Hoorde K, Valentin L, Testa AC, Fischerova D, Van Holsbeke C, Savelli L, Franchi D, Epstein E, Kaijser J, Van Belle V, Czekierdowski A, Guerriero S, Fruscio R, Lanzani C, Scala F, Bourne T, Timmerman D; International Ovarian Tumour Analysis Group. Evaluating the risk of ovarian cancer before surgery using the ADNEX model to differentiate between benign, borderline, early and advanced stage invasive, and secondary metastatic tumours: prospective multicentre diagnostic study. BMJ. 2014 Oct 15;349:g5920. doi: 10.1136/bmj.g5920.

  PMID: 25320247 BACKGROUND

• Timmerman D, Testa AC, Bourne T, Ameye L, Jurkovic D, Van Holsbeke C, Paladini D, Van Calster B, Vergote I, Van Huffel S, Valentin L. Simple ultrasound-based rules for the diagnosis of ovarian cancer. Ultrasound Obstet Gynecol. 2008 Jun;31(6):681-90. doi: 10.1002/uog.5365.

  PMID: 18504770 BACKGROUND

• Jacobs I, Oram D, Fairbanks J, Turner J, Frost C, Grudzinskas JG. A risk of malignancy index incorporating CA 125, ultrasound and menopausal status for the accurate preoperative diagnosis of ovarian cancer. Br J Obstet Gynaecol. 1990 Oct;97(10):922-9. doi: 10.1111/j.1471-0528.1990.tb02448.x.

  PMID: 2223684 BACKGROUND

• Davies AP, Jacobs I, Woolas R, Fish A, Oram D. The adnexal mass: benign or malignant? Evaluation of a risk of malignancy index. Br J Obstet Gynaecol. 1993 Oct;100(10):927-31. doi: 10.1111/j.1471-0528.1993.tb15109.x.

  PMID: 8217976 BACKGROUND

• Timmerman D, Van Calster B, Jurkovic D, Valentin L, Testa AC, Bernard JP, Van Holsbeke C, Van Huffel S, Vergote I, Bourne T. Inclusion of CA-125 does not improve mathematical models developed to distinguish between benign and malignant adnexal tumors. J Clin Oncol. 2007 Sep 20;25(27):4194-200. doi: 10.1200/JCO.2006.09.5943. Epub 2007 Aug 13.

  PMID: 17698805 BACKGROUND

• Van Calster B, Timmerman D, Bourne T, Testa AC, Van Holsbeke C, Domali E, Jurkovic D, Neven P, Van Huffel S, Valentin L. Discrimination between benign and malignant adnexal masses by specialist ultrasound examination versus serum CA-125. J Natl Cancer Inst. 2007 Nov 21;99(22):1706-14. doi: 10.1093/jnci/djm199. Epub 2007 Nov 13.

  PMID: 18000221 BACKGROUND

• Nustad K, Bast RC Jr, Brien TJ, Nilsson O, Seguin P, Suresh MR, Saga T, Nozawa S, Bormer OP, de Bruijn HW, Nap M, Vitali A, Gadnell M, Clark J, Shigemasa K, Karlsson B, Kreutz FT, Jette D, Sakahara H, Endo K, Paus E, Warren D, Hammarstrom S, Kenemans P, Hilgers J. Specificity and affinity of 26 monoclonal antibodies against the CA 125 antigen: first report from the ISOBM TD-1 workshop. International Society for Oncodevelopmental Biology and Medicine. Tumour Biol. 1996;17(4):196-219. doi: 10.1159/000217982.

  PMID: 8685601 BACKGROUND

• Sarandakou A, Protonotariou E, Rizos D. Tumor markers in biological fluids associated with pregnancy. Crit Rev Clin Lab Sci. 2007;44(2):151-78. doi: 10.1080/10408360601003143.

  PMID: 17364691 BACKGROUND

• Yazbek J, Salim R, Woelfer B, Aslam N, Lee CT, Jurkovic D. The value of ultrasound visualization of the ovaries during the routine 11-14 weeks nuchal translucency scan. Eur J Obstet Gynecol Reprod Biol. 2007 Jun;132(2):154-8. doi: 10.1016/j.ejogrb.2006.07.013. Epub 2006 Aug 17.

  PMID: 16914254 BACKGROUND

• Mukhopadhyay A, Shinde A, Naik R. Ovarian cysts and cancer in pregnancy. Best Pract Res Clin Obstet Gynaecol. 2016 May;33:58-72. doi: 10.1016/j.bpobgyn.2015.10.015. Epub 2015 Oct 30.

  PMID: 26707193 BACKGROUND

• Akazawa M, Onjo S. Malignant Transformation of Mature Cystic Teratoma: Is Squamous Cell Carcinoma Different From the Other Types of Neoplasm? Int J Gynecol Cancer. 2018 Nov;28(9):1650-1656. doi: 10.1097/IGC.0000000000001375.

  PMID: 30358706 BACKGROUND

• Ayhan A, Aksu T, Develioglu O, Tuncer ZS, Ayhan A. Complications and bilaterality of mature ovarian teratomas (clinicopathological evaluation of 286 cases). Aust N Z J Obstet Gynaecol. 1991 Feb;31(1):83-5. doi: 10.1111/j.1479-828x.1991.tb02773.x.

  PMID: 1872783 BACKGROUND

• Caspi B, Levi R, Appelman Z, Rabinerson D, Goldman G, Hagay Z. Conservative management of ovarian cystic teratoma during pregnancy and labor. Am J Obstet Gynecol. 2000 Mar;182(3):503-5. doi: 10.1067/mob.2000.103768.

  PMID: 10739498 BACKGROUND

• Hoo WL, Yazbek J, Holland T, Mavrelos D, Tong EN, Jurkovic D. Expectant management of ultrasonically diagnosed ovarian dermoid cysts: is it possible to predict outcome? Ultrasound Obstet Gynecol. 2010 Aug;36(2):235-40. doi: 10.1002/uog.7610.

  PMID: 20201114 BACKGROUND

• Caspi B, Appelman Z, Rabinerson D, Zalel Y, Tulandi T, Shoham Z. The growth pattern of ovarian dermoid cysts: a prospective study in premenopausal and postmenopausal women. Fertil Steril. 1997 Sep;68(3):501-5. doi: 10.1016/s0015-0282(97)00228-8.

  PMID: 9314922 BACKGROUND

• Morice P. Borderline tumours of the ovary and fertility. Eur J Cancer. 2006 Jan;42(2):149-58. doi: 10.1016/j.ejca.2005.07.029. Epub 2005 Dec 2.

  PMID: 16326097 BACKGROUND

• Hoover K, Jenkins TR. Evaluation and management of adnexal mass in pregnancy. Am J Obstet Gynecol. 2011 Aug;205(2):97-102. doi: 10.1016/j.ajog.2011.01.050. Epub 2011 May 14.

  PMID: 21571247 BACKGROUND

• Fauvet R, Brzakowski M, Morice P, Resch B, Marret H, Graesslin O, Darai E. Borderline ovarian tumors diagnosed during pregnancy exhibit a high incidence of aggressive features: results of a French multicenter study. Ann Oncol. 2012 Jun;23(6):1481-7. doi: 10.1093/annonc/mdr452. Epub 2011 Oct 14.

  PMID: 22003244 BACKGROUND

• Poder L, Coakley FV, Rabban JT, Goldstein RB, Aziz S, Chen LM. Decidualized endometrioma during pregnancy: recognizing an imaging mimic of ovarian malignancy. J Comput Assist Tomogr. 2008 Jul-Aug;32(4):555-8. doi: 10.1097/RCT.0b013e31814685ca.

  PMID: 18664842 BACKGROUND

• Condous G, Khalid A, Okaro E, Bourne T. Should we be examining the ovaries in pregnancy? Prevalence and natural history of adnexal pathology detected at first-trimester sonography. Ultrasound Obstet Gynecol. 2004 Jul;24(1):62-6. doi: 10.1002/uog.1083.

  PMID: 15229918 BACKGROUND

• Pateman K, Moro F, Mavrelos D, Foo X, Hoo WL, Jurkovic D. Natural history of ovarian endometrioma in pregnancy. BMC Womens Health. 2014 Oct 15;14:128. doi: 10.1186/1472-6874-14-128.

  PMID: 25315259 BACKGROUND

• Mascilini F, Savelli L, Scifo MC, Exacoustos C, Timor-Tritsch IE, De Blasis I, Moruzzi MC, Pasciuto T, Scambia G, Valentin L, Testa AC. Ovarian masses with papillary projections diagnosed and removed during pregnancy: ultrasound features and histological diagnosis. Ultrasound Obstet Gynecol. 2017 Jul;50(1):116-123. doi: 10.1002/uog.17216.

  PMID: 27484484 BACKGROUND

• Moro F, Mascilini F, Pasciuto T, Leombroni M, Li Destri M, De Blasis I, Garofalo S, Scambia G, Testa AC. Ultrasound features and clinical outcome of patients with malignant ovarian masses diagnosed during pregnancy: experience of a gynecological oncology ultrasound center. Int J Gynecol Cancer. 2019 Sep;29(7):1182-1194. doi: 10.1136/ijgc-2019-000373. Epub 2019 Jul 19.

  PMID: 31326950 BACKGROUND

• Testa AC, Mascilini F, Quagliozzi L, Moro F, Bolomini G, Mirandola MT, Moruzzi MC, Scambia G, Fagotti A. Management of ovarian masses in pregnancy: patient selection for interventional treatment. Int J Gynecol Cancer. 2021 Jun;31(6):899-906. doi: 10.1136/ijgc-2020-001996. Epub 2020 Nov 10.

  PMID: 33172924 BACKGROUND

• Hasson J, Tsafrir Z, Azem F, Bar-On S, Almog B, Mashiach R, Seidman D, Lessing JB, Grisaru D. Comparison of adnexal torsion between pregnant and nonpregnant women. Am J Obstet Gynecol. 2010 Jun;202(6):536.e1-6. doi: 10.1016/j.ajog.2009.11.028. Epub 2010 Jan 8.

  PMID: 20060090 BACKGROUND

• Ginath S, Shalev A, Keidar R, Kerner R, Condrea A, Golan A, Sagiv R. Differences between adnexal torsion in pregnant and nonpregnant women. J Minim Invasive Gynecol. 2012 Nov-Dec;19(6):708-14. doi: 10.1016/j.jmig.2012.07.007.

  PMID: 23084674 BACKGROUND

• Bignardi T, Condous G. The management of ovarian pathology in pregnancy. Best Pract Res Clin Obstet Gynaecol. 2009 Aug;23(4):539-48. doi: 10.1016/j.bpobgyn.2009.01.009. Epub 2009 Feb 20.

  PMID: 19230784 BACKGROUND

• Yen CF, Lin SL, Murk W, Wang CJ, Lee CL, Soong YK, Arici A. Risk analysis of torsion and malignancy for adnexal masses during pregnancy. Fertil Steril. 2009 May;91(5):1895-902. doi: 10.1016/j.fertnstert.2008.02.014. Epub 2008 Mar 21.

  PMID: 18359024 BACKGROUND

• Schmeler KM, Mayo-Smith WW, Peipert JF, Weitzen S, Manuel MD, Gordinier ME. Adnexal masses in pregnancy: surgery compared with observation. Obstet Gynecol. 2005 May;105(5 Pt 1):1098-103. doi: 10.1097/01.AOG.0000157465.99639.e5.

  PMID: 15863550 BACKGROUND

• Germain A, Brunaud L. Visceral surgery and pregnancy. J Visc Surg. 2010 Jun;147(3):e129-35. doi: 10.1016/j.jviscsurg.2010.07.005. Epub 2010 Sep 1.

  PMID: 20813621 BACKGROUND

• Balinskaite V, Bottle A, Sodhi V, Rivers A, Bennett PR, Brett SJ, Aylin P. The Risk of Adverse Pregnancy Outcomes Following Nonobstetric Surgery During Pregnancy: Estimates From a Retrospective Cohort Study of 6.5 Million Pregnancies. Ann Surg. 2017 Aug;266(2):260-266. doi: 10.1097/SLA.0000000000001976.

  PMID: 27617856 BACKGROUND

• Soriano D, Yefet Y, Seidman DS, Goldenberg M, Mashiach S, Oelsner G. Laparoscopy versus laparotomy in the management of adnexal masses during pregnancy. Fertil Steril. 1999 May;71(5):955-60. doi: 10.1016/s0015-0282(99)00064-3.

  PMID: 10231065 BACKGROUND

• Education and Practical Standards Committee, European Federation of Societies for Ultrasound in Medicine and Biology. Minimum training recommendations for the practice of medical ultrasound. Ultraschall Med. 2006 Feb;27(1):79-105. doi: 10.1055/s-2006-933605. No abstract available.

  PMID: 16508866 BACKGROUND

• Riley RD, Debray TPA, Collins GS, Archer L, Ensor J, van Smeden M, Snell KIE. Minimum sample size for external validation of a clinical prediction model with a binary outcome. Stat Med. 2021 Aug 30;40(19):4230-4251. doi: 10.1002/sim.9025. Epub 2021 May 24.

  PMID: 34031906 BACKGROUND

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Dirk Timmerman, Professor

CONTACT

+3216344201; dirk.timmerman@uzleuven.be

Wouter Froyman, Professor

CONTACT

+3216344201; wouter.froyman@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: August 3, 2023
• Study Start: June 5, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 3, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)