M Lemmers1,2, M A C Verschoor3, K Oude Rengerink3, C Naaktgeboren4, B C Opmeer5, P M Bossuyt5, J A F Huirne2, C A H Janssen6, C Radder7, E R Klinkert8, J Langenveld9, R Catshoek10, L Van der Voet11, F Siemens12, P Geomini13, M H Van Hooff14, J M Van der Ploeg15, S F P J Coppus16, W M Ankum3, B W J Mol17. 1. Department of Obstetrics and Gynaecology, Academic Medical Center, P.O. Box 22770, 1100 DE Amsterdam, the Netherlands m.lemmers@amc.uva.nl. 2. Department of Obstetrics and Gynaecology, VU Medical Center, P.O. Box 7057, 1007 MB Amsterdam, the Netherlands. 3. Department of Obstetrics and Gynaecology, Academic Medical Center, P.O. Box 22770, 1100 DE Amsterdam, the Netherlands. 4. Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, P.O. Box 85500, 3508 GA Utrecht, the Netherlands. 5. Clinical Research Unit, University of Amsterdam, Academic Medical Center, P.O. Box 22770, 1100 DE Amsterdam, the Netherlands. 6. Department of Obstetrics and Gynaecology, Groene Hart Hospital, P.O. Box 1098, 2800 BB Gouda, the Netherlands. 7. Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis West, P.O. Box 9243, 1006 AE Amsterdam, the Netherlands. 8. Department of Obstetrics and Gynaecology, University Medical Center Groningen, P.O. Box 30001, 9700 RB Groningen, the Netherlands. 9. Department of Obstetrics and Gynaecology, Atrium Medical Center, P.O. Box 4446, 6401 CX Heerlen, the Netherlands. 10. Department of Obstetrics and Gynaecology, Maastricht University Medical Center, P.O. Box 5800, 6202 AZ Maastricht, the Netherlands. 11. Department of Obstedtrics and Gynaecology, Deventer Hospital, P.O. Box 5001, 7400 GC Deventer, the Netherlands. 12. Department of Obstetrics and Gynaecology, Reinier de Graaf Hospital, P.O. Box 5011, 2600 GA Delft, the Netherlands. 13. Department of Obstetrics and Gynaecology, Maxima Medical Center, Postbus 7777, 5500 MB Veldhoven, the Netherlands. 14. Department of Obstetrics and Gynaecology, Sint Franciscus Gasthuis, Rotterdam, P.O. Box 10900, 3004 BA Rotterdam, the Netherlands. 15. Department of Obstetrics and Gynaecology, Martini Hospital Groningen, P.O Box 30033, 9700 RM Groningen, the Netherlands. 16. Department of Obstetrics and Gynaecology, University Medical Center St. Radboud, P.O. Box 9101, 6500 HB Nijmegen, the Netherlands. 17. The Robinson Research Institute, School of Paediatrics and Reproductive Health, University of Adelaide, 55 King William Road, North Adelaide SA 5006; and The South Australian Health and Medical Research Institute, Adelaide, Australia.
Abstract
STUDY QUESTION: Is curettage more effective than expectant management in case of an incomplete evacuation after misoprostol treatment for first trimester miscarriage? SUMMARY ANSWER: Curettage leads to a higher chance of complete evacuation but expectant management is successful in at least 76% of women with an incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage. WHAT IS KNOWN ALREADY: In 5-50% of the women treated with misoprostol, there is a suspicion of incomplete evacuation of the uterus on sonography. Although these women generally have minor symptoms, such a finding often leads to additional curettage. STUDY DESIGN, SIZE, DURATION: From June 2012 until July 2014, we conducted a nationwide multicenter randomized controlled trial (RCT). Women who had had primary misoprostol treatment for miscarriage with sonographic evidence of incomplete evacuation of the uterus were randomly allocated to either curettage or expectant management (1:1), using a web-based application. PARTICIPANTS/MATERIALS, SETTING, METHODS: We included 59 women in 27 hospitals; 30 were allocated to curettage and 29 were allocated toexpectant management. A successful outcome was defined as sonographic finding of an empty uterus 6 weeks after randomization. MAIN RESULTS AND THE ROLE OF CHANCE: Baseline characteristics of both groups were comparable. Empty uterus on sonography or uneventful clinical follow-up was seen in 29/30 women (97%) allocated to curettage compared with 22/29 women (76%) allocated to expectant management (RR 1.3, 95% CI 1.03-1.6) with complication rates of 10% versus 10%, respectively (RR 0.97, 95% CI 0.21-4.4). In the group allocated to curettage, no woman required re-curettage, while two women (6.7%) underwent hysteroscopy (for other or unknown reasons). In the women allocated to expectant management, curettage was performed in four women (13.8%) and three women (10.3%) underwent hysteroscopy. LIMITATIONS, REASONS FOR CAUTION: Due to a strong patient preference, mainly for expectant management, the targeted sample size could not be included and the trial was stopped prematurely. WIDER IMPLICATIONS OF THE FINDINGS: In women suspected of incomplete evacuation of the uterus after misoprostol, curettage is more effective than expectant management. However, expectant management is equally safe and prevents curettage for most of the women. This finding could further restrain the use of curettage in the treatment of first trimester miscarriage. STUDY FUNDING/COMPETING INTERESTS: This study was funded by ZonMw, a Dutch organization for Health Research and Development, project number 80-82310-97-12066. There were no conflicts of interests. TRIAL REGISTRATION NUMBER: Dutch Trial Register NTR3310, http://www.trialregister.nl TRIAL REGISTRATION DATE: 27 February 2012. DATE OF FIRST PATIENT'S ENROLMENT: 12 June 2012.
RCT Entities:
STUDY QUESTION: Is curettage more effective than expectant management in case of an incomplete evacuation after misoprostol treatment for first trimester miscarriage? SUMMARY ANSWER: Curettage leads to a higher chance of complete evacuation but expectant management is successful in at least 76% of women with an incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage. WHAT IS KNOWN ALREADY: In 5-50% of the women treated with misoprostol, there is a suspicion of incomplete evacuation of the uterus on sonography. Although these women generally have minor symptoms, such a finding often leads to additional curettage. STUDY DESIGN, SIZE, DURATION: From June 2012 until July 2014, we conducted a nationwide multicenter randomized controlled trial (RCT). Women who had had primary misoprostol treatment for miscarriage with sonographic evidence of incomplete evacuation of the uterus were randomly allocated to either curettage or expectant management (1:1), using a web-based application. PARTICIPANTS/MATERIALS, SETTING, METHODS: We included 59 women in 27 hospitals; 30 were allocated to curettage and 29 were allocated to expectant management. A successful outcome was defined as sonographic finding of an empty uterus 6 weeks after randomization. MAIN RESULTS AND THE ROLE OF CHANCE: Baseline characteristics of both groups were comparable. Empty uterus on sonography or uneventful clinical follow-up was seen in 29/30 women (97%) allocated to curettage compared with 22/29 women (76%) allocated to expectant management (RR 1.3, 95% CI 1.03-1.6) with complication rates of 10% versus 10%, respectively (RR 0.97, 95% CI 0.21-4.4). In the group allocated to curettage, no woman required re-curettage, while two women (6.7%) underwent hysteroscopy (for other or unknown reasons). In the women allocated to expectant management, curettage was performed in four women (13.8%) and three women (10.3%) underwent hysteroscopy. LIMITATIONS, REASONS FOR CAUTION: Due to a strong patient preference, mainly for expectant management, the targeted sample size could not be included and the trial was stopped prematurely. WIDER IMPLICATIONS OF THE FINDINGS: In women suspected of incomplete evacuation of the uterus after misoprostol, curettage is more effective than expectant management. However, expectant management is equally safe and prevents curettage for most of the women. This finding could further restrain the use of curettage in the treatment of first trimester miscarriage. STUDY FUNDING/COMPETING INTERESTS: This study was funded by ZonMw, a Dutch organization for Health Research and Development, project number 80-82310-97-12066. There were no conflicts of interests. TRIAL REGISTRATION NUMBER: Dutch Trial Register NTR3310, http://www.trialregister.nl TRIAL REGISTRATION DATE: 27 February 2012. DATE OF FIRST PATIENT'S ENROLMENT: 12 June 2012.
Authors: Pushplata Kumari; R N Preethi; Anuja Abraham; Swati Rathore; Santosh Benjamin; M Gowri; Jiji Elizabeth Mathews Journal: J Family Med Prim Care Date: 2019-12-10
Authors: Joyce van den Berg; Charlotte C Hamel; Marcus P Snijders; Sjors F Coppus; Frank P Vandenbussche Journal: BMC Pregnancy Childbirth Date: 2019-11-27 Impact factor: 3.007
Authors: Jay Ghosh; Argyro Papadopoulou; Adam J Devall; Hannah C Jeffery; Leanne E Beeson; Vivian Do; Malcolm J Price; Aurelio Tobias; Özge Tunçalp; Antonella Lavelanet; Ahmet Metin Gülmezoglu; Arri Coomarasamy; Ioannis D Gallos Journal: Cochrane Database Syst Rev Date: 2021-06-01