Duration of vaginal bleeding after the medical induction of an early pregnancy failure with Mifepristone and Misoprostol - What is the best time to evaluate success?
Organizational Data
- DRKS-ID:
- DRKS00013515
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2017-12-05
- Last update in DRKS:
- 2021-11-15
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
The main objective of this observational study is to record the duration of vaginal bleeding after the medical induction of an early pregnancy failure with a combination of 2 drugs (mifepristone and misoprostol). The results of this survey should help to determine the best time to evaluate the success of the therapy in order to avoid unnecessary surgery in the future or to be able to offer necessary operations at the earliest opportunity.
Brief summary in scientific language
The main objective of this observational study is to record the duration of vaginal bleeding after the medical induction of an early pregnancy failure with a combination of Mifepriston and Misoprostol. The results of this survey should help to determine the best time to evaluate the success of the medical induction in order to avoid unnecessary surgery in the future or to be able to offer necessary operations at the earliest opportunity.
Health condition or problem studied
- ICD10:
- O02.1 - Missed abortion
- ICD10:
- O02.0 - Blighted ovum and nonhydatidiform mole
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Patients who undergo medical induction with a mifepristone-misoprostol regimen will be asked to fill out a data sheet daily on the extent of their vaginal bleeding (bleeding in/above normal strength, spotting, no bleeding). Follow-up appointment 2 weeks after initiation.
Endpoints
- Primary outcome:
- Evaluation of the duration of vaginal bleeding following medical induction on the basis of a data sheet filled in daily by the patients themselves
- Secondary outcome:
- Evaluation of predictive factors for the success of a medical induction (success = no additional measures such as curettage or additional misoprostol doses necessary). The parameters used in the analysis are routinely collected at the beginning of a medical induction of an early pregnancy failure.
Study Design
- Purpose:
- Treatment
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Austria
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Kepler Universitätsklinikum, Universitätsklinik für Gynäkologie, Geburtshilfe und Gyn. Endokrinologie Linz
- Medical center LKH Kirchdorf Kirchdorf an der Krems
- Medical center LKH Steyr Steyr
Recruitment period and number of participants
- Planned study start date:
- 2017-12-20
- Actual study start date:
- 2017-12-20
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2019-09-01
- Target Sample Size:
- 250
- Final Sample Size:
- 197
Inclusion Criteria
- Sex:
- Female
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- - Women with Missed Abortion or Windmole who choose Mifegyne® and Cyprostol® for medical induction - Sonographic ≤ 12+6 pregnancy week or CRL ≤ 60 mm
Exclusion Criteria
- Clinically/sonographically Abortus incipiens - Abortus incompletus - Infection - Trophoblastic disease - Multiple pregnancy - Request for appointment at the resident specialist - Insufficient knowledge of German
Addresses
Primary Sponsor
- Address:
- Kepler Universitätsklinikum Linz4020 LinzAustria
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Kepler Universitätsklinikum - Universitätsklinik für Gynäkologie, Geburtshilfe und Gyn. EndokrinologieDr. Simon-Hermann EnzelsbergerKrankenhausstraße 26-304020 LinzAustria
- Telephone:
- +43 5 7680 84 23718
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.kepleruniklinikum.at/versorgung/kliniken/gynaekologie-geburtshilfe-und-gyn-endokrinologie/was-wir-tun/
Contact for Public Queries
- Address:
- Kepler Universitätsklinikum - Universitätsklinik für Gynäkologie, Geburtshilfe und Gyn. EndokrinologieDr. Simon-Hermann EnzelsbergerKrankenhausstraße 26-304020 LinzAustria
- Telephone:
- +43 5 7680 84 23718
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.kepleruniklinikum.at/versorgung/kliniken/gynaekologie-geburtshilfe-und-gyn-endokrinologie
Principal Investigator
- Address:
- Kepler Universitätsklinikum - Universitätsklinik für Gynäkologie, Geburtshilfe und Gyn. EndokrinologieDr. Simon-Hermann EnzelsbergerKrankenhausstraße 26-304020 LinzAustria
- Telephone:
- +43 5 7680 84 23718
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.kepleruniklinikum.at/versorgung/kliniken/gynaekologie-geburtshilfe-und-gyn-endokrinologie/was-wir-tun/
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Kepler Universitätsklinikum4020 LinzAustria
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Kepler UniversitätsklinikumEthikkommission Land Oberösterreich Neuromed Campus [Ethikkommission des Landes Oberösterreich]Wagner-Jauregg Weg 15A-4020 LinzAustria
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://ooe-ethikkommission.at
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2017-10-31
- Ethics committee number:
- C-142-17
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2017-11-21
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Publikation
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry