3.2 Implementation for MDC
3.2.2 Search Setups
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One particularly notable aspect of this study was the fact that MVA was the established and accepted form of uterine evacuation in the first trimester. There was initial reluctance in accepting misoprostol for management of first trimester abortion among colleagues and patients.
This was partly because it was a new treatment and its outcomes are untested and unknown in this environment. It could also be due to the fact that there was fear of infection of retained products of conception if not immediately evacuated. However, with counseling of patients and colleagues on the successful outcomes of research done in other African countries and the importance of harnessing this low cost technology changed their views and gained their confidence.
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and reduce the burden on skilled surgical provider’s, surgical equipments and supplies.
Misoprostol has the additional benefit of being highly acceptable to women as it is less medicalized and less invasive than the standard surgical treatment.
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APPENDIX 1
DATA FORM ON THE COMPARATIVE MISOPROSTOL TRIAL VERSUS MANUAL VACUUM ASPIRATION IN THE MANAGEMENT OF FIRST TRIMESTER SPONTANOUESS MISCARRIAGE IN AHMADU BELLO UNIVERSITY TEACHING
HOSPITAL, SHIKA-ZARIA.
INTRODUCTION/RESPONDENTS
The survey is intended to be applied to women presenting with missed or incomplete first trimester abortion who satisfy the inclusion criteria. They will be randomized by selecting the serially numbered opaque envelops and either misoprostol will be given or MVA will be done.
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AP PE ND IX 1I
Subject ID:
CONSENT FORM
Protocol Title: COMPARATIVE TRIAL OF MISOPROSTOL VERSUS MVA IN THE MANAGEMENT OF FIRST TRIMESTER SPONTANUEOUS MISCARRIAGE Principal Investigator: DR H.A.IDRIS
Description of Subject Population: Women with first trimester uncomplicated miscarriage
About this consent form
Please read this form carefully. This form provides important information about participating in a research study. As a prospective research participant, you have the right to take your time in making decisions about participating in this research and you are encouraged to discuss your decision with your family and your doctor. If you have any questions about the research or any portion of this form, please ask us. If you decide to participate in this research study you will be asked to sign this form. A copy of the signed form will be provided to you for your record.
Participation is voluntary
It is your choice whether or not to take part in this research. If you choose to take part, you may change your mind and leave the study at any time without penalty. Refusal to participate or withdrawal will not involve a penalty or loss of benefits to which you are otherwise entitled.
Why is this research study being done?
The purpose of this research is to compare a medical treatment using misoprostol with the standard treatment of evacuation of the uterus MVA in first trimester spontaneous miscarriage What will happen in this research study?
Guidance for filling out this questionnaire:
1. Obtain informed consent prior to applying the survey
2. Ask each question in turn, circle any answer (s) that the respondent gives (some questions will have more than one response), and add additional answers in the
“other” column. Where noted, probe for more information to responses.
3. You may rephrase the question if the respondent does not understand. In some instances you will read out loud the possible responses to the question.
4. Do a PCV,Blood group and clotting time( for missed abortion only) Write legibly and briefly, without leaving any important content out.
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Patients presenting with uncomplicated first trimester spontaneous miscarriage (missed or incomplete) will be eligible for the study. Patient’ may receive misoprostol or have MVA as the randomized treatment. Follow up is at one and two week’s interval after treatment
If you do not consent to participate in the study, then you are excluded and will have MVA.
Statement of Consent
I have read the information in this consent form including risks and possible benefits. All my questions about the research study have been answered to my satisfaction.
I consent to participate in the study. I authorize the use and disclosure of my health information to the parties listed in the privacy section of this consent form.
SIGNATURE
________________________________________ __________________
Signature of Subject Date
________________________________________ __________________
Signature of Legally Authorized Representative Date (When applicable)
APPENDIX 11I
DATA FORM ON THE COMPARATIVE TRIAL OF MISOPROSTOL VERSES MANUAL VACUUM ASPIRATION FOR THE MANAGEMENT OF FIRST
TRIMESTER MISCARRIAGE
Hospital No……….
Envelope No………..
Phone No. of patient………..
Demographics
1. Age ………years 2. Ethnic group
Hausa…….Igbo……Yoruba ………Others………..
3. Marital Status
Single…..Married……...Divorced……Separated……Widowed…..
4. Religion
Islam…….Christianity……..Traditional……..Others……
5. Educational Status
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None….. Koranic…… Primary…….Secondary……Tertiary……
6. Occupation
Housewife………Business/trader………….civil servant………
Artisan……….Student……….Others (specify) 7. Reproductive profile
Parity………
LMP……….
Diagnosis……… USS report………
8. Previous MVA? Yes (how many)…….. No……
If yes at what GA. ……….
9. Base line investigations
PCV……… clotting time (missed abortion)………..
Blood group………..
10 .Outcome of treatment with misoprostol
Duration of vaginal bleeding (days)………
Pain……….
Expulsion time (after misoprostol)………
Side effects………
PCV after treatment………..
Need for MVA: Yes/No
11. Outcome of treatment with MVA Complications
Pain………... Score for pain and bleeding 0= none Blood loss……… 1= mild Cervical tear ………. 2= moderate Infection ……… 3= severe Perforation ……….
PCV after treatment…………
12. Follow up at one week