Quinacrine Non-surgical Method of Voluntary Female Sterilization: Current News  
 
   
  

THE QUINACRINE METHOD PROCEDURE MANUAL - Appendices
 
 
 

Appendix A



Contents

QUINACRINE STERILIZATION REGISTER:
DIRECTIONS FOR USE

Objectives and Content of the Register

Quinacrine Register and Study Procedures

QUINACRINE STERILIZATION REGISTER

QUINACRINE STERILIZATION FOLLOWUP RECORD

QUINACRINE STERILIZATION REGISTER RETROSPECTIVE DATA:
INSTRUCTIONS

QUINACRINE STERILIZATION REGISTER RETROSPECTIVE DATA:






INTERNATIONAL FEDERATION FOR FAMILY HEALTH QUINACRINE STERILIZATION REGISTER



DIRECTIONS FOR USE

Objectives and Content of the Register

The general objective is to gather information to evaluate the safety and efficacy of quinacrine sterilization (QS). Specifically, the data recorded in the Register will permit calculation of life table pregnancy failure rates and the incidence of serious complications. For the latter we utilize definitions of the Centers for Disease Control and Prevention as follows:

1. Unintended major surgery because of a problem related to quinacrine insertion.

2. Blood transfusion required for a problem related to QS.

3. Febrile morbidity: oral temperature 38.0 C or higher at least 2 post insertion days, excluding the first 24 hours

4. Life-threatening event attributable to quinacrine insertion: examples are myocardial infarction, anaphylactic shock, peritonitis or severe vaginal bleeding.

5. Hospitalization after quinacrine insertion because of a complaint or problem that the woman perceived to be related to QS.

6. Death: death or complication leading to death occurring within 42 days of QS.


An estimate of incidence of side effects can be made from information recorded in the Register. These are usually lower abdominal pain, complaints of yellow discharge (quinacrine is a yellow dye), a sensation of feverishness, and oligomenorrhea or amenorrhea.

For more detailed information the investigator should use the Female Sterilization Study Procedure Record and Follow-up Record found in the Protocol for Straight and Comparative Studies of Nonsurgical Female Sterilization by Quinacrine Pellets and Quinacrine Pellets Plus Other Drugs. Copies are available from the International Federation for Family Health and related Data Collection Centers.

Quinacrine Register and Study Procedures

At the time of study initiation the investigator will be thoroughly oriented about QS, shown a video describing QS and its counseling and provided with initial supplies of quinacrine pellets, inserters, a training manual, and sheets of the Register. The items in the Register are self-explanatory except for definitions of side effects and complications described above.

Shortly after your study initiation, you will receive from the Data Collection Coordinator your Center Number and Study Number. Some studies require only a single insertion of quinacrine pellets and others multiple insertions. Some studies add adjuvants and others do not. The handling of completed Register forms will be described in detail by the Data Collection Coordinator. In brief, copies of the Register forms, upon containing information on 10 consecutive cases, are to be mailed to the Data Collection Coordinator as completed, preferably on a monthly basis. In copying the first page of the Register kindly cover with an opaque strip the patient's name section. Copy both sides of each Register page. The front and back of each sheet should have the same Page No. The Data Collection Coordinator will acknowledge receipt of each batch of mailed Registers.

Additional quinacrine or inserter supplies or Register forms may be ordered from the Data Collection Coordinator. S/he may send you queries regarding your completed Registers, which should be answered promptly.

Record any late complication or pregnancy in your Register. Also record these two pieces of information as they occur, on the Quinacrine Sterilization Follow-up Record. Copies of the Follow-up Record will be requested from time to time. One such time is when your data set is to be analyzed. At that time, a complete listing of all patients is to be listed on the Follow-up Record including the last patient contact date, to be taken from your own clinic records. For cases with no complication record none under Complication. For cases with no pregnancy record none under Pregnancy outcome.

If you have questions regarding your study, direct them to the Data Collection Coordinator who is responsible for obtaining an answer and forwarding it to you.

Any very serious complication should be reported to the Data Collection Coordinator immediately.

The address of your Data Collection Coordinator is:



INTERNATIONAL FEDERATION FOR FAMILY HEALTH QUINACRINE STERILIZATION REGISTER RETROSPECTIVE DATA


DIRECTIONS FOR USE
Objectives and Content of the Retrospective Register
The general objective is to gather information to evaluate the safety and efficacy of quinacrine sterilization (QS) for centers that have not utilized the prospective Quinacrine Sterilization Register. Specifically, the data recorded in the Register will permit calculation of life table pregnancy failure rates and the incidence of serious complications. For the latter we utilize definitions of the Centers for Disease Control and Prevention as follows:
1. Unintended major surgery because of a problem related to quinacrine insertion.
2. Blood transfusion required for a problem related to QS.
3. Febrile morbidity: oral temperature 38.0° C or higher at least 2 post insertion days, excluding the first 24 hours
4. Life-threatening event attributable to quinacrine insertion: examples are myocardial infarction, anaphylactic shock, peritonitis or severe vaginal bleeding.
5. Hospitalization after quinacrine insertion because of a complaint or problem that the woman perceived to be related to QS.
6. Death: death or complication leading to death occurring within 42 days of QS.

An estimate of incidence of side effects can be made from information recorded in the Register. These are usually lower abdominal pain, complaints of yellow discharge (quinacrine is a yellow dye), a sensation of feverishness, and oligomenorrhea or amenorrhea.
A double asterisk (**) indicates data required for calculation of life table rates. All other data are optional, except for the Patient Order Number. The more data provided, the more meaningful the analysis will become.
Completed Retrospective Data Registers should be sent to your Data Collection Coordinator who will acknowledge receipt and may have queries which should be promptly answered. You will be provided as minimum feedback life table pregnancy rates with their standard error. Other feedback will depend on data you have provided.
If you have questions regarding your study, direct them to the Data Collection Coordinator. The address of your Data Collection Coordinator is:


Appendix B

Client Brochure




Appendix C


Volunteer's Consent Form for the Quinacrine Hydrochloride Pellet Female Sterilization Study


Name of Volunteer:_________________________________ Age:__________
Hospital/Clinic: _________________________________
Patient Registration No.:__________
Volunteer's Statement:
I, the undersigned, agree to undergo permanent sterilization by the intrauterine insertion of Quinacrine Hydrochloride pellets. I understand that there is a possibility of complications arising out of the procedure which may include pain, discharge, fainting, sweating, headache and/or other unknown complications as a result of the sterilization procedure and that the procedure is not 100 percent effective in preventing pregnancy. I also understand that there may be surgical accidents, such as perforation, laceration and cervical tears caused by the procedure and that I shall receive medical consultation and appropriate treatment including referral services, if necessary. I understand that I can obtain other methods of reversible contraception.
I understand that I can withdraw from the study at any time and still receive the services of this clinic. The contents of the above statement have been explained to me in a language I understand and I agree to participate as a voluntary subject.
___________Date
________________________________________________
Signature of volunteer or legal representative
Investigator's Statement:
I, the undersigned, have defined and explained to the volunteer in her native language the risks and benefits of the study, as well as the study procedures.
____________Date
_________________________________________________
Signature of investigator

___________Date
_________________________________________________
Signature of witness to above signature and explanation


Appendix D




How To Be Reasonably Sure a Client is not Pregnant

You can be reasonably sure a client is not pregnant if she has no signs or symptoms of pregnancy (e.g., breast tenderness or nausea) and:
  • has not had intercourse since her last menses
  • has been correctly and consistently using a reliable contraceptive method
  • is within the first seven days after the start of her menses (days 1-7), or
  • is within six weeks postpartum (for women who are not breast-feeding), or
  • is within the first seven days postabortion, or
  • is fully breast-feeding, less than six months postpartum and has had no menstrual bleeding


    • APPENDIX E


     

    Treatment For an Anaphylactic Reaction

     

    After the receipt of an immunization or medication such asquinacrine, a person may become pale and feel faint; or may suddenly faint.

    I. ANAPHYLAXISMUST FIRST BE DISTINGUISHED FROM SIMPLE FAINTING:

    II. SIGNS AND SYMPTOMS OF A SIMPLE FAINTINGcan occur before, during or shortly after administration of an immunization or drug.

    1.     IF A PERSON HAS FAINTED:

    A.    The pulse will remain steady and the respirations normal even if the person becomes unconscious; and

    B.    The episode will only last seconds after the head and heart are at the same level.

    C.    The necessary action for a faint is:

    a.      Have the person lie flat or sit in a head-down position forseveral minutes.

    b.     If the person faints completely, place them flat with theirfeet (not the head) elevated and allow the person to rest in a quiet area for10 minutes.

    III. SIGNS AND SYMPTOMS OF AN ACUTEANAPHYLAXIS usually occur within the first 15 minutes following administration but may occur as early as 30 seconds after. The appearance of hives may be an early indication of a life-threatening collapse:

    START TREATMENT IMMEDIATELY!

    DO NOT WAIT FOR MILD SYMPTOMS TO SUBSIDE.

    1.     EARLY SYMPTOMS MAY INCLUDE: Apprehension; Tingling around themouth; Dizziness; Nausea; Intense itching.

    FOLLOWED BY: Hives in the form of itching patches or wheals; A choking sensation or tightness in the chest;Coughing and wheezing; A weak or hard to find pulse; or A drop in bloodpressure.

    2.     THE MOST SERIOUS SIGNS ARE:

    A. Shock;

    B.    Respiratory distress, which may include the following: Cyanosis; Increased temperature; Convulsions; and Loss of consciousness.

    IV. TREATMENT

    1. Lay the patient flat and administer the following medications:

    A. FIRST subcutaneaously inject in a limb (NOT IN THE BUTTOCKS) :

    a. EPINEPHRINE HYDROCHLORIDE(Adrenalin) 1:1000 in the following dose: 0.5 ml

    B. HAVESOMEONE CONTACT THE MEDICAL OFFICER, if one is available.

    C. IFNO IMPROVEMENT OCCURS WITHIN 3 TO 4 MINUTES, REPEAT AS ABOVE;

    D. TAKEAND RECORD VITAL SIGNS;

    E. IFTHE PATIENT IS WHEEZING OR HAVING RESPIRATORY TROUBLE, elevate the headslightly.

    F. IFSEVERE HIVES OR EDEMA OF THE THROAT OR LARYNIX ARE PRESENT, TO INCREASE THEEFFECT OF THE EPINEPHRINE, INJECT INTRAMUSCULARLY:

    a. BENADRYL (Diphenhydramine Hydrochloride) in the following dose: 2.0 ml.

    G. RECORDALL MEDICATIONS ADMINISTERED including the following: Time; Dosage; Patient’s response; Name of person who administered them.

    H. If possible, obtain immediate consultation with the Medical Officer.

    I. REPEATTHE SAME DOSE OF EPINEPHRINE IN 10-15 MINUTES AS NEEDED.

    V. PREPARATIONS:

    1.
    ALL STAFF MEMBERS WHO ADMINISTER QUINACRINE SHOULD BE TRAINED IN RESPONDING TO AN ANAPHYLACTIC REACTION.

    2.
    THE FOLLOWING MEDICATIONS AND SUPPLIES SHOULD BE AVAILABLE IN THE CLINIC OR MOBILE VAN AT ALL TIMES:

    A.
    MEDICATIONS

    a.
    Epinephrine (Adrenalin) 1:1000

    b.
    Benadryl(Diphenhydramine Hydrochloride)


    50mg/cc.

    B.                
    NECESSARY EQUIPMENT

    a.
    Syringes (1 cc and 5 cc) 4 of each.

    b. Sphygmomanometer and stethoscope.

    Reference List

    Butta, Phyllis. Project Coordinator. Informed Consent and Voluntary Surgical Sterilization. Association for Voluntary Surgical Sterilization., New York, NY, 1988.
    Cleaning and Maintenance of Manual Vacuum Aspiration Equipment. International Projects Assistance Service.
    Counseling Makes a Difference. Population Reports, Series J, No. 35, November 1987.
    Training Course in Women's Health, Module Series, Institute for Development Training.
    Hieu, D. et al. A Retrostrospective Study of Quinacrine Sterilization in Vietnam. Report Presented at Quinacrine Sterilization Dissemination Meeting in Hanoi, Vietnam, February 1995.
    Kessel E., Zipper J., Mumford S., The Quinacrine Pellet Method for Nonsurgical Female Sterilization: A Collection of Background Material. Center for Research on Population and Security, Research Triangle Park, NC, 1994.
    McIntosh N., Kinzie B., Blouse A., eds. IUD Guidelines for Family Planning Service Programs: A Problem-Solving Reference Manual. JHPIEGO, Baltimore, MD., 1992.
    Safe and Voluntary Surgical Contraception. World Federation of Health Agencies of the Advancement of Voluntary Surgical Contraception, New York, NY, 1988. Voluntary Female Sterilization. Population Reports, Series C, No. 10, November 1990.
    Why Counseling Counts. Population Reports, Series J, No. 36, December 1987.


    		  
             
     
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