I.

INTRODUCTION An estimated 211 million pregnancies occur worldwide each year and that 14% to 19 % of these ended in abortion [1]. According to a study[2], approximately 26 million legal and 20 million illegal abortions were performed worldwide in 1995 resulting in abortion rate of 35 per 1000 women aged 15-44. Among the subregions of the world, Eastern Europe had the highest abortion rate (90 per 1000) and Western Europe had the lowest rate (11 per 1000). Among countries where abortion is legal without restrictions as to reason, the highest abortion rate, 83 per 1000, was reported for Vietnam, and the lowest, 7 per 1000, for Belgium and the Netherlands. However, statistics shows that there is a decline in abortion incidence according to studies in 2003 In the Philippines, the estimated abortion rate was 25 per 1000 woman per year in 1994 and increases to 27 per 1000 in 2000[3 ].At BGHMC, there are about 50 cases of abortion per month. Abortion is defined as pregnancy termination prior to 20 weeks age of gestation or with a fetus born weighing less than 500 g[4]. Several complications are related to abortion which includes infections, cervical laceration, incomplete elimination, uterine perforation, bleeding and anesthetic complications[5]. It could be managed either medically or surgically. Surgical procedures includes cervical dilatation followed by evacuation which maybe done by sharp curettage and vacuum aspiration. Sharp curettage is a surgical procedure that involves dilatation of the cervix with mechanical dilators or pharmacological agents followed by the use of sharp metal curettes to scrape the walls of the uterus. It has been used for many years as the standard procedure in the management of abortion. Manual vacuum aspiration may also involve dilatation of the cervix followed by manual aspiration to evacuate the uterus. This is performed with the use of a handheld syringe as a source of suction for removing uterine contents.A vacuum is created in the syringe and attached to the cannula which is inserted transcervically into the uterus.The vaccum is activated and produces up to 60 mmHg suction[4 ]. The procedure time is 5-15 minutes and is performed in settings such as a doctors office, clinic or emergency room. The manual vacuum aspiration method has been used for thirty years throughout the world as a safe and effective alternative to uterine curettage.It was pioneered in 1958 by Drs Wu Yuantai and Xianzhen in China. In Canada, this method was improved by Henry Morgentaler achieving a complication rate of 0.48 % and no deaths in over 5,000 cases.This technique was refined in the United States by Harvey Karman in 1970s with the development of Karman cannula, a soft, flexible cannula that avoided the need for initial cervical dilatation and so reduced the risks of puncturing the 1

uterus[6 ]. It was then further developed by the International Projects Assistance Services (Ipas).At present, this procedure uses easy tool and this technique is easily performed. Besides these, other advantages of the method are satisfaction of patients and professionals, use of local anesthetics to replace general anesthesia, decreased hospital stay and consequent reduction of maternal morbidity and hospital costs.

REVIEW OF RELATED LITERATURE Through the years, Dilatation and curettage using sharp curette has been the standard in the management of abortion. However, studies show that MVA could be an alternative treatment in such condition and has been used for over 30 years throughout the world [7]. Several studies have been made over the past years to compare the effectiveness of MVA and sharp curettage. A study of 1769 patients treated with MVA showed that the technique was effective in 99.5 % of the abortions up to 12 weeks of gestational age. The complications were: infection (0.7%), retention of ovular remains (0.5%) and uterine perforation (0.05%)[8].. Similar study was done with 100 patients.The mean duration of procedure was significantly higher in D&C(8.982.64 minutes) as compared to 5.882.43 minutes in MVA. The duration of hospital stay was significantly lower in MVA group(3.481.2 hours) as compared to7.421.93 minutes in D&C group. Similarly the cost of procedure was also significantly lower in MVA group[9].A recent study was done in 2012 involving 240 patients. 120 women inMVA group and 120 in sharp curettage.The success rate achieved by MVA was 97.4% and sharp curettage was 98.3% which was not significantly different[10]. Results of a review study, which compared MVA to uterine Curettage, indicated that MVA is faster and less painful than sharp curettage[11]. In 2004, a study was conducted at JRRMMC including 100 patients which aimed to compare the cost-effectiveness between MVA and D&C in the treatment of first trimester abortion. It showed that there was a significant difference in the actual cost in the D&C group. It ranged from P1,346.00-1,789.00 while in MVSA group, it ranged from P1,100.001,536.00.No complications were noted in the MVA group while 2 complications were found in the D&C group which includes reaction to anesthesia and uterine perforation[12 ].Another study was done in the same institution in 2006 comparing the accuracy, safety and side effects of MVA and Novak curette as a diagnostic procedure for the evaluation of the endometrium in women presenting with abnormal uterine bleeding.The percentage of inadequate samples was significantly higher in novak curette group(21.4%) than in the MVA group (2.9%).The mean operating time was also significantly higher in the novak curette group, the percentage of patients who reported tachycardia and pain in the MVA and novak curette groups were 17.9 %, respectively. There were significantly higher percentage of patients who needed additional analgesic in the novak curette group (75%)[13 ]. 3

These studies show that MVA is as effective sharp curettage in the management of first trimester abortion. This could be used then as an alternative procedure in the hospital setting.

OBJECTIVES This study aims to determine the efficacy and safety of MVA as compared to sharp curettage including its cost-effectiveness in treating patients diagnosed of incomplete abortion among women who are seen at the emergency room of the Department of Obstetrics and Gynecology of BGHMC. Specifically, this study aims to compare MVA versus sharp curettage in terms of: 1. efficacy of MVA in the evacuation of retained product of conception in incomplete abortion as compared to sharp curettage by doing pelvic ultrasound after the procedure; 2. frequency of complications which includes uterine perforation and infections; and other complications, if any; 3. amount of blood loss by measuring the hemoglobin and hematocrit level before and after the procedure. 4. duration of the operation(minutes);and, 5. duration of hospitalization(days) between the 2 procedures. Significance of the study This study will show that MVA is an effective and safe procedure that could also be use in our institution as an alternative in the treatment of first trimester abortion. Limitations of the study All procedures including the MVA will be done at the Delivery room since the Emergency room is not feasible for the procedure.

I.

PROPOSED METHODOLOGY

Schematic Diagram
ERC approval of Protocol

Emergency room (History and Physical Examination)

Inclusion Criteria / Exclusion Criteria

60 patients included will be given consent form (Appendix A)

Admitted to Delivery room (PT, CBC,UA,PUS will be done) L MVA(30 patients) (Appendix D&E) Sharp Curettage(30 patients) (Appendix D&E)

Comparison

Result/Conclusions

Recommendations

This study is a randomized, open, two-arm parallel experiment over a 6 months period to be done at the Department of Obstetrics and Gynecology at Baguio General Hospital and Medical Center. Patients seen at the OB-Emergency room with a diagnosis of incomplete abortion who meets the required criteria and who signs the consent will be included in the study. They will be randomly selected to undergo either procedure. This study will include patients with: 1) (+) Pregnancy test; 2) (+) vaginal bleeding; 3) (+) history of passage of meaty material; 4) 1-2cm cervical dilatation; 5) 9-12 weeks age of gestation; 6) (+) retained placental fragments; 7) baseline hemoglobin of at least 10 g/dl; 8) endometrial stripe of 1.2cm; 9) spontaneous abortion; 10) incomplete abortion;and, 11) no fever This study excludes patients with: 1) >12 weeks age of gestation 2) Closed cervix 3) < 1.2 endometrial stripe 4) Induced abortion 5) Baseline hemoglobin of < 10g/dl 6) Medical problems 7) (+) fever After thorough history and physical examination, patients who are qualified for the study will sign consent after all the procedures to be done will be fully explained including its risks and benifits.The patients then will be admitted at the delivery room where the procedure will be performed( Appendix A). At the emergency room, all necessary laboratory procedures must be done which includes pregnancy test, urinalysis, and CBCand Pelvic ultrasound.Blood loss will also be measured during the procedure. The duration of the procedure and the length 7

of hospital stay would also be noted. A repeat PUS must also be done after the procedure to determine if the products of conception are completely evacuated.Follow up will be done after 7 days at the OPD. The main outcome measure is to determine completion of abortion following treatment with either manual vacuum aspiration or sharp curettage. MVA is done by suction through a cannula into a hand-held vacuum syringe. Naproxen 550mg PO will be given 30 minutes before the procedure.On the other hand, sharp curettage is done by scraping the endometrium using a sharp curette to evacuate the uterine contents under IV sedation using nalbuphine 10mg and midazolam 5mg. Post-operatively, patients on both groups will be given methylergometrine maleate 1 amp IM, Clindamycin 300mg BID and Mefenamic acid 500mg TID. To characterize the study population, frequency, percentage and ratios will be used. Significance of percentages will be used to evaluate the efficacy of manual vacuum aspiration as compared to sharp curettage in the management of incomplete abortion in terms of completeness in the evacuation of retained product of conception, risk of developing complication such as infection and uterine perforation, blood loss, duration of the procedure and hospital stay.

REFERENCES 1. Wen,J. Manual versus Electric Vacuum Aspiration for First Trimester Abortion: A Systematic Review. An International Journal of Obstetrics and Gynecology.2008,115(1):5-13. 2. Henshaw,S.,etal.,. The Incidence of Abortion Worldwide. Family Planning Perspectives.1999,Volume 25. 3. Juarez,F.,et at.,.The Incidence of Induced Abortion in the Philippines: Current Level and Recent Trends.International Family Planning Perspectives.Volume 31,Number 3. 4. Cunningham,F., et al.,.2010.Williams Obstetrics, 23rd Edition.Pp215,222,231. 5. Baird TL,et al.,.MVA in Compliance with Incomplete Abortion: Clinical and Programmatic Experience.Carrboro:IPAS.1996. 6. Coombes,R.2008.Obtetrician seek Recognition for Chinese Pioneere of Safe Abortion.BMJ 336(7657):1332-3. 7. Morgentaler,H.Allan F. Guttmacher Lecture. Am J Gynecol Health. 1989:38-45. 8. Managing complications in pregnancy and Childbirth: A Guide to Doctors and Midwives. World Health Organization.2003.Retrieved2006-09-14. 9. Farooq,F.,et al.,.Comparison of Manual Vacuum Aspiration and Dilatation and Curettage in the Treatment of Early Pregnancy Failure.Journal of Pakistan Medical Association.2011. 10. Norzilawati,F.A Comparison of Manual Vacuum Airation (MVA) and Sharp Curettage(Traditional ERPOC) in the Management of Incomplete Miscarriage in Universiti Kebangsaan Malaysia Medical Centre(UKMMC). Journal of Surgical Academia.Volume 2,Number 2. 11. Leksakulchai O,B.Comparison of Level of Pain Between Using Manual Vacuum Aspiration and Sharp Curettage in the Management of Abnormal Utewrine Bleeding. J Med Asso Thai.Pp57-61. 12. Fopalan,M.Comparison of Cost-eefectiveness Between Manual Vacuum Aspiration and Dilatation and Curettage in the Treatment of First Trimester Incomplete Abortion-JRRMMC Experience.Journal of the Perinatology Association of the Philippines.2004. Volume 2.Pp50-57. 13. Mochtar,F.,et al..Randomized Controlled Trial of MVA versus Novak Curette for Endometrial Sampling.Philippine Journal of Obstetrics and Gynecology.2006.Volume 30,Number3,Pp115-119.

APPENDICES APPENDIX A: OPERATIVE TECHNIQUE Sharp curettage

Patient placed in dorsal lithotomy position IV Sedation( Nalbuphine 10 mg and Midazolam 5mg) Asepsis/Antisepsis. Sterile drapes placed Evacuation of urine by straight catheter insertion Internal examination Placement of posterior vaginal retractor Grasping of the anterior lip of the cervix using tenaculum forceps Fishing out of products of conception using ovum forceps Initial Hysterometry Endometrium scraped using sharp curettage until gritty sensation. Repeat hysterometry Swabbing of the endometrium with betadinized sterile os Removal of instruments Perineal care

Manual Vacuum aspiration: 30 minutes before the procedure is started, Naproxen 550mg PO is given to the patient.
Patient placed in dorsal lithotomy position Asepsis/Antisepsis. Sterile drapes placed Internal examination Evacuation of urine by straight catheter insertion Placement of posterior vaginal retractor Grasping of the anterior lip of the cervix using tenaculum forcep Evacuation of the product of conception using manual vacuum aspirator Hysterotomy Swabbing of the endometrium with betadinized sterile os Removal of instruments Perineal care

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APPENDIX B: Glossary Abortion: pregnancy termination prior to 20 weeks age of gestation or with a fetus born weighing less than 500 g Incomplete abortion: The fetus and placenta may remain entirely in utero or may partially extrude to the dilated os. The internal os opens and allow passage of blood. Spontaneous abortion:Termination of pregnancy prior to 20 weeks age of gestation not induced by any means. Manual vacuum aspiration: simple evacuation of the uterus through a cannula attached to a manual vacuum source. Sharp curettage: evacuation of the uterus using sharp curette.

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APPENDIX C: PATIENT INFORMATION AND CONSENT FORM (English Version) Patient information and Informed Consent Form Research Title: MANUAL VACCUM ASPIRATION (MVA) VS SHARP CURETTAGE IN THE MANAGEMENT OF INCOMPLETE ABORTION IN BAGUIO GENERAL HOSPITAL AND MEDICAL CENTER Investigator: Dr. Elvira T. Lampacan Department of Obstetrics and Gynecology

Purpose and conduct of the Study Good day. I am Dr. Lampacan and I would like to invite you to take part in a research study. The study aims to compare manual vacuum aspiration and sharp curettage in the management of early first trimester abortion among patients who are seen at the emergency room of the Department of Obstetrics at Baguio General Hospital and Medical Center. If you are eligible for the study, you will be among the 100 patients who will voluntarily participate in the study. Upon entry to the study, you will be interviewed and you will undergo physical examination. Pelvic ultrasound will be done to confirm the diagnosis. Baseline hemoglobin and hematocrit will also be taken which are usually done in patient seen with such case. Contact Person If you have any questions, concerns or complaints about the research, you can ask me personally or you can contact me at this number: 09324584700. I am also available at the Department of Obstetrics and Gynecology, BGHMC. I will be glad to answer any of your questions. Voluntariness of participation Your taking part in this study is your choice. There will be no penalty if you decide not to be part in the study. You doctor/investigator can withdraw you from the study as she sees fit for safety reasons. Confidentiality All data collected during the study will be kept confidential. Your identity will be known only to the investigator/doctor who conducted the examination. The corresponding Ethics Committee involved would have access to your medical records to check if all procedures have been followed. Your name will never be used in any publication or presentation of this study. 12

APPENDIX C: PATIENT INFORMATION AND CONSENT FORM (Tagalog Version) Pahintulot ng Pasyente Research Title: MANUAL VACCUM ASPIRATION (MVA) VS SHARP CURETTAGE IN THE MANAGEMENT OF INCOMPLETE ABORTION IN BAGUIO GENERAL HOSPITAL AND MEDICAL CENTER Investigator: Dr. Elvira T. Lampacan Department of Obstetrics and Gynecology Purpose and conduct of the study Magandang araw po. Ako si Dr. Lampacan at nais kitang imbitahan na lumahok sa isang pananaliksik. Ang pananaliksik na ito ay naglalayong ikumpara kung gaano kaepektibo ang Manual Vacuum Aspiration sa Sharp curettage sa pagtanggal ng mga naiwang bahagi ng placenta kapag nakanun ang isang buntis.Ang mga kalahok ditto ay lahat ng nakunan na buntis na nakita sa emergency room ng OB-BGHMC Ikaw ay isa sa mga 100 pasyente na boluntaryong lalahok sa pananaliksik na ito. Sa pagpasok sa pananaliksik, ikaw ay susuriin ng doktor. Ang mga kalahok ay ipapa-ultrasound at kukuhanan din ng dugo para sa hemoglobin at hematocrit na karaniwang ginagawa kapag na-aadmit ang isang pasyente na may ganitong kaso. Contact person Kung mayroon kayong katanungan o reklamo patungkol sa pananaliksisk na ito, maaari niyo akong tanungin o tawagan sa numero: 09287521104. Maaari din ninyo akong puntahan sa Department of Obstetrics and Gynecology BGHMC. Ako po ay nagagalak na sagutin kung anuman ang inyong katanungan. Voluntariness of participation Ang iyong pagsali sa pananaliksik na ito ay sarili mong desisyon. Maaari kang tanggalin ng doktor sa pagsusuri kung ito ay makabubuti sa iyo. Confidentiality Lahat ng impormasyon mula sa pananaliksik na ito ay hindi malalaman ng ibang tao maliban sa Ethics Committee na maaaring tumingin sa iyong records upang malaman kung nasunod ang tamang proseso ng pagsusuri. Ang iyong pangalan ay hindi gagamitin sa anumang papel o presentasyon ng pananaliksik na ito.

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APPENDIX C: CONSENT FORM I have read the information in this form as explained to me by _________________________ and I understand everything that would be done during the course of the study. I have asked questions about the procedure and any questions that I asked have been answered in full. I have been informed that my participation is voluntary and I can withdraw my consent anytime for whatever reasons. I agree to participate in this study and do whatever is written in this paper.

Nabasa ko ang impormasyon na inilahad sa akin at ipinaliwanag sa akin ni __________________________ at naintindihan ko lahat ng maaaring mangyari sa kabuuan ng pananaliksik na ito. Nagtanong ako tungkol sa proseso at nasagot ang aking mga katanungan. Naipaliwanag sa akin na ang aking paglahok ay boluntaryo at maaari kong bawiin and aking pahintulot anumang oras sa anumang dahilan. Ako ay sumasang-ayon na lumahok sa pagsusuring ito at gawin kung ano ang nakasulat sa papel na ito.

Patient signature:

____________________________ Name of Patient

______________________ Signature

_______/_____/_____ Date

Witness or legal guardians signature:

___________________________ ___________________________ ______/_____/______ Name of witness or legal guardian Physicians signature I, the undersigned, certify to the best of my knowledge, that the patient signing this consent form has read the above information sheet fully, that this has been carefully explained to her and that she clearly understands the nature, risks and benefits of her participation in this study. Signature Date

____________________________

________________________ _____/_____/_____ 14

Name of physician APPENDIX D: CASE REPORT FORM Case Number: Name:

Address; OB Score: LMP: AOG:

Signature

Date

Age:
CP #: Admission date: Discharge date:

Procedure

MVA

Sharp curettage Yes: No:

Retained product of Yes: conception No:

Infection(If w/ Fever)

Yes: No:

Yes: No: Yes: No:

Perforation

Yes: No:

Baseline Hemoglobin(g/dl) Baseline Hematocrit(%) Duration of Operation (minutes) Length of stay(hours) Hospital

Blood Loss(ml)

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