rEsEaRch Proposal COnTENtS

7/28/2019 rEsEaRch Proposal COnTENtS

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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 areabout 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 to60 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


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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.


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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 P1,100.00-

1,536.00.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 ].


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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.


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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.


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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)

MVA(30 patients)

(Appendix D&E)

Sharp Curettage(30 patients)

(Appendix D&E)

Comparison

Result/Conclusions

Recommendations


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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


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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.


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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 Aspirationand Dilatation and Curettage in the Treatment of First Trimester IncompleteAbortion-JRRMMC Experience.Journal of the Perinatology Association of thePhilippines.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.


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APPENDICES

APPENDIX A: OPERATIVE TECHNIQUE

Sharp curettagePatient placed in dorsal lithotomy positionIV Sedation( Nalbuphine 10 mg and Midazolam 5mg)Asepsis/Antisepsis. Sterile drapes placed

Evacuation of urine by straight catheter insertionInternal examination

Placement of posterior vaginal retractorGrasping of the anterior lip of the cervix using tenaculum forcepsFishing out of products of conception using ovum forceps

Initial HysterometryEndometrium scraped using sharp curettage until gritty sensation.

Repeat hysterometry

Swabbing of the endometrium with betadinized sterile osRemoval of instrumentsPerineal care

Manual Vacuum aspiration:30 minutes before the procedure is started, Naproxen 550mg POis given to the patient.

Patient placed in dorsal lithotomy position

Asepsis/Antisepsis. Sterile drapes placedInternal examinationEvacuation of urine by straight catheter insertionPlacement of posterior vaginal retractorGrasping of the anterior lip of the cervix using tenaculum forcep

Evacuation of the product of conception using manual vacuum aspiratorHysterotomy

Swabbing of the endometrium with betadinized sterile osRemoval of instrumentsPerineal 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 gestat ion 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.


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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 GENERALHOSPITAL 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 ngplacenta 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 nalumahok 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 Signature Date

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.

____________________________ ________________________ _____/_____/_____


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Name of physician Signature Date

APPENDIX D: CASE REPORT FORM

Case Number:

Name: Age:Address; CP #:

OB Score: Admission date:

LMP: Discharge date:

AOG:

Procedure MVA Sharp curettage

Retained product of

conception

Yes:

No:

Yes:

No:

Infection(If w/ Fever) Yes:

No:

Yes:

No:

Perforation Yes:

No:

Yes:

No:

Baseline

Hemoglobin(g/dl)

Baseline

Hematocrit(%)

Duration of Operation

(minutes)

Length of Hospital

stay(hours)

Blood Loss(ml)

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rEsEaRch Proposal COnTENtS