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Complication of miscarriage and unsafe abortion are major public health problem that threaten the lives of women around the world particularly in developing countries1,2. Globally, approximately 52 million abortions are carried out each years, world health organization estimated that more than 19 millions of these abortions are unsafe, between one and five of every women of these got severe complications and 68,000 of these women die each year3. Nearly 200 women die each day from unsafe abortion4. Around 13% of maternal death globally is due to abortions, 95% of their occur in developing countries.2,5,6,7. In Pakistan approximately 890,000 women present with miscarriage annually, age 15-49 years8, about 197,000 women treated each years for complications resulting from unsafe abortion9. Deaths are easily preventable by safe, cost effective method of abortion4. Currently available methods include manual vacuum aspiration, sharp uterine curettage, medical evacuation and expectant management5.
Use of sharp uterine curettage is discouraged by WHO10,11. Many studies demonstrated that manual vacuum aspiration is safer, cost effective than sharp curettage for patient and health care system12,13,14,15. Manual vacuum aspiration is useful in low resource setting5,11,16 .Can be effectively use by mid level health service provider such as mid wives17,18. Have lower cost per procedure of manual vacuum aspiration12,13,19,20,21,22. Associated with less discomfort, so acceptable for patients5,22. Easily Perform procedure, can be done without delay so decreased waiting time, associated with less pain, required local anesthesia rather than general anesthesia so no need of operating theater setting and decrease risk regarding general Anesthesia, shorter procedure time and hospital stay, enable women to return home on same day5,11,13,20,23,24,25. Blood loss is statistically found lower with manual vacuum aspiration12,26,27, had fewer transfusion rate than sharp curettage ( 17% vs. 35% )26. Equipment is portable, less expensive, and reusable after appropriate processing26,28. Manual vacuum aspiration has decrease incidence of complication like blood loss, perforation, cervical laceration and retain products of conception23,29.
So manual vacuum aspiration is attractive alternative of conventional surgical curettage as rate of major complication is two to three times high with sharp curettage10. We will have the best chance to minimize abortion related morbidity and mortality by using manual vacuum aspiration22,30. High efficacy of manual vacuum aspiration with success rate between 95-100% has been reported31,32.
Although the technique of manual vacuum aspiration has been used widely in Asian and European countries, its use in Pakistan despite being a low resource country is low, No local data is available to prove its feasibility, safety and efficacy over sharp uterine curettage in our setup.
Hence we will conduct this study with the aim of comparing the safety and efficacy of manual vacuum aspiration over sharp curettage in first trimester abortion that will lower the rate of maternal mortality and morbidity in term of complication of first trimester abortion.
To compare the efficacy. Safety and cost effectiveness of manual vacuum aspiration with sharp uterine curettage in the management of first trimester pregnancy loss.
MANUAL VACUUM ASPIRATION:
Manual vacuum aspiration has been used since 1973 for treatment of elective abortion as well as spontaneous abortions 21, 33. It is 60ml hand held syringe with Flexible cannula to aspirate the product of conception from uterus , thus offering a gentle , safe and effective technology , ideal for use low resource setting11,26,34,35.
SHARP UTERINE CURETAGE:
Dilatation and curettage is referred to a procedure involving a curette and also called sharp curettage; it is a therapeutic gynecological procedure36.uses a sharp instrument to remove tissue from inside the uterus. It is rarely performed type of surgical abortion done on first 12 week (first trimester) of pregnancy37, 38.
FIRST TRIMESTER PREGNANCY:
The first trimester of pregnancy is the first 12 weeks after the first day of last menstrual period.
Manual vacuum aspiration is safe , cost effective method of abortion in comparison of sharp uterine curettage.
MATINAL AND METHODS:
STUDY DESIGN: The present study will be a randomize control clinical trial.
SETTING: The study will be conducted in obstetrics and Gynae unit III at Abbasi shaheed hospital, tertiary care teaching hospital in Karachi.
DURATION OF STUDY: The duration of 6 months stating from approval of synopsis.
SAMPLE SIZE: Total 100 patients, 50 in each group.
SAMPLING TECHNIQUE: Probability, random sampling.
Women of age between 15 - 49 years, Gestational age between 1 - 12 weeks, Haemoglobin level 10 g/dl or above with the diagnosis of an embryonic pregnancy, in complete abortion, missed abortion and septic induce abortion will recruit in this study effect modifiers will be controlled through random allocation. Diagnosis will be made using amalgam of history, physical examination and ultrasonographic scanning.
Patient with uterine anomalies, abnormal coagulation profile, extreme anxiety, know or expected ectopic pregnancy, allergy to xylocain, pelvic infection, arterio venous malformation, use of anticoagulants, medically and haemodynamically unstable, will be excluded from study.
DATA COLLECTION PROCEDURE:
Patients meeting the inclusion criteria will be selected from labour room. Informed consent and detailed history will be obtained, physical and pelvic information will be done. Routine investigation including haemoglobin, urinanalysis, blood group and Rh will be carried out. Patient will be randomly allocated, randomization will be done by opening sealed opaque envelops by staff nurse. Randomization will be unknown to the surgeon. Abdominal pain will be graded on a scale 0 - 3 (0=no pain, 1=mild pain, 2=moderated, 3=severe pain). Preoperative vaginal bleeding will be recorded as scale 0 - 3 (0=No bleeding, 1=minimal spotting, 2=bleeding like menstrual flow, 3=heavy bleeding with clots). Duration of procedure will be measure from paracervical block until the end of curettage. Intra operative blood loss will be measure with graduated cylinder after sieving away the products of conception. Any cervical injury or uterine perforation will be noted, duration of hospital stay recorded.
Data will be analyzed on SPSS version 13. Descriptive statistics will be presented by frequency and percentage for qualitative variable like cervical and uterine injuries.
Chi- square test will be applied to compare the significance of proportion in these variables.
Quantitative variable like age, parity, gravidity, gestation in weeks, haemoglobin, pre and intra operative vaginal bleeding score, duration of procedure, pain score, hospital stay of patient will be analyze by independent t - test, mean standard deviation will be compared for these quantitative variables. P ≤ 0.05 will be considered significant