Manual Vacuum Aspiration for First Trimester Pregnancy Loss

Manual Vacuum Aspiration for First Trimester Pregnancy Loss Dr. Sindhoo TO DETERMINE THE EFFICACY OF MANNUAL VACUM ASPIRATION IN MANAGEMENT OF FIRST TRIMESTER PREGNANCY LOSS INTRODUCTION: An estimated 46 million abortions are performed globally each year, with one-third of all abortions are performed under unsafe conditions leading to 13% of all maternal death1. 10–12% of these abortions are performed in the early first trimester1, 2. Local data shows an annual abortion rate of 29 per 1000 in women aged 15-49 years. Incomplete and missed miscarriage being the commonest occurs in approximately 15 % of clinically recognized pregnancies and in 890,000 women per year3. One study conducted by Shonali Agarwal and Dolly Gupta reported the efficacy of MVA 90% in management of first trimester pregnancy loss5. First trimester of pregnancy ranges between 5–13 weeks and is associated with 3 to 5 times lower maternal mortality and morbidity risks than termination during second trimester4. Although the etiologies of first trimester loss are multi factorial and often remain unknown, certain risk factors increase the likelihood of pregnancy loss. Findings such as absenc e of cardiac activity after 5 wks, gestational sac smaller than expected for dates, an abnormal-appearing yolk, intrauterine hematoma (sub chorionic hemorrhage), vaginal bleeding after 7 weeks of gestation are potential markers for subsequent pregnancy loss4. Once a first trimester pregnancy loss has been diagnosed, there are three forms of management: expectant, medical, or surgical evacuation (with electrical or manual vacuum aspirator). The optimal mode of management is determined by gestational age, whether the pregnancy loss is delayed or incomplete, maternal hemodynamic stability, the presence of infection, and, most importantly, patient preference5. Manual vacuum aspiration (MVA) employs a vacuum pump in which the vacuum is created using a hand-held, hand activated plastic syringe. 4,5,6 Manual vacuum aspiration is safe, effective, easy to use, portable, and reusable. It is appropriate for use in many different clinical settings (Including office, emergency room, or the operating room) thus avoiding the need for the use of an operating theatre and the risks of general anesthesia. It does not require lengthy training for proper operation, and may be performed by a wide range of trained medical personnel including midwives and nurses. When conducted in the outpatient setting rather than operating room, manual vacuum uterine aspiration can result in substantial cost savings, electrical power saving and significant reduction in procedure time (3.7 minutes for MVA vs. 10.2 minutes for DC).The World Health Organization (WHO) recommends MVA as a preferred method of uterine evacuation2,7. RATIONALE: On robust literature search there was scant relatively old data available on efficacy of MVA but no one focused on efficacy of manual vacuum aspiration in management of first trimester pregnancy loss. This provide me the strong rationale to conduct this study, the aim of my study is to set a baseline data which will help to generate the current local statistics of MVA in terms of efficacy on this particular group of women with loss of pregnancy. If we found the significant efficacy of MVA then we will recommend MVA as first line of treatment in future in management of first trimester pregnancy loss. OBJECTIVES: The aim of our study is to determine the efficacy of Manual vacuum aspiration in management of first trimester pregnancy loss. OPERATIONAL DEFINITION: FIRST TRIMESTER PREGNANCY LOSS: An abortion is the spontaneous or induced loss of an early pregnancy. Miscarriage occurs within 12 weeks of gestation will be confirmed on ultrasound. EFFICACY: If an empty uterus with no evidence of retained products of conception seen within 24 hours on Ultrasound will be label as efficacy positive. MATERIAL AND METHODS: SETTING: Liaquat university hospital Jamshoro /Hyderabad DURATION: Six months after approval of synopsis. STUDY DESIGN: Case series study. SAMPLE SIZE: By using WHO sample size calculator taken efficacy of MVA i.e P=90% (5) margin of error (d) = 5.5% confidant interval 95% then the estimated sample size will be at least n=115. SAMPLING TECHNIQUE: Non-probability consecutive sampling INCLUSION CRITERIA: All women with gestational age of ≠¤ 12 weeks confirm from last menstrual period with pregnancy loss (as mention in operational definition) Age 18-35 years Women with any parity Exclusion Criteria: Women who are hemodynamically unstable (systolic B.P Ectopic pregnancy assess on ultrasound Known systemic disease including hepatic or renal dysfunction. Had a history of cervical surgery. DATA COLLECTION PROCEDURE: All patients fulfilling inclusion criteria and not having any of exclusion criteria attending Outpatient department/emergency department of Liaquat university hospital Jamshoro after evaluation by consultant will be included in the study. Informed consent will be taken from each patient about procedure and this study. Approval of the ethical committee will be sought. Patients will undergo elective abortion. All operations will be performed by fourth year residents under supervision of consultant having more than 5 years of post-fellowship experience. Intravenous anesthesia will be used in all the cases. Manual vacuum aspiration will be performed under par cervical block with 10-20 ml of 1% lignocaine using Glick technique3. MVA will be performed using a flexible Ipas Easy Grip cannula attached to a 60 ml syringe (aspirator), with a double locking valve mechanism. To assess the efficacy(as mentioned in operational definition) of MVA. Patients will be fallowed till 24 hours. Demographi c variables of name, gestational age, and parity will be noted. The final outcome in terms of efficacy will be noted after 24 hours will be recorded on approved Performa. DATA ANALYSIS PROCEDURE: Statistical analysis will be performed using statistical software SPSS version 16 on computer. Mean  ± standard deviation will be calculated for age gestational age and parity. Frequency and percentage will be calculated for efficacy. Effects modifier will be controlled through stratification of age gestational age and parity to see the association with outcome i.e (efficacy) by applying Chi-square test taking P≠¤0.05 will be considered statically significant. REFERENCES Wen J, Cai QY, Deng F, Li YP. Manual versus electric vacuum aspiration for first-trimester abortion: a systematic review. BJOG. 2008 Jan;115(1):5-13.Review. PubMed PMID:18053098. Yan J, Saravelos SH, Ma N, Ma C, Chen Z-J, Li T-C. Consecutive repeat miscarriages are likely to occur in the same gestational period. Reproductive BioMedicine;2012;24:634-38. Tasnim N, Mahmud G, Fatima S, Sultana M. Manual vacuum aspiration: a safe and cost-effective substitute of electric vacuum aspiration for the surgical management of early pregnancy loss. J Pak Med Assoc. 2011 Feb;61(2):149-53.PubMed PMID: 21375164. Allison JL, Sherwood RS, Schust DJ. Management of first trimester pregnancy loss can be safely moved into the office. Rev Obstet Gynecol. 2011;4(1):5-14.PubMed PMID: 21629493; PubMed Central PMCID: PMC3100102. 5. Agarwal S, Gupta D. Comparison of manual vacuum aspiration (mva) versus traditional suction evacuation in first trimester medical termination of pregnancy. Int J Res Med.2013;2(1);11-14. Farooq F, Javed L, Mumtaz A, Naveed N. Comparison of manual vacuum aspiration,and dilatation and curettage in the treatment of early pregnancy failure. J Ayub Med Coll Abbottabad. 2011 Jul-Sep;23(3):28-31. PubMed PMID: 23272429. Harwood B, Nansel T; National Institute of Child Health and Human Development.Management of Early Pregnancy Failure Trial. Quality of life and acceptability of medical versus surgical management of early pregnancy failure. BJOG. 2008 Mar;115(4):501-8. Doi: 10.1111/j.1471-0528.2007.01632.x. Pubmed PMID: 18271887;pubmed Central PMCID: PMC2424403. PROFORMA TO ASSESS THE EFFICACY OF MANUAL VACUUM ASPIRATION IN MANAGEMENT OF FIRST TRIMESTER PREGNANCY LOSS Date: ________________ Reg No: serial No: ___________________ Name: W/O Age: Gestational age: weeks Parity: EFFICACY: YES NO