Abstract of research proposal with study protocol
Title
A randomized controlled trial on the use of intra-cervical misoprostol
for termination of missed abortion versus vaginal misoprostol
Aim of the study
To compare the efficacy of misoprostol given intra-cervical versus
vaginal for termination of missed abortion
Background
It has been approved that misoprostol alone is effective for medical
abortion (1). The PGE1 analogue; misoprostol can be administered
by various routes with minimal side effects and high efficacy(2).
Several studies have been conducted to establish the best route with
regards to dose, interval and efficacy. Giving misoprostol transcervical through catheter has been shown effective in termination of
second trimester pregnancy with out increasing maternal risk (3) and
when compared with PGE2 for induction of labor at term, intracervical misoprostol (of same vaginal dose 50 microgram) was more
effective with out increased adverse intra-partum or neonatal
outcomes(4).
In addition utilization of misoprostol intra-vaginal or intra-cervical
with Foley catheter for pre-induction cervical ripening in third
trimester was comparable with regards to efficacy and safety on the
mother and fetus as well (5).
This study is designed to establish effectiveness of intra-cervical
misoprostol through Foley catheter for termination of missed
abortion.
REFERENCES
1-BLOHM F: RCT COMPARING MISOPROSTOL OR PLACEBO
IN THE ANAGEMNT OF EARLY MISSCARRIAGE.BJOG 2005
112(*):1090-5
2-KULIEER R: MEDICAL METHODS FOR FIRST TRIMESTER
ABORTION .COCHRANE DATABASE SYSTEMIC REVIEW
2004;2:CD002855
3-GHORAB M:SECOND TRIMESTER TERMINATION OF
PREGNANCY BY EXTRA-AMNIOTIC PGF2 ALPHA OR
ENDOCERVICAL MISOPROSTOL; A COMPARATIVE
STUDY;ACTA OBSTETRIC ET GYNECOLOGICA SCAND.1998
;77($):429-432
4-CHANG Y: INTRACERVICAL MISOPROSTOL AND PGE2
FOR LABOR INDUCTION ;INT J OBSTET GYNE 80(2003) 23-28
5-JUDITH H: APROSPECTIVE RCT THAT COMPAREE
MISOPROSTOL FOLEY CATHETER AND COMINATION OF
MISOPROSTOL-FOLEY CATHETER FOR LABOR
INDUCTION; AM J OBST GYNE ;189(4) 2003;1031-35
Method
-in hospital Patients with confirmed diagnosis of missed abortion in
the first trimester will be assigned randomly by computer generated
numbers to either vaginal misoprostol or intra-cervical misoprostol.
-Patients with significant bleeding and/or pain, with bronchial
asthma, with coagulation defect or with fever (38 or more) will be
excluded.
-diagnostic measures for both groups will be done (as routine in usual
cases of missed abortion)
- primary out come: observation for bleeding and expulsion of POC
-follow up ultrasound to confirm evacuation complete
-out patient follow up as routine
-Secondary out comes: infection- bleeding –need for surgical
interventions
Material
Misoprostol 800microgram
Expected result
-Intra-cervical misoprostol might be effective as vaginal misoprostol
for termination of missed abortion with shorter duration and no
increased risk.
Work plan
-research proposal
-Approval of hospital ethical committee
-distribute the study protocol to members participating in the study
-orientation of resident, registrar and nurses about the study
-recruitment of patients including obtaining informed consent
(written or verbal)
-randomization and management accordingly
-data collection and analysis using SPSS-16
-updating the literature to write the manuscript for publication