Download RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE, KARNATAKA
ANNEXURE – II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1
Name of the Candidate and Address Dr. SUJAYASRI SANGITA
(in Block Letters)
D/o PROF. SATYANARAYANA
SANGITA, NAGARBHAVI,
BANGALORE.
KARNATAKA
2
Name of the Institution
J.J.M. MEDICAL COLLEGE
DAVANGERE– 577 004.
KARNATAKA.
3
Course of Study and Subject
MEDICAL
M.S. IN OBSTETRICS AND
GYNAECOLOGY
4
Date of Admission to Course
5
Title of the Topic
07.06.2008
“COMPARITIVE STUDY OF THE
EFFECT OF VAGINAL pH ON THE
EFFICACY OF VAGINAL
MISOPROSTOL FOR INDUCTION OF
MID TRIMESTER ABORTION”
6
Brief resume of the intended work:
6.1 Need for the study:
Termination of pregnancy in the second trimester may be indicated due to
maternal or foetal conditions.
Misoprostol is widely used for cervical priming, medical abortion and
induction of labour. Vaginal abortion by misoprostol is inconsistent and it is not
uncommon to identify particulate remnants of tablets in the vagina, indicating
that dissolution and absorption are variable and incomplete.
Misoprostol tablets are known to liquefy better in acidic medium. Compared
with the misoprostol tablets moistened with saline, those moistened with acetic
acid were more effective in the termination of pregnancy. Some studies reveal
that vaginal pH of the patient influences the efficacy of vaginally administered
misoprostol, which extends beyond the pharmokinetics of the drug.
Hence the purpose of the study is to evaluate the influence of vaginal pH on
the efficacy and side effects of misoprostol for induction of mid trimester
abortion.
6.2 Review of Literature
Karim H.I. et al (2008): According to this study, 110 women with
gestational age 14-26 weeks with missed abortion were selected. Based on
vaginal pH, two groups were generated ‘low pH’ with pH <5 and ‘high pH’ with
pH ≥ 5 and received 200µg misoprostol tablets moistened with 3ml of 5% acetic
acid every 4 hours for maximum of 5 doses within 24 hours. The mean induction
– abortion interval was significantly shorter in low pH group than high pH group
and abortion rate at 24 hours being 100% and 63.8% respectively. This study
concluded that vaginal pH influences efficacy of vaginal misoprostol beyond
affecting the pharmacokinetic of the drug.1
Yilmaz B et al (2005): In this study 66 patients seeking mid trimester
termination of pregnancy were assigned two groups, one received misoprostol
moistened with 3ml of5% acetic acid and the other, saline. Median inductionabortion interval was significantly shorter in the first group. Hence it was
concluded that misoprostol moistened with acetic acid was more effective than
misoprostol moistened with saline.2
Gunalp S et al (2000): According to this study 103 women admitted for
induction of labour were divided into two groups based on vaginal pH, < 5 and ≥
5 respectively. All of them received intravaginal misoprostol tablets, 50µg every
4 hours upto 3 doses and in cases of failed induction, oxytocin augmentation was
used. Induction-abortion interval was shorted and oxytocin augmentation was
required less commonly in lower pH group. Hence it was concluded that vaginal
pH may affect the pharmacokinetics of vaginally administered misoprostol.3
Ramsey P.S. et al (2000): In this study 37 women seeking labour induction
were assigned into two groups based on the vaginal pH, pH ≤ 4.5 and pH > 4.5.
All the women received 50 µg misoprostol intravaginally every 6 hours for 12
hours. Patients not in active labour at 12 hours were placed on standardized
oxytoxin regimens. No significant difference was observed in induction-delivery
interval, time of complete dilatation and time to deliver. Hence study concluded
that vaginal pH does not appear influence efficacy of intravaginally administered
misoprostol for cervical priming and labour induction.4
Chandra S. et al (2005): In this study 120 women for labour induction were
divided into lower pH group (< 5) and higher pH group (≥ 5) . All of them were
induced with 25 µg of vaginal misoprostol placed every 6 hours until active
labour was established. No significant difference observed in the induction
delivery interval. This study concluded that pH of the vagina may not affect the
delivery interval.5
6.3 Objectives of the study:
(1) To evaluate the effect of the vaginal pH on the efficacy of misoprostol for
induction of mid trimester abortion.
7.
MATERIALS AND METHODS
7.1 Source of data
The main source of data for this study are the patients from teaching
Hospitals attached to J.J.M. Medical College namely

Bapuji Hospital, Davangere

Chigateri General Hospital, Davangere

Women and Children Hospital, Davangere
7.2 Method of collection of data (including sample procedure if any)
Patients with gestational age 14-20 weeks seeking termination of pregnancy
are included in this study.
Inclusion Criteria:
Singleton pregnancy at 14-20 gestational weeks (relying on date of last
menstrual period or prior ultrasonography) with following maternal indications like

Missed abortion,

Cardiac disease,

Hypertensive vascular disease,

Autoimmune disease,

Psychiatric disease and

Foetal indications like anomalous foetus
Exclusion Criteria:

Presence of uterine contractions.

Multiple gestation

Underlying medical condition like cardiac disease, diabetes mellitus, asthma.

Cervical Incompetence

Contraindication to medical abortion- scarred uterus due to previous uterine
perforation or surgery.

Pregnancy with cervical fibroid

Presence of disseminated intravascular coagulopathy

Known maternal allergy to prostaglandins or previous adverse reaction.
Procedure of the study:
Patients were assigned into two groups by measuring the vaginal pH: (A)
those with pH < 5 (B) those with pH  5.Following digital examination,200µg
misoprotol tablet moistened with 3 ml. of 5% acetic acid (pH2) was inserted in the
posterior vaginal fornix at 4 hrs. Intervals for a maximum of 5 doses within 24 hrs. If
the patient did not have adequate contractions within 8 hrs. Following the 5th dose,
same regimen was repeated over the following 24 hrs. The study was considered
completed, if the participant aborted within 48 hrs. If no response was achieved, this
was considered failure of therapy and alternative interventions are carried out on the
basis of the judgment of the clinicians.
7.3 Does the study require any investigations or interventions to be conducted
on patients or other humans or animals? If so describe briefly.
Yes

Blood: Hb%, Blood grouping and Rh typing

Urine: Sugar, Albumin, Microscopy

HIV, HBsAg

Obstetric Scan
The study involves only humans
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
Yes
8.
LIST OF REFERENCE
1) Karim HI. Abd-El_Maeboud, Abbas A.S.Ghazy et al. Effect of vaginal pH on the
efficacy of vaginal misoprostol for induction of mid trimester abortion. J Obstet
Gynaecol 2008; 34: 78-84.
2) Yilmaz B, Kelekci S, Ertaas IE. Misoprosol moistened with acetic acid or saline
for second trimester pregnancy termination: a randomized prospective doubleblind trial. Hum Reprod 2005; 20: 3067-3071
3) Gunalp S, Bildirici I. The effect of vaginal pH on the efficacy of vaginal
misoprostol for induction of labor. Acta Obstet Gynecol Scand 2000; 79: 283285.
4) Ramsey PS, Ogburn PL Jr, Harris DY, Heise RH, Ramin KD. Effect of vaginal
pH on efficacy of misoprostol for cervical ripening and labor induction. Am J
Obstet Gynecol 2000; 182: 1616-1619.
5) Chandra S, Allen V,Lee W. et al. The effect of vaginal pH on labour induction
with vaginal misoprostol. J Matern Foetal Neonatal Med 2005; 17:387-391.
9.
Signature of the Candidate
10. Remarks of the Guide
11. Name & Designation of (in Block
letters)
11.1 Guide
Dr. MALLIKARJUNAPPA MD, DGO
PROFESSOR
DEPARTMENT OF OBSTETRICS &
GYNAECOLOGY,
J.J.M. MEDICAL COLLEGE,
DAVANGERE – 577 004.
12
11.2
Signature
11.3
Co-Guide (If any)
11.4
Signature
11.5
Head of the Department
11.6 Signature
12.1 Remarks of the Chairman & the
Principal
12.2 Signature
Dr. B.R. DAKSHAYINI MD, DGO.
PROFESSOR & HOD,
DEPARTMENT OF OBSTETRICS &
GYNAECOLOGY,
J.J.M. MEDICAL COLLEGE,
DAVANGERE – 577 004.