ONGOING STUDIES

I. “MULTICENTRIC PHASE-III CLINICAL

TRIAL WITH SUBDERMAL SINGLE-ROD
CONTRACEPTIVE IMPLANT – IMPLANON.”
(starting date 09.11.04. Ending date 04.05.05.)
TOTAL NO. OF CASES ENROLLED :110
NO. OF CASES ENROLLED :110
NO. OF CASES DISCONTINUED : 08
NO. OF CASES REMOVED : 102
NO. OF CASES WITH SEVERELY MIGRATED IMPLANTS
: 02
NO. OF CASES WHO ARE LOST TO FOLLOW UP (MIGRATED
TO OTHER STATES) : 02

RETURN OF FERTILITY OF 102 REMOVED CASES

1.Pregnancy occurred till date

(including method failure cases) : 20
2.Baby born till date : 02
3.MTP / Spont. Abortion : 12
4.Continuing Pregnancy : 06
5.Interval of conception since removal: All cases Within 1 yr,
majority ( 16 cases i.e. 80% )within 6 months.
DISCONTINUATIONS – DETAILS:
Sl.N. Subject Date of Date of Reason of Discontinuation Difficulty in
No. Insertion Removal removal if
any
1 04 19.11.04. 16.03.05. Jaundice. No

2 70 18.01.05. 26.07.05. Prolonged bleeding and Migration,

spotting. fibrosis &
rod broken.
3 37 29.12.04. 10.08.05. Removed outside – husband’s No
objection due to prolonged
bleeding.
4 25 21.12.04. 03.09.05. Prolonged bleeding. No
 5 05 08.12.04. 07.09.05. Husband’s objection due to No
prolonged bleeding.
6 19 20.12.04. 17.02.06. She wanted to conceive. No
conceived after 1yr.
LMP 08.10.07. EDD 15.07.08.
Delivered safely a normal baby.
7 13 23.12.04. 02.11.06. Separated from husband No

8 107 19.04.05. 25.11.06. Husband’s death No

Salient physiological changes seen in Implanon users:

I. Change of weight in 110 enrolled cases at the end of the study:

Weight (Kg.) Increased Decreased Unchanged
<2 15 (9.09%) 04(8.18%)
2–5 37 (49.09%) 09(10.00%) 10(7.27%)
>5 21 (11.81%) 00
10 & more 14 (4.54%) 00
82 (74.54%) 20 (18.18%) 08 (7.27%)
II. Menstrual changes as reported by 110 clients during follow up visits:
Pattern of change No. %
Amenorrhoea since insertion of 17 12.72
Implanon
Prolonged and Irregular 71 14.60
spotting
Predominantly normal cycle, but 18 3.63
less flow or spotting
Prolonged bleeding 04 (discontinued) 69.10
110 100.00
Complaints encountered during follow ups:
1. Itching at the site of implantation – 05 cases (4.5%).
2. Weakness & vertigo –10 cases (9.1%)
3. Loss of libido – 02 cases (1.8%)
4. Jaundice – 01 case (0.9%)
5. Dimness of vision – 03 cases (2.7%)
6. Acidity – 06 cases

Conclusion:
1. The clients having amenorrhoea for prolonged period are accepting it for proper pre-
insertion & constant counselling, though they felt worried. Incident of prolonged
and/or irregular spotting and/or bleeding decreased after 2nd. Yr. of use.
Few clients experienced regular cycle but bleeding pattern was changed
(spotting or less flow), i.e., in none of the clients pre-insertion bleeding pattern exists.
2. Unusual weight gain, loss of libido, jaundice & dimness of vision seen as side effects
 are to be studied, though the clients with dimness of vision were referred to the Dept.
of Ophthalmology & the Ophthalmologists opined that it was not related with the
method.
3. After 3 yrs, 42 clients wanted to continue the method for another 1or 2yr & signed
consent forms.
Implanon was removed in 102 cases after completion of 3 - 4yrs. Of the 8
continued cases till date, 2 cases are with severely migrated implants and after MRI, as
per advice of ICMR HQ, we have located the sites & consulted surgeons &
Orthopaedicians & planned to remove the implants as early as possible.

II. LOW DOSE VERSUS STANDARD DOSE MAGNESIUM SULPHATE

REGIMEN FOR MANAGEMENT OF ECLAMPSIA –
A RANDOMIZED CONTROLLED TRIAL.
Enrollment started on: 11.08.07.
Enrollment stopped from 02.09.07. to 23.11.07.
(problems in round –the-clock blood collection)
Enrollment started again on: 24.11.07.
( after local arrangement of a blood-collector)
Enrollment completed on 25.12.08.
Total No. of patients screened: 373
Total No. of patients enrolled : 140
Total No. of Cases Not Enrolled - 233
REASONS FOR NON-ENROLMENT
REASRONSReasons NO. %
1. ELIGIBLE BUT NOT 62 26.6
WILLING
2.NOT 171 73.4
ELIGIBLE/OTHER
CAUSES
TOTAL 233 100

REASONS FOR NON-ELIGIBLITY

REASONS NO %
1. DIAGNOSIS UNCERTAIN 22 12.9
2.GOT STD, LOADING DOSE 35 20.5
FROM OUTSIDE
3. REFUSAL by ON-DUTY 18 10.5
DOCTORS
4. H/O EPILEPSY 02 01.2
5. BLOOD COLLECTOR NOT 53 31.0
AVAILABLE
6. Pt. PARTY NOT 27 15.8
AVAILABLE FOR CONSENT
7. L.R. DOCTOR’S MISTAKE 11 06.4
TO GIVE SCHEDULE DOSE.
8. CONVULSIONS STARTED 03 01.7
> 72 Hrs. AFTER DELIVERY
TOTAL 171 100

OUTCOME
OUTCOME LD(N=71) SD(N=69) TOTAL(N=140)
NO % NO % NO %
A. RECC. 09 12.7 02 02.9 11 07.9
CONVULSION
B. MATERNAL DEATH 02 02.8 03 04.3 05 03.6

C. PERINATAL DEATH 06 08.4 09 13.0 15 10.7

i) Still birth 04 05.6 03 04.3 07 05.0

ii) Death within 7d. 02 02.8 06 08.6 08 05.7

D. CHANGE OF REGIMEN 02 02.8 00 00 02 01.4

(by on-duty Doctor)
• Recurrent Convulsion were more in LD gr (12.7% vs. 2.9%).
• Maternal death were more in SD gr. (4.3% vs. 2.8%)
• Perinatal death were more in SD gr (13.0% vs.8.4%).

III. Task Force Study “Prevalence of Infertility in India” - We have

received the necessary orders for the field work from the respective district authorities
(24PGSN & Hooghly) after several discussions & meetings at different levels.
The randomly selected sites are as follows:

A. 24 PGS(N) (24-parganas, north): [C.M.O.H. - Dr. Prabas Chowdhury]

a. P.H.C.(Rural)
i) Baduria(RUDRAPUR)Block PHC.
ii)Chhoto Jagulia Block PHC
b. Towns (Urban)
i) Bangaon ii)Panihati
iii)Taki iv)Bidhan Nagar (Salt Lake) v) Madhyamgram.
B. HOOGHLY: [CMOH – Dr. Bhushan Chakraborty]
a. P.H.C.(Rural)
i) Goghat-II (Kamarpukur) Block PHC
ii) Dhaniakhali Block PHC
 b. Towns (Urban)
i) Uttarpara-Kotrang ii) Banshberia
iii) Baidyabati iv) Chandan Nagar v) Rishra
We were suggested by the district authorities to start the field work after declaration of
Election result. We are about to start the field survey.

IV. “ A Simple Behavioural Intervention to Reduce Episiotomy Rates” (ICMR

Task Force Study) – Period - From 20.04.09. to 19.05.09. (1 month)

SALIENT FEATURES ( as recorded in R.G.K.M.C.& H.):

Total Mothers Enrolled 1226

Total VD 796 (64.9%)
Primi with Epi 360 (45.2%)
Primi without Epi 116 (14.6%)
Para>= 2 with Epi 85 (10.7%)
Para >=2 without Epi 235 (29.5%)
LUCS (including 2 PMCS) 430 (35.1%)
Episiotomy is done more (45.2% vs. 10.7%)in primi than in multi cases.

% of Perineal Tear in Epi Vs. Non-Epi cases

Perineal tear with Epi (Total VD with Epi: 445):
1st.degree 03 (0.7%)
2nd. Degree 02 (0.4%)
CPT 02 (0.4%)
Vulval Hematoma 01 (0.2%)
Extension 01 (0.2%)

Perineal tear without Epi (total VD without Epi: 351):

1st.degree 116 (33.0%)
2nd. Degree 044 (12.5%)
CPT 02 (0.6%)
Paraurethral tear 02 (0.6%)
Cervical tear 01 (0.3%)
Vulval Hematoma 00 (00%)
Extension 00 (00%)
In VD, 1st. degree perineal tear occurs in majority of cases, specially in
without Epi cases.
V. ‘Childhood Morbidity & Mortality.’ -

It is in preparatory phase.

Co-investigators selected & informed in the meetings, about the study, as per ICMR
HQ instruction -
HOD-Dept. of Paed. Med, R.G.K.M.C. & H. & CMOH, Dist. Of 24 PGS(N).

Necessary orders have been received from the District authority to work in the
District Hospital.

We are going to start the study very soon.

VI. Determination of Wastage Factor for vaccines during routine

immunization under the Universal Immunization Programme (UIP)
– a Multicentre Task Force study. –
We have received the necessary orders for the field work from the respective district
authorities (24PGSN & Hooghly) after several discussions & meetings at different
levels.

We have received the cheque of Rs. 45,000/- , as grant for the study, just few
days ago.

We were suggested by the district authorities to start the field work after declaration
of Election result. We are about to start the field survey.
 COMPLETED STUDIES

I. Study on Management & outcome of Eclampsia (Base line information)

study period: Feb.06. to July 07.

Month Total Total Total Primi Ante- Intra- Post- Maternal Perinatal
(year) deli- primi eclamp with partum partum partum mortality mortality
06-07 Very cases eclamp Eclamp. Eclamp. Eclamp. In With
eclampsia Eclamp.
(SB +
Deaths
within 7
days of
birth)
Feb. 0843 0468 15 10 10 02 03 00 5+1 = 6
Mar. 0847 0460 13 07 10 00 03 00 0+2 = 2
April 1042 0561 22 17 14 00 08 00 1+3 = 4
May 1268 0654 19 14 13 01 05 01 3+2 = 5
June 1146 0606 14 11 07 00 07 00 2+0 = 2
July 1304 0657 23 13 15 00 08 02 4+1 = 5
Aug. 1631 0821 34 27 28 01 05 01 2+2 = 4
Sep. 1572 0828 33 25 27 01 05 00 2+1 = 3
Oct. 1303 0668 39 31 31 00 08 02 5+3 = 8
Nov. 1304 0720 30 23 22 00 08 01 3+2 = 5
Dec. 1161 0615 38 30 33 00 05 02 3+1 = 4
Jan. 0896 0452 28 19 22 01 05 03 0+0 = 0
Feb. 0604 0325 13 10 12 00 01 01 0+0 = 0
March 0358 0196 07 05 07 00 00 01 1+0 = 1
April 0547 0348 10 09 08 00 02 01 1+2 = 3
May 1302 0715 21 15 13 01 07 01 1+1 = 2
June 1084 0573 16 11 14 00 02 00 0+1 = 1
July 1188 0604 22 17 15 00 07 02 2+0 = 2
Total 19,400 10, 397 294 301 07 89 18 35+22
271 =57
* i) Inj. Pethidine ii) Labetelol ** i) Inj. Largactil & Phenergan ii) Inj. Pethidine &
Inj. Phenergan
*** i) Inj. Pethidine & Phenergan ii) Amlodipine
# Inj. Pethidine & Phenergan ## Inj. Pethidine & Diazepam (from outside) in both
the cases.
### Inj. Pethidine & Phenergan in one case & Inj. Diazepam in another case
All these cases were referred from other hospitals and got drugs other than Mag. Sulf. before referal.

I. DATA BASE ON OBSTETRICAL FISTULAE

( ref. No. – Misc/5/7/1/2000-RHN 10th. October, 2006.)

It was informed that there were only 8 cases of obstetric fistulas operated in our
institution during last 1 year, of which VVF – 06, UVF – 01, & RVF – 01.

It was also informed that, data recording system in this regard , as far as the details are
concerned, is not satisfactory and we can keep detailed prospective records if you so
desire.

APPROVED STUDIES

I. “ Comparative acceptability of male condom and FC 2 Female Condom in young

Indian couples seeking contraceptive options” –

Got the Ethical Clearance of the local Ethical Committee.

Received a cheque of Rs. 34,000/- only, as grant, on 22.05.09.
Awareness programme is going on.
Waiting for the final instruction from ICMR HQ to initiate the study.

II. “ Phase IV Multicentric Study with Centchroman” initiated by ICMR. –

Got the Ethical Clearance of the local Ethical Committee.

Awareness programme is going on.
Waiting for the fund and instruction from ICMR HQ to initiate the study & to recruit the
sanctioned staff for this project .

III. A Task-Force, multicentre study entitled

“ A study on teen age pregnancy and its outcome” – local Ethical
Clearance till not received ( Opinions from the Dept. of FSM &
Radio-diagnosis wanted by the Local Committee for determination of age. Informations
regarding the dispute sent to ICMR HQ.).

THANK YOU