Obstetrics and Gynaecology

DRUG REGISTRY OF PREGNANT WOMEN ADMITTED IN THE DEPT OF OBSTETRICS & GYNAECOLOGY OF SETH GSMC & KEM HOSPITAL

Rationale:
As many as 35% of women are reported to be taking at least one drug during pregnancy. It has been estimated that the average pregnant woman ingests 3.8 drugs during the course of her pregnancy. Almost all drugs reach the fetus to a greater or lesser extent despite the placental barrier.
The effects of drugs on the fetus in terms of anomalies, developmental problems behavioural problems & problems of psychosocial adjustment have been studied extensively in the Western population
However, in India there is a paucity of such data. At KEMH it was felt that since it is a well documented fact that pharmacokinetics of drugs differ in different population groups, it is imperative that such data bases are compiled for the Indian population as well. KEMH being a major referral center with a large annual workload it is the appropriate place for such a registry.

Objectives:

Short term-
1. To formulate a database of drugs (over the counter & prescription)
2. To compile statistics and draw inferences on the use of various drugs.

Long term-
1. Formation of guidelines for the better care of pregnant women.

Methodology:
A prospective descriptive study with data collection on structured data sheets maintained in registers. The data was obtained from case papers & admission papers of women who had delivered /aborted within the last 7 days of entry of data. Additional information was obtained from the women themselves.

Proposal sent to ICMR HQRs in Sept. 2002. No grant received.

Salient Findings:
This ongoing study was commenced in October 2001. It was stopped for a short period due to shortage of staff. An interim analysis follows:-
No. of deliveries / abortions in one unit : 1223
No. of women with anomalous fetuses : 35

Analysis was considered in 2 parts
1. Analysis of women with anomalous fetuses/neonates
2. Analysis of women on specific drugs (medication)

1. Women with anomalous fetuses/neonates
a) The maternal age and parity did not have any statistical significance.

b) The abnormal neonates weighed on an average less than and were born earlier than the normal ones.

c) Of 1223 women 35 were found to have anomalous fetuses.

• Proportion of women on specific medication with abnormal fetuses is 7/185 (or 3.8%)

• Proportion of women on routine medication group is 28/1038 (or 2.7%)

• The relative risk was 1.4 with a confidence interval (0623, 317) which means that women on specific medication are 1-4 times as likely to have an anomalous fetus as those on routine medication ( Vits, Cal , iron )

d) The anomalies detected were Cranial (12), GI Tract (5), Limb (6) and others (13).
The commonest anomaly was Hydrocephalus. None of the anomalies detected were known to have an association with medication ingested. None of the anomalies detected were known to have a specific association with the medication ingested

2. Analysis of women on specific drugs (medication)

a) Data was analyzed to study the relationship between specific medication used and the average gestational age and average birth weight. There was no significant difference in gestational age. However, there was a significant difference in neonatal weights.

• We further analysed the effects of the specific diseases on gestational age and birth weight. Weight of the neonates was least in cases of PIH.
• We then went on to study the effect of specific diseases and the drugs used in their treatment.
• Drugs like Aldomet and Depin (PIH) and Atenolol (essential hypertension) were specifically analysed (since about 50% of pregnancies are unplanned and 1 to 6% women have pre-existing hypertension). Also there are reports in literature that Atenolol may cause fetal growth restriction.

In our study Atenolol did not appear to cause growth restriction. It appears that the average birth weight is comparable when only of the drugs (Digoxin, Lasix, Depin & Aldoment) are used in PIH or RHD.

Status:
This study is ongoing and is now confined to women on specific medication only and has been restarted from 1st July 2004.
1st July 2004 - 31st July 2005
Data from 2 units (Dr. Vinita Salvi & Dr. V.S. Raut)
Total No. of Deliveries- 3009
Total No. of Women on medication -133 (4.42%)
Total No. of women with anomalous babies/fetuses- 32 (1.03%)
Total No. of women on specific medication with anomalous babies/fetus - 05 (3.8%)