Obstetrics and Gynaecology

ACCEPTABILITY AND CONTINUATION RATES OF 2 MONTHLY INJECTABLE CONTRACEPTIVE - NET EN. PROTOCOL AMENDMENT-DEXA STUDY

This is an injectable contraceptive containing 200 mg of Norethisterone Enanthate which is given by intramuscular route every two months.

100 subjects were enrolled for a 2 year period starting 5/7/2002. They came to the ICMR-HRRC for their injections. They were regularly followed up regarding general well being, side effects and any other complaints.

Out of 100 subjects enrolled 36 subjects have completed the course of 12 injections. 62 subjects dropped out after 1 -11 injections. 2 subjects are still continuing. Injection Net En was fairly well tolerated by most subjects.

Commonest complaint was menstrual irregularity which manifested as prolonged bleeding/spotting, irregular bleeding, scanty bleeding, and amenorrhoea.

There were a sizeable number of subjects who were lost to follow up. Amongst others who discontinued before 12 injections were completed, the reasons included menstrual irregularity, desire to conceive again, weight gain, skin rash and no need of further contraception.

Follow up of subjects who discontinued is also done, every effort is made to trace these women for a period of 1 year (2 years if she wishes to conceive again), if pregnant follow up is done till outcome of pregnancy.

Till date 14 subjects have conceived, out of which 7 delivered normally (1 of them had a missed abortion earlier after stopping injections), 2 had a spontaneous abortion,2 had a MTP and 1 a missed abortion, 2 are still pregnant.

Another component to the study was added in August"2005 DEXA study" in which the Bone Density of women who were taking injection Net En was evaluated. 13 women underwent this study, the results are being evaluated.