Clinical experience with the GYNE-T 380 postpartum intrauterine device.

OBJECTIVE: The insertion of conventional intrauterine devices (IUDs) during the 1st 10 days after delivery is associated with a high rate of expulsions. DESIGN: The GYNE-T 380 (Ortho Pharmaceutical [Canada] Ltd., Toronto, Ontario, Canada) IUD was modified by the addition of a loose loop of knotted biodegradable no. 2 catgut to the top of the IUD (GYNE-T 380 postpartum IUD). After delivery, a special inserter was used to imbed the knotted portion of the loop into the myometrium of the uterine fundus. PATIENTS, PARTICIPANTS: This modified IUD was evaluated in a phase II trial involving 190 women at four clinical sites. MAIN OUTCOME MEASURES: There were no pregnancies during the 1st year of the study. The continuation rate was 74 per 100 women and a life table expulsion rate of 9.6 and 13.3 per 100 women was observed at 6 and 12 months, respectively. RESULTS: Complications associated with the insertion and the use of this IUD were minimal. Large scale trials evaluating this IUD are in progress.

PIP: The insertion of conventional IUDs during the 1st 10 days after delivery is associated with a high rate of expulsions. The Gyne T 380 (Ortho Pharmaceutical, Canada Ltd., Toronto, Ontario, Canada) IUD was modified by the addition of a loose loop of knotted biodegradable no.2 catgut to the top of the IUD (Gyne T 380 postpartum IUD). After delivery, a special inserter was used to imbed the knotted portion of the loop into the myometrium of the of the uterine fundus. This modified IUD was evaluated in a phase II trial involving 190 women at 4 clinical sites; continuation rate was 74/100 women, the life table expulsion rate as 9.6 and 13.3/100 women observed at 6 and 12 months, respectively. There were no pregnancies during the 1st year of study. Complications associated with the insertion and use of this IUD were minimal and largescale trials evaluating this IUD are now in progress.

Hypertrophic cardiomyopathy and pregnancy: a report of three cases.

In this paper three pregnancies in association with hypertrophic cardiomyopathy are reported. Management of pregnancy and delivery are discussed based upon recommendations in literature.

First trimester abortions associated with a translocation t(1;20)(p36;p11).

A large family with a high rate of spontaneous abortions was found also to have a high incidence of a reciprocal translocation.

Estradiol medicated IUDs: release and influence on menstruation pattern.

In a double blind trial of 90 women with three types of IUD (MLCu250; MLCu250 + 0.3 mg estradiol releasing about 1 microgram per day; and MLCu250 + 1.0 mg estradiol releasing about 3 micrograms per day) no difference in intensity or duration of bleeding was found.

Comparison of three multiload IUDs: MLCu250, MLCu375 and MLAgCu250.

A comparative study was made of three differently loaded Multiload intrauterine contraceptive devices. The IUDs were used by 450 women for 3 years unless the device was removed earlier. The reasons for IUD removal (pregnancy, bleeding and/or pain, and other) were recorded, and the data analyzed after 1 year and after 3 years using the log-rank method. No statistically significant differences could be found among the three devices either in rate of pregnancy nor IUD removal for any reason.

The multiload intra-uterine contraceptive device. Comparison of 4 different models.

A study of conducted in the Outpatients' Gynaecological Department of St Elisabeth's of Groote Gasthuis, Haarlem, The Netherlands, to compare the performance of 14 IUCDs, namely the Multiload (ML) Cu 250-standard, the ML Cu 250-short (which has a shortened vertical stem), the ML Cu 250-mini and the ML Cu 375 (which has an increased copper area of 375 mm2). Sound length was the sole method governing insertion: greater than or equal to 7 cm with the ML Cu 250-standard and ML Cu 375, 5-7 cm with the ML Cu 250-short and less than 5 cm with the ML Cu 250-mini. All the ML Cu 250-minis and 10% of the ML Cu 250-shorts were inserted in nulliparous women. Data were recorded and evaluated over a period of 36 months according to the table method Tietze. Performance of the ML Cu 250-standard and the ML Cu 250-short were nearly similar after 3 years of use with a continuation rate of 70,6 and 70,3 and a cumulative pregnancy rate of 1,3 and 1,7 respectively. Results with the ML Cu 250-mini were less successful. The continuation rate after 3 years of use was 60,1 with a cumulative pregnancy rate of 3,1. The expulsion and removal rates because of medical reasons were twice those with the standard model. At 12 months the ML Cu 375 proved to be superior in the prevention of pregnancy compared with the ML Cu 250-standard.

Comparison of four different models of the Multiload copper IUD.

PIP: This study evaluates the standard Multiload model (ML Cu 250) IUD in order to develop more effective and acceptable variants. The experiments consisted of 1) shortening the vertical stem of the standard model (ML Cu 250-short); 2) reducing the size of the skeleton (ML Cu 250-mini); and 3) increasing the copper area of the ML Cu 250 to 375 mm square (ML CU 375). Data used in this multicenter assessment of ML models were derived from different time periods: 1) from November 1, 1974 to December 31, 1977, 2786 women were fitted with a standard ML Cu 250; 2) from February 1, 1977 to February 1, 1980, 813 were fitted with a ML Cu 250-short, and 444 with a ML Cu 250-mini; and 3) from December 1, 1978 to December 1, 1979, 746 women were fitted with a ML Cu 375. Net cumulative event rates at 12-month intervals and up to 3 years of use were calculated by life-table analysis using a computer program. No important differences in performance were observed between the ML Cu 250-standard and ML Cu 250-short during the first year of use. However, the ML Cu 250-mini was associated with a slightly higher pregnancy rate and a removal rate for bleeding/pain twice that of the standard model. The ML Cu 375 had a pregnancy rate of only 0.1 and a low removal rate for the other events. Results for the second and third years of use further confirmed the poor performance of the ML Cu 250-mini: a relatively high cumulative pregnancy rate (3.1 at 3 years), a higher rate for other complications, and a markedly reduced continuation rate. It is concluded that reducing the overall size of the ML Cu 250-standard skeleton results in loss of flexibility, especially the side arms. Because of high pregnancy and complication rates associated with the ML Cu 250-mini, use of this device should be restricted to women having a very small uterus (sound length 5 cm) and should be removed after 1 year.^ieng

The fetal autonomic nervous system, the fetal heart rate and the beat-to-beat irregularity.

In the exteriorized fetal lamb an experimental study on the influence of the fetal autonomic nervous system upon the heart rate pattern is described by means of blockage of the cholinergic, alpha-adrenergic and beta-adrenergic system. The alpha-adrenergic system proved to have no effect upon heart rate. The beta-adrenergic system had a positive chronotropic effect and the parasympathetic system had a negative chronotropic effect. Beat-to-beat irregularity was independent of a functional alpha-adrenergic system, but at a high basic heart rate disappeared completely after cholinergic blockage and at a low rate after beta-adrenergic blockage. It is concluded that most probably the beat-to-beat irregularity is the result of the competition of the enhancing influence of the beta-adrenergic system and the inhibiting influence of the cholinergic system on fetal heart rate.