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Biomedical subjects

T Agoestina

Publications and source records attributed to T Agoestina.

12 recordsLinked to original sources

8-year follow-up in a randomized trial of one vs two transcervical insertions of quinacrine pellets for sterilization in Indonesia.

OBJECTIVE: To evaluate the efficacy of one vs two insertions of quinacrine and the long-term safety of quinacrine sterilization (QS) 8 years after the procedure in Indonesia. METHODS: Between March 1993 and September 1995, a randomized trial was conducted in 6 academic centers in Indonesia. In February 2003, a follow-up study was undertaken in Bandung, one of those centers. This survey required a home visit of each woman. A questionnaire was designed to elicit information regarding current general health status, method failure, pregnancy outcomes and other contraceptive methods now used by women who experienced failures. Among the 70 patients receiving a single insertion of quinacrine pellets, 14.3% had become pregnant. There were no pregnancies among the 30 who received 2 insertions. All the women were found to be in good health. No long-term side effects or complications were identified. CONCLUSION: The two-insertion protocol is unmistakably superior to the single insertion. This study provides further evidence that QS is a safe contraceptive method.

Adult↗

Neonatal vitamin A supplementation: effect on development and growth at 3 y of age.

We reported recently that neonatal supplementation with 52 micromol vitamin A reduced infant mortality by 64%; acute side effects were limited to a 3% excess rate of a bulging fontanelle. The current study was conducted to identify developmental changes at 3 y of age associated with neonatal vitamin A supplementation or a bulging fontanelle. Children who had a bulging fontanelle (n = 91) and 432 children who had normal fontanelles after receiving vitamin A or placebo were evaluated with the Bayley Scales of Infant Development. Mean scores for the mental, psychomotor, and behavioral rating scale (BRS) plus 3 subscales of the BRS were not significantly different for treatment-fontanelle-specific groups. In regression models predicting each score, a bulging fontanelle had a small negative effect in all models; when 1 child who was injured from birth was removed from the analysis the effect of a bulging fontanelle was not significant in any model (P > or = 0.35). Vitamin A supplementation had a small beneficial effect on all developmental scores, which was significant for one of the BRS subscales (orientation-engagement) and also for a second (motor quality) when the outlier child was removed. Compared with children with normal fontanelles in the placebo group, children with a bulging fontanelle in the vitamin A group tended to grow less (-0.5 cm, P = 0.33), whereas those with normal fontanelles in the vitamin A group grew significantly more (0.68 cm, P < 0.05), over the first 3 y of life. This study provides no evidence that neonatal vitamin A supplementation is associated with biologically significant adverse growth or developmental sequelae.

Body Height↗

Impact of neonatal vitamin A supplementation on infant morbidity and mortality.

OBJECTIVE: To determine whether vitamin A supplementation at birth could reduce infant morbidity and mortality. STUDY DESIGN: We conducted a placebo-controlled trial among 2067 Indonesian neonates who received either 52 micromol (50,000 IU) orally administered vitamin A or placebo on the first day of life. Infants were followed up at 1 year to determine the impact of this intervention on infant mortality. A subgroup (n = 470) was also examined at 4 and 6 months of age to examine the impact on morbidity. RESULTS: Vital status was confirmed in 89% of infants in both groups at 1 year. There were 19 deaths in the control group and 7 in the vitamin A group (relative risk = 0.36; 95% confidence interval = 0.16, 0.87). The impact was stronger among boys, infants of normal compared with low birth weight, and those of greater ponderal index. Among infants examined at 4 months of age, the 1-week period prevalence of common morbidities was similar for vitamin A and control infants. However, during this same 4-month period, 73% and 51% more control infants were brought for medical treatment for cough (p = 0.008) and fever (p = 0.063), respectively. CONCLUSIONS: Neonatal vitamin A supplementation may reduce the infant mortality rate and the prevalence of severe respiratory infection among young infants.

Birth Weight↗

Safety of one 52-mumol (50,000 IU) oral dose of vitamin A administered to neonates.

A placebo-controlled trial was carried out among 2067 Indonesian neonates to assess the safety of administering one oral 52-mumol (50,000 IU) dose of vitamin A. Infants were assessed for potential acute side-effects before and throughout 48 hours after the dose. The first 965 infants were examined by cranial ultrasound before and at 24 hours after dosing to rule out intracranial haemorrhage and determine the resistive index (RI) of the anterior cerebral artery using duplex Doppler. Groups were comparable at the baseline. A bulging fontanelle occurred in the control and vitamin A groups, respectively, among 2.7% and 4.6% of the infants at 24 hours, and 2.4% and 4.5% of the infants at 48 hours. The groups did not differ in any other sign or symptom assessed. No infant developed intracranial haemorrhage. Mean RI values were normal and not different between groups at baseline or at 24 hours. Mean RI fell during the 24 hours, as normally occurs; the mean decrease was nearly identical in the two groups. A bulging fontanelle was not associated with increased rates of any sign or symptom or with an increase in RI. The 52-mumol dose of oral vitamin A may cause a small increase in intracranial volume in a small proportion of infants, but no increase in intracranial pressure. Acute side-effects following this intervention were rare and mild.

Administration, Oral↗

Clinical evaluation of quinacrine pellets for chemical female sterilization.

Under the auspices of the Coordinating Board of Indonesian Fertility Research (BKS PENFIN), a clinical trial was undertaken to examine the safety and effectiveness of the quinacrine pellet method for nonsurgical female sterilization. One hundred women were selected to receive 3 monthly insertions of 250 mg of quinacrine and were followed up at 1, 3, 6 and 12 months after the third insertion. Socioeconomic data and complaints and menstrual patterns at each insertion and every follow-up visit were recorded, as were all failures. The life-table failure rate was determined to be 3.1. The continuation rate in this study was 96% at 1 year. Just over one-fifth of the women had amenorrhea by the third insertion, but most returned to normal by 1 year, and it appears that this amenorrhea was transient in nature. The method proved to be safe and effective, suggesting that larger clinical trials are in order.

Administration, Intravaginal↗

A study comparing a gestoden triphasic formulation with a fixed combination OC.

Metabolic parameters were studied in 30 patients over 12 treatment cycles in a double-blind randomized comparative trial of the new progestogen gestoden in a triphasic formulation against a fixed dose combination pill containing desogrestrel, in Bandung, Indonesia. The results of this laboratory experience affirm findings in similar previous metabolic studies that: (1) the changes induced by modern low-dose pills are clinically and statistically insignificant; (2) throughout the treatment cycles, the values of the various laboratory tests remain well within the normal range; and (3) the favorable balance between coagulation and fibrinolysis is maintained. Results of lipoprotein, coagulation, fibrinolytic and liver function tests in 27 patients are presented. Gestoden's pharmacologic profile and the worldwide clinical experience with the triphasic gestoden formulation in 4285 women are discussed.

Blood Coagulation↗

Evaluation of gemeprost vaginal pessaries in the termination of abnormal intra-uterine pregnancies at twelve teaching hospitals in Indonesia.

Vaginal pessaries, up to a maximum of 5, each containing 1 mg of 16,16-dimethyl-trans-delta squared-prostaglandin E1, ester (Gemeprost) were inserted as high as possible into the posterior fornix of the vagina at 3 hourly intervals in 459 women with abnormal intrauterine pregnancies presenting for termination of the pregnancy. There were 145 missed abortions (31.6%), 207 intrauterine fetal deaths (45.1%), 86 molar pregnancies (18.7%), 5 anencephalics (1.1%), and 16 others (3.5%). The study was conducted from July 1981-March 1982. 402 women (87.6%) underwent abortion within the 30 hour observation period, including 139 women (30.3%) who required additional procedures to complete evacuation of the uterus. Expulsion of the uterine contents failed to occur within 30 hours in 57 women (12.4%) and alternative procedures were employed. These failures consisted of 37 missed abortions, 17 intrauterine fetal deaths, 2 molar pregnancies, and 1 pregnancy with an IUD in situ. Side effects caused by the drug were basically tolerable. 234 women (51.0%) had 1 or more side effects, gastrointestinal tract disturbances (nausea, vomiting, and diarrhea) being the most frequently observed, and moderate fever the next most frequent. There was 1 ruptured uterus.

Abortion, Induced↗

Menstrual regulation with prostaglandin (Pg ONO 802) in Indonesia.

This study was conducted to evaluate the safety, efficacy and acceptability of PGE1 vaginal suppositories (Pg ONO 802) in menstrual regulation. Each vaginal suppository contains 1 mg of 16,16 dimethyl-trans-delta 2 PGE1 methyl ester. Five suppositories were inserted as high as possible into the fornix posterior of the vagina at intervals of 3 h. Five hundred thirty four subjects with delay of menses mostly of up to 14 days were included in the study. Blood chemistry was evaluated and urine analysis performed in all subjects. Success of treatment was assessed on two alternative groups of criteria: (A) induction of bleeding by Pg ONO 802; (B) induction of bleeding achieved by Pg ONO 802 and not followed by surgical intervention. The success rate based on criteria A was 98.9%, and on criteria B 86%. If heavy bleeding occurred and signs of pregnancy were found during the trial period, intervention was made by vacuum aspiration or curettage when necessary. If bleeding did not occur and/or pregnancy continued, treatment was declared a failure and pregnancy was terminated by vacuum extraction or curettage. For non-pregnant subjects no intervention was made but careful re-evaluation was carried out. Mean duration of bleeding after Pg ONO 802 treatment was 6.7 days. Side-effects were generally mild. The incidence of diarrhea was 8.8%, nausea 7.8%, headache 5.8%, vomiting 2.8%; abdominal cramp occurred in as many as 66% of subjects. No treatment was given for these side-effects as they were within acceptable limits.(ABSTRACT TRUNCATED AT 250 WORDS)

Abortion, Induced↗

Maternal mortality at twelve teaching hospitals in Indonesia-an epidemiologic analysis.

Records on 36,062 maternity cases admitted to 12 teaching hospitals throughout Indonesia between 1977 and 1980 were analyzed. A hospital maternal mortality rate of 37.4/10,000 cases (39.0/10,000 live births) was derived that was about ten times higher than rates reported from developed countries in the early seventies. Hemorrhage, infection and toxemia accounted for 91.2% of deaths resulting from direct obstetric causes and for 86,1% of total deaths. It is postulated that if all pregnant women received adequate antenatal care, and if all women wanting no additional children were sterilized, maternal mortality would be cut in half. It is recommended that maternal health services in Indonesia be integrated into its successful family planning program.

Adolescent↗