RESUMO
The contraceptive efficacy and safety of a progesterone-releasing vaginal ring (PVR) manufactured in Chile were compared to that of the Copper T 380A IUD (T-Cu) in nursing women enrolled at three Chilean clinics. A total of 285 volunteers chose to use the PVR and 262 the T-Cu. Plasma progesterone levels attained with the ring decreased from 25 to 14 nmol/L from month 1 to month 3 of use. Ring replacement was scheduled every 3 months. Volunteers continued in the study until weaning or completing the continuous use of four PVRs. No pregnancies occurred in 2320 and 2183 woman-months of exposure with the PVR and the T-Cu, respectively. Lower continuation rates in the first 6 months because of problems with use and a longer lactational amenorrhea were observed in the PVR than in the T-Cu group. Breast-feeding performance and infant growth were similar in both groups. These results confirm the high efficacy and safety of the PVR for nursing women and have led to the registration of the PVR by Chilean health authorities.
PIP: This study compares the contraceptive efficacy and safety of a progesterone-releasing vaginal ring (PVR) manufactured in Chile and a Copper T 380A IUD (T-Cu) in nursing women enrolled at three Chilean clinics. A total of 285 volunteers used the PVR and 262 used T-Cu. Plasma progesterone levels attained with the ring decreased from 25 to 14 nmol/l from month 1 to month 3 of use. Ring replacement was scheduled every 3 months. Volunteers continued in the study until weaning or completing the continuous use of 4 PVRs. There were no pregnancies in 2320 and 2183 woman-months of exposure with the PVR and the T-Cu, respectively. Lower continuation rates in the first 6 months because of problems with use and a longer lactational amenorrhea were seen in the PVR group. Breast-feeding performance and infant growth were similar in both groups. These results prove the high efficacy and safety of the PVR for nursing women. This has led to the registration of the PVR by Chilean health authorities.
Assuntos
Aleitamento Materno , Dispositivos Anticoncepcionais Femininos/normas , Leite Humano/efeitos dos fármacos , Progesterona/farmacocinética , Adulto , Amenorreia/induzido quimicamente , Peso ao Nascer , Peso Corporal , Chile , Colposcopia , Dispositivos Anticoncepcionais Femininos/efeitos adversos , Feminino , Hemoglobinas/análise , Humanos , Lactente , Dispositivos Intrauterinos de Cobre/efeitos adversos , Dispositivos Intrauterinos de Cobre/normas , Lactação , Masculino , Paridade , Pacientes Desistentes do Tratamento , Satisfação do Paciente , Progesterona/sangue , Progesterona/farmacologia , Radioimunoensaio , Vagina/efeitos dos fármacosRESUMO
This study evaluated the performance of progesterone vaginal rings (n = 187), progestin-only pills (n = 117), Norplant implants (n = 120), and Copper T 380-A intrauterine devices (n = 122) in lactating women. Contraceptive efficacy, bleeding pattern, and influence of the method upon breastfeeding duration and infant growth were compared with those of untreated women (n = 236) who relied on lactational infertility. Participants were healthy, 18 to 38 years, had had a normal delivery, and were intending to breastfeed for as long as possible. Contraceptives were initiated at day 57 +/- 3 postpartum. Results are reported for the first year of use. All methods were highly effective, with pregnancy rates below 1%. None affected breastfeeding performance or the rate of infant growth. Users of the progestin-only methods experienced a period of lactational amenorrhea 4 to 5 months longer than did users of Copper T or untreated women. More than half of the women in each contraceptive group reported a bleeding in the first month after treatment initiation, which was not considered in the calculation of the duration of amenorrhea. Prolonged or frequent bleedings were infrequent. The proportion of bleedings lasting more than 10 days ranged from 0 in the progestin-only pills group to 7% in the Norplant implants group. The four methods, initiated around the eighth postpartum week, provided effective contraception with no negative effects upon lactation or infant growth and without the bleeding problems associated with their use in nonlactating women.
Assuntos
Aleitamento Materno , Anticoncepção/métodos , Anticoncepcionais Orais Sintéticos/administração & dosagem , Dispositivos Intrauterinos de Cobre , Lactação/efeitos dos fármacos , Levanogestrel/administração & dosagem , Linestrenol/administração & dosagem , Progesterona/administração & dosagem , Adulto , Chile , Anticoncepção/efeitos adversos , Anticoncepcionais Orais Sintéticos/efeitos adversos , Implantes de Medicamento , Feminino , Seguimentos , Humanos , Dispositivos Intrauterinos de Cobre/efeitos adversos , Lactação/fisiologia , Levanogestrel/efeitos adversos , Linestrenol/efeitos adversos , Masculino , Pacientes Desistentes do Tratamento/estatística & dados numéricos , Taxa de Gravidez , Progesterona/efeitos adversos , Valores de Referência , Fatores de TempoRESUMO
The duration of breast-feeding and the growth of fully breast-fed infants during the first year of life were analyzed according to sex, birth weight, characteristics of the mother, and breast-feeding pattern. All infants (n = 1217) were healthy and fully breast-fed at 30 d postpartum and 63% and 24% were still fully breast-fed at 6 and 12 mo, respectively. The median ages at introduction of nondairy food and of milk supplements were 6.0 and 7.4 mo, respectively. The probability of remaining fully breast-fed for 12 mo was significantly higher in infants with higher birth weight and higher maternal weight, and in infants who breast-fed seven times a day or more in the first 6 mo. The comparison of the monthly weight and length of fully breast-fed infants with the World Health Organization/National Center for Health Statistics reference data showed the adequacy of breastfeeding to support infant growth. When mothers and infants are healthy, breast milk is sufficient to support adequate infant growth and health during the first months of life. The main variables that affect the duration of breast-feeding, nutrition and suckling frequency, are susceptible to interventions by health services. The results reinforce the need to care for maternal nutrition during pregnancy and to provide the support that women need to sustain a high suckling frequency.
Assuntos
Aleitamento Materno , Desenvolvimento Infantil/fisiologia , Saúde da População Urbana , Adolescente , Adulto , Análise de Variância , Peso ao Nascer/fisiologia , Chile , Feminino , Seguimentos , Alimentos Fortificados/normas , Humanos , Lactente , Recém-Nascido , Masculino , Fatores de Tempo , Organização Mundial da SaúdeRESUMO
The contraceptive efficacy of breastfeeding was assessed in 236 healthy urban women who were followed at monthly intervals during the first postpartum year. Proportional hazard models were used to evaluate the influence of time postpartum, menstrual status and breastfeeding pattern upon the risk of pregnancy. Time and menstrual status had a highly significant effect on this risk. Those women who remained in amenorrhea had cumulative probabilities of pregnancy of 0.9% and 17% at 6 and 12 months postpartum, respectively. In those who recovered menstrual cycles, the risk rose to 36% and 55% at 6 and 12 months, respectively. Milk supplementation also increased significantly the risk when considered alone but not when time and/or menstrual status were included in the analysis. However, amenorrheic women who introduced bottle feeding, had a higher risk of pregnancy after 6 months postpartum than those who remained fully nursing. The analysis was unable to detect a significant influence of the nursing frequency. The results confirm that lactational amenorrhea is an effective contraceptive during the first six months postpartum. The first postpartum bleeding marks a great increase in the risk of pregnancy. Supplementation also increases the risk, particularly in amenorrheic women.
Assuntos
Amenorreia/fisiopatologia , Infertilidade Feminina , Lactação/fisiologia , Adulto , Chile , Feminino , Humanos , Pessoa de Meia-Idade , Período Pós-Parto , Gravidez/estatística & dados numéricos , RiscoAssuntos
Aleitamento Materno , Promoção da Saúde , Humanos , Lactente , Recém-Nascido , Enfermagem Materno-InfantilRESUMO
The influence of the breastfeeding pattern and several clinical variables upon the duration of postpartum amenorrhea was assessed in a group of healthy women selected for having had a normal pregnancy and delivery and being highly motivated for prolonged breastfeeding on demand. 676 women who were fully nursing at the second month postpartum entered the study. Supplements were administered to 11% and 48% of the infants by the end of the 3rd and 6th month, respectively. The first bleeding was experienced before the end of the sixth month postpartum by 57% of the cases. Supplementation had a strong negative influence while nursing frequency had a significant positive influence upon the length of amenorrhea. Notwithstanding, a frequency of 8+ suckling episodes per 24 h could not maintain amenorrhea in around half of the subjects. Age and parity had a moderate negative influence upon the risk of experiencing the first postpartum bleeding. Maternal weight and ponderal index, infant sex, birth weight and growth rate showed no significant influence upon the length of amenorrhea. In this urban population selected for having the highest motivation and best breastfeeding performance, the association of breastfeeding with amenorrhea was weak in comparison with what has been described for other populations. The risk of experiencing the first bleeding was reduced while fully breastfeeding with a high number of nursing episodes per day and night, particularly in older women with higher parity. But even in such situation 25% and 50% of the women had started to cycle by the end of the fifth and eight postpartum month.
Assuntos
Amenorreia , Aleitamento Materno , Período Pós-Parto/fisiologia , População Urbana , Adulto , Chile , Feminino , Seguimentos , Humanos , Dispositivos Intrauterinos , Menstruação , Gravidez , Fatores de TempoRESUMO
The probability of experiencing the first postpartum bleeding, the first ovulation and the risk of pregnancy during exclusive breastfeeding was assessed in a selected group of urban Chilean women. Admission criteria included having had a normal pregnancy and a vaginal term delivery of a healthy infant and the desire to maintain breastfeeding for as long as possible. The risk of bleeding and the recovery of ovulation was assessed in 48 women selected for being amenorrheic and fully nursing at day 75 postpartum and their willingness to participate in the blood sampling protocol. The first bleeding and ovulation was experienced while fully nursing by 28% and 26% of these subjects, respectively, at day 180 postpartum. The probability of experiencing the first bleeding and the probability of pregnancy during full nursing were calculated for 236 women not contracepting who were enrolled during the first month postpartum. The cumulative probability of bleeding and of pregnancy was 52% and 9.4% at day 180 postpartum, respectively. The risk of pregnancy was less than 2% in the subset of amenorrheic cases. In this urban population selected for having the highest motivation and best breastfeeding performance, the association of breastfeeding with infertility was too weak to serve as an effective birth spacer, except for the period of lactational amenorrhea. When the first postpartum bleeding took place before the sixth postpartum month in fully nursing women, it had a good predictive value to indicate the onset of a higher risk period.