Effects of hormonal contraceptives on milk volume and infant growth. WHO Special Programme of Research, Development and Research Training in Human Reproduction Task force on oral contraceptives. Cluster randomised trial of an active, multifaceted educational intervention based on the WHO Reproductive Health Library to improve obstetric practices. A randomized controlled trial of the effect of advanced supply of emergency contraception in postpartum teens: a feasibility study. Computer-assisted provision of emergency contraception a randomized controlled trial.
WHO conducted a three-centre study in Hungary and Thailand to evaluate the effects of hormonal contraception on lactation and infant growth. Women choosing oral contraceptives were randomly assigned to a combined oral contraceptive containing 30 micrograms ethinyl estradiol and 150 micrograms levonorgestrel (N = 86) or a progestin-only preparation containing 75 micrograms dl-norgestrel (N = 85). Identical packaging and treatment schedules allowed double-blind observation. One-hundred-and-eleven women using no contraception or non-hormonal methods acted as controls. In the two Thai centres 59 women using depot-medroxyprogesterone acetate formed an additional comparison group. All subjects were healthy women with normal deliveries, whose infants had normal birth weights and satisfactory growth in the neonatal period. Breast milk volume was determined by pump expression using standardized procedures. Information was obtained on nursing frequency and supplementation, infant growth and morbidity. Pretreatment observations at 6 weeks post-partum were used as a baseline, and subjects were followed-up at 9, 12, 16, 20 and 24 weeks post-partum. Women using combined oral contraceptives had a decline in milk volume within 6 weeks of initiating treatment, whereas no significant decrease was observed in the other treatment groups. After 18 weeks of treatment, combined oral contraceptive users experienced a 41.9% decline in milk volume, compared to 12.0% with progestin-only minipills and 6.1% in the non-hormonal controls. The prevalence of complementary feeding and withdrawals due to inadequate milk supply were comparable in the four treatment groups. However, data were not available on the daily amounts of complementary feeds. There were no significant differences in growth of infants between treatment groups. Thus, women may have compensated for declines in milk volume by more supplementary feeding or by more prolonged and intense suckling episodes. We conclude that 30 micrograms estrogen-containing combined oral contraceptives impair milk secretion, but in the selected healthy group of mothers and children studied with the prevailing level of supplementary feeding, this did not adversely affect infant growth. We conducted a trial to evaluate the effect of an active, multifaceted educational strategy to promote the use of the WHO Reproductive Health Library (RHL) on obstetric practices.
                Cluster randomised trial. The trial was assigned the International Standardised Randomised Controlled Trial Number ISRCTN14055385.
                Twenty-two hospitals in Mexico City and 18 in the Northeast region of Thailand.
                The intervention consisted primarily of three interactive workshops using RHL over a period of 6 months. The focus of the workshops was to provide access to knowledge and enable its use. A computer and support for using both the computer and RHL were provided at each hospital. The control hospitals did not receive any intervention.
                The main outcome measures were changes in ten selected clinical practices as recommended in RHL starting approximately four to six months after the third workshop. Clinical practice data were collected at each hospital from 1000 consecutively delivered women or for a 6-month period whichever was reached sooner.
                The active, multifaceted educational intervention we employed did not affect the ten targeted practices in a consistent and substantive way. Iron/folate supplementation, uterotonic use after birth and breastfeeding on demand were already frequently practiced, and we were unable to measure external cephalic version. Of the remaining six practices, selective, as opposed to routine episiotomy policy increased in the intervention group (difference in adjusted mean rate = 5.3%; 95% CI -0.1 to 10.7%) in Thailand, and there was a trend towards an increased use of antibiotics at caesarean section in Mexico (difference in adjusted mean rate = 19.0%; 95% CI: -8.0 to 46.0%). There were no differences in the use of labour companionship, magnesium sulphate use for eclampsia, corticosteroids for women delivering before 34 weeks and vacuum extraction. RHL awareness (24.8-65.5% in Mexico and 33.9-83.3% in Thailand) and use (4.8-34.9% in Mexico and 15.5-76.4% in Thailand) increased substantially after the intervention in both countries.
                The multifaceted, active strategy to provide health workers with the knowledge and skills to use RHL to improve their practice led to increased access to and use of RHL, however, no consistent or substantive changes in clinical practices were detected within 4-6 months after the third workshop. The study was conducted to test the feasibility of conducting a randomized controlled contraceptive trial in postpartum teens and to assess whether postpartum advanced supply of emergency contraception (EC) to teenaged mothers helps to prevent repeat pregnancies of close proximity.
                We performed a randomized controlled trial of 50 postpartum teens at an urban academic medical center. Participants in the intervention arm received routine postpartum contraceptive care and advanced supply of one pack of EC pills with unlimited supply thereafter upon request. The routine care arm (RCA) received routine postpartum contraceptive care. We asked open-ended questions about how we might maximize study retention and implemented the participants' requests in both arms.
                Our retention rate was 78%. There were three (13%) pregnancies out of 23 participants in the intervention arm and eight (30%) pregnancies out of 27 participants in the RCA. The risk of pregnancy occurring in the intervention arm was 0.57 times that of the RCA (95% CI 0.20-1.60; p=.23).
                A randomized controlled trial of postpartum teens to receive and not to receive advanced supply of EC is both feasible and necessary. Our study provides preliminary data to suggest that advanced supply of EC may help decrease repeat teen pregnancies. Emergency contraception (EC) can prevent unintended pregnancy. However, many women continue to lack information needed to use EC effectively and clinician time to counsel women about EC is limited.
                To evaluate whether computer-assisted provision of EC can increase knowledge and use of EC among women able to access EC without a prescription.
                We conducted a randomized controlled trial in which the intervention group received a 15-minute computerized educational session and 1 pack of EC. The control group received education about periconception folate supplementation, but no information about EC. Participants were contacted 7 months after enrollment.
                Four hundred forty-six women recruited from 2 urgent care clinics in San Francisco in 2005.
                Knowledge of EC, use of EC, and self-reported pregnancy.
                At follow-up, women in the intervention group answered an average of 2 more questions about EC correctly than they had at baseline, whereas women in the control group answered only 1 more item correctly (2.0 vs 1.2, p < .001). There was a trend toward more use of EC during the study period in the intervention group (10% vs 4% of women followed, p = .06; 6% vs 3%, p = .09 of women enrolled). Fewer women in the intervention group were pregnant at the time of follow-up (0.8% vs 6.5%, p = .01 of women followed; 0.5% vs 4.0%, p = .01 of women enrolled).
                Computer-assisted provision of EC in urgent care waiting areas increased knowledge of EC in a state where EC had been available without a prescription for 3 years.
The existing trials are insufficient to establish any effect of hormonal contraception on milk quality and quantity. At least one properly conducted randomized controlled trial of adequate size is needed to address hormonal contraceptive use for lactating women.