Counseling and in-advance provision of levonorgestrel emergency contraceptive pills decrease the rate of unplanned pregnancy during breastfeeding: a randomized controlled trial.

OBJECTIVE: To evaluate the effect of counseling and in-advance provision of levonorgestrel emergency contraceptive pills (LNG-ECPs) during postpartum counseling on the incidence of occurrence of unplanned pregnancy during breastfeeding. MATERIALS AND METHODS: The current study is an open-label, parallel, randomized controlled trial carried out in a university hospital in Egypt. All women who delivered and planning to birth-space and breastfeed for at least 1 year were approached for participation during a postpartum hospital stay. Eligible participants were randomly allocated to receive adequate lactational amenorrhea method (LAM) counseling Group 1 (LAM-only) or the above LAM counseling in addition to counseling and in advance provision of one packet of 0.75-mg LNG-ECPs Group 2 (LAM + EC). The two study groups were followed 6 months and the primary outcome was the unplanned pregnancy rate. RESULTS: The study included 2708 women randomized into two groups; LAM-only and LAM + EC groups. Demographic characteristics were homogenous between the groups at the time of recruitment. Unplanned pregnancy was significantly higher in LAM-only group 70 (5.3%) as compared with 5 (0.4%) in LAM-EC group (p = .0001). Also, 619 women (46.6%) used LNG-ECPs with minor side effects like nausea in 175 (28.3%) women, headache in 94 (15.2%) women, vomiting in 24 (3.9%) women. CONCLUSION: In-advance counseling and provision of LNG-ECPs for those opt to use LAM during postpartum family planning counseling can decrease the rate of unplanned pregnancy during breastfeeding and increase the initiation of long-term use of contraception.

Levonorgestrel emergency contraceptive pills use during breastfeeding; effect on infants' health and development.

OBJECTIVE: The current study aims to evaluate the effect of the use of single packet of levonorgestrel emergency contraceptive pills (LNG-ECPs) during breastfeeding on the health and development of the nursing infant. MATERIALS AND METHODS: The current study was an ancillary observational cohort study carried out in a university hospital. We counseled all women delivered and planning birth-space and breastfeed for at least 1 year for participation during postpartum hospital stay. Eligible participants for inclusion in the randomized controlled trial (NCT01111929) were allocated to receive adequate Lactational Amenorrhea Method (LAM) counseling (LAM-only group) or the LAM counseling in addition to counseling about LNG-ECPs use (LAM + emergency contraception (EC) group). These pills were to be used once if unprotected intercourse did occur after expiry of any of the LAM prerequisites and before the couples started to use a reliable method of contraception. We included the first 100 women in the LAM + EC who did use the pills and the first 100 women in the control group who completed the follow-up visits for 6 months to draw the infants' outcome. The primary outcome was the difference of anthropometric measurements of the infants at 3 and 6 months postpartum. Secondary outcome was the difference in the Psycho-social, fine and gross motor, and language development using Denver development screening test. RESULTS: There were no statistical significant differences between both the groups regarding the infants' weight, length, head circumference, chest circumference, and mid-arm circumference at each visit (p > .05). Additionally, there were no statistically significant differences regarding all items (psycho-social, fine and gross motor, and language) of Denver development screening test between the infants in LAM-only and LAM + EC groups (p = .081). CONCLUSIONS: The use of single packet of LNG-ECPs during breastfeeding not objectively affects health and development of nursing infants or subjectively affects the quantity of breast milk.