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The Journal of Maternal-Fetal & Neonatal Medicine
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Levonorgestrel emergency contraceptive pills use during breastfeeding; effect on infants’ health and development Omar M. Shaaban, Ahmed M. Abbas, Hanaa R. Mahmoud, Entsar M. Yones, Ahmed Mahmoud & Mahmoud S. Zakherah To cite this article: Omar M. Shaaban, Ahmed M. Abbas, Hanaa R. Mahmoud, Entsar M. Yones, Ahmed Mahmoud & Mahmoud S. Zakherah (2018): Levonorgestrel emergency contraceptive pills use during breastfeeding; effect on infants’ health and development, The Journal of Maternal-Fetal & Neonatal Medicine, DOI: 10.1080/14767058.2018.1439470 To link to this article: https://doi.org/10.1080/14767058.2018.1439470
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THE JOURNAL OF MATERNAL-FETAL & NEONATAL MEDICINE, 2018 https://doi.org/10.1080/14767058.2018.1439470
ORIGINAL ARTICLE
Levonorgestrel emergency contraceptive pills use during breastfeeding; effect on infants’ health and development Omar M. Shaabana, Ahmed M. Abbasa, Hanaa R. Mahmoudb, Entsar M. Yonesb, Ahmed Mahmoudc and Mahmoud S. Zakheraha a Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt; bDepartment of Obstetric and Gynecological Nursing, Faculty of Nursing, Assiut University, Assiut, Egypt; cDepartment of Pediatrics, Faculty of Medicine, Assiut University, Assiut, Egypt
ABSTRACT
ARTICLE HISTORY
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 (NCT 01111929) 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 þ 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 þ 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 þ EC groups (p ¼ .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.
Received 7 November 2017 Revised 7 February 2018 Accepted 7 February 2018
Introduction The use of breastfeeding as a contraceptive is not new. Women have taken advantage of the subfertility status during breastfeeding for thousands of years. The lactational amenorrhea method (LAM) is a harmless and applicable contraceptive for breastfeeding mothers and their babies. LAM is a universally available as a family planning method that has health benefits for the infant and mother [1]. Emergency contraception (EC) has the potential to reduce women’s risk of unintended pregnancy [2]. Although ECPs thought to be made for prevention of pregnancy outside the marital wedlock, it can be used within marital context, in case of failure of use of any CONTACT Ahmed M. Abbas Egypt, Egypt
bmr90@hotmail.com
ß 2018 Informa UK Limited, trading as Taylor & Francis Group
KEYWORDS
Breastfeeding; emergency contraception; infant growth; postpartum contraception
other methods, like condom break and missing multiple pills in a row [3]. EC has the potential as the last resort to avoid unwanted pregnancy and therefore abortion. Health professionals should inform couples about the use of ECPs and the available options, this discussion should emphasis the advantages and disadvantages of each method, including efficacy and sideeffects [4]. Breast milk is the principal natural source of nutrients for the newborn. In many countries, attitudes toward breastfeeding have been changed in the last few years favoring active prolonged breastfeeding on demand [5]. Therefore, the intention to breastfeed is almost universal but other factors may interplay to
Department of Obstetrics and Gynecology, Assiut University, Women Health Hospital, Assiut,
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O. M. SHAABAN ET AL.
cause either partial breastfeeding or weaning at an early-stage postpartum [6]. The concern about the risks for the breastfeeding infant has limited the contraceptive choice for postpartum women. The combined pills are known to affect both the quantity and the quality of breast milk; the estrogen component has the major predominant inhibitory effect on lactation [7]. On the other hand, many studies demonstrated that progestin only preparations have no adverse effects on lactation, breast milk, health, and growth of the infant. Most significantly is the multicentric study sponsored by WHO, comparing the growth, development, and health of infants whose mothers used progestin-only contraceptives during lactation [8]. Using LNG-ECPs (like Plan B One-Step, Next Choice One Dose) once will probably not affect either the quantity or quality of breast milk which are producing. Although some hormones may be passed through mother’s breast milk, the child is not likely to experience any adverse effects from it. This is unlike, ulpristal acetate (UPA) for EC; its label states that nursing mothers should avoid breastfeeding for 8 hours, a note that make practitioners as well as the users think that all types of ECPs should be avoided during breastfeeding [9]. Therefore, the aim of the current study was to evaluate the effect of single use of LNG-ECPs during breastfeeding on the health and development of nursing infants.
Materials and methods Study design The current study was an ancillary observational cohort study derived from the original randomized clinical trial (RCT: NCT01111929) that evaluated the effect of counseling and in-advance provision of LNGECPs during postpartum counseling on the incidence of occurrence of unplanned pregnancy during lactation. Details pertained to recruitment, intervention, follow up of the study participants, and the initial results of the RCT have been previously published [10].
Study setting and participants The study was carried out in the Department of Obstetrics & Gynecology of Assiut Women’s Health Hospital, Egypt between June 2010 and December 2015. We invited all women who delivered a single living fetus to participate in the study before hospital discharge. We included women who are planning to
birth-space and breastfeed for at least 1 year using the LAM as contraceptive method. We excluded women who were intended to use a contraceptive method other than LAM and those with chronic medical diseases. Additionally, we excluded those anticipated to have difficulty for further regular communication. The Institutional Ethical Review Board approved the study protocol.
Intervention All eligible participants included in the study signed a written informed consent before participation after explaining the nature of the study. Women were divided into two groups: Group 1 (LAM-only) who used LAM-only as a method of contraception, and Group 2 (LAM þ EC) who used LNG-ECPs during the course of LAM. We included the first 100 women in the LNGECPs who did use the ECPs while still nursing their infants and the first 100 women from the LAM-only group as a control group in the current study. Two follow-up visits were scheduled at the third and sixth months postpartum. Women were asked to bring their nursing infants to receive their scheduled vaccination. In each visit, women were asked about any changes they had encountered in their breast milk as well as the health condition of their child during the follow-up period (diarrhea, cough, elevated temperature). Anthropometric assessments of infant growth parameters as weight, length, head, chest, and mid arm circumferences were done by a specialized trained nurse at each visit (part of routine follow-up before vaccination). Measurement of weight was done using electronic weighing scale in grams. Length was measured from crown to heel using an infantometer. Head circumference was taken as the largest circumference of the skull using a flexible nonstretchable tape to the nearest 0.1 cm. Moreover, chest circumference was taken at the level of the nipple at the end of expiration using the same tape to the nearest 0.1 cm. Finally, mid arm circumference was measured in the left arm at a point midway between the tip of the acromion and the olecranon process using the same tape to the nearest 0.1 cm Additionally, Denver development screening test (DDST) was used to assess social-adaptive, fine and gross motor (movement), and language [11]. Scoring of the DDST: “Normal” performance was scored when the infant passed all the test items in the four sectors that should be passed by 90% of the newborn infant at his chronological age, or if there was one delay in one sector. “Questionable” when any one sector had
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Table 1. Anthropometric measurements of infants at the third and sixth month in LAM-only and LAM þ EC) groups. Third month of life Measurements Infant length/cm Infant wt/kg Head circumference/cm Chest circumference/cm Mid arm circumference/cm
LAM þ EC 55.6 ± 2.4 5.4 ± 0.3 37.7 ± 0.8 38.4 ± 1 9.4 ± 0.6
LAM-only 56 ± 1.7 5.5 ± 0.2 37.9 ± 1.1 38.6 ± 1 9.6 ± 0.9
Sixth month of life p Value 0.409 0.109 0.143 0.159 0.066
LAM þ EC 65.8 ± 2.5 6.7 ± 0.3 38.7 ± 0.9 39.5 ± 1 10.5 ± 0.6
LAM-only 66.3 ± 2.1 6.9 ± 0.4 39.0 ± 1.5 39.8 ± 1.2 10.7 ± 0.9
p Value .342 .077 .087 .056 .066
LAM-only: lactational amenorrhea only; LAM þ EC: lactational amenorrhea þ emergency contraception. All data are presented as mean ± standard deviation.
Table 2. Denver developmental screening test items between infants in the LAM-only and LAM þ EC groups during the first 3 months. LAM-only n ¼ 100 Items Psycho-social Regards face Smile responsively Smile spontaneous Follows to midline Fine motor Symmetrical movement Follow past midline Follow 180 degrees Prone, lifts head Gross motor Prone, head up 45 degrees Prone, head up 90 degrees Prone, chest up, arm support Language Responds to bell Vocalizes not crying Squeals Turns to rattling sound
No.
%
Table 3. Denver developmental screening test items between infants in the LAM-only and LAM þ EC groups during the second 3 months.
LAM þ EC n ¼ 100 No.
%
LAM-only n ¼ 100 p Value
100 100 100 100
100.0 100.0 100.0 100.0
100 100 100 100
100.0 100.0 100.0 100.0
– – – –
100 100 100 95
100.0 100.0 100.0 95.0
100 100 100 97
100.0 100.0 100.0 97.0
– – – .998
100 100 96
100.0 100.0 96.0
100 100 94
100.0 100.0 94.0
– – .987
100 100 100 100
100.0 100.0 100.0 100.0
100 100 100 100
100.0 100.0 100.0 100.0
– – – –
LAM-only: lactational amenorrhea only; LAM þ EC: lactational amenorrhea þ emergency contraception.
two or more delays or if one or more sectors had only one delay. “Abnormal” when two or more sectors had two or more delays or when one sector had two or more delays and one other sector has one delay. “Untestable” when refusals occur in a number or items large enough to cause the test result to be questionable or abnormal if they scored as failure [11].
Items Psycho-social Shy with strangers Feed self-cracker Work for toy Regard own hands Fine motor Hands together Grasps rattle Regards raisin Regards for object Gross motor Sits, hands steady Rolls over Language Dada to mama nonspecific Turns to voice Laughs
LAM þ EC n ¼ 100
No.
%
No.
%
p Value
100 95 100 100
100.0 95.0 100.0 100.0
100 97 100 100
100.0 97.0 100.0 100.0
– .999 – –
100 100 100 95
100.0 100.0 100.0 95.0
100 100 100 97
100.0 100.0 100.0 97.0
– – – .998
100 96
100.0 96.0
100 98
100.0 98.0
– .835
97 100 100
97.0 100.0 100.0
98 100 100
98.0 100.0 100.0
.987 – –
LAM-only: lactational amenorrhea only; LAM þ EC: lactational amenorrhea þ emergency contraception.
variables were presented as frequency and percentage. Comparison between qualitative variables in both the groups was done by Chi-square test. Quantitative variables were presented in terms of mean and standard deviation and Student’s t-test was used for comparison between two groups. For analysis, p value < .05 was considered as significant.
Results Study outcomes The primary outcome of the study was the difference of anthropometric measurements of the infants at 3 and 6 months postpartum between both the groups (users and nonusers). Secondary outcomes included the rate of health-related problems occurred to infants, the change in quantity of breast milk, and the difference in DSST scores between both the groups.
Statistical analysis Data entry and statistical analysis were done using SPSS software Chicago, IL, version 21. Qualitative
Table 1 show a comparison between the infants of mothers in the LAM-only and mothers who did use LNG-ECPs in the LAM þ EC groups as regards anthropometric measurements at the third and sixth months of life. No statistical significant difference between both the groups regarding the infants’ weight, length, head circumference, chest circumference, and mid-arm circumference at each visit. Tables 2 and 3 show that there were neither statistically significant differences regarding all items (Psycho-social, fine and gross motor, and language) of DDST achievement between the infants in LAM-only and LAM þ EC groups nor at the end of the third or
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O. M. SHAABAN ET AL.
Table 4. Denver developmental screening test scores between infants in the LAM-only and LAM þ EC groups at the sixth month. LAM þ EC (n ¼ 100)
LAM-only (n ¼ 100) Scoring
No.
%
No.
%
p Value
Normal Abnormal Questionable
95 0 5
95.0 0.0 1.0
97 0 3
97.0 0.0 3.0
.081
LAM-only: lactational amenorrhea only; LAM þ EC: lactational amenorrhea þ emergency contraception.
sixth months of baby’s life. Table 4 shows no statistically significant differences between infants in both the groups as regard to the final results of Denver Developmental Screening Test scoring at the end of the sixth month (p ¼ .081). Eight women in (LAM-only) group versus seven women in (LAM þ EC) group reported decrease in the quantity of breast milk at 6 months (p ¼ .785). Meanwhile, nearly one-quarter (24%) of infants of the (LAM þ EC) group had episodes of diarrhea compared to (18%) of (LAM-only) group during the period of follow-up with no statistical difference between both the groups (p ¼ .291).
Discussion Previous clinical trials demonstrated the safety of the use of progestine only contraceptives during breastfeeding; however, none of them did include the LNGECPs in their analysis [12]. Our working group demonstrated in our previous publication that LNG-ECPs could be used as a pack up LAM [10]. This article demonstrates the safety of LNG-ECPs use during breastfeeding on the nursing infants; hence we can include LNG-ECPs within the counseling portfolio of breastfeeding mothers as a backup of LAM or other contraceptives. Women in Egypt and many other developing countries commonly breastfeed their infants for long periods up to 2 years [13]. The WHO emphasizes the importance to deliver safe and effective contraception for lactating women and in the meantime does not affect breastfeeding. This is of special importance, if alternative infant’s formulas are not readily available or affordable [14]. There is no evidence that LNG-ECPs harm a developing baby. It can be used even if there has been an earlier episode of unprotected sex in the menstrual cycle in addition to the current episode. LNG-ECPs can be taken while breastfeeding. In both the WHO and CDC medical eligibility criteria, LNG-ECPs are classified as Category 1 for all users [15,16].
A recent systematic review on the effect of use of progestogen-only contraceptive methods in the breastfeed women concluded no adverse effects on the breastfeeding performance or the outcomes of the nursing infant [12]. Therefore; most of recent guidelines advise women to continue breastfeeding after using LNG-ECPs [17,18]. To our knowledge, this is the first study to document the real safety of LNG-ECPs on infants as it is ancillary to the first RCT on the use of LNG-ECPs as a back-up of LAM. In the present cohort there were no significant differences with regard infant weight at each corresponding visit between breastfeeding women who had used EC pills or not. The same observed with other physical parameters of growth (weight, length, head circumference, mid arm circumference). Previous reports showed that exposure of infants to progestogen in breast milk have no effect on gross or fine motor development. Also vision, hearing, language, and social skills were not affected [19]. Early studies reported that prolonged exposure to LNG in milk may decrease the thyroid hormones if the nursing infant is male [20], and increased rates of infection [21]. Additionally, present work examined social-adaptive, fine and gross motor (movement), and language skills among women who used or not LNG-ECPs during breastfeeding. In case of LNG-ECPs use; the pills are administered as a single dose. However, the above studies were testing the effect of chronic low-dose exposure and not the effect of single high-dose administration as the case in the LNG-ECPs. Previous study by Gainer et al. 2007 evaluated the pharmacokinetics of levonorgestrel in the plasma and milk of breastfeeding women who take a dose of 1.5 mg for EC. They recommended the mothers to discontinue breastfeeding for 8 hours after taking LNGECPs to minimize the infant exposure to the period of maximum LNG excretion in milk [22]. On the contrary, Hale [23] reported that levonorgestrel is a progestogen that is not expected to have any effect on the nursing infant or on maternal milk production. The same observed in a clinical study by Polakow-Farkash et al. [24] and found effects neither on the infants nor on the continuation of breastfeeding among women who used LNG-ECPs. In our study, there was no difference in the number of women reported decrease quantity of breast milk between LNG-ECPs users and nonusers. Only eight (8%) women in LNG-ECPs users versus 7 (7%) women in LAM-only group (p ¼ .78). This coincides with the results of Polakow-Farkash et al. [24], who reported
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decrease milk production in 7% of ECPs users versus 6% of nonusers (p ¼ .74). The limitations of the current study were a special sample size for infant outcomes were not calculated, lack of objective analysis of the quantity or quality of breast milk. Additionally, the low number of included patients is insufficient to assess the safety of ECPs. Longer follow-up of the children to further documenting long-term safety is advisable. In conclusion, the use of single packet of LNG-ECPs during breastfeeding does not objectively affect health and development of nursing infants or subjectively affects the quantity of breast milk.
[11]
[12]
[13]
[14]
[15]
Disclosure statement The authors declare that they have no conflict of interest.
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