348 Letters to the Editor / Contraception 78 (2008) 346349
coital acts with the potential to lead to pregnancy. Our
primary argument for this conclusion was based on two
premises: that EC is efficacious in preventing pregnancy and
that the intervention group as a whole had more EC failures
(pregnancies that occurred despite use of EC) than the
control group. We inferred from these premises that the
intervention group probably also had more EC successes
(coital acts that would have led to pregnancy but for the use
of EC). Given that the two groups had the same number of
observed pregnancies, if the intervention group indeed had
more EC successes, then it must have had more coital acts at
risk for pregnancy.
Because our trial was randomized, all post-randomization
differences between groups whether directly observed or
not are attributable either to the randomized assignment
or to chance. Therefore, we have at least as much confidence
in the assertion that our intervention caused the inferred
increase in high-risk coital acts as we would in an assertion
that it caused a similar difference detected post hoc for any
conventionally ascertained trial outcome. In fact, our
conclusion is in retrospect quite plausible: when we make
a new method available to people, we should expect that
some will substitute it for their old methods.
Dr. Raine is mistaken in her claim that to reach our
conclusion, we needed to examine data from women who
did not become pregnant. As long as our two premises
are valid, our pregnancy ascertainment was complete, and
the trial was properly randomized, our conclusion is
logically indisputable.
In addition to this logical argument, our paper also
included a separate analysis comparing contraceptive use in
pregnancy cycles between the two groups. Although the
implications of this second analysis are consistent with those
of the first, the two analyses were utterly independent.
Neither is necessary to support the other.
We dispute Dr. Raine's allegation that the conclusions in
our recent paper are inconsistent with the findings presented
in our initial trial report, in which we failed to find evidence of
a difference between groups in self-reported contraceptive
use and coital activity at 6 and 12 months after enrollment [1].
Absence of evidence is not evidence of absence, and
accepting a null hypothesis based on a nonsignificant result
is generally inappropriate [3]. In addition, the pertinent ana-
lyses in the two papers were based on distinct data sources
that most likely differ in their reliability.
We do agree with Dr. Raine, however, that our new
conclusions should be interpreted with equanimity. The
intervention tested in our trial was extremely aggressive, and
its effects may differ from those of real world EC provision
approaches in other populations.
Elizabeth G. Raymond
Mark A. Weaver
Family Health International
Research Triangle Park, NC 27709, USA
E-mail address: eraymond@fhi.org
doi:10.1016/j.contraception.2008.06.005
References
[1] Raymond EG, Stewart F, Weaver M, Monteith C, Van Der Pol B. Impact
of increased access to emergency contraceptive pills: a randomized
controlled trial. Obstet Gynecol 2006;108:1098106.
[2] Raymond EG, Weaver MA. Effect of an emergency contraceptive pill
intervention on pregnancy risk behavior. Contraception 2008;77:3336.
[3] Altman DG, Bland JM. Absence of evidence is not evidence of absence.
BMJ 1995;311:485.
Miscarriage rate in pregnancybreastfeeding overlap
To the Editor:
Shaaban and Glasier [1] report on the prevalence of
pregnancy during breastfeeding. We would like to highlight
a point of this study: Table 1 of the paper shows a rate of 22%
miscarriages (2.83 previous deliveries and 0.79 previous
miscarriages per study participant). Instead, the 1995
Stratification, Social Mobility and Fertility Survey in
Egypt (SSMF) reports a 13% pregnancy loss from a
nationally representative sample (9669 pregnancies reported
by 2596 women) [2]. There is a significant difference
between Shaaban and Glasier's sample and SSMF results
(chi 258, pb.00001).
Shaaban and Glasier have found a rate of miscarriages
higher than expected. In fact, most studies demonstrate a
spontaneous recognized miscarriage rate of 1015% [3].
Shaaban and Glasier's finding is unexpected because the
research is performed in a rural setting and the mean age
of participants is 28 years; these patient characteristics
result in a low rate of pregnancy loss [2,3]. A possible
explanation for this finding is that the study's patients have
a high rate of pregnancybreastfeeding overlap (25.3%).
Data on miscarriage of the subsample of 661 pregnant
patients during breastfeeding would confirm or discard
this hypothesis. We would welcome this piece of informa-
tion because it would help to decide about safety of
tandem breastfeeding.
Tandem breastfeeding (TN) is the term for nursing
siblings who are not twins, concurrently. Lactation is more
demanding than pregnancy in energy terms. Therefore, a
sustained decline in weight gain from birth to 6 months (0.7
SD) [4] and a decline in height until 1 year of age have been
reported in TN infants from undernourished populations. On
the other hand, there is a good fit to the 2006 WHO Child
Growth standards within a well-nourished population of TN
infants: when expressed as SD scores, TN infants' weights
were +0.35 at 3 months and +0.38 at 1 year, and lengths were
0.05 at 3 months and +0.28 at 1 year of age [5].
As far as we know, there are no data at all on the effects of
TN on pregnancy loss and there is only one position paper on
TN. It was written by the American College of Family
Physicians, and they cautiously state that if the pregnancy is
 Letters to the Editor / Contraception 78 (2008) 346349
normal and the mother is healthy, breastfeeding during
pregnancy is the woman's personal decision. The elegant
paper of Shaaban and Glasier could begin to fill this gap.
Sergio Verd, MD
Paediatric Clinic, Av. Alejandro Rosselo, 10
Palma de Mallorca, Spain
E-mail address: drsverd@terra.es
Joana Moll, RN
Balearic Breastfeeding League (ABAM)
Barbara Villalonga, RN
Department of Primary Care
Balearic Health Authority
doi:10.1016/j.contraception.2008.06.003
References
[1] Shaaban OM, Glasier AF. Pregnancy during breastfeeding in rural
Egypt. Contraception 2008;77:3504.
[2] el-Saadani S. High fertility does not cause spontaneous intrauterine fetal
loss: the determinants of spontaneous fetal loss in Egypt. Soc Biol 2000;47:
21843.
[3] Nybo Andersen AM, Wohlfahrt J, Christens P, Olsen J, Melbye M.
Maternal age and fetal loss: population based register linkage study.
BMJ 2000;320:170812.
[4] Marquis GS, Penny ME, Diaz JM, Marin RM. Postpartum consequences
of an overlap of breastfeeding and pregnancy: reduced breast milk
intake and growth during early infancy. Pediatrics 2002;109:e56.
[5] Moll J, Villalonga B, Dmenec I, Rodrguez M, Verd Set. Weight gain of
tandem breastfed infants. IV Congreso Espaol de Lactancia Materna
2006; Comunicacin O007.
Response to letter to the editor
To the Editor:
Miscarriage rate was not evaluated in our study. A higher
prevalence of previous miscarriage encountered in our study
349
[1] compared with the previous 1995 national study [2] may
probably be secondary to a kind of difference in the study
population. In the current hospital-based study, we included
women from the outpatient antenatal clinic of a university
hospital. These women usually carry a higher rate of risky
pregnancy (women of Upper Egypt with uneventful present
or past pregnancy may not routinely visit medical care).
As regards the effect of lactation during pregnancy on
miscarriage rate, this is an important issue that may add to
the significance of the problem raised in our report [1].
However, it is not possible to evaluate that from our set of
data for two important reasons. First, that a good deal of
women who aborted early in pregnancy were not included
in our study. Secondly, and because of respect for patient
confidentiality, the data collection was anonymous and we
were not able to follow the outcome of the current
pregnancy. Finally, the idea of safety of pregnancy during
lactation is worthy of further study.
Omar M. Shaaban
Department of Obstetrics and Gynecology
Faculty of Medicine
Assiut University Hospital
71511 Assiut, Egypt
E-mail address: omshaaban2000@yahoo.com
Anna F. Glasier
Department of Reproductive and Developmental Science
University of Edinburgh
Edinburgh, EH16 4SB Scotland, UK
doi:10.1016/j.contraception.2008.05.012
References
[1] Shaaban OM, Glasier AF. Pregnancy during breastfeeding in rural
Egypt. Contraception 2008;77:3504.
[2] El-Saadani S. High fertility does not cause spontaneous intrauterine fetal
loss: the determinants of spontaneous fetal loss in Egypt. Soc Biol
2000;47:21843.