Lactational Amenorrhea Method Clinical Trial
— ECLAMOfficial title:
Emergency Contraception as a Back up of Lactational Amenorrhea Method of Contraception
| Verified date | November 2017 |
| Source | Assiut University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Prolonged breast-feeding is an encouraged tradition in Egypt. Breastfeeding is associated
with variable degrees of amenorrhea and infertility but there is a risk of resumption of
fertility and therefore, of conception during lactation. A consensus statement formalized the
lactational amenorrhea method of contraception (LAM), which has subsequently been included in
the family planning programs in some developing countries. It has proved to be effective with
cumulative pregnancy rates ranging from only 0.9% to 1.2%. However, if any of the
prerequisites of LAM expire at any time, the contraceptive efficacy will be much reduced.
The expiry of LAM requirements can occur unexpectedly at a time the woman is not ready to
visit a clinic to initiate another contraceptive. Pregnancy during breast-feeding may result
in mistimed, unplanned and sometimes unwanted childbirth. A study done in Egypt has shown
that one in 4 of pregnancies during lactation were unplanned Such pregnancies, in addition to
their negative social impact may lead some women to seek induced abortion; a procedure which,
in settings (like Egypt) where abortion is illegal (except on very restricted grounds), is
often unsafe.
Levonorgestrel 1.5 mg EC pills has been used for long time and proved to decrease the
incidence of pregnancy by 75-85% in each act of unprotected sexual intercourse. Its safety
has been documented. It can be used safely during lactation and has been classified by the
WHO medical eligibility criteria for contraception as category-1 for lactating mother. Even
if take early in pregnancy it is not abortifacient and does not by any mean affect the
continuation of pregnancy or cause any side effects to the growing baby (WHO category 1).
The present study tries to estimate the efficacy of in advance provision of 1.5
Levonorgestrel EC pills (as a back-up of LAM) at the time of counseling of LAM when used in
increasing the incidence of initiation of another long term method of contraception and
probably decreasing the incidence of unintended pregnancy during breast-feeding in rural
Egypt.
The investigators are planning to include all women who deliver in the investigators service
and intent to breast-feed and planning of birth spacing. Women who refused to participate or
planned to use a method of contraception other than LAM and those with expected difficulty of
subsequent communication were excluded from participation.
All eligible participants will receive proper counseling for LAM by trained research nurse.
Women who choose to use LAM will be advised to return to the investigators contraception
outpatient clinic to have a long term method of contraception as soon as any of the
requirements of LAM expires. All eligible participants who accept to participate in the study
will be randomly assigned to one of two groups:Group 1 will only receive the above described
care (control group). Group II (Intervention group) in which women will have the above proper
counseling. Additionally, they will be advised to use the EC pills if one of the
prerequisites of LAM expires and sexual relation with their husband had occurred before the
initiation of another contraceptive. Each women assigned to the intervention group will be
supplied with one packet containing two 0.75 mg Levonorgestrel emergency contraceptive (EC)
pills and advised to swallow the two tablets as soon as possible after having sexual
intercourse with their husband after the expiry of LAM. They will be informed that they
should not use the method after more than 5 days of having intercourse. They will be also
advised not to use EC pills more than once. All women who have used the EC pills need to
visit the clinic within few days of use for contraception advise. All the above information
will be additionally given to the patient in a small flyer.
| Status | Completed |
| Enrollment | 1174 |
| Est. completion date | November 2016 |
| Est. primary completion date | May 2016 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - All women who delivers in the obstetric intent to breast-feed. - Eligible participants should have been planning of birth spacing Exclusion Criteria: - Women refusal to participate in the study - Women planned to use a method of contraception other than LAM - Anticipation of difficulty of subsequent communication with the woman |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Assiut University |
Shaaban MM, Kennedy KI, Sayed GH, Ghaneimah SA, Abdel-Aleem AM. The recovery of fertility during breast-feeding in Assiut, Egypt. J Biosoc Sci. 1990 Jan;22(1):19-32. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Initiation of long term contraception with 6 month postpartum | 6 month | ||
| Secondary | Use/non-use of EC pills | 6 months | ||
| Secondary | Use/non-use of any other type of EC ( e.g insert IUD if eligible) | 6 months | ||
| Secondary | Pregnancy rate in each group | 6 months | ||
| Secondary | Side effects of LNG EC pills | 6 months | ||
| Secondary | The prevalence of unwanted pregnancy in each study group | 6 months |