Emergency Contraception as a Back up of Lactational Amenorrhea Method(LAM)
Condition: Pregnancy During Breastfeeding; Lactational Amenorrhea Method
MeSH terms: Emergencies; Amenorrhea
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): Counseling for LAM+ LNG-EC
Intervention type(s): Drug
Intervention description(s): They will be provided by the above proper LAM counseling and contraceptive counseling. Additionally, they will be provided by EC pills and advised to use these pills if one of the prerequisites of LAM expires and sexual relation with their husband had occurred before the initiation of another long term contraceptive. Each women in this group will be supplied with one packet containing two 0.75 mg Levonorgestrel 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 advice. All the above information will be additionally given to the patient in a small flyer.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Emergency contraception; pregnancy during breastfeeding; Lactational amenorrhea Method; unplanned pregnancy