Please select the eligibility criteria that correspond to the clinical trial below.
Title: Emergency Contraception as a Back up of Lactational Amenorrhea Method of Contraception
Brief 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.


Options:
A: Inclusion Criteria:1. Between 18-35 years old

2. In need of EC (had unprotected intercourse within 120 hours - 5 days)

3. Desire to prevent pregnancy for 1 year

4. Fluent in English and/or Spanish

5. Have a regular menstrual cycle (24-35 days)

6. Know their last menstrual period (+/-3 days)

7. Be willing to comply with the study requirements

8. Participants current preferred phone number must be functioning at the time of study entry and will be tested prior to enrollment

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Exclusion Criteria:

* 1. Current pregnancy

  2. Breastfeeding

  3. Intrauterine infection within the past 3 months

  4. Sterilization

  5. Already have an IUD or contraceptive implant (Implanon) in place

  6. Vaginal bleeding of unknown etiology

  7. Known Gonorrhea or Chlamydia infection in the last 30 days (unless successfully treated at least 7 days prior to study entry)

  8. Allergy to LNG (for LNG IUD patients)

  9. Allergy to copper or Wilson's disease (for Copper IUD patients)

  10. Known abnormalities of the uterus that distort the uterine cavity
B: Inclusion Criteria

* Sexual intercourse with a male partner at least twice in the month prior to study entry
* Does not desire pregnancy within 1 year of study entry
* 6 weeks since the end of her last pregnancy and has had at least one menstrual period since resolution of her last pregnancy
* Literate in English or Spanish

Exclusion Criteria

* Surgically sterilized or intends to become sterilized within 1 year of study entry
* Intrauterine device or a hormonal implant in place or intends to have one inserted within 1 year of study entry
* Received an injection of a long-term contraceptive hormone (such as depot-medroxyprogesterone acetate) within 6 months of study entry or intends to receive one within 1 year of study entry
* Intends to use Lunelle, the vaginal contraceptive ring, or the contraceptive patch for contraception within 1 year of study entry
* Intends to use partners' vasectomy as her method of contraception within 1 year of study entry
* Pregnant or breastfeeding
* Known or suspected infertility
* Previously participated in this study
* Planning to move out of the study area within 1 year of study entry
* Currently participating in another research study that would interfere with the conduct of this study
C: Inclusion Criteria:

* Menstruating women at least 18 years old;
* Give voluntary, written informed consent, and agree to observe all study requirements;
* Request emergency contraception within 72 hours (3 days) after unprotected coitus, as defined by lack of contraceptive use, or condom breakage (including condoms lubricated with spermicide) or other barrier contraceptive method failure;
* Reports that all acts of unprotected coitus during the current cycle are within 72 hours prior to enrollment;
* Willing to abstain from further acts of unprotected intercourse during that cycle;
* History of regular menstrual cycles (mean length of 24-42 days with intra-individual variation of ±5 days);
* At least one normal menstrual cycle (2 menses) post delivery or abortion;
* If subject recently discontinued hormonal contraception, one normal menstrual cycle (2 menses) must have been completed before entry in the study
* For women with a recent history of Depo Provera use, the most recent injection must be at least 3 months before study entry and the subject must have had at least one normal menstrual cycle (2 menses);
* Available for follow-up for at least the next four weeks.

Exclusion Criteria:

* Currently pregnant (positive high-sensitivity urine pregnancy test);
* pregnant or breast-feeding within the past two months;
* use of hormonal methods of contraception during the current or previous two cycles;
* current user of IUD;
* tubal ligation;
* partners with history of vasectomy;
* unsure about the date of the last menstrual period (+3 days);
* irregular menstrual cycles as defined in the inclusion criteria;
* nausea and vomiting within the previous two weeks;
* impaired hypothalamic-pituitary-adrenal reserve or oral glucocorticoid replacement therapy in the last year.

Subjects cannot be currently enrolled in any other investigational trial or re-enrolled in this study.
D: 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

Answer: D