Emergency Contraception as a Back up of Lactational Amenorrhea Method(LAM)

2014-07-24 14:05:56 | BioPortfolio


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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Pregnancy During Breastfeeding


Counseling for LAM+ LNG-EC


Active, not recruiting


Assiut University

Results (where available)

View Results


Published on BioPortfolio: 2014-07-24T14:05:56-0400

Clinical Trials [1371 Associated Clinical Trials listed on BioPortfolio]

Breastfeeding Education Support Tool for Baby

This study will compare data associated with breastfeeding experiences and outcomes--specifically, breastfeeding continuation after initiation, exclusivity for 6 months of an infant's life...

The LATCHING Pilot Project

The purpose of this study is to learn if group-based phone counseling is effective for increasing breastfeeding rates, reducing the early introduction of solids and increasing maternal wei...

A Randomised Controlled Trial to Compare Antenatal Preparation and Postnatal Counseling

This is a randomised controlled trial to compare antenatal preparation and postnatal counseling strategies for improving breastfeeding rates. The objectives are: 1. to study the ...

Orientation Effects of Breastfeeding for Mothers

The benefits of breastfeeding are increasingly known of the population and breastfeeding rates in the country have been increasing, but still are below satisfactory to the Ministry of Heal...

Motivational Counseling in Preventing Smoking Relapse After Pregnancy in Pregnant Women Who Quit Smoking During Pregnancy

RATIONALE: Motivational counseling may help prevent pregnant women from smoking again after pregnancy. PURPOSE: This randomized clinical trial is studying three different types of counsel...

PubMed Articles [2776 Associated PubMed Articles listed on BioPortfolio]

The impact of maternal BMI, gestational weight gain, and breastfeeding on early childhood weight: Analysis of a statewide WIC dataset.

Early childhood obesity is a persistent health concern with more frequent and significant impact on low-income families. Maternal weight factors impact offspring weight status, but evidence on whether...

The Impact of Vitamin D on the Maternal and Infant Epigenome: The Role of Pregnancy and Breastfeeding.

Associations of Maternal Beliefs and Distress in Pregnancy and Postpartum With Breastfeeding Initiation and Early Cessation.

Breastfeeding plays an important role in both maternal and infant health and well-being. While researchers have examined the relationship between postpartum psychological distress and breastfeeding be...

Impact of maternal nutritional supplementation in conjunction with a breastfeeding support program during the last trimester to 12 weeks postpartum on breastfeeding practices and child development at 30 months old.

Maternal nutrition during pregnancy and breastfeeding is important for the healthy growth and development of the fetus and infant.

Breastfeeding protection according to the law on the reform of maternity protection.

On 1 January 2018, a new Maternity Protection Act came into force in Germany. The Maternity Protection Act has been made more appropriate and coherent by the reform. In addition, the regulations on m...

Medical and Biotech [MESH] Definitions

An organized and comprehensive program of health care that identifies and reduces a woman's reproductive risks before conception through risk assessment, health promotion, and interventions. Preconception care programs may be designed to include the male partner in providing counseling and educational information in preparation for fatherhood, such as genetic counseling and testing, financial and family planning, etc. This concept is different from PRENATAL CARE, which occurs during pregnancy.

Counseling during which a professional plays an active role in a client's or patient's decision making by offering advice, guidance, and/or recommendations.

Counseling conducted via electronic or other non-face-to-face interactions.

Proteins produced by organs of the mother or the PLACENTA during PREGNANCY. These proteins may be pregnancy-specific (present only during pregnancy) or pregnancy-associated (present during pregnancy or under other conditions such as hormone therapy or certain malignancies.)

The state of PREGNANCY in women with DIABETES MELLITUS. This does not include either symptomatic diabetes or GLUCOSE INTOLERANCE induced by pregnancy (DIABETES, GESTATIONAL) which resolves at the end of pregnancy.

More From BioPortfolio on "Emergency Contraception as a Back up of Lactational Amenorrhea Method(LAM)"

Quick Search


Relevant Topics

Breast Cancer
Track and monitor developments in breast cancer research and commercial development.  Follow the tabs above to read the latest global news, research, clinical trials on breast cancer and follow companies active in the development of breast cancer tr...

Obstetrics and gynaecology
Fertility Menopause Obstetrics & Gynaecology Osteoporosis Women's Health Obstetrics and gynaecology comprises the care of the pregnant woman, her unborn child and the management of diseases specific to women. Most consultant...

Searches Linking to this Trial