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

Primary Purpose

Pregnancy During Breastfeeding, Lactational Amenorrhea Method

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Counseling for LAM+ LNG-EC
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy During Breastfeeding focused on measuring Emergency contraception, pregnancy during breastfeeding, Lactational amenorrhea Method, unplanned pregnancy

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Counseling for LAM

    Counseling for LAM+ LNG-EC

    Arm Description

    Will receive proper postpartum counseling for LAM by trained research nurse. This is in addition to, adequate contraceptive counseling including information about LAM and its prerequisites. Women that choose to use LAM will be advised to return to our contraception outpatient clinic to have a long term method of contraception as soon as any of the requirements of LAM expires.

    LAM counseling and contraceptive counseling +two 0.75 mg Levonorgestrel EC pills

    Outcomes

    Primary Outcome Measures

    Initiation of long term contraception with 6 month postpartum

    Secondary Outcome Measures

    Use/non-use of EC pills
    Use/non-use of any other type of EC ( e.g insert IUD if eligible)
    Pregnancy rate in each group
    Side effects of LNG EC pills
    The prevalence of unwanted pregnancy in each study group

    Full Information

    First Posted
    April 23, 2010
    Last Updated
    November 20, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01111929
    Brief Title
    Emergency Contraception as a Back up of Lactational Amenorrhea Method(LAM)
    Acronym
    ECLAM
    Official Title
    Emergency Contraception as a Back up of Lactational Amenorrhea Method of Contraception
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2009 (Actual)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    November 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pregnancy During Breastfeeding, Lactational Amenorrhea Method
    Keywords
    Emergency contraception, pregnancy during breastfeeding, Lactational amenorrhea Method, unplanned pregnancy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1174 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Counseling for LAM
    Arm Type
    Active Comparator
    Arm Description
    Will receive proper postpartum counseling for LAM by trained research nurse. This is in addition to, adequate contraceptive counseling including information about LAM and its prerequisites. Women that choose to use LAM will be advised to return to our contraception outpatient clinic to have a long term method of contraception as soon as any of the requirements of LAM expires.
    Arm Title
    Counseling for LAM+ LNG-EC
    Arm Type
    Experimental
    Arm Description
    LAM counseling and contraceptive counseling +two 0.75 mg Levonorgestrel EC pills
    Intervention Type
    Drug
    Intervention Name(s)
    Counseling for LAM+ LNG-EC
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Initiation of long term contraception with 6 month postpartum
    Time Frame
    6 month
    Secondary Outcome Measure Information:
    Title
    Use/non-use of EC pills
    Time Frame
    6 months
    Title
    Use/non-use of any other type of EC ( e.g insert IUD if eligible)
    Time Frame
    6 months
    Title
    Pregnancy rate in each group
    Time Frame
    6 months
    Title
    Side effects of LNG EC pills
    Time Frame
    6 months
    Title
    The prevalence of unwanted pregnancy in each study group
    Time Frame
    6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Omar M Shaaban, MD
    Organizational Affiliation
    Department of Obstetrics and Gynecology, Assiut University, Egypt
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    2298758
    Citation
    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. doi: 10.1017/s0021932000018344.
    Results Reference
    background
    PubMed Identifier
    22935323
    Citation
    Shaaban OM, Hassen SG, Nour SA, Kames MA, Yones EM. Emergency contraceptive pills as a backup for lactational amenorrhea method (LAM) of contraception: a randomized controlled trial. Contraception. 2013 Mar;87(3):363-9. doi: 10.1016/j.contraception.2012.07.013. Epub 2012 Aug 27.
    Results Reference
    derived

    Learn more about this trial

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

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