Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201409000880157 Date of Registration: 04/09/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Expanding Contraceptive Health Options (ECHO-1): a randomised clinical trial of injectable contraceptives versus the IUD
Official scientific title A randomised clinical trial of the efficacy, safety and acceptability of injectable contraceptives versus the IUD
Brief summary describing the background and objectives of the trial In the Eastern Cape, South Africa, unintended pregnancies are a major contributor to maternal and perinatal mortality and morbidity. Until recently, women here have had limited contraceptive choice, with the majority of women (95%) receiving DMPA. In 2005, we initiated a program to improve contraceptive method availability in the region, called the Expanding Contraceptive Health Options program. We procured supplies of the copper 380 intrauterine device (IUD) which had not previously been available, and initiated training of health care staff in the counselling, insertion and removal of the IUD. Due to the lack of good evidence on the comparative efficacy, safety and acceptability of these two methods in out population, we designed this RCT with the purpose of providing objective evidence on which to base advice for women in the future to enable them to make more informed choices.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ECHO
Disease(s) or condition(s) being studied contraception, reproductive health,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 06/07/2009
Actual trial start date 06/07/2009
Anticipated date of last follow up 22/10/2011
Actual Last follow-up date 17/10/2012
Anticipated target sample size (number of participants) 7000
Actual target sample size (number of participants) 2512
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Computer-generated random sequence in balanced blocks of variable size. Numbered sealed opaque envelopes. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Copper 380 IUD Copper 380 IUD once continuous non-hormonal contraception 1258
Experimental Group Injectable contraceptive (DMPA or NET) DMPA - 3 monthly; NET - two monthly continuous long acting hormonal contraception 1254
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women undergoing pregnancy termination who consented to participation post-termination, with random allocation of contraception methods. Not consenting. Contraindications to DMPA, NET or IUD. 16 Year(s) 45 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/07/2008 Wits Medical Ethics Committee
Ethics Committee Address
Street address City Postal code Country
10th Floor, Senate House, University of the Witwatersrand Johannesburg 2000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome unplanned pregnancy 12 months
Secondary Outcome HIV acquisition 12 months
Secondary Outcome HIV disease progression 12 months
Secondary Outcome Menstrual effects 3, 6, 9 and 12 months
Secondary Outcome Other effects, including sexual desire, weight gain, depression and condom use 3, 6, 9, 12 months
Secondary Outcome Discontinuation 3, 6, 9, 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
East London Hospital Complex (Frere and Celcelia Makiwane Hospitalsl Private Bag X9047 Cambridge 5206 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Effective Care Research Unit Private Bag X9047 Cambridge 5206 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Effective Care Research Unit Private Bag X9047 Cambridge 5206 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Justus Hofmeyr ECRU, East London Hospital Complex Private Bag X9047 5206 South Africa
Mandisa Singata ECRU, East London Hospital Complex Cambridge 5206 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Justus Hofmeyr justhof@gmail.com +27 43 708 2353 ECRU, East London Hospital Complex
City Postal code Country Position/Affiliation
East London South Africa Director
Role Name Email Phone Street address
Public Enquiries Mandisa Singata mandisa.singata@gmail.com +27 43 708 2353 ECRU, East London Hospital Complex
City Postal code Country Position/Affiliation
East London South Africa Project Manager
Role Name Email Phone Street address
Scientific Enquiries Justus Hofmeyr justhof@gmail.com +27 43 708 2353
City Postal code Country Position/Affiliation
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information