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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR201210000420221 |
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Date of registration:
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26/09/2012 |
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Primary sponsor: |
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Public title:
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Effects of the copper intrauterine device and injectable progestogen contraceptive on depression and sexual functioning
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Scientific title:
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A randomised control trial studying the effects of the copper intrauterine device and injectable progestogen contraceptive on depression and sexual functioning of women in the Eastern Cape |
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Date of first enrolment:
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2012-10-15 |
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Target sample size:
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200 |
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Recruitment status: |
Not yet recruiting |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201210000420221 |
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Study type:
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interventional |
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Study design:
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Single group: all participants receive same intervention throughout study,
Randomised,
simple randomisation using a randomisation table created by a computer program ,
Sealed opaque envelopes,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Mandisa
Singata |
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Address:
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Room 68 Admin Block, Cecilia Makiwane Hospital,Mdantsane
5201
East London
South Africa |
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Telephone:
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+27 43 708 2134 |
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Email:
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mandisa.singata@gmail.com |
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Affiliation:
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Deputy Director |
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Name:
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Mandisa
Singata |
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Address:
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Room 68 Admin Block, Cecilia Makiwane Hospital,Mdantsane
5201
East London
South Africa |
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Telephone:
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+27 43 708 2134 |
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Email:
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mandisa.singata@gmail.com |
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Affiliation:
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Deputy Director |
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Key inclusion & exclusion criteria
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Inclusion criteria: Women of child bearing age between 18 to 35 years
Women with no evidence of active pelvic infection
Women who have no contraindications to injectable Progestogen or IUD
Women who are prepared to use either method of contraception
Women delivered less than 48 ago.
Women who are willing and able to give consent.
Exclusion criteria: Recent noticed vaginal bleeding that is unusual.
Any contraindication for deport injection and IUD as stated on the WHO contraceptive eligibility criteria will.
Women at baseline screening with depression score of 29 - 63(severe depression)
Women with no access to telephone
Age minimum:
18 Year
Age maximum:
35 Year
Gender:
Female
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Health Condition(s) or Problem(s) studied
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depression,sectual functioning
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Primary Outcome(s)
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depression and sexual functioning
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Source(s) of Monetary Support
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Effective Care Research Unit
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