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.: PACTR201201000349329 Date of Approval: 26/01/2012
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The influence of Antenatal Counselling on use of modern postpartum contraception in Ile-Ife
Official scientific title The influence of antenatal counselling on use of modern postpartum contraception in Ile-Ife
Brief summary describing the background and objectives of the trial Of late there has been intense global desire to reduce maternal morbidity and mortality by reducing the rate of unplanned pregnancy. It is believed that improvement of contraceptive knowledge has the potential to positively impact the myths, negative beliefs and misconceptions regarding contraception, which discourage contraceptive use. However contention abounds on the optimal time to provide this knowledge.This study aims to determine the influence of antenatal contraceptive counselling on modern postpartum contraceptive use when compared to traditional single-encounter postpartum contraceptive counselling.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Contraceptive uptake,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Education /Training
Anticipated trial start date 01/04/2011
Actual trial start date 01/06/2011
Anticipated date of last follow up 31/01/2012
Actual Last follow-up date 31/03/2012
Anticipated target sample size (number of participants) 216
Actual target sample size (number of participants) 216
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
ERC/2011/04/12 IRB/IEC/0004553 ; NHREC/27/02/2009a
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 Simple randomisation using a randomisation table created by a computer software Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Antenatal Counselling Group 3 or more times during antenatal care 25 minutes intervention group will receive one-to-one antenatal contraceptive counselling and will be exempted from the traditional single-encountered postpartum contraceptive counselling 108
Control Group Postnatal Counselling Group Once during sixth week postnatal clinc visit 25 minutes Patients in this group will be offered the standard local care with regard to contraceptive advice, that is, the traditional single-encounter contraceptive counselling when they come at the sixth week postnatal check. 108 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All booked pregnant women in third trimester within the gestational ages of 28-37 weeks. 1.Pregnant women in First and Second trimester. 2.Pregnant women who request for contraception on their own at the Antenatal clinic 3.Women in whom postpartum contraception is indicated e.g. Sickle cell patients, women with de-compensating cardiac disease, e.t.c. 4.Booked pregnant women in third trimester who refuse to give consent. 15 Year(s) 49 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 01/04/2011 Obafemi Awolowo University Teaching Hospital Ethics and research committee
Ethics Committee Address
Street address City Postal code Country
OAUTHC, ILESA ROAD, Ile-Ife 10001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Use of modern method of contraception 6-9 months after delivery
Secondary Outcome Use of traditional method of contraception 6-9 months after delivery
Secondary Outcome Level of unmet need 6-9 months after delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Obafemi Awolowo University Teaching Hospital Ilesa Road, Ile-Ife 10001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Obafemi Awolowo University Teaching Hospital Ilesa road Ile-Ife 10001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Obafemi Awolowo University Teaching Hospital Ilesa road Ile-Ife 10001 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Obafemi Awolowo University Teaching hospital Ilesa road Ile-Ife 10001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abiodun Adanikin adanikinbiodun@yahoo.com +2348034252126 P.O.BOX 1799, Lagere
City Postal code Country Position/Affiliation
Ile-Ife 10001 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Olabisi Loto bisiloto@yahoo.co.uk +2348066546725 OAUTHC, Ilesa road
City Postal code Country Position/Affiliation
Ile-Ife 10001 Nigeria Consultant
Role Name Email Phone Street address
Scientific Enquiries Uche Onwudiegwu uonwudie@yahoo.com +2348065984191 OAUTHC, Ilesa road
City Postal code Country Position/Affiliation
Ile-Ife 10001 Nigeria Professor
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information