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.: PACTR201910683607569 Date of Approval: 08/10/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Intrauterine contraception among postpartum women in Uganda
Official scientific title A randomized controlled trial of copper and levonorgestrel intrauterine contraceptive devices among postpartum women in Uganda.
Brief summary describing the background and objectives of the trial Utilization of postpartum contraception for maternal and child survival has long been a recognized concept. Thus, implementing of special family planning programs for postpartum women has been recognized as the standard of care since 1966 (Akinlo A etal 2013). Evidence shows that, the risk of maternal and child mortality and morbidity are very high when pregnancy occurs at short intervals after childbirth (Cleland J et al 2006). Contraception may be initiated in the immediate (one week after child birth), delayed (4-6 weeks postpartum) and extended (within one year) postpartum. Uganda’s key reproductive health indicators are poor with high fertility rate of 5.4%, low contraceptive prevalence of 36% and a very high unmet need for family planning of 34 % resulting in high maternal and perinatal morbidity and mortality (UBOS, 2011). Sadly, 56% of all the pregnancies in Uganda are unwanted, contributing to the poor maternal and newborn outcomes. While about one-third (33%) of all pregnancies nationally terminate as unsafe abortions, a further one-quarter (25%) non-first deliveries are high risk as they occur within 12 months of delivery despite the recommended 36 months (UBOS, 2011). Although antenatal care attendance for pregnant women is as high as 94% during the first visit and 73% of the women deliver at health facilities, only 10% of them return to initiate contraception at the 6 weeks postpartum clinics (UBOS, 2011). Thus the need to initiate contraception in the immediate postpartum period
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PPIUC
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Prevention
Anticipated trial start date 18/11/2019
Actual trial start date
Anticipated date of last follow up 02/12/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 232
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Insertion of copper T 360A Copper T 380A 12 months Copper T 380A will be inserted into the uteri of postpartum women within 48hours of child birth 116 Active-Treatment of Control Group
Experimental Group Levonorgestrel intrauterine system Levonorgestrel-releasing intrauterine system consists of a T-shaped polyethylene frame with a steroid reservoir around the vertical stem. The reservoir consists of a white or almost white cylinder, made of a mixture of levonorgestrel and silicone, containing a total of 52 mg of levonorgestrel. Levonorgestrel is released at a rate of approximately 20 μg/day. This rate decreases progressively to half that value after 5 years 12 Levonorgestrel-releasing intrauterine system will be inserted into the uteri of postpartum women within 48hours of child birth 116
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Postpartum women who will be willing to be followed up and give informed consent • Intrapartum chorioamnionitis (defined as maternal fever >100.4 and two of the following conditions: Maternal leukocytosis (greater than 15,000 cells/cubic millimeter), Maternal tachycardia (greater than 100 beats/minute), Fetal tachycardia (greater than 160 beats/minute), Uterine tenderness, Foul odor of the amniotic fluid • Postpartum Hemorrhage (defined as >500cc EBL for spontaneous vaginal delivery or >1000cc for cesarean delivery) • Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity • Acute liver disease or liver tumor • Hypersensitivity to any component of the product • Known or suspected carcinoma of the breast • Current breast cancer or breast cancer within the past 5 years • Decompensated cirrhosis or a liver tumor • Known or suspected uterine or cervical neoplasia or unresolved, abnormal pap smear • Unexplained vaginal bleeding prior to pregnancy Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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
No 05/08/2019 Uganda National council fpor Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Rd, Kampala P.O. BOX 6884, KAMPALA Kampala 0414 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Expulsion of copper T 380A and Levonorgetstrel intrauterine system 3weeks, 3, 6 and 12 months
Secondary Outcome Discontinued of intrauterine contraceptives, Abnormal vaginal bleeding, Cramping, satisfaction with intrauterine contraception Post insertion sepsis and breastfeeding continuation over the 12 months. 3weeks, 3, 6 and 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gulu Regional referral Hospital Gulu Town Gulu Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Makerere University Kampala Kampala Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Makerere Unversity Kampala Kampala Uganda University
COLLABORATORS
Name Street address City Postal code Country
Prof. Byamugisha Josasphat Makerere University College of Health Sciences, Old Mulago Hill Kampala Uganda
Prof James Tumwine Makerere University College of Health Sciences, Old Mulago Hill Kampala Uganda
Prof. Kristina Gemzell Danielsson 17177 Stockholm Stockholm Sweden
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Othman Kakaire kakaireothman@hotmail.com +256772514616 Old Mulago Hill
City Postal code Country Position/Affiliation
Kampala Uganda Senior Lecturer
Role Name Email Phone Street address
Scientific Enquiries Josaphat Byamugisha jbyamugisha@gmail.com +256772580330 Old Mulago Hill
City Postal code Country Position/Affiliation
Kampala Uganda Associate Professor department of Obstetrics and Gyneacolgy MakCHS
Role Name Email Phone Street address
Public Enquiries Ponsiano Ocama pocama@idi.co.ug +256772421190 Old Mulago Hill
City Postal code Country Position/Affiliation
Kampala Uganda Prof. Department of internal medicine MakCHS
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data set, analytical codes and summary results will be included within the trail registration record Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 12 months of data collection completion Open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information