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.: PACTR201804003324963 Date of Registration: 12/04/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Immediate Versus Delayed IUD Insertion After Second Trimester Medical Abortion
Official scientific title Immediate Versus Delayed Insertion of the Copper IUD After Second-trimester Medical Abortion - a Randomised Controlled Trial.
Brief summary describing the background and objectives of the trial Studies have shown that it is safe to insert an IUD immediately after surgical or medical abortion in the first trimester. Insertion of an IUD after second-trimester surgical abortion is also safe and does not lead to greater rates of infection compared to delayed insertion. The IUD is somewhat more likely to be expelled in women with immediate insertion but this is compensated by a much higher continued use at 6 months. Immediate insertion of an IUD after medical abortion in the second trimester, without surgical evacuation of the placenta, has however not yet been investigated. This research collaboration between the Women¿s Health Research Unit (WHRU) and Groote Schuur Hospital (GSH) will investigate how many women are still using the copper IUD at 3 and 6 months following immediate insertion compared to the delayed insertion at community health centres.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Contraception after second trimester medical abortion,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 10/05/2019
Actual trial start date 01/08/2018
Anticipated date of last follow up 18/01/2020
Actual Last follow-up date 30/01/2020
Anticipated target sample size (number of participants) 110
Actual target sample size (number of participants)
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 The randomisation scheme will be based on computer-generated permuted blocks of varying size 4-6. The allocation ratio will be one-to-one Sequentially numbered, opaque, sealed envelopes containing the allocation Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Delayed group 2-4 weeks after abortion The copper IUD will be inserted at a local community health centre 2-4 weeks after discharge 55
Experimental Group Immediate group within 24 hours of complete abortion The copper IUD will be inserted within 24 hours of the expulsion of the fetus and placenta or after surgical evacuation for placental remains, and prior to discharge from the facility. 55 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age 18 years or older; Able to speak English, Afrikaans or Xhosa; Requesting abortion and eligible for legal termination of pregnancy according to standard practice at the hospital; Gestational age (GA) 13-20 weeks verified by ultrasound (most women will be >16 weeks GA at the study site, however women with GA 13-15 weeks will be eligible); Interested and eligible for the copper IUD as a post-abortion contraceptive method; Willing to do a telephone interview at 3- and 6-months post-abortion; Able to provide a working phone telephone number to allow for contact for follow up interviews; Willing to be randomized to immediate or delayed IUD insertion; and Willing and able to provide informed consent Active pelvic inflammatory disease, pelvic tuberculosis; severe thrombocytopenia; Severe dysmenorrhea Copper allergy Hb <10g/dL Uterine anomaly preventing placement of the IUD; cervical cancer or carcinoma in-situ, untreated high grade squamous intraepithelial lesions Desire for repeat pregnancy in following 12 months Hemorrhage; or ruptured uterus 18 Year(s) 60 Year(s) Male
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 05/04/2018 University of Cape Town Huan Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
MAin Rd Observatory 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Insertion and use of the IUD 6 weeks
Secondary Outcome Use of the IUD 3 months
Secondary Outcome Spontaneous expulsion of the IUD 6 weeks post abortion
Secondary Outcome Abortion-related and IUD-related complications 3 months post abortion
Secondary Outcome Removal of the IUD and associated factors 3 and 6 months after abortion
Secondary Outcome Women's satisfaction and acceptability of the IUD 3 and 6 months post abortion
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Groote Schuur Hospital Main Rd Observatory 7925 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Anonymous donor
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Cape Town Faculty of Health Sciences Anzio Rd Obesrvatory 7925 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Deborah Constant Main Rd Observatory 7925 South Africa
Malika Patel Main Rd Observatory 7925 South Africa
Margit Endler Main Rd Observatory 7925 South Africa
Gregory Petro Main Rd Green Point 8001 South Africa
Daniel Grossman Oakland San Francisco United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Malika Patel m.patel@uct.ac.za + 27 21 404 2032 Main Rd
City Postal code Country Position/Affiliation
Observatory 7925 South Africa Head of Family Planning, Dept O&G, GSH
Role Name Email Phone Street address
Principal Investigator Deborah Constant deborah.constant@uct.ac.za 0214066722 University of Cape Town
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Senior Researcher, Women's Health Research Unit
Role Name Email Phone Street address
Scientific Enquiries Margit Endler margit.endler@ki.se + 27 64 61764 77 Main Rd
City Postal code Country Position/Affiliation
Observatory 7925 South Africa Senior Researcher, Women's Health Research Unit
REPORTING
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