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.: PACTR202408852551318 Date of Approval: 01/08/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Foley catheter versus laminaria for cervical preparation prior to second trimester dilation and evacuation: Open label a non-inferiority randomized trial
Official scientific title Foley catheter versus laminaria for cervical preparation prior to second trimester dilation and evacuation: Open label a non-inferiority randomized trial
Brief summary describing the background and objectives of the trial Background: Although the use of Foley catheter for cervical ripening during third trimester is well studied, little is known regarding the use of Foley for cervical preparation prior to second trimester dilation and evacuation(D&E). Too few studies show it is safe and effective method of cervical preparation prior to second trimester D&E. Objectives: To determine the effectiveness of the trans-cervical Foley balloon for cervical preparation compared to Laminaria prior to second trimester dilation and evacuation (D&E).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) La Foca
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Abortion
Purpose of the trial Treatment: Surgery
Anticipated trial start date 22/07/2024
Actual trial start date 02/08/2024
Anticipated date of last follow up 31/12/2024
Actual Last follow-up date 05/12/2024
Anticipated target sample size (number of participants) 128
Actual target sample size (number of participants) 60
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Cervical preparation with Foley catheter prior to second trimester D and E Single catheter overnight After enrollment, each patient in the trans-cervical Foley group will have Foley balloon placed in a standard and sterile fashion ( In all cases, the day prior to the procedure a vaginal speculum will be placed and the cervix will be prepared with povidine-iodine) by residents or family planning fellows.Foley catheter will be placed under direct visualization using ring forceps to guide the tip of the catheter into the cervical os and the Foley catheter balloon will be inflated to 50 mL of normal saline and taped to the patient’s leg. Mifepristone 200 mg oral stat will also be given at the time of insertion of the Foley catheter. 30
Control Group Laminaria Gestational age dependenent ( BPD measurment in Centimeters/2) overnight In the case of Laminaria group , laminaria will be placed in their cervix in in a standard, sterile fashion by family planning fellows or attending(senior sub-specialist). In the laminaria group, sufficient number of laminaria as judged by the individual provider will be inserted into the cervix, under direct visualization using ring forceps to guide the tip of the laminaria into the cervical os. Mifepristone 200 mg oral stat will also be given at the time of insertion of laminaria. 30 Active-Treatment of Control Group
Experimental Group Cervical preparation with Foley catheter prior to second trimester D and E Single catheter overnight After enrollment, each patient in the trans-cervical Foley group will have Foley balloon placed in a standard and sterile fashion ( In all cases, the day prior to the procedure a vaginal speculum will be placed and the cervix will be prepared with povidine-iodine) by residents or family planning fellows.Foley catheter will be placed under direct visualization using ring forceps to guide the tip of the catheter into the cervical os and the Foley catheter balloon will be inflated to 50 mL of normal saline and taped to the patient’s leg. Mifepristone 200 mg oral stat will also be given at the time of insertion of the Foley catheter. 30
Control Group Laminaria Gestational age dependenent ( BPD measurment in Centimeters/2) overnight In the case of Laminaria group , laminaria will be placed in their cervix in in a standard, sterile fashion by family planning fellows or attending(senior sub-specialist). In the laminaria group, sufficient number of laminaria as judged by the individual provider will be inserted into the cervix, under direct visualization using ring forceps to guide the tip of the laminaria into the cervical os. Mifepristone 200 mg oral stat will also be given at the time of insertion of laminaria. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Women undergoing second trimester D&E -Gestational age at 16-22 weeks -Volunteering to participate in the study Elective D&E procedure -Incomplete abortion -Molar pregnancy Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 16 Year(s) 44 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 12/07/2024 SPHMMC Institutional Research Ethics Review Committee IRERC
Ethics Committee Address
Street address City Postal code Country
Swaziland street, Addis Ababa, Ethiopia. Addis Ababa 1271 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean dilation and evacuation- D&E -procedure time (in minutes) after overnight laminaria or Foley catheter placement From vaginal speculum insertion until vaginal speculum removal
Secondary Outcome requirement of additional doses of misoprostol ( 2 or more doses) , Foley or Laminaria insertion to D&E time, D&E complications ( hemorrhage, cervical tear, infection, uterine perforation , failed cervical preparation, and incomplete abortion ), and patient acceptability of the cervical preparation methods within 24 hours untill 21 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
St. Pauls Hospital Millennium Medical College Swaziland street, Addis Ababa, Ethiopia. Addis Ababa 1271 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
St. Paul Institute for Reproductive Health and Rights Swaziland street, Addis Ababa, Ethiopia. Addis Ababa 1271 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor St. Paul Institute for Reproductive Health and Rights Swaziland street, Addis Ababa, Ethiopia. Addis Ababa 1271 Ethiopia NGO
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abraham Fessehaye Sium abrahamfessehaye4@gmail.com +25129123745 Swaziland street, Addis Ababa, Ethiopia.
City Postal code Country Position/Affiliation
Addis Ababa 1271 Ethiopia SPHMMC
Role Name Email Phone Street address
Public Enquiries Abraham Fessehaye Sium abrahamfessehaye4@gmail.com +251929123745 Swaziland street, Addis Ababa, Ethiopia.
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia SPHMMC
Role Name Email Phone Street address
Scientific Enquiries Abraham Fessehaye Sium abrahamfessehaye4@gmail.com +251929123745 Swaziland street, Addis Ababa, Ethiopia.
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia SPHMMC
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data requests can be submitted starting 2 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact abrahamfessehaye4@gmail.com. Analytic Code,Study Protocol March 2025 Access is controlled and it can be granted from the department of obsteterics and Gynecology at SPHMMC up on reasonable request
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 09/04/2025 Data collection started after trial registration confirmation, which is August 2, 2024 29 Jul 2024 02 Aug 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 18/04/2025 Data collection was concluded on December 5 31 Jan 2025 05 Dec 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 18/04/2025 Up on intrerim analysis, the margin of benefit -primary outcome- was attained. 128 60
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 18/04/2025 Data collection concluded Not yet recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 06/05/2025 The final sample size was modified to 60, and only 30 participants were included in this group Experimental Group, Cervical preparation with Foley catheter prior to second trimester D and E, Single catheter , overnight , After enrollment, each patient in the trans-cervical Foley group will have Foley balloon placed in a standard and sterile fashion ( In all cases, the day prior to the procedure a vaginal speculum will be placed and the cervix will be prepared with povidine-iodine) by residents or family planning fellows.Foley catheter will be placed under direct visualization using ring forceps to guide the tip of the catheter into the cervical os and the Foley catheter balloon will be inflated to 50 mL of normal saline and taped to the patient’s leg. Mifepristone 200 mg oral stat will also be given at the time of insertion of the Foley catheter., 30,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 06/05/2025 The final sample size was modified to 60, and only 30 participants were included in this group Control Group, Laminaria , Gestational age dependenent ( BPD measurment in Centimeters/2), overnight , In the case of Laminaria group , laminaria will be placed in their cervix in in a standard, sterile fashion by family planning fellows or attending(senior sub-specialist). In the laminaria group, sufficient number of laminaria as judged by the individual provider will be inserted into the cervix, under direct visualization using ring forceps to guide the tip of the laminaria into the cervical os. Mifepristone 200 mg oral stat will also be given at the time of insertion of laminaria., 64, Active-Treatment of Control Group Control Group, Laminaria , Gestational age dependenent ( BPD measurment in Centimeters/2), overnight , In the case of Laminaria group , laminaria will be placed in their cervix in in a standard, sterile fashion by family planning fellows or attending(senior sub-specialist). In the laminaria group, sufficient number of laminaria as judged by the individual provider will be inserted into the cervix, under direct visualization using ring forceps to guide the tip of the laminaria into the cervical os. Mifepristone 200 mg oral stat will also be given at the time of insertion of laminaria., 30, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 23/07/2024 We have been requested by the PACTR Admin to make the changes. Individual Participant Data (IPD) Sharing Statement will be secured among the study group and for any external request , access will be controlled and it can be granted up on reasonable request from the department of Obstetrics and Gynecology at SPHMMC. We will avail summarly results or a link to summary results shortly after completion of the data collection by March 2025. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research within one month after completion of data completion, February to March 2025. For more information or to submit a request, please contact abraham.fessehaye@sphmmc.edu.et
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 30/07/2024 Requested by PACTR Admin to rewrite it appropriately. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research within one month after completion of data completion, February to March 2025. For more information or to submit a request, please contact abraham.fessehaye@sphmmc.edu.et Data requests can be submitted starting 2 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact abrahamfessehaye4@gmail.com.