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.: PACTR201901521518882 Date of Approval: 24/01/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title process of labor in women with female genital mutilation / cutting
Official scientific title The assessment of pain score, anxiety levels and process of labor in women with female genital mutilation / cutting: A Multicenter, prospective, randomized, controlled study.
Brief summary describing the background and objectives of the trial Female genital mutilation is widely practiced in Africa and especially Somalia. There is stenosis in the vagina after the procedure. We aimed to evaluate the effect of female genital mutilation on the labor process with a multicentre, prospective, randomized and controlled study.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Female genital mutilation labor process
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 13/11/2018
Actual trial start date 13/11/2018
Anticipated date of last follow up 31/03/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 400
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 Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group FGM Group from admission to postpartum 45th day In both centers, participants with an odd number of file numbers will be placed in groups. The patients who have double numbers of file will not be taken into groups. In this way, randomization will be provided in both centers. A total of 200 pregnant women who had undergone FGM were randomized in Mogadishu Somali Turkey Recep Tayyip Erdogan Education and Research Hospital and a total of 200 pregnant women who had undergone without FGM were randomized in Trabzon Kanuni Education and Research Hospital. Totally, 400 patient will be taken in the study. All labor processes in the delivery room (delivery week, 1st stage of delivery, latent and active phase duration, duration of 2nd stage, duration of 3rd stage, episiotomy and obstetric tears, amount of bleeding, The amount of hemoglobin before and after birth, visual analog pain score, anxiety scale, maternal and fetal complications, fetus intensive care need, weight and apgar score) will be recorded. Visual analogue pain score and axiality score will be applied to patients at both centers at the beginning of labor. During the labor, the pain score will be re-examined in the active phase. 200
Control Group Without FGM group from admission to postpartum 45th day In both centers, participants with an odd number of file numbers will be placed in groups. The patients who have double numbers of file will not be taken into groups. In this way, randomization will be provided in both centers. A total of 200 pregnant women who had undergone FGM were randomized in Mogadishu Somali Turkey Recep Tayyip Erdogan Education and Research Hospital and a total of 200 pregnant women who had undergone without FGM were randomized in Trabzon Kanuni Education and Research Hospital. Totally, 400 patient will be taken in the study. All labor processes in the delivery room (delivery week, 1st stage of delivery, latent and active phase duration, duration of 2nd stage, duration of 3rd stage, episiotomy and obstetric tears, amount of bleeding, The amount of hemoglobin before and after birth, visual analog pain score, anxiety scale, maternal and fetal complications, fetus intensive care need, weight and apgar score) will be recorded. Visual analogue pain score and axiality score will be applied to patients at both centers at the beginning of labor. During the labor, the pain score will be re-examined in the active phase. 200 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Women aged 18-45 2. Women with previous female circumcision (RTE EAH) 3. Pregnant women who have not undergone female genital mutilation (Trabzon Kanuni EAH) 4. Women with BMI <35 5. Women who agree to participate in the study 6. Pregnant women with nulliparity 7. Women with 37-42 weeks of pregnancy 1. Women with BMI> 35 2. Women who have undergone previous vaginal surgery 3. Women who do not want to participate in the study 4. multiparity Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 45 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 13/11/2018 MOGADISHU SOMALI TURKEY RECEP TAYYIP ERDOGAN EDUCATION AND RESEARCH HOSPITAL ETTICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
RECEP TAYYIP ERDOGAN STREET Mogadishu 12345 Somalia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome All labor processes in the delivery room (delivery week, 1st stage of delivery, latent and active phase duration, duration of 2nd stage, duration of 3rd stage, episiotomy and obstetric tears, amount of bleeding, The amount of hemoglobin before and after birth, maternal and fetal complications, fetus intensive care need, weight and apgar score) will be recorded. from admission to discharge
Primary Outcome Visual analogue pain score and axiality score will be applied to patients at both centers at the beginning of labor. During the labor, the pain score will be re-examined in the active phase. from admission to discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
MOGADISHU SOMALI TURKEY RECEP TAYYIP ERDOGAN EDUCATION AND RESEARCH HOSPITAL RECEP TAYYIP ERDOGAN STREET MOGADISHU Somalia
TRABZON KANUNI EDUCATION AND RESEARCH HOSPITAL MARAS STREET TRABZON Turkey
FUNDING SOURCES
Name of source Street address City Postal code Country
MOGADISHU SOMALI TURKEY RECEP TAYYIP ERDOGAN EDUCATION AND RESEARCH HOSPITAL RECEP TAYYIP ERDOGAN STREET MOGADISHU Somalia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor MOGADISHU SOMALI TURKEY RECEP TAYYIP ERDOGAN EDUCATION AND RESEARCH HOSPITAL RECEP TAYYIP ERDOGAN STREET MOGADISHU Somalia Hospital
COLLABORATORS
Name Street address City Postal code Country
Kubra Baki Erin Trabzon Kanuni Eitim ve Arastrma Hastanesi Numune Kanpusu Inonu mahallesi, Maras Caddesi, Ortahisar/Trabzon Trabzon 61029 Turkey
Deniz Kulaksiz Trabzon Kanuni Eitim ve Arastrma Hastanesi Numune Kanpusu Inonu mahallesi, Maras Caddesi, Ortahisar/Trabzon Trabzon 61029 Turkey
Yesim Bayoglu Tekin Trabzon Kanuni Eitim ve Arastrma Hastanesi Numune Kanpusu Inonu mahallesi, Maras Caddesi, Ortahisar/Trabzon Trabzon 61029 Turkey
Ifra Abdi Nor Recep Tayyip Erdogan Street Mogadishu 12345 Somalia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator RECEP ERIN erinrecep@gmail.com +905335629874 Recep Tayyip Erdogan Street
City Postal code Country Position/Affiliation
Mogadishu Somalia Ass. Prof. Dr.
Role Name Email Phone Street address
Principal Investigator Ifrah Abdi Nor evrahabdi@live.com +252615092754 Recep Tayyip Erdogan Street
City Postal code Country Position/Affiliation
Mogadishu Somalia Ass. Dr.
Role Name Email Phone Street address
Principal Investigator Kubra Baki Erin kubrabakierin@gmail.com +905064068593 Kisarna Street
City Postal code Country Position/Affiliation
Trabzon Turkey Ass. Prof. Dr.
Role Name Email Phone Street address
Principal Investigator Yesim Bayoglu Tekin yesimbay@yahoo.com +905055171973 Maras Street
City Postal code Country Position/Affiliation
Trabzon Turkey Asc. Prof. Dr.
Role Name Email Phone Street address
Principal Investigator Deniz Kulaksiz drdenizkulaksiz@gmail.com +905538671461 Maras Street
City Postal code Country Position/Affiliation
Trabzon Turkey Ass. Prof. Dr.
Role Name Email Phone Street address
Scientific Enquiries Recep Erin erinrecep@gmail.com +905335629874 Recep Tayyip Erdogan Street
City Postal code Country Position/Affiliation
Mogadishu Somalia Ass. Prof. Dr.
Role Name Email Phone Street address
Public Enquiries Samaara Hassan samaara010@gmail.com +252615937497 Recep Tayyip Erdogan Street
City Postal code Country Position/Affiliation
Mogadishu Somalia Miss.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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