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.: PACTR201810731753052 Date of Approval: 30/10/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Outcomes of Medical versus Surgical Management of First Trimester Incomplete Abortion on Among Women Admitted at Kampala International University Teaching Hospital (KIU -TH)
Official scientific title Outcomes of Medical versus Surgical Management of First Trimester Incomplete Abortion on Among Women Admitted at Kampala International University Teaching Hospital (KIU -TH)
Brief summary describing the background and objectives of the trial Abortion is common occurring in about 54 women per 1000 pregnant women in Uganda. Management is by either medical ( misoprostol tabs) or surgical (manual vacuum aspiration). Surgical management is believed to reduce hemorrhage and infection while providing immediate evacuation. However, its complications include trauma, endometritis, anesthesia, uterine synachiae, subfertility, ectopic pregnancy nad morbid placenta adherence. It also requires skilled health workers , special equipment and anesthesia. Medical method can be administered by low and middle providers and is thought to work well especially in areas lacking skilled personnel, uterine abnormalities, areas with no surgical instruments or anesthetic capability and patients already with established complications of surgical method. Also,misoprostol to be kept at room temperature, it is inexpensive and widely available making it favorable in resource - limited areas. However, medical method has complications like need for emergency surgical evacuation, hemorrhage, pain, increase in induction – abortion time and increase in analgesia requirement. No studies have been done comparing the two methods in KIU-TH. GENERAL OBJECTIVE To compare the effectiveness, secondary outcomes and satisfaction level between surgical and medical management of first trimester incomplete abortion among women admitted at KIU-TH. RESEARCH QUESTIONS 1. What is the comparative effectiveness of medical and surgical management in the management of first trimester incomplete abortion among women admitted at KIU-TH? 2. What are the comparative secondary outcomes encountered among women admitted in KIU-TH when first trimester incomplete abortion is managed using medical versus surgical methods? 3. What is the comparative level of satisfaction with the management method assigned to women with first trimester incomplete abortion admitted at KIU-TH?
Type of trial RCT
Acronym (If the trial has an acronym then please provide) incomp
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/11/2018
Actual trial start date
Anticipated date of last follow up 31/01/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group medical management Misoprostol tablets 800micrograms in the posterior vaginal fornix 6 hourly to a maximum of three doses 24 hours given to a maximum of three doses 6 hourly depending on condition of patient.the patient is then admitted for 48 hours and reviewed PRN. the final review is after 48 hours to confirm uterine evacuation using pelvic ultrasound scan 50
Control Group surgical management using Manual vacuum aspiration done as early as feasible in minor theatre immediately done in minor theatre once under paracervical block as anaesthesia. patients admitted for 48 hours and reviewed PRN. final review is after 48 hours using pelvic ultrasound scan to confirm complete evacuation. 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women with first trimester incomplete abortion admitted in gynaecology ward who are; 1. Hemodynamically stable with no signs of hypovolaemia or shock due to excessive bleeding. 2. In first trimester of pregnancy with weeks of amenorrhea at ≤12 weeks. 3. Having Per vaginal bleeding with retained products of conception suggestive of incomplete abortion. 4. No contraindication for misoprostol use like allergy to prostaglandins and previous uterine scars. 6. No major organ disease like renal, cardiovascular, nervous, liver, hematological or immunosuppressive disease. Women with evidence of infection: temperature <36 or >38 degrees Celsius, Pulse Rate >100, Respiratory rate >20 respirations/min 2 .Women with structural uterine abnormalities like unicornuate or bicornuate uterus and uterine septum. 3. Women with previous fresh uterine scars (less than 18 months) since they are at increased risk of uterine rupture 4. Patients with ≥2 previous scars as this increases the risk of uterine rupture. 5. Patients with more than three abortions as this would alter the findings on satisfaction and secondary outcomes. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 51 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 02/07/2018 Research Ethics Committee of Kampala International University
Ethics Committee Address
Street address City Postal code Country
71 Ishaka Uganda Bushenyi 000256 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome (effectiveness) was assessed by complete uterine evacuation within 48 hours. This was done by history of no vaginal bleeding or abdominal pain, physical exam of the abdomen to rule out tenderness and pelvic exam by speculum to check for no retained products. Trans-abdominal ultrasound scan was used to confirm complete evacuation by ruling out retained products of >30mls. If the retained products was >30mls, this was captured as failure of the primary method to cause complete evacuation. 48 hours
Secondary Outcome 1. Duration of bleeding while on the ward. Mild - less than 6 hours of bleeding Moderate - between 7- 12 hours of bleeding Severe – more than 12 hours. 2. Infections using vitals, pelvic examination by speculum and digital examination, laboratory findings of CBC and imaging studies like abdominal pelvic ultrasound. Temperature <36 or >38degrees Celcius, Pulse rate >100/min, offensive smelling yellowish or pus like vaginal discharge, adnexal tenderness, cervical motion tenderness and elevated white blood cells pointed towards an infection. 3. Pain using Likert scale Use of seven circles progressively increasing in size for the patient to pick the circle that is proportionate to her pain. Smallest being the least pain while greatest maximum pain. Mild pain – Likert scale between1-3 Moderate – Likert scale between 4-5 Severe – Likert scale between 6-7 4. If they would recommend the method determined by interview. 5. Hospital stay or need for readmission if admitted for more than 48 hours. 6. Need for second method if there is primary failure. 7.Trauma to genitourinary tract evidenced by abdominal examination, pelvic examination and trans-abdominal pelvic ultrasound scan. 8.Satisfaction Satisfaction with the method determined through satisfaction tool (Powell; 2010). The parameters used to asses this were: a) Level of pain of less than 3 on Likert scale ( 1 point) b) If they recommended the method (1 point) c) Completion of abortion (1 point) d) Any complications (syncope, blood transfusion, severe headaches and dizziness, infection, genitourinary trauma). 1 point if there was no any complication. This was then awarded scores between 0/4 to 4/4 and this determined satisfaction. ≤1/4 – very dissatisfied 2/4 – somewhat dissatisfied. 3/4 – somewhat satisfied 4/4 –very satisfied 48 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kampala International University Teaching Hospital ishaka Bushenyi Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
personal savings ishaka Bushenyi Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor victor tetty otieno 71 bushenyi bushenyi 00256 Uganda Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator victor Otieno tettyvictor@yahoo.com +256750813662 ishaka Bushenyi
City Postal code Country Position/Affiliation
Bushenyi 00256 Uganda medical officer
Role Name Email Phone Street address
Public Enquiries pwaveno Bamaiyi pwaveno.bamaiyi@kiu.ac.ug +256703966538 71 ishaka
City Postal code Country Position/Affiliation
Bushenyi 00256 Uganda Director Post graduate studies KIU
Role Name Email Phone Street address
Scientific Enquiries Emilio Sanchez esanchez72@gmail.com +256703966538 71 ishaka
City Postal code Country Position/Affiliation
Bushenyi 00256 Uganda senior lecturer KIU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes questionnaire, lab reports and ultrasound reports will be used to capture IPD that will be analysed that will include baseline characteristics,clinical presentation, management plan assigned, primary outcome, secondary outcome and satisfaction levels. Informed Consent Form,Statistical Analysis Plan,Study Protocol 6 months after study completion misoprostol versus MVA outcomes when reviewed after 48 hours
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