Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202009857889210 Date of Approval: 23/09/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Sublingual Misoprostol Versus Manual Vacuum Aspiration for Treatment of Incomplete Abortion in Nigeria: A Randomized Control Study
Official scientific title Misoprostol for incomplete miscarriage
Brief summary describing the background and objectives of the trial Incomplete abortion contributes significantly to maternal morbidity and mortality in developing countries. The constraints associated with accessing post-abortion care services with manual vacuum aspirator including the need for theatre space, sterile instruments, and skilled providers; call for the exploration of other effective, accessible, and acceptable non-surgical options. This study compared the effectiveness of single-dose sublingual misoprostol to manual vacuum aspiration in the treatment of incomplete spontaneous abortion in Enugu, Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 01/08/2014
Actual trial start date 01/08/2014
Anticipated date of last follow up 01/08/2015
Actual Last follow-up date 01/08/2015
Anticipated target sample size (number of participants) 212
Actual target sample size (number of participants) 203
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group immediate manual vacuum aspiration in the theater by trained medical practitioners once once Participants in the MVA group (B) were offered immediate manual vacuum aspiration in the theatre by trained medical practitioners, using standard procedure. After the procedure, each was observed for 2 hours then, discharged home on the analgesics and prophylactic antibiotics described above. Each was scheduled for a follow-up clinic visit after 1 week of treatment, during which they were evaluated by ultrasound scan for complete uterine evacuation. In the case of incomplete uterine evacuation, the protocol was a repeat uterine evacuation by MVA. 101 Active-Treatment of Control Group
Experimental Group sublingual misoprostol 400mcg Once Each participant in the misoprostol group was given 400mcg of misoprostol (Cytotec®) placed under their tongues for 30 minutes to enable the tablets to dissolve. They were observed for about 8 hours after the drug administration and allowed home. Each participant was given the mobile phone number of the principal investigator for the reporting of any side effects or complications. They were discharged on analgesics – oral ibuprofen 400mg twelve hourly for 5 days, and prophylactic antibiotics - oral amoxicillin/clavulanic acid 625mg 8 hourly, and metronidazole 400mg 8 hourly for 1 week. Follow-up at the gynaecology clinic visit was scheduled for each participant after one week. 102
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All consenting women at the study centres with first-trimester incomplete abortion, confirmed by a trans-abdominal ultrasound scan of the uterus, were eligible for the study Women with excessive vaginal bleeding, severe anaemia (Hb < 7.0g%), or suspected ectopic pregnancy were excluded from the study. A history of allergy to prostaglandins, Evidence of genital infection such as offensive vaginal discharge, uterine tenderness, and pyrexia. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 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 09/09/2020 Health Research Ethics Committee of the University of Nigeria Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
University of Nigeria Teaching Hospital, Enugu, Nigeria Enugu 1000006 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure was the incidence of complete uterine evacuation (complete abortion) after one week of treatment with single-dose sublingual misoprostol 400mcg or MVA. 1 WEEK
Secondary Outcome The secondary outcome measures included incidence, types, and tolerability of treatment side effects as well as participants’ satisfaction with the treatment received 0ne week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Nigeria Teaching Hospital Department of Obstetrics and Gynaecology, Enugu 100006 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded University of Nigeria Teaching Hospital Ituku/ Ozalla Enugu 100006 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Self University of Nigeria Teaching Hospital Ituku-Ozalla Enugu 100006 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Cyril Chukwudi Dim Institute of Maternal and Child Health, College of Medicine, University of Nigeria Ituku-Ozalla Campus. Enugu 100006 Nigeria
Joseph Tochukwu Enebe Enugu State University of Science and Technology, College of Medicine Enugu 100006 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Vincent Ani anivinc@yahoo.com +2347038943761 Departments of Obstetrics and Gynaecology, College of Health Sciences Nnamdi Azikiwe University Nnewi Campus
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria Consultantt
Role Name Email Phone Street address
Public Enquiries Cyril Chukwudi Dim cyril.dim@unn.edu.ng +2348033341960 Department of Obstetrics and Gynaecology College of Medicine University of Nigeria, Ituku-Ozalla
City Postal code Country Position/Affiliation
Enugu 100006 Nigeria Consultantt
Role Name Email Phone Street address
Scientific Enquiries Joseph Tochukwu Enebe drenebe2002@yahoo.co.uk +2348064065851 Enugu State University of Science and Technology College of Medicine
City Postal code Country Position/Affiliation
Enugu 100006 Nigeria Consultantt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Background: Incomplete abortion contributes significantly to maternal morbidity and mortality in developing countries. The constraints associated with accessing post-abortion care services with manual vacuum aspirator including the need for theatre space, sterile instruments, and skilled providers; call for the exploration of other effective, accessible, and acceptable non-surgical options. This study compared the effectiveness of single-dose sublingual misoprostol to manual vacuum aspiration in the treatment of incomplete spontaneous abortion in Enugu, Nigeria. Methods: A randomized controlled study of consenting women with sonologically confirmed, first-trimester incomplete spontaneous abortion at the University of Nigeria Teaching Hospital Enugu and Julius Memorial Specialist Hospital Enugu, Nigeria. Intervention group (n = 102) received single-dose sublingual misoprostol 400mcg while the control group (n = 101) received manual vacuum aspiration. Both groups were followed up for 1 week and assessed for complete abortion rate, treatment side effects, and satisfaction. Data analysis was descriptive and inferential at 95% confidence level. Results: Incidence of complete abortion was 86.3% for the misoprostol group and 100.0% for the control group, RR = 0.86, (CI 95%: 0.80 - 0.93), p <0.001. The most common side effect was abdominal pain with an incidence of 27.5% versus 48.55 for the misoprostol and control groups respectively (p = 0.002). Most participants in each group (81.1% versus 77.6%) considered the side effects as tolerable. The mean visual analogue scale score for maternal satisfaction was higher in the misoprostol group (86.7 ± 14.11) than the control group (81.36 ± 11.10), p < 0.001. Conclusions: The treatment of incomplete spontaneous abortion with single-dose sublingual misoprostol 400mcg produced a high rate of complete abortion among women in Enugu, Nigeria. Despite having a lower complete abortion rate, maternal satisfaction was higher when compared with women that had manual vacuum aspiration of the uterus. Informed Consent Form After publication Access to be granted on subtle request
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Result URL Hyperlinks Link To Protocol
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