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.: PACTR202208496861650 Date of Approval: 11/08/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative study of labor induction by Misoprostol on maternal and perinatal prognosis
Official scientific title Efficacy and Safety of Labor Induction by Oral versus Vaginal Misoprostol: A Randomized Controlled Clinical Trial
Brief summary describing the background and objectives of the trial Labor induction is a common practice in developed countries. However, in developing countries, its prevalence is low. The objectives of this study is to compare the efficacy and safeties of 50 µg of Misoprostol administered orally versus 50 µg of Misoprostol administered vaginally every six hours for labor induction on a term pregnancy in under-equipped health structures, and assess the maternal and perinatal prognosis.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) ESLIOvVM
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/09/2022
Actual trial start date
Anticipated date of last follow up 31/01/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 177
Actual target sample size (number of participants)
Recruitment status 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
Crossover: all participants receive all interventions in different sequence during study Randomised Dynamic (adaptive) random allocation such as minimization Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Oral Misoprostol Three doses of 50 microgram of Misoprostol To repeat 50 Microgram every six hours After evaluation of the socio-demographic and clinical parameters, 50µg of Misoprostol will be administered orally with a cup of water every six hours until effective uterine contractions will be obtained, without exceeding three doses. Drug administration will be stopped when the patient reached three uterine contractions per ten minutes or four centimeters cervical dilation. 89
Control Group Vaginal Misoprostol Three doses of 50 microgram of Misoprostol Every six hours After evaluation of the socio-demographic and clinical parameters, 50µg of Misoprostol will be administered vaginally in the posterior fornix every six hours until effective uterine contractions will be obtained, without exceeding three doses. Drug administration will be stopped when the patient reached three uterine contractions per ten minutes or four centimeters cervical dilation. 88 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Nulliparous and multiparous, followed prenatal counselling in one of the selected structures, term pregnancy, one fetus, fetal heart sounds within the norms (110-160 beats per minute) and cephalic presentation Women who have already given birth more than 5 times, pregnant women with twin or multiple pregnancies, gravid hypertension, preeclampsia, gestational diabetes or chronic unbalanced diabetes, uterine height greater than 36 cm presentation other than cephalic, fetal heart rhythm disorders before induction, placenta previa, pregnancy on fibromyomatous uterus, petal-pelvic disproportion, pelvic anomalies, fetal death. Adult: 19 Year-44 Year 19 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 10/09/2020 ethics committee of research of Kisangani University
Ethics Committee Address
Street address City Postal code Country
Makiso/Kisangani Kisangani 2012 Zaire
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 08/08/2022 Ethics committee of research of Kisangani University
Ethics Committee Address
Street address City Postal code Country
Makiso Kisangani 2012 Zaire
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcomes were the effectiveness of Misoprostol in inducing uterine contractions by both routes When uterine contractions appear to delivery
Secondary Outcome Secondary outcomes were the safety of the route of administration as well as its assessment elements which were time to first uterine contractions compared to the first dose, duration of labor and rate of vaginal delivery, the maternal prognosis: hyperkinesia, hypertonia, prerupture or uterine rupture, cesarean section rate, postpartum hemorrhage, fever, chills, nausea, vomiting, diarrhea, and perinatal prognosis: fetal distress, meconium staining of amniotic fluid, Apgar score at the first, fifth and tenth minute, need and duration of resuscitation, perinatal mortality. During labor and postpartum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cliniques Universitaires de Kisangani Makiso Kisangani 2012 Zaire
FUNDING SOURCES
Name of source Street address City Postal code Country
Matega Habiragi Teddy Makiso Kisangani Zaire
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Matega Habiragi Makiso Kisangani Zaire Individual
COLLABORATORS
Name Street address City Postal code Country
Katenga Bosunga Makiso Kisangani Zaire
Juakali Sihalikyolo Makiso Kisangani Zaire
Maindo Alongo Makiso Kisangani Zaire
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Matega Habiragi teddymatega@gmail.com +243990798344 Makiso
City Postal code Country Position/Affiliation
Kisangani Zaire Resident gynecology and obstetrics Kisangani University
Role Name Email Phone Street address
Public Enquiries Maindo Alongo maindo21@gmail.com +243851970360 Makiso
City Postal code Country Position/Affiliation
Kisangani Zaire Gynecologist and Obstetrician Kisangani University
Role Name Email Phone Street address
Scientific Enquiries Juakali Sihalikyolo drjuakali@gmail.com +243998505796 Makiso
City Postal code Country Position/Affiliation
Kisangani Zaire Professor gynecologist and obstetrician Kisangani University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I declare on honor to share the results obtained in scientific reviews and conferences Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol One year gynecologist and obstetrician
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