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.: PACTR202401578504771 Date of Approval: 23/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title ORAL VERSUS VAGINAL MISOPROSTOL FOR INDUCTION OF LABOUR IN UNIVERSITY OF MAIDUGURI TEACHING HOSPITAL. A RANDOMISED CONTROLLED TRIAL
Official scientific title ORAL VERSUS VAGINAL MISOPROSTOL FOR INDUCTION OF LABOUR IN UNIVERSITY OF MAIDUGURI TEACHING HOSPITAL. A RANDOMISED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial Background: Misoprostol is a pharmacologic agent of choice use for induction of labour in low resource setting. It is cheap, available and stable at room temperature.Route of administration of Misoprostol are buccal, oral, rectal, or vaginal. The risks associated with induction of labour using misoprostol are fetal distress, tachysystole, hypertonus, hyperstimulation syndrome, caesarean section and uterine rupture.These risks are dose and route of administration dependent. Objective: To determine the effectiveness, safety and maternal satisfaction of equal low dose 25-μg of oral versus vaginal misoprostol for induction of labour at term.
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: Drugs
Anticipated trial start date 27/04/2022
Actual trial start date 28/04/2022
Anticipated date of last follow up 28/10/2022
Actual Last follow-up date 28/10/2022
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 Oral misoprostol for induction of labour 25 microgram of oral misoprostol 4 hourly maximium of 24 hours Oral route (group A) All eligible participants will receive 25-ᶙg (1 tablet) of oral misoprostol 4 hourly (Angusta, Danish pharmaceutical company) for a maximum of 24 hours. The participant will be given one tablet containing 25-ᶙg of misoprostol to swallow with a sip of water(50-100mls), under direct observation by the researcher or research assistants Participants will rest for 30 minutes after receiving misoprostol during which the fetal wellbeing will be monitored with aid of pinnard stethoscope. Maternal observations like temperature, pulse rate, blood pressure, respiratory rate and uterine contractions will be assessed. Thirty minutes after receiving misoprostol, patient will be asked some questions about side effects of misoprostol,fetal heart rate and maternal vital signs will be checked. A subsequent dose of misoprostol will be administered when adequate uterine contractions have not been achieved or 24 hours after administration of the first dose of misoprostol have not elapse. If adequate uterine contraction (at least 3 contractions in 10 minutes) failed to occur 4 hours from the last dose of misoprostol, patient will be re-evaluated for possible repeat course of misoprostol or recourse to oxytocin or emergency Caesarean section will be carried out. Other reasons for Caesarean section will be based on other standard obstetric indications. Progress of labour in the both groups will be monitored closely and documented clearly. Active management of labour will be carried out for both groups. Artificial rupture of membranes will be performed for all women who are found to be in active phase of labour.External electronic fetal monitoring will be done for all foetuses with meconium-stained liquor or those with suspected abnormal fetal heart rate pattern with pinnard stethoscope. Participants who have reached active phase of labour, but develop inadequate uterine contractions will undergo oxytocin augmentation. Partograph will be used to monitor 50
Control Group vaginal misoprostol 25 microgram of Misoprostol 4 hourly for a maximium of 24 hours Vaginal route (group B) All the eligible participants will receive 25-ᶙg (1 tablet) of vaginal misoprostol 4 hourly (Angusta, Danish pharmaceutical company) for a maximum of 24 hours. The participant will be placed in dorsal lithotomy position, vulva cleaned with cotton wool soaked in diluted chlorhexidine solution, 25-ᶙg misoprostol tablet will be placed intravaginally, into the posterior fornix of the vagina by the researcher or research assistant. Participants in both groups will rest for 30 minutes after receiving misoprostol during which the fetal wellbeing will be monitored with aid of pinnard stethoscope. Maternal observations like temperature, pulse rate, blood pressure, respiratory rate and uterine contractions will be assessed. Thirty minutes after receiving misoprostol, patient will be asked some questions about side effects of misoprostol,fetal heart rate and maternal vital signs will be checked. A subsequent dose of misoprostol will be administered when adequate uterine contractions have not been achieved or 24 hours after administration of the first dose of misoprostol have not elapse. If adequate uterine contraction (at least 3 contractions in 10 minutes) failed to occur 4 hours from the last dose of misoprostol, patient will be re-evaluated for possible repeat course of misoprostol or recourse to oxytocin or emergency Caesarean section will be carried out. Other reasons for Caesarean section will be based on other standard obstetric indications. Progress of labour in the both groups will be monitored closely and documented clearly. Active management of labour will be carried out for both groups. Artificial rupture of membranes will be performed for all women who are found to be in active phase of labour.External electronic fetal monitoring will be done for all foetuses with meconium-stained liquor or those with suspected abnormal fetal heart rate pattern with pinnard stethoscope. Participants who have reached active phase of labour, but develop ina 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The following inclusion criteria will be applied: 1) All booked pregnant women who are planned for induction of labour at term with singleton pregnancy presenting cephalic and with favourable cervix (Bishop score of ≥6). 2) Patients that are informed, counseled, and consented to participate in the study. 3) Patients that is para 0 to 4. 4) No known contraindications to misoprostol The following criterial will be excluded 1) Previous uterine scar and/or malpresentation 2) Antepartum heamorrhage. 3) Patients with intrauterine fetal death, HIV, active hepatitis B infection 4) Patients refusal to consent Adult: 19 Year-44 Year 19 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 04/01/2022 University of Maiduguri Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Bama road, maiduguri Maiduguri 600104 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome will be incidence of vaginal delivery in both arms after delivery of the baby
Secondary Outcome secondary outcomes will be induction-delivery interval, fetal heart abnormalities (tachycardia, bradycardia), maternal satisfaction, adverse effects of misoprostol fever, shivering, nausea, vomiting, and diarrhoea, Apgar score at fifth minute, and number of caesarean sections in both arms. during and after the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Maiduguri Teaching Hospital Borno state Nigeria Bama Maiduguri 600104 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
my monthly salary University of Maiduguri Teaching Hospital Quaters Maiduguri 600104 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Maduka Chike Joachim University of Maiduguri Teaching Hospital Maiduguri 600104 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Maduka Chike Joachim akinjoe83@gmail.com 08037830703 University of Maiduguri Teaching Hospital Quarters
City Postal code Country Position/Affiliation
Maiduguri 600104 Nigeria Senior registra
Role Name Email Phone Street address
Public Enquiries Ihefobi Angela Chikaodili akinjoe83@gmail.com 08104351088 University of Maiduguri Teaching Hospital, Bama Road
City Postal code Country Position/Affiliation
Maiduguri 600104 Nigeria Nurse
Role Name Email Phone Street address
Scientific Enquiries Chinda GershonWali chindagwali@gmail.com 07044462882 Lagos street
City Postal code Country Position/Affiliation
Maiduguri 600104 Nigeria Resident doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data that would be shared is for individual participant data that underlie the results obtained from the trial. the data will be made available immediately after publication. the data would be available for any researcher who wishes to access it. the data could be used for individual participant meta-analysis. the link to access for the data would be made available after publication Informed Consent Form,Statistical Analysis Plan,Study Protocol 1 year open access
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