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.: PACTR202306581858623 Date of Approval: 23/06/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A randomized control trial of elective induction at 40 weeks and 41 weeks to prevent prolonged pregnancy.
Official scientific title A randomized controlled trial of elective induction at 40 weeks and 41 weeks to prevent prolonged pregnancy.
Brief summary describing the background and objectives of the trial BACKGROUND: Prolonged pregnancy is a major cause of perinatal and maternal morbidity and mortality and also a source of significant anxiety to the pregnant woman and family. Data has shown that the lowest incidence of perinatal morbidity and mortality is between 39 and 40 weeks gestation. A policy of routine induction of labour at 40 weeks could further reduce perinatal mortality and morbidity without increasing maternal anxiety and cesarean section rate . OBJECTIVES: The overall objective of the study is to compare obstetrics and perinatal outcomes of induction of labour at 40 weeks versus 41 weeks in healthy woman with low risk singleton pregnancy.
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 induction of labour to prevent prolonged pregnancy
Purpose of the trial Prevention
Anticipated trial start date 19/06/2023
Actual trial start date
Anticipated date of last follow up 25/09/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 322
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 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 induction at 40 weeks 25 microgram 6 hours Pregnant women who met the inclusion criteria and who consented, will be recruited at 39 weeks . They will be randomized into two groups, A(40 weeks group) and B (41 weeks group) by blocked randomization using the random table, computer generated numbers in sealed opaque envelopes. Group allocation will be predetermined and placed in consecutively numbered and sealed opaque envelopes, all these numbered envelopes will be again kept in a box sequentially. Once a patient is deemed eligible at 39 weeks and has given informed consent for study. she will be assigned a sequential study number. Allocation of patients will start from the first sealed opaque envelop until the last pack will be completed sequentially. Using this method, equal numbers of participants will be assigned to each arm of the study .The primary investigator will be responsible for maintaining the sequence of the envelopes, but not directly involved in patient care. Participants in group A (40 weeks arm) will have a preliminary non-stress test to assess fetal condition and then a vaginal examination performed at hospital admission at 40 weeks to determine the Bishop’s score. Oxytocin was not commenced until 6hrs after the last dose of misoprostol was passed. Artificial rupture of membranes was performed when the cervical dilation was≥4 cm and presenting part had been applied to the cervix. Labour was monitored with the aid of a partograph. Oxytocin administration was commenced in subjects with favourable cervical scores (Bishop’s score ≥6) who had not developed active phase labour. Oxytocin was delivered using gravity method. Oxytocin infusion was started at 2 and 4 mIU/min and increased by 2 and 4 mIU/min at 30-min interval in multiparas and nulliparas respectively until adequate uterine contractions(three to five contractions in ten minutes, each lasting for 40-60 seconds) were achieved. The maximum oxytocin infusion rate was 32 mIU/min. For patients who developed spontaneous labour, 161
Control Group induction at 41 weeks 25 microgram 6 hours Pregnant women who met the inclusion criteria and who consented, will be recruited at 39 weeks . They will be randomized into two groups, A(40 weeks group) and B (41 weeks group) by blocked randomization using the random table, computer generated numbers in sealed opaque envelopes. Group allocation will be predetermined and placed in consecutively numbered and sealed opaque envelopes, all these numbered envelopes will be again kept in a box sequentially. Once a patient is deemed eligible at 39 weeks and has given informed consent for study. she will be assigned a sequential study number. Allocation of patients will start from the first sealed opaque envelop until the last pack will be completed sequentially. Using this method, equal numbers of participants will be assigned to each arm of the study .The primary investigator will be responsible for maintaining the sequence of the envelopes, but not directly involved in patient care. Participants in the B group ( 41 weeks arm) will have a biophysical profile and a scheduled visit weekly . They will be admitted at 41 weeks after a preliminary non- stress test and vaginal examination performed. Oxytocin was not commenced until 6hrs after the last dose of misoprostol was passed. Artificial rupture of membranes was performed when the cervical dilation was≥4 cm and presenting part had been applied to the cervix. Labour was monitored with the aid of a partograph. Oxytocin administration was commenced in subjects with favourable cervical scores (Bishop’s score ≥6) who had not developed active phase labour. Oxytocin was delivered using gravity method. Oxytocin infusion was started at 2 and 4 mIU/min and increased by 2 and 4 mIU/min at 30-min interval in multiparas and nulliparas respectively until adequate uterine contractions(three to five contractions in ten minutes, each lasting for 40-60 seconds) were achieved. The maximum oxytocin infusion rate was 32 mIU/min. For patients who developed spontaneous labour, the need for 161 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Singleton pregnancies 2. Cephalic fetal presentation 3. Gestational age of 40 weeks to 41 weeks and 3 days gestation from the first day of the last menstrual period and ultrasound biometry before the 12th week of gestation. 4. Patients who gave consent to participate in the study. 5. Parity of ≤ to 4. 1. Multiple gestations. 2. Non cephalic presentation 3. Intrauterine fetal death. 4. Previous caesarean section scar. 5. Multiparous of 5 and above 6. Medical conditions in pregnancy e.g hypertension, diabetes mellitus and sickle cell anemia. 7. Pregnancies with fetuses having ultrasound diagnosed congenital abnormalities. 8. Women who had no early ultrasound scan report before 12th weeks 9. Women who declined consent. Adult: 19 Year-44 Year 18 Year(s) 49 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 08/11/2022 Human Research and Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Federal Teaching Hospital P.M.B. 201 , Ido- Ekiti Ekiti State. Ido -Ekiti. 371101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome caesarean section rate at delivery
Secondary Outcome Maternal outcomes included vaginal delivery rate, maternal satisfaction, and genital tract laceration. Fetal outcomes included : incidence of macrosomia , birth trauma, meconium staining of amniotic fluid, neonatal intensive care unit admission, APGAR score at 1 and 5 minutes and perinatal death. at delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre Ifaki - Ido Road Ido Ekiti Ekiti State Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
MYSELF Onala St, B Zone ,Adehun Ado Ekiti 362001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor IPINNIMO OLUWADARE MARTINS Onala St, B Zone ,Adehun Ado Ekiti 362001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
DR ADULOJU OLUSOLA PETER EKITI STATE UNIVERSITY TEACHING HOSPITAL ADO EKITI 362001 Nigeria
DR ADE OJO IDOWU PIUS EKITI STATE UNIVERSITY TEACHING HOSPITAL ADO EKITI 362001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator OLUWADARE MARTINS IPINNIMO stilldrdre2000@yahoo.com +2348033748593 Onala St, B Zone, Adehun
City Postal code Country Position/Affiliation
ADO EKITI 362001 Nigeria consultant
Role Name Email Phone Street address
Public Enquiries OLUWADARE MARTINS IPINNIMO stilldrdre2000@yahoo.com +2348033748593 Onala St, B Zone, Adehun
City Postal code Country Position/Affiliation
Ado Ekiti 362001 Nigeria consultant
Role Name Email Phone Street address
Scientific Enquiries OLUWADARE MARTINS IPINNIMO stilldrdre2000@yahoo.com +2348033748593 Onala St, B Zone, Adehun
City Postal code Country Position/Affiliation
Ado Ekiti 362001 Nigeria consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data collected during the trial period will be shared after deidentification in batches of 20 within 1 year of study completion. This will include the informed consent form and statistical analysis plan. IPD that makes my summarized result or a link to summary result will be available to anyone who wish to access the data within one year of study completion. Informed Consent Form,Statistical Analysis Plan This sharing will be done within 1 year of study completion Anyone who wish to access the data
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